Damian McNamara, MA

More children and preteens are taking melatonin to help them sleep, a new study found, while experts cautioned parents may be unaware of some risks, particularly with long-term use. 

The investigators noted not all melatonin supplements contain what they say they do – some tested in a separate study contained two to three times the amount of melatonin on the label, and one supplement contained none at all.
 

A matter of timing?

While not completely advising against the sleep supplement, the study researchers pointed out that short-term use is likely safer. 

“We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long term,” lead study author Lauren Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado in Boulder, said in a news release.

“If, after weighing potential risks and benefits, melatonin is recommended as the appropriate treatment, [a sleep medicine specialist] can recommend a dose and timing to treat the sleep issue,” said Raj Bhui, MD, a sleep medicine specialist and American Academy of Sleep Medicine spokesperson, who was not involved in the study.
 

An increasing trend

From 2017 to 2018, only about 1.3% of parents reported their children used melatonin in national data looking at supplement use in children and teenagers. In fact, usage more than doubled in this younger population from 2017 to 2020, another study revealed. “All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” Dr. Hartstein said.

She and colleagues surveyed the parents of 993 children, aged 1 to less than 14, from January to April 2023. They found about 20% of these school-aged children and preteens took melatonin as a sleep aid. The findings, published in the journal JAMA Pediatrics, also suggest that some parents routinely give their preschool children melatonin.

They found nearly 6% of preschoolers aged 1-4, 18.5% of children aged 5-9, and 19.4% of kids aged 10-13 had taken melatonin in the previous month. 

The researchers also discovered that many took melatonin for longer than a few nights. Preschool children took the supplement for a median of 1 year, grade school children for a median 18 months, and preteens for 21 months. 
 

What’s in your supplement? 

In a different study published April 25 (JAMA. 2023. doi: 10.1001/jama.2023.2296), researchers looked at 25 melatonin gummy products and found that 22 of them contained different amounts of melatonin than listed on the label. In fact, one called Sleep Plus Immune contained more than three times the amount, and with a supplement called Sleep Support, researchers could not detect any melatonin. 

There is a general misconception that supplements are natural and therefore safe, Dr. Bhui said. “Multiple investigations of commercially available supplements have shown we cannot assume that what is on the label is in the pill or that what is in the pill is disclosed on the label. Formal laboratory testing has revealed some supplements to be adulterated with unapproved pharmaceutical ingredients, contaminated with microbes, or even tainted with toxins like arsenic, lead, and mercury.”

Choosing a product with the “USP Verified Mark” may give parents some comfort regarding melatonin content and consistency with labeling, Dr. Bhui said. Taking steps to safeguard the supply at home is also important in making sure children don’t take the supplements by accident. “With the increased use of melatonin, this has been a growing problem.”

A version of this article first appeared on WebMD.com.

More children and preteens are taking melatonin to help them sleep, a new study found, while experts cautioned parents may be unaware of some risks, particularly with long-term use. 

The investigators noted not all melatonin supplements contain what they say they do – some tested in a separate study contained two to three times the amount of melatonin on the label, and one supplement contained none at all.
 

A matter of timing?

While not completely advising against the sleep supplement, the study researchers pointed out that short-term use is likely safer. 

“We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long term,” lead study author Lauren Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado in Boulder, said in a news release.

“If, after weighing potential risks and benefits, melatonin is recommended as the appropriate treatment, [a sleep medicine specialist] can recommend a dose and timing to treat the sleep issue,” said Raj Bhui, MD, a sleep medicine specialist and American Academy of Sleep Medicine spokesperson, who was not involved in the study.
 

An increasing trend

From 2017 to 2018, only about 1.3% of parents reported their children used melatonin in national data looking at supplement use in children and teenagers. In fact, usage more than doubled in this younger population from 2017 to 2020, another study revealed. “All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” Dr. Hartstein said.

She and colleagues surveyed the parents of 993 children, aged 1 to less than 14, from January to April 2023. They found about 20% of these school-aged children and preteens took melatonin as a sleep aid. The findings, published in the journal JAMA Pediatrics, also suggest that some parents routinely give their preschool children melatonin.

They found nearly 6% of preschoolers aged 1-4, 18.5% of children aged 5-9, and 19.4% of kids aged 10-13 had taken melatonin in the previous month. 

The researchers also discovered that many took melatonin for longer than a few nights. Preschool children took the supplement for a median of 1 year, grade school children for a median 18 months, and preteens for 21 months. 
 

What’s in your supplement? 

In a different study published April 25 (JAMA. 2023. doi: 10.1001/jama.2023.2296), researchers looked at 25 melatonin gummy products and found that 22 of them contained different amounts of melatonin than listed on the label. In fact, one called Sleep Plus Immune contained more than three times the amount, and with a supplement called Sleep Support, researchers could not detect any melatonin. 

There is a general misconception that supplements are natural and therefore safe, Dr. Bhui said. “Multiple investigations of commercially available supplements have shown we cannot assume that what is on the label is in the pill or that what is in the pill is disclosed on the label. Formal laboratory testing has revealed some supplements to be adulterated with unapproved pharmaceutical ingredients, contaminated with microbes, or even tainted with toxins like arsenic, lead, and mercury.”

Choosing a product with the “USP Verified Mark” may give parents some comfort regarding melatonin content and consistency with labeling, Dr. Bhui said. Taking steps to safeguard the supply at home is also important in making sure children don’t take the supplements by accident. “With the increased use of melatonin, this has been a growing problem.”

A version of this article first appeared on WebMD.com.

More children and preteens are taking melatonin to help them sleep, a new study found, while experts cautioned parents may be unaware of some risks, particularly with long-term use. 

The investigators noted not all melatonin supplements contain what they say they do – some tested in a separate study contained two to three times the amount of melatonin on the label, and one supplement contained none at all.
 

A matter of timing?

While not completely advising against the sleep supplement, the study researchers pointed out that short-term use is likely safer. 

“We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long term,” lead study author Lauren Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado in Boulder, said in a news release.

“If, after weighing potential risks and benefits, melatonin is recommended as the appropriate treatment, [a sleep medicine specialist] can recommend a dose and timing to treat the sleep issue,” said Raj Bhui, MD, a sleep medicine specialist and American Academy of Sleep Medicine spokesperson, who was not involved in the study.
 

An increasing trend

From 2017 to 2018, only about 1.3% of parents reported their children used melatonin in national data looking at supplement use in children and teenagers. In fact, usage more than doubled in this younger population from 2017 to 2020, another study revealed. “All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” Dr. Hartstein said.

She and colleagues surveyed the parents of 993 children, aged 1 to less than 14, from January to April 2023. They found about 20% of these school-aged children and preteens took melatonin as a sleep aid. The findings, published in the journal JAMA Pediatrics, also suggest that some parents routinely give their preschool children melatonin.

They found nearly 6% of preschoolers aged 1-4, 18.5% of children aged 5-9, and 19.4% of kids aged 10-13 had taken melatonin in the previous month. 

The researchers also discovered that many took melatonin for longer than a few nights. Preschool children took the supplement for a median of 1 year, grade school children for a median 18 months, and preteens for 21 months. 
 

What’s in your supplement? 

In a different study published April 25 (JAMA. 2023. doi: 10.1001/jama.2023.2296), researchers looked at 25 melatonin gummy products and found that 22 of them contained different amounts of melatonin than listed on the label. In fact, one called Sleep Plus Immune contained more than three times the amount, and with a supplement called Sleep Support, researchers could not detect any melatonin. 

There is a general misconception that supplements are natural and therefore safe, Dr. Bhui said. “Multiple investigations of commercially available supplements have shown we cannot assume that what is on the label is in the pill or that what is in the pill is disclosed on the label. Formal laboratory testing has revealed some supplements to be adulterated with unapproved pharmaceutical ingredients, contaminated with microbes, or even tainted with toxins like arsenic, lead, and mercury.”

Choosing a product with the “USP Verified Mark” may give parents some comfort regarding melatonin content and consistency with labeling, Dr. Bhui said. Taking steps to safeguard the supply at home is also important in making sure children don’t take the supplements by accident. “With the increased use of melatonin, this has been a growing problem.”

A version of this article first appeared on WebMD.com.

Can green tea lower your risk of colorectal cancer? It depends on who – and what research – you believe. 

Evidence that links green tea and a lower risk of colorectal cancer goes both ways. Some researchers have found little or no significant risk from drinking the popular tea, while others point to a potential benefit. Now add two more studies – one that found no reduced risk and another that seems to strengthen the link between green tea and a lower risk of colon cancer. 

Randomized controlled trials – where some people get randomly assigned to drink green tea and others do not – are considered the gold standard of medical research. Combine the findings from several of these trials, the thinking goes, and the findings get even stronger. 

Combining random trials so far shows no advantage from green tea. But there may still be a benefit, said lead researcher Vishal Chandel, MD, who is affiliated with Suburban Community Hospital in Norristown, Pa. It could be that there are just not enough randomized controlled trials yet to show green tea has a protective effect.

“Many, many factors contribute to colorectal cancer, and one of them is diet. One thing which struck me was tea, because tea is something that people consume all over the world, and it has shown some stronger effects in Japan and in China,” said Dr. Chandel. 
 

Comparing hundreds of people 

Dr. Chandel and colleagues found three randomized controlled trials that looked at the link between green tea and colorectal cancer risk. Combined, the data included 451 people with colorectal cancer and 460 others without cancer who made up a control, or comparison, group. 

They found green tea consumption did not reduce the risk of colorectal cancer in a statically significant way. 

“There are only three randomized controlled trials from anywhere concerning green tea and colon cancer,” Dr. Chandel said. “We really need more. If we had 7, 8, or 10 … I’m very positive we will have a much stronger association to say that green tea can have a positive effect.”
 

Comparing thousands of people 

Dr. Chandel and colleagues also performed another study where they looked at less rigorous evidence – 10 cohort studies and 15 prospective case-control studies. These studies included 198,488 cancer cases and 581,556 controls. This time, they found a stronger link between green tea and a reduced risk of colorectal cancer. 

The “meta-analysis results indicate a lower tendency to develop colorectal cancer with green tea consumption, with reduced risk of colorectal cancer more pronounced in Asia than America or Europe,” the authors note. “Although there is insufficient epidemiological data to conclude at present that green tea can have protective effects in human beings.”

Dr. Chandel presented the findings of both studies in Vancouver at the American College of Gastroenterology annual scientific meeting.
 

Why green tea?

Dr. Chandel said he studied colorectal cancer because it is the third most diagnosed cancer worldwide, accounting for about 10% of all new cancer cases in 2020, according to the World Health Organization’s Global Cancer Observatory data. It is also a common cause of cancer death globally, second only to lung cancer. 

Green tea contains high level of polyphenols known as catechins. The main catechin in green tea believed to provide cancer protective effects is epigallocatechin-3 gallate (EGCG). EGCG “has been shown in some studies to inhibit or prevent colon cancer,” Dr. Chandel said. 

EGCG is present in higher amounts in green tea, compared with black or oolong tea, because green tea is made from unfermented, unoxidized tea leaves.
 

Difficult to read the tea leaves

These studies “add to the literature, which remains undefined regarding the role of green tea in reducing the risk of colorectal cancer,” Catherine Eng, MD, a spokesperson for the American Society of Clinical Oncology, said when asked to comment.

Although combining three trials did not reveal a significant benefit, looking at a greater number of studies did in some populations, said Dr. Eng, codirector of gastrointestinal oncology and chair of surgical and medical oncology at Vanderbilt-Ingram Cancer Center in Nashville. 

“Potential benefit for green tea in reducing the risk of colorectal cancer was noted in the Asian cases but was not found to be statistically significant in the European or U.S. studies,” she said. “Currently, the role of dietary consumption of green tea on reducing the risk of colorectal cancer is not well established and requires further investigation.”

A version of this article appeared on WebMD.com.

Can green tea lower your risk of colorectal cancer? It depends on who – and what research – you believe. 

Evidence that links green tea and a lower risk of colorectal cancer goes both ways. Some researchers have found little or no significant risk from drinking the popular tea, while others point to a potential benefit. Now add two more studies – one that found no reduced risk and another that seems to strengthen the link between green tea and a lower risk of colon cancer. 

Randomized controlled trials – where some people get randomly assigned to drink green tea and others do not – are considered the gold standard of medical research. Combine the findings from several of these trials, the thinking goes, and the findings get even stronger. 

Combining random trials so far shows no advantage from green tea. But there may still be a benefit, said lead researcher Vishal Chandel, MD, who is affiliated with Suburban Community Hospital in Norristown, Pa. It could be that there are just not enough randomized controlled trials yet to show green tea has a protective effect.

“Many, many factors contribute to colorectal cancer, and one of them is diet. One thing which struck me was tea, because tea is something that people consume all over the world, and it has shown some stronger effects in Japan and in China,” said Dr. Chandel. 
 

Comparing hundreds of people 

Dr. Chandel and colleagues found three randomized controlled trials that looked at the link between green tea and colorectal cancer risk. Combined, the data included 451 people with colorectal cancer and 460 others without cancer who made up a control, or comparison, group. 

They found green tea consumption did not reduce the risk of colorectal cancer in a statically significant way. 

“There are only three randomized controlled trials from anywhere concerning green tea and colon cancer,” Dr. Chandel said. “We really need more. If we had 7, 8, or 10 … I’m very positive we will have a much stronger association to say that green tea can have a positive effect.”
 

Comparing thousands of people 

Dr. Chandel and colleagues also performed another study where they looked at less rigorous evidence – 10 cohort studies and 15 prospective case-control studies. These studies included 198,488 cancer cases and 581,556 controls. This time, they found a stronger link between green tea and a reduced risk of colorectal cancer. 

The “meta-analysis results indicate a lower tendency to develop colorectal cancer with green tea consumption, with reduced risk of colorectal cancer more pronounced in Asia than America or Europe,” the authors note. “Although there is insufficient epidemiological data to conclude at present that green tea can have protective effects in human beings.”

Dr. Chandel presented the findings of both studies in Vancouver at the American College of Gastroenterology annual scientific meeting.
 

Why green tea?

Dr. Chandel said he studied colorectal cancer because it is the third most diagnosed cancer worldwide, accounting for about 10% of all new cancer cases in 2020, according to the World Health Organization’s Global Cancer Observatory data. It is also a common cause of cancer death globally, second only to lung cancer. 

Green tea contains high level of polyphenols known as catechins. The main catechin in green tea believed to provide cancer protective effects is epigallocatechin-3 gallate (EGCG). EGCG “has been shown in some studies to inhibit or prevent colon cancer,” Dr. Chandel said. 

EGCG is present in higher amounts in green tea, compared with black or oolong tea, because green tea is made from unfermented, unoxidized tea leaves.
 

Difficult to read the tea leaves

These studies “add to the literature, which remains undefined regarding the role of green tea in reducing the risk of colorectal cancer,” Catherine Eng, MD, a spokesperson for the American Society of Clinical Oncology, said when asked to comment.

Although combining three trials did not reveal a significant benefit, looking at a greater number of studies did in some populations, said Dr. Eng, codirector of gastrointestinal oncology and chair of surgical and medical oncology at Vanderbilt-Ingram Cancer Center in Nashville. 

“Potential benefit for green tea in reducing the risk of colorectal cancer was noted in the Asian cases but was not found to be statistically significant in the European or U.S. studies,” she said. “Currently, the role of dietary consumption of green tea on reducing the risk of colorectal cancer is not well established and requires further investigation.”

A version of this article appeared on WebMD.com.

Can green tea lower your risk of colorectal cancer? It depends on who – and what research – you believe. 

Evidence that links green tea and a lower risk of colorectal cancer goes both ways. Some researchers have found little or no significant risk from drinking the popular tea, while others point to a potential benefit. Now add two more studies – one that found no reduced risk and another that seems to strengthen the link between green tea and a lower risk of colon cancer. 

Randomized controlled trials – where some people get randomly assigned to drink green tea and others do not – are considered the gold standard of medical research. Combine the findings from several of these trials, the thinking goes, and the findings get even stronger. 

Combining random trials so far shows no advantage from green tea. But there may still be a benefit, said lead researcher Vishal Chandel, MD, who is affiliated with Suburban Community Hospital in Norristown, Pa. It could be that there are just not enough randomized controlled trials yet to show green tea has a protective effect.

“Many, many factors contribute to colorectal cancer, and one of them is diet. One thing which struck me was tea, because tea is something that people consume all over the world, and it has shown some stronger effects in Japan and in China,” said Dr. Chandel. 
 

Comparing hundreds of people 

Dr. Chandel and colleagues found three randomized controlled trials that looked at the link between green tea and colorectal cancer risk. Combined, the data included 451 people with colorectal cancer and 460 others without cancer who made up a control, or comparison, group. 

They found green tea consumption did not reduce the risk of colorectal cancer in a statically significant way. 

“There are only three randomized controlled trials from anywhere concerning green tea and colon cancer,” Dr. Chandel said. “We really need more. If we had 7, 8, or 10 … I’m very positive we will have a much stronger association to say that green tea can have a positive effect.”
 

Comparing thousands of people 

Dr. Chandel and colleagues also performed another study where they looked at less rigorous evidence – 10 cohort studies and 15 prospective case-control studies. These studies included 198,488 cancer cases and 581,556 controls. This time, they found a stronger link between green tea and a reduced risk of colorectal cancer. 

The “meta-analysis results indicate a lower tendency to develop colorectal cancer with green tea consumption, with reduced risk of colorectal cancer more pronounced in Asia than America or Europe,” the authors note. “Although there is insufficient epidemiological data to conclude at present that green tea can have protective effects in human beings.”

Dr. Chandel presented the findings of both studies in Vancouver at the American College of Gastroenterology annual scientific meeting.
 

Why green tea?

Dr. Chandel said he studied colorectal cancer because it is the third most diagnosed cancer worldwide, accounting for about 10% of all new cancer cases in 2020, according to the World Health Organization’s Global Cancer Observatory data. It is also a common cause of cancer death globally, second only to lung cancer. 

Green tea contains high level of polyphenols known as catechins. The main catechin in green tea believed to provide cancer protective effects is epigallocatechin-3 gallate (EGCG). EGCG “has been shown in some studies to inhibit or prevent colon cancer,” Dr. Chandel said. 

EGCG is present in higher amounts in green tea, compared with black or oolong tea, because green tea is made from unfermented, unoxidized tea leaves.
 

Difficult to read the tea leaves

These studies “add to the literature, which remains undefined regarding the role of green tea in reducing the risk of colorectal cancer,” Catherine Eng, MD, a spokesperson for the American Society of Clinical Oncology, said when asked to comment.

Although combining three trials did not reveal a significant benefit, looking at a greater number of studies did in some populations, said Dr. Eng, codirector of gastrointestinal oncology and chair of surgical and medical oncology at Vanderbilt-Ingram Cancer Center in Nashville. 

“Potential benefit for green tea in reducing the risk of colorectal cancer was noted in the Asian cases but was not found to be statistically significant in the European or U.S. studies,” she said. “Currently, the role of dietary consumption of green tea on reducing the risk of colorectal cancer is not well established and requires further investigation.”

A version of this article appeared on WebMD.com.

The 10 best-selling liver health supplements on Amazon bring in an estimated $2.5 million each month. But none of them contain ingredients recommended by major groups of doctors who treat liver issues in the United States or Europe.

Like many supplements, popular online liver products are unregulated, meaning they do not have to meet the same safety and effectiveness standards as prescription medications. 

Sales of liver supplements are growing, particularly in the last few years, said Ahmed Eltelbany, MD, MPH, a first-year gastrointestinal fellow at the University of New Mexico. One reason could be increased alcohol use during the COVID-19 pandemic.

Some manufacturers make bold claims on Amazon, said Dr. Eltelbany, author of a study that looked into the supplements. “The most recurrent claims were that their supplements maintain normal liver function, are scientifically formulated, and – my personal favorite – are a highly effective liver detox formulation developed according to the latest scientific findings.”

While these claims might sound reassuring and scientifically grounded to an average consumer, he said, most of them are not backed up by rigorous clinical research.
 

Does natural mean safe?

Many supplements are marketed as “liver cleansing,” for “liver detox,” or for “liver support,” Dr. Eltelbany said as he presented the study results at the annual meeting of the American College of Gastroenterology. 

“People take these supplements because they believe they’re natural and therefore they’re safe,” said Paul Y. Kwo, MD, who moderated a session on the study at the meeting, when asked to comment. “As I tell every patient in clinic, a great white shark is natural, a scorpion is natural, and so is a hurricane. So just because they’re natural doesn’t mean they’re safe.”

At the same time, “it’s not that every supplement is bad for you. Nonetheless, there’s just a dizzying array of these out there” said Dr. Kwo, a professor of medicine at Stanford Medicine in Redwood, Calif.

“We have to be very cautious,” he said. For example, some people might believe that “if a little bit of a supplement is good, a tremendous amount must be really good.” The antioxidant turmeric, for example, has a pretty good safety record, he said. But this past year, some liver toxicity concerns arose about preparations with “very, very high concentrations” of turmeric. 
 

The top 10 sellers

Dr. Eltelbany and colleagues studied prices for 1-month supplies, monthly sales, and revenue for the top 10 liver supplements sold on Amazon on June 3, 2023:

Ranking by sales:

• 1. Liver Cleanse Detox & Repair Formula – Herbal Liver Supplement with Milk Thistle, Dandelion Root, Organic Turmeric and Artichoke Extract for Liver Health – Silymarin Milk Thistle Detox Capsules
• 2. Ancestral Supplements Grass Fed Beef Liver Capsules. Supports Energy Production, Detoxification, Digestion, Immunity and Full Body Wellness, Non-GMO, Freeze Dried Liver Health Supplement, 180 Capsules
• 3. Bronson Milk Thistle 1,000 mg Silymarin Marianum & Dandelion Root Liver Health Support, 120 Capsules
• 4. PUREHEALTH RESEARCH Liver Supplement – Herbal Liver Cleanse Detox & Repair with Milk Thistle, Artichoke Extract, Dandelion Root, Turmeric, Berberine to Healthy Liver Renew with 11 Natural Nutrients
• 5. TUDCA Bile Salts Liver Support Supplement, 500-mg Servings, Liver and Gallbladder Cleanse Supplement (60 Capsules 250 mg) Genuine Bile Acid. TUDCA Strong Bitter Taste by Double Wood
• 6. 28-in-1 Liver Cleanse Detox & Repair Fatty Liver Formula, Milk Thistle Silymarin, Artichoke Extract, Dandelion & Apple Cider Vinegar – Liver Health Supplement Support Pills – Vegan Capsules
• 7. Vita-Liver Liver Health Supplement – Support Liver Cleanse & Detox – Liquid Delivery for Absorption – Milk Thistle, Artichoke, Chanca Piedra, Dandelion & More
• 8. Liver Supplement with Milk Thistle, Liver Detox Formula, Artichoke and Turmeric. Supports Liver Health Defense & Liver Renew. Liver Cleanse Detox & Repair for Fatty Liver Support. 60 Capsules
• 9. Liver Cleanse Detox & Repair. Milk Thistle Extract with Silymarin 80%, Artichoke Extract, Dandelion Root, Chicory, 25+ Herbs – Premium Liver Health Formula, Liver Support Detox Health Formula – Liver Support Detox Cleanse Supplement
• 10. Arazo Nutrition Liver Cleanse Detox & Repair Formula – Milk Thistle Herbal Support Supplement: Silymarin, Beet, Artichoke, Dandelion, Chicory Root

The investigators found a total of 65 unique ingredients. “Most of these ingredients have historical uses linked to liver health. But our research revealed that strong scientific evidence supporting the efficacy of any of these supplements is currently lacking,” Dr. Eltelbany said. They started the study by creating a new account on Amazon to make sure the search would not be influenced by prior shopping or purchases. They next searched for supplements using the keywords “liver” and “cleanse.” To figure out sales numbers, they used the AMZScout proprietary analytics software that Amazon sellers use to track sales. 
 

Reviewing the reviews

The researchers discovered an average 11,526 reviews for each supplement product. The average rating was 4.42 stars out of 5. 

Using Fakespot.com, proprietary Amazon customer review software that analyzes the timing and language of reviews, they found that only 65% of product reviews were genuine. 

“We felt it was crucial to vet the authenticity of customer feedback,” Dr. Eltelbany said.
 

Few other options?

Liver disease remains a persistent and significant global health burden. Despite advances in many areas of gastroenterology, there remains no curative treatment for liver cirrhosis, Dr. Eltelbany said. 

The primary option for people with end-stage liver disease is a liver transplant. “However, given the scarcity of donors and the vast number of patients in need, many individuals, unfortunately, do not get a timely transplant,” he said. “This void of treatment options and the desperation to find relief often drives patients towards alternative therapies.”

Also, online shopping has made getting these supplements “as simple as a click away. But what’s more concerning is the trust placed in these products by our patients,” Dr. Eltelbany said.

“There’s a strong need for rigorous scientific investigation into the actual health benefits of any liver detox supplements,” he said. “Above all, patient education remains paramount, warning them of potential risks and unknowns of these supplements.”

A version of this article appeared on WebMD.com.

The 10 best-selling liver health supplements on Amazon bring in an estimated $2.5 million each month. But none of them contain ingredients recommended by major groups of doctors who treat liver issues in the United States or Europe.

Like many supplements, popular online liver products are unregulated, meaning they do not have to meet the same safety and effectiveness standards as prescription medications. 

Sales of liver supplements are growing, particularly in the last few years, said Ahmed Eltelbany, MD, MPH, a first-year gastrointestinal fellow at the University of New Mexico. One reason could be increased alcohol use during the COVID-19 pandemic.

Some manufacturers make bold claims on Amazon, said Dr. Eltelbany, author of a study that looked into the supplements. “The most recurrent claims were that their supplements maintain normal liver function, are scientifically formulated, and – my personal favorite – are a highly effective liver detox formulation developed according to the latest scientific findings.”

While these claims might sound reassuring and scientifically grounded to an average consumer, he said, most of them are not backed up by rigorous clinical research.
 

Does natural mean safe?

Many supplements are marketed as “liver cleansing,” for “liver detox,” or for “liver support,” Dr. Eltelbany said as he presented the study results at the annual meeting of the American College of Gastroenterology. 

“People take these supplements because they believe they’re natural and therefore they’re safe,” said Paul Y. Kwo, MD, who moderated a session on the study at the meeting, when asked to comment. “As I tell every patient in clinic, a great white shark is natural, a scorpion is natural, and so is a hurricane. So just because they’re natural doesn’t mean they’re safe.”

At the same time, “it’s not that every supplement is bad for you. Nonetheless, there’s just a dizzying array of these out there” said Dr. Kwo, a professor of medicine at Stanford Medicine in Redwood, Calif.

“We have to be very cautious,” he said. For example, some people might believe that “if a little bit of a supplement is good, a tremendous amount must be really good.” The antioxidant turmeric, for example, has a pretty good safety record, he said. But this past year, some liver toxicity concerns arose about preparations with “very, very high concentrations” of turmeric. 
 

The top 10 sellers

Dr. Eltelbany and colleagues studied prices for 1-month supplies, monthly sales, and revenue for the top 10 liver supplements sold on Amazon on June 3, 2023:

Ranking by sales:

• 1. Liver Cleanse Detox & Repair Formula – Herbal Liver Supplement with Milk Thistle, Dandelion Root, Organic Turmeric and Artichoke Extract for Liver Health – Silymarin Milk Thistle Detox Capsules
• 2. Ancestral Supplements Grass Fed Beef Liver Capsules. Supports Energy Production, Detoxification, Digestion, Immunity and Full Body Wellness, Non-GMO, Freeze Dried Liver Health Supplement, 180 Capsules
• 3. Bronson Milk Thistle 1,000 mg Silymarin Marianum & Dandelion Root Liver Health Support, 120 Capsules
• 4. PUREHEALTH RESEARCH Liver Supplement – Herbal Liver Cleanse Detox & Repair with Milk Thistle, Artichoke Extract, Dandelion Root, Turmeric, Berberine to Healthy Liver Renew with 11 Natural Nutrients
• 5. TUDCA Bile Salts Liver Support Supplement, 500-mg Servings, Liver and Gallbladder Cleanse Supplement (60 Capsules 250 mg) Genuine Bile Acid. TUDCA Strong Bitter Taste by Double Wood
• 6. 28-in-1 Liver Cleanse Detox & Repair Fatty Liver Formula, Milk Thistle Silymarin, Artichoke Extract, Dandelion & Apple Cider Vinegar – Liver Health Supplement Support Pills – Vegan Capsules
• 7. Vita-Liver Liver Health Supplement – Support Liver Cleanse & Detox – Liquid Delivery for Absorption – Milk Thistle, Artichoke, Chanca Piedra, Dandelion & More
• 8. Liver Supplement with Milk Thistle, Liver Detox Formula, Artichoke and Turmeric. Supports Liver Health Defense & Liver Renew. Liver Cleanse Detox & Repair for Fatty Liver Support. 60 Capsules
• 9. Liver Cleanse Detox & Repair. Milk Thistle Extract with Silymarin 80%, Artichoke Extract, Dandelion Root, Chicory, 25+ Herbs – Premium Liver Health Formula, Liver Support Detox Health Formula – Liver Support Detox Cleanse Supplement
• 10. Arazo Nutrition Liver Cleanse Detox & Repair Formula – Milk Thistle Herbal Support Supplement: Silymarin, Beet, Artichoke, Dandelion, Chicory Root

The investigators found a total of 65 unique ingredients. “Most of these ingredients have historical uses linked to liver health. But our research revealed that strong scientific evidence supporting the efficacy of any of these supplements is currently lacking,” Dr. Eltelbany said. They started the study by creating a new account on Amazon to make sure the search would not be influenced by prior shopping or purchases. They next searched for supplements using the keywords “liver” and “cleanse.” To figure out sales numbers, they used the AMZScout proprietary analytics software that Amazon sellers use to track sales. 
 

Reviewing the reviews

The researchers discovered an average 11,526 reviews for each supplement product. The average rating was 4.42 stars out of 5. 

Using Fakespot.com, proprietary Amazon customer review software that analyzes the timing and language of reviews, they found that only 65% of product reviews were genuine. 

“We felt it was crucial to vet the authenticity of customer feedback,” Dr. Eltelbany said.
 

Few other options?

Liver disease remains a persistent and significant global health burden. Despite advances in many areas of gastroenterology, there remains no curative treatment for liver cirrhosis, Dr. Eltelbany said. 

The primary option for people with end-stage liver disease is a liver transplant. “However, given the scarcity of donors and the vast number of patients in need, many individuals, unfortunately, do not get a timely transplant,” he said. “This void of treatment options and the desperation to find relief often drives patients towards alternative therapies.”

Also, online shopping has made getting these supplements “as simple as a click away. But what’s more concerning is the trust placed in these products by our patients,” Dr. Eltelbany said.

“There’s a strong need for rigorous scientific investigation into the actual health benefits of any liver detox supplements,” he said. “Above all, patient education remains paramount, warning them of potential risks and unknowns of these supplements.”

A version of this article appeared on WebMD.com.

The 10 best-selling liver health supplements on Amazon bring in an estimated $2.5 million each month. But none of them contain ingredients recommended by major groups of doctors who treat liver issues in the United States or Europe.

Like many supplements, popular online liver products are unregulated, meaning they do not have to meet the same safety and effectiveness standards as prescription medications. 

Sales of liver supplements are growing, particularly in the last few years, said Ahmed Eltelbany, MD, MPH, a first-year gastrointestinal fellow at the University of New Mexico. One reason could be increased alcohol use during the COVID-19 pandemic.

Some manufacturers make bold claims on Amazon, said Dr. Eltelbany, author of a study that looked into the supplements. “The most recurrent claims were that their supplements maintain normal liver function, are scientifically formulated, and – my personal favorite – are a highly effective liver detox formulation developed according to the latest scientific findings.”

While these claims might sound reassuring and scientifically grounded to an average consumer, he said, most of them are not backed up by rigorous clinical research.
 

Does natural mean safe?

Many supplements are marketed as “liver cleansing,” for “liver detox,” or for “liver support,” Dr. Eltelbany said as he presented the study results at the annual meeting of the American College of Gastroenterology. 

“People take these supplements because they believe they’re natural and therefore they’re safe,” said Paul Y. Kwo, MD, who moderated a session on the study at the meeting, when asked to comment. “As I tell every patient in clinic, a great white shark is natural, a scorpion is natural, and so is a hurricane. So just because they’re natural doesn’t mean they’re safe.”

At the same time, “it’s not that every supplement is bad for you. Nonetheless, there’s just a dizzying array of these out there” said Dr. Kwo, a professor of medicine at Stanford Medicine in Redwood, Calif.

“We have to be very cautious,” he said. For example, some people might believe that “if a little bit of a supplement is good, a tremendous amount must be really good.” The antioxidant turmeric, for example, has a pretty good safety record, he said. But this past year, some liver toxicity concerns arose about preparations with “very, very high concentrations” of turmeric. 
 

The top 10 sellers

Dr. Eltelbany and colleagues studied prices for 1-month supplies, monthly sales, and revenue for the top 10 liver supplements sold on Amazon on June 3, 2023:

Ranking by sales:

• 1. Liver Cleanse Detox & Repair Formula – Herbal Liver Supplement with Milk Thistle, Dandelion Root, Organic Turmeric and Artichoke Extract for Liver Health – Silymarin Milk Thistle Detox Capsules
• 2. Ancestral Supplements Grass Fed Beef Liver Capsules. Supports Energy Production, Detoxification, Digestion, Immunity and Full Body Wellness, Non-GMO, Freeze Dried Liver Health Supplement, 180 Capsules
• 3. Bronson Milk Thistle 1,000 mg Silymarin Marianum & Dandelion Root Liver Health Support, 120 Capsules
• 4. PUREHEALTH RESEARCH Liver Supplement – Herbal Liver Cleanse Detox & Repair with Milk Thistle, Artichoke Extract, Dandelion Root, Turmeric, Berberine to Healthy Liver Renew with 11 Natural Nutrients
• 5. TUDCA Bile Salts Liver Support Supplement, 500-mg Servings, Liver and Gallbladder Cleanse Supplement (60 Capsules 250 mg) Genuine Bile Acid. TUDCA Strong Bitter Taste by Double Wood
• 6. 28-in-1 Liver Cleanse Detox & Repair Fatty Liver Formula, Milk Thistle Silymarin, Artichoke Extract, Dandelion & Apple Cider Vinegar – Liver Health Supplement Support Pills – Vegan Capsules
• 7. Vita-Liver Liver Health Supplement – Support Liver Cleanse & Detox – Liquid Delivery for Absorption – Milk Thistle, Artichoke, Chanca Piedra, Dandelion & More
• 8. Liver Supplement with Milk Thistle, Liver Detox Formula, Artichoke and Turmeric. Supports Liver Health Defense & Liver Renew. Liver Cleanse Detox & Repair for Fatty Liver Support. 60 Capsules
• 9. Liver Cleanse Detox & Repair. Milk Thistle Extract with Silymarin 80%, Artichoke Extract, Dandelion Root, Chicory, 25+ Herbs – Premium Liver Health Formula, Liver Support Detox Health Formula – Liver Support Detox Cleanse Supplement
• 10. Arazo Nutrition Liver Cleanse Detox & Repair Formula – Milk Thistle Herbal Support Supplement: Silymarin, Beet, Artichoke, Dandelion, Chicory Root

The investigators found a total of 65 unique ingredients. “Most of these ingredients have historical uses linked to liver health. But our research revealed that strong scientific evidence supporting the efficacy of any of these supplements is currently lacking,” Dr. Eltelbany said. They started the study by creating a new account on Amazon to make sure the search would not be influenced by prior shopping or purchases. They next searched for supplements using the keywords “liver” and “cleanse.” To figure out sales numbers, they used the AMZScout proprietary analytics software that Amazon sellers use to track sales. 
 

Reviewing the reviews

The researchers discovered an average 11,526 reviews for each supplement product. The average rating was 4.42 stars out of 5. 

Using Fakespot.com, proprietary Amazon customer review software that analyzes the timing and language of reviews, they found that only 65% of product reviews were genuine. 

“We felt it was crucial to vet the authenticity of customer feedback,” Dr. Eltelbany said.
 

Few other options?

Liver disease remains a persistent and significant global health burden. Despite advances in many areas of gastroenterology, there remains no curative treatment for liver cirrhosis, Dr. Eltelbany said. 

The primary option for people with end-stage liver disease is a liver transplant. “However, given the scarcity of donors and the vast number of patients in need, many individuals, unfortunately, do not get a timely transplant,” he said. “This void of treatment options and the desperation to find relief often drives patients towards alternative therapies.”

Also, online shopping has made getting these supplements “as simple as a click away. But what’s more concerning is the trust placed in these products by our patients,” Dr. Eltelbany said.

“There’s a strong need for rigorous scientific investigation into the actual health benefits of any liver detox supplements,” he said. “Above all, patient education remains paramount, warning them of potential risks and unknowns of these supplements.”

A version of this article appeared on WebMD.com.

VANCOUVER – New evidence from the phase 3 EoE KIDS trial supports the safety and efficacy of dupilumab (Dupixent) treatment for children aged 1-11 years with eosinophilic esophagitis (EoE).

High exposure to dupilumab was associated with significantly improved histologic, endoscopic, and transcriptomic improvements, compared with placebo at week 16. Sustained response or improvements continued to week 52 with continued treatment in the high-exposure dupilumab group. Children in the high-exposure dupilumab group also gained more weight during the study than those initially assigned to placebo.

“Eosinophilic esophagitis is a chronic, aggressive, type 2 inflammatory disease that has a substantial impact on quality of life,” said Mirna Chehade, MD, MPH, of the Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai in New York. And the incidence and prevalence of the disease is increasing.

Dupilumab is already indicated for treating EoE in adolescents aged 12 or older as well as adults, but “there are no approved treatments for EoE in children under 12,” said Dr. Chehade, who presented the results of the late-breaking abstract at the ACG: American College of Gastroenterology 2023 annual scientific meeting.

She and her colleagues randomly assigned 102 children aged 1-11 years with active EoE to three groups for the first 16 weeks of the study: 37 to high-exposure dupilumab; 31 to low-exposure dupilumab; and 34 others to placebo, followed by either high- or low-dose dupilumab. Baseline demographics and disease characteristics were comparable between groups.

During an active 36-week extension period, the 37 participants who were initially assigned to receive high-exposure dupilumab continued the same treatment up to week 52. A total of 29 participants initially assigned to receive low-exposure dupilumab continues their regimen as well. Those initially assigned to receive placebo switched to a preassigned active treatment group; 18 children started to take high-exposure dupilumab, and 14 began to take low-exposure dupilumab.

The children in the study had a high burden of disease, as reflected by the duration of EoE as well as histologic, endoscopic, and clinical scores. The mean age was 7.2 years in the placebo group and 6.8 years in the dupilumab group. They were mostly White boys, Dr. Chehade said.
 

Key outcomes

At week 16, the high-exposure dupilumab group met the primary study endpoint with a peak esophageal intraepithelial eosinophil count ≤ 6 on high-power field assessment. This was significantly different from the placebo group (least squares mean difference, 64.5; 95% confidence interval, 48.19-80.85; P < .0001).

At week 52, 63% of children who remained on high-exposure dupilumab and 53% of those who switched from placebo to high-exposure dupilumab achieved a peak eosinophil count ≤ 6.

The study included multiple secondary outcomes. For example, at week 16, the following measures improved from baseline with high-exposure dupilumab, compared with placebo:

• EoE-Histologic Scoring System grade and stage scores (–0.88 and –0.84 vs. +0.02 and +0.05; both P < .0001).
• EoE-Endoscopic Reference Score (–3.5 vs. +0.3; P < .0001).
• Change in body weight for age percentile (+3.09 vs. +0.29).
• Numeric improvement in caregiver-reported proportion of days experiencing one or more EoE sign (–0.28 vs. –0.17).

At week 52, these outcomes were sustained or improved with continued high-exposure dupilumab. The researchers also saw improvements among the placebo recipients who switched to high-exposure dupilumab.

The reason the children were randomly assigned to high-exposure or low-exposure groups instead of high-dose and low-dose cohorts is because the children grew during the study, Dr. Chehade explained. “As you can see, there was a nice change in weight, and at specific time periods the doses were adjusted to match.”
 

‘Good safety profile’

Dupilumab was well tolerated. “The safety profile is very similar to what has been so far described and published for dupilumab in adults,” said Dr. Chehade. At week 16, adverse events that were more frequent with dupilumab vs. placebo included COVID-19, rash, headache, and injection-site erythema, for example. Similar safety results were seen up to week 52.

“I think it’s promising as we wait for the actual study to be published,” said Asmeen Bhatt, MD, PhD, co-moderator of the session and assistant professor of medicine at University of Texas Health Science Center, Houston. “The drug was recently approved for adult EOE use, just last year, and it has been shown to be effective.”

“There are a lot of adult drugs that are now being tested in the pediatric population, and this is one of them,” Dr. Bhatt added. “It has a very good safety profile. I’m not a pediatric gastroenterologist but I expect that it will have a lot of utility.”

The study was funded by Regeneron and Sanofi. Dr. Chehade is a consultant for Sanofi and Regeneron and receives research funding from Regeneron. Dr. Bhatt had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

VANCOUVER – New evidence from the phase 3 EoE KIDS trial supports the safety and efficacy of dupilumab (Dupixent) treatment for children aged 1-11 years with eosinophilic esophagitis (EoE).

High exposure to dupilumab was associated with significantly improved histologic, endoscopic, and transcriptomic improvements, compared with placebo at week 16. Sustained response or improvements continued to week 52 with continued treatment in the high-exposure dupilumab group. Children in the high-exposure dupilumab group also gained more weight during the study than those initially assigned to placebo.

“Eosinophilic esophagitis is a chronic, aggressive, type 2 inflammatory disease that has a substantial impact on quality of life,” said Mirna Chehade, MD, MPH, of the Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai in New York. And the incidence and prevalence of the disease is increasing.

Dupilumab is already indicated for treating EoE in adolescents aged 12 or older as well as adults, but “there are no approved treatments for EoE in children under 12,” said Dr. Chehade, who presented the results of the late-breaking abstract at the ACG: American College of Gastroenterology 2023 annual scientific meeting.

She and her colleagues randomly assigned 102 children aged 1-11 years with active EoE to three groups for the first 16 weeks of the study: 37 to high-exposure dupilumab; 31 to low-exposure dupilumab; and 34 others to placebo, followed by either high- or low-dose dupilumab. Baseline demographics and disease characteristics were comparable between groups.

During an active 36-week extension period, the 37 participants who were initially assigned to receive high-exposure dupilumab continued the same treatment up to week 52. A total of 29 participants initially assigned to receive low-exposure dupilumab continues their regimen as well. Those initially assigned to receive placebo switched to a preassigned active treatment group; 18 children started to take high-exposure dupilumab, and 14 began to take low-exposure dupilumab.

The children in the study had a high burden of disease, as reflected by the duration of EoE as well as histologic, endoscopic, and clinical scores. The mean age was 7.2 years in the placebo group and 6.8 years in the dupilumab group. They were mostly White boys, Dr. Chehade said.
 

Key outcomes

At week 16, the high-exposure dupilumab group met the primary study endpoint with a peak esophageal intraepithelial eosinophil count ≤ 6 on high-power field assessment. This was significantly different from the placebo group (least squares mean difference, 64.5; 95% confidence interval, 48.19-80.85; P < .0001).

At week 52, 63% of children who remained on high-exposure dupilumab and 53% of those who switched from placebo to high-exposure dupilumab achieved a peak eosinophil count ≤ 6.

The study included multiple secondary outcomes. For example, at week 16, the following measures improved from baseline with high-exposure dupilumab, compared with placebo:

• EoE-Histologic Scoring System grade and stage scores (–0.88 and –0.84 vs. +0.02 and +0.05; both P < .0001).
• EoE-Endoscopic Reference Score (–3.5 vs. +0.3; P < .0001).
• Change in body weight for age percentile (+3.09 vs. +0.29).
• Numeric improvement in caregiver-reported proportion of days experiencing one or more EoE sign (–0.28 vs. –0.17).

At week 52, these outcomes were sustained or improved with continued high-exposure dupilumab. The researchers also saw improvements among the placebo recipients who switched to high-exposure dupilumab.

The reason the children were randomly assigned to high-exposure or low-exposure groups instead of high-dose and low-dose cohorts is because the children grew during the study, Dr. Chehade explained. “As you can see, there was a nice change in weight, and at specific time periods the doses were adjusted to match.”
 

‘Good safety profile’

Dupilumab was well tolerated. “The safety profile is very similar to what has been so far described and published for dupilumab in adults,” said Dr. Chehade. At week 16, adverse events that were more frequent with dupilumab vs. placebo included COVID-19, rash, headache, and injection-site erythema, for example. Similar safety results were seen up to week 52.

“I think it’s promising as we wait for the actual study to be published,” said Asmeen Bhatt, MD, PhD, co-moderator of the session and assistant professor of medicine at University of Texas Health Science Center, Houston. “The drug was recently approved for adult EOE use, just last year, and it has been shown to be effective.”

“There are a lot of adult drugs that are now being tested in the pediatric population, and this is one of them,” Dr. Bhatt added. “It has a very good safety profile. I’m not a pediatric gastroenterologist but I expect that it will have a lot of utility.”

The study was funded by Regeneron and Sanofi. Dr. Chehade is a consultant for Sanofi and Regeneron and receives research funding from Regeneron. Dr. Bhatt had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

VANCOUVER – New evidence from the phase 3 EoE KIDS trial supports the safety and efficacy of dupilumab (Dupixent) treatment for children aged 1-11 years with eosinophilic esophagitis (EoE).

High exposure to dupilumab was associated with significantly improved histologic, endoscopic, and transcriptomic improvements, compared with placebo at week 16. Sustained response or improvements continued to week 52 with continued treatment in the high-exposure dupilumab group. Children in the high-exposure dupilumab group also gained more weight during the study than those initially assigned to placebo.

“Eosinophilic esophagitis is a chronic, aggressive, type 2 inflammatory disease that has a substantial impact on quality of life,” said Mirna Chehade, MD, MPH, of the Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai in New York. And the incidence and prevalence of the disease is increasing.

Dupilumab is already indicated for treating EoE in adolescents aged 12 or older as well as adults, but “there are no approved treatments for EoE in children under 12,” said Dr. Chehade, who presented the results of the late-breaking abstract at the ACG: American College of Gastroenterology 2023 annual scientific meeting.

She and her colleagues randomly assigned 102 children aged 1-11 years with active EoE to three groups for the first 16 weeks of the study: 37 to high-exposure dupilumab; 31 to low-exposure dupilumab; and 34 others to placebo, followed by either high- or low-dose dupilumab. Baseline demographics and disease characteristics were comparable between groups.

During an active 36-week extension period, the 37 participants who were initially assigned to receive high-exposure dupilumab continued the same treatment up to week 52. A total of 29 participants initially assigned to receive low-exposure dupilumab continues their regimen as well. Those initially assigned to receive placebo switched to a preassigned active treatment group; 18 children started to take high-exposure dupilumab, and 14 began to take low-exposure dupilumab.

The children in the study had a high burden of disease, as reflected by the duration of EoE as well as histologic, endoscopic, and clinical scores. The mean age was 7.2 years in the placebo group and 6.8 years in the dupilumab group. They were mostly White boys, Dr. Chehade said.
 

Key outcomes

At week 16, the high-exposure dupilumab group met the primary study endpoint with a peak esophageal intraepithelial eosinophil count ≤ 6 on high-power field assessment. This was significantly different from the placebo group (least squares mean difference, 64.5; 95% confidence interval, 48.19-80.85; P < .0001).

At week 52, 63% of children who remained on high-exposure dupilumab and 53% of those who switched from placebo to high-exposure dupilumab achieved a peak eosinophil count ≤ 6.

The study included multiple secondary outcomes. For example, at week 16, the following measures improved from baseline with high-exposure dupilumab, compared with placebo:

• EoE-Histologic Scoring System grade and stage scores (–0.88 and –0.84 vs. +0.02 and +0.05; both P < .0001).
• EoE-Endoscopic Reference Score (–3.5 vs. +0.3; P < .0001).
• Change in body weight for age percentile (+3.09 vs. +0.29).
• Numeric improvement in caregiver-reported proportion of days experiencing one or more EoE sign (–0.28 vs. –0.17).

At week 52, these outcomes were sustained or improved with continued high-exposure dupilumab. The researchers also saw improvements among the placebo recipients who switched to high-exposure dupilumab.

The reason the children were randomly assigned to high-exposure or low-exposure groups instead of high-dose and low-dose cohorts is because the children grew during the study, Dr. Chehade explained. “As you can see, there was a nice change in weight, and at specific time periods the doses were adjusted to match.”
 

‘Good safety profile’

Dupilumab was well tolerated. “The safety profile is very similar to what has been so far described and published for dupilumab in adults,” said Dr. Chehade. At week 16, adverse events that were more frequent with dupilumab vs. placebo included COVID-19, rash, headache, and injection-site erythema, for example. Similar safety results were seen up to week 52.

“I think it’s promising as we wait for the actual study to be published,” said Asmeen Bhatt, MD, PhD, co-moderator of the session and assistant professor of medicine at University of Texas Health Science Center, Houston. “The drug was recently approved for adult EOE use, just last year, and it has been shown to be effective.”

“There are a lot of adult drugs that are now being tested in the pediatric population, and this is one of them,” Dr. Bhatt added. “It has a very good safety profile. I’m not a pediatric gastroenterologist but I expect that it will have a lot of utility.”

The study was funded by Regeneron and Sanofi. Dr. Chehade is a consultant for Sanofi and Regeneron and receives research funding from Regeneron. Dr. Bhatt had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

VANCOUVER – Use of sodium glucose cotransporter-2 (SGLT2) inhibitors is associated with a reduced risk of gastrointestinal cancers among patients with type 2 diabetes, compared with dipeptidyl peptidase IV (DPP4) inhibitors, new evidence reveals.

The SGLT2 inhibitors emerged superior to DPP4 inhibitors for reducing risk of colorectal, hepatic, esophageal, and other GI cancers except pancreatic cancer, said study investigator Shu-Yen Emily Chan, MD, a gastroenterologist in the departments of medicine and epidemiology at Weiss Memorial Hospital, Chicago.

On the basis of the findings, physicians could consider the SGLT2s canagliflozin, dapagliflozin, and empagliflozin or a GLP-1 as first-line therapy, particularly for people with T2D who are at elevated risk for GI cancers, Dr. Chan said in an interview at the American College of Gastroenterology (ACG): 2023 Annual Scientific Meeting.

Previous research focused on potential cardiovascular or renal benefits associated with SGLT2s, “but there are few looking at GI cancer risk and these medications,” she added. Most earlier studies in cancer have been preclinical and observational studies on colorectal cancer or hepatocellular carcinoma.

Using the TriNetX database of millions of medical claims from 92 hospitals across the United States, Dr. Chan and colleagues identified 706,390 adults who began first-line SGLT2 inhibitor therapy. They used propensity matching to link these patients with 706,390 other adults who began taking a DDP4 inhibitor (sitagliptin, saxagliptin, linagliptin, or alogliptin).

All participants had been diagnosed with type 2 diabetes. Patients were prescribed an SGLT2 inhibitor at least three times, and any cancer diagnosis that occurred at least 6 months after starting therapy was noted. Anyone with a history of cancer, cancer recurrence, or metastatic disease was excluded from the population-based cohort study.

In addition to evaluating a large number of patients, the study is notable for including people with ulcerative colitis and Crohn’s disease and for evaluating every GI cancer – esophageal, gastric, small intestinal, colorectal, rectal, anal, hepatic, biliary, and gallbladder malignancies.
 

Key findings

Among adults who received an SGLT2 inhibitor, there was a 15% decrease in overall risk of developing any GI cancer, compared with those who received a DPP4 inhibitor (hazard ratio, 0.85; 95% confidence interval, 0.82-0.88).

Colon cancer was the most common malignancy in the study. Dr. Chan and colleagues identified colon cancer among 1,789 people, or 0.25% of those taking an SGLT2 inhibitor, compared with 3,283 people, or 0.46%, of those taking a DPP4 inhibitor.

SGLT2 inhibitors were associated with a 16% decrease in risk of gastric cancer (HR, 0.84; 95% CI; 0.74-0.945; P = .005), a 13% decrease in risk of liver and intrahepatic bile duct cancer (HR, 0.87; 95% CI, 0.81-0.95), and a 22% decrease in risk of colon cancer (HR, 0.781; 95% CI, 0.74-0.83; P < .001), compared with the DPP4 medications.

The only cancer more likely in the SGLT2 inhibitor group than in the DPP4 inhibitor group was pancreatic cancer (HR, 1.035; 95% CI, 0.964-1.111; P = .340).

The SLGT2 inhibitor class also was superior to metformin for reducing risk of GI cancers.

Asked whether the study findings should alter current practice, Dr. Chan said that the study is new and hasn’t yet been published. “More studies will be needed and included in official guidelines before the findings become practice-changing,” she said.

Limitations of the study include residual confounding, absence of family cancer history, and information bias. Strengths include the large, national database and propensity score matching.
 

‘Eye-opening’ study

“It is a good study, and eye-opening because it shows that one class of diabetes medications is better than another one,” said session co-moderator Kenneth J. Vega, MD, professor of medicine and chief of the division of gastroenterology and hepatology at Augusta University–Medical College of Georgia.

Dr. Vega shared his theory on why diabetes medications could reduce risk of GI cancers. “I would think reducing diabetes means you can control inflammation ... and better controlling inflammation leads you to have less cancers.”

He added, “I think we need more long-term studies.”

The study was independently supported. Dr. Chan and Dr. Vega report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

VANCOUVER – Use of sodium glucose cotransporter-2 (SGLT2) inhibitors is associated with a reduced risk of gastrointestinal cancers among patients with type 2 diabetes, compared with dipeptidyl peptidase IV (DPP4) inhibitors, new evidence reveals.

The SGLT2 inhibitors emerged superior to DPP4 inhibitors for reducing risk of colorectal, hepatic, esophageal, and other GI cancers except pancreatic cancer, said study investigator Shu-Yen Emily Chan, MD, a gastroenterologist in the departments of medicine and epidemiology at Weiss Memorial Hospital, Chicago.

On the basis of the findings, physicians could consider the SGLT2s canagliflozin, dapagliflozin, and empagliflozin or a GLP-1 as first-line therapy, particularly for people with T2D who are at elevated risk for GI cancers, Dr. Chan said in an interview at the American College of Gastroenterology (ACG): 2023 Annual Scientific Meeting.

Previous research focused on potential cardiovascular or renal benefits associated with SGLT2s, “but there are few looking at GI cancer risk and these medications,” she added. Most earlier studies in cancer have been preclinical and observational studies on colorectal cancer or hepatocellular carcinoma.

Using the TriNetX database of millions of medical claims from 92 hospitals across the United States, Dr. Chan and colleagues identified 706,390 adults who began first-line SGLT2 inhibitor therapy. They used propensity matching to link these patients with 706,390 other adults who began taking a DDP4 inhibitor (sitagliptin, saxagliptin, linagliptin, or alogliptin).

All participants had been diagnosed with type 2 diabetes. Patients were prescribed an SGLT2 inhibitor at least three times, and any cancer diagnosis that occurred at least 6 months after starting therapy was noted. Anyone with a history of cancer, cancer recurrence, or metastatic disease was excluded from the population-based cohort study.

In addition to evaluating a large number of patients, the study is notable for including people with ulcerative colitis and Crohn’s disease and for evaluating every GI cancer – esophageal, gastric, small intestinal, colorectal, rectal, anal, hepatic, biliary, and gallbladder malignancies.
 

Key findings

Among adults who received an SGLT2 inhibitor, there was a 15% decrease in overall risk of developing any GI cancer, compared with those who received a DPP4 inhibitor (hazard ratio, 0.85; 95% confidence interval, 0.82-0.88).

Colon cancer was the most common malignancy in the study. Dr. Chan and colleagues identified colon cancer among 1,789 people, or 0.25% of those taking an SGLT2 inhibitor, compared with 3,283 people, or 0.46%, of those taking a DPP4 inhibitor.

SGLT2 inhibitors were associated with a 16% decrease in risk of gastric cancer (HR, 0.84; 95% CI; 0.74-0.945; P = .005), a 13% decrease in risk of liver and intrahepatic bile duct cancer (HR, 0.87; 95% CI, 0.81-0.95), and a 22% decrease in risk of colon cancer (HR, 0.781; 95% CI, 0.74-0.83; P < .001), compared with the DPP4 medications.

The only cancer more likely in the SGLT2 inhibitor group than in the DPP4 inhibitor group was pancreatic cancer (HR, 1.035; 95% CI, 0.964-1.111; P = .340).

The SLGT2 inhibitor class also was superior to metformin for reducing risk of GI cancers.

Asked whether the study findings should alter current practice, Dr. Chan said that the study is new and hasn’t yet been published. “More studies will be needed and included in official guidelines before the findings become practice-changing,” she said.

Limitations of the study include residual confounding, absence of family cancer history, and information bias. Strengths include the large, national database and propensity score matching.
 

‘Eye-opening’ study

“It is a good study, and eye-opening because it shows that one class of diabetes medications is better than another one,” said session co-moderator Kenneth J. Vega, MD, professor of medicine and chief of the division of gastroenterology and hepatology at Augusta University–Medical College of Georgia.

Dr. Vega shared his theory on why diabetes medications could reduce risk of GI cancers. “I would think reducing diabetes means you can control inflammation ... and better controlling inflammation leads you to have less cancers.”

He added, “I think we need more long-term studies.”

The study was independently supported. Dr. Chan and Dr. Vega report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

VANCOUVER – Use of sodium glucose cotransporter-2 (SGLT2) inhibitors is associated with a reduced risk of gastrointestinal cancers among patients with type 2 diabetes, compared with dipeptidyl peptidase IV (DPP4) inhibitors, new evidence reveals.

The SGLT2 inhibitors emerged superior to DPP4 inhibitors for reducing risk of colorectal, hepatic, esophageal, and other GI cancers except pancreatic cancer, said study investigator Shu-Yen Emily Chan, MD, a gastroenterologist in the departments of medicine and epidemiology at Weiss Memorial Hospital, Chicago.

On the basis of the findings, physicians could consider the SGLT2s canagliflozin, dapagliflozin, and empagliflozin or a GLP-1 as first-line therapy, particularly for people with T2D who are at elevated risk for GI cancers, Dr. Chan said in an interview at the American College of Gastroenterology (ACG): 2023 Annual Scientific Meeting.

Previous research focused on potential cardiovascular or renal benefits associated with SGLT2s, “but there are few looking at GI cancer risk and these medications,” she added. Most earlier studies in cancer have been preclinical and observational studies on colorectal cancer or hepatocellular carcinoma.

Using the TriNetX database of millions of medical claims from 92 hospitals across the United States, Dr. Chan and colleagues identified 706,390 adults who began first-line SGLT2 inhibitor therapy. They used propensity matching to link these patients with 706,390 other adults who began taking a DDP4 inhibitor (sitagliptin, saxagliptin, linagliptin, or alogliptin).

All participants had been diagnosed with type 2 diabetes. Patients were prescribed an SGLT2 inhibitor at least three times, and any cancer diagnosis that occurred at least 6 months after starting therapy was noted. Anyone with a history of cancer, cancer recurrence, or metastatic disease was excluded from the population-based cohort study.

In addition to evaluating a large number of patients, the study is notable for including people with ulcerative colitis and Crohn’s disease and for evaluating every GI cancer – esophageal, gastric, small intestinal, colorectal, rectal, anal, hepatic, biliary, and gallbladder malignancies.
 

Key findings

Among adults who received an SGLT2 inhibitor, there was a 15% decrease in overall risk of developing any GI cancer, compared with those who received a DPP4 inhibitor (hazard ratio, 0.85; 95% confidence interval, 0.82-0.88).

Colon cancer was the most common malignancy in the study. Dr. Chan and colleagues identified colon cancer among 1,789 people, or 0.25% of those taking an SGLT2 inhibitor, compared with 3,283 people, or 0.46%, of those taking a DPP4 inhibitor.

SGLT2 inhibitors were associated with a 16% decrease in risk of gastric cancer (HR, 0.84; 95% CI; 0.74-0.945; P = .005), a 13% decrease in risk of liver and intrahepatic bile duct cancer (HR, 0.87; 95% CI, 0.81-0.95), and a 22% decrease in risk of colon cancer (HR, 0.781; 95% CI, 0.74-0.83; P < .001), compared with the DPP4 medications.

The only cancer more likely in the SGLT2 inhibitor group than in the DPP4 inhibitor group was pancreatic cancer (HR, 1.035; 95% CI, 0.964-1.111; P = .340).

The SLGT2 inhibitor class also was superior to metformin for reducing risk of GI cancers.

Asked whether the study findings should alter current practice, Dr. Chan said that the study is new and hasn’t yet been published. “More studies will be needed and included in official guidelines before the findings become practice-changing,” she said.

Limitations of the study include residual confounding, absence of family cancer history, and information bias. Strengths include the large, national database and propensity score matching.
 

‘Eye-opening’ study

“It is a good study, and eye-opening because it shows that one class of diabetes medications is better than another one,” said session co-moderator Kenneth J. Vega, MD, professor of medicine and chief of the division of gastroenterology and hepatology at Augusta University–Medical College of Georgia.

Dr. Vega shared his theory on why diabetes medications could reduce risk of GI cancers. “I would think reducing diabetes means you can control inflammation ... and better controlling inflammation leads you to have less cancers.”

He added, “I think we need more long-term studies.”

The study was independently supported. Dr. Chan and Dr. Vega report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

VANCOUVER – In contrast to some previous research, investigators found no significant correlation between common biologic and oral small molecule treatments for inflammatory bowel disease (IBD) and an increased risk of major adverse cardiovascular events (MACE).

In addition, biologics such as infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab, and ustekinumab not only did not increase risk, but they were also linked to a significantly lower risk of major cardiovascular and thromboembolic events.

Risk reduction with biologics ranged from 15% for venous thromboembolism to 34% for myocardial infarction.

“The decrease in MACE with biologics was significant – and a bit surprising – but it correlates with the theory that by decreasing inflammation, there is a decrease in MACE,” said Miguel Regueiro, MD, chief of the Digestive Disease Institute at Cleveland Clinic, and senior author of the study.

“Our thought was that we would not see an increase in MACE and it would be equivalent between patients with IBD treated with advanced therapies and patients not treated with advanced therapies,” he told this news organization.

The findings “are consistent with some of the emerging long-term extension data from IBD clinical trials,” Dr. Regueiro reported at the ACG: American College of Gastroenterology annual scientific meeting. “And I’ll make an editorial comment for those that treat and practice in inflammatory bowel disease: I think these data continue to support, affirm, and hopefully comfort us.”
 

Therapies previously implicated in increased MACE risk

IBD itself is associated with increased MACE risk, likely because of chronic inflammation and endothelial dysfunction, the researchers note. While biologic and small molecule therapies are effective IBD treatments, some therapies have been implicated in an increased risk for MACE.

The Oral Surveillance postmarketing safety study of tofacitinib in rheumatoid arthritis, for example, linked the agent to higher MACE and venous thromboembolism rates vs. a TNF inhibitor. As a result, the FDA restricted the JAK inhibitor drug class that includes tofacitinib.

While long-term extension studies in IBD have not linked oral small molecules to increases in MACE, the sample sizes and duration of follow-up have been limited, the authors noted. For this reason, Dr. Regueiro and colleagues decided to further evaluate the potential associations in people with IBD.

The cohorts included 67,607 adults with IBD taking a biologic and another 67,607 with IBD not receiving a biologic between January 2021 and June 2023. The researchers also compared 3,194 adults with IBD taking an oral small molecule treatment vs. another 3,194 people with IBD not receiving these medications. These large sample sizes were possible through use of TriNetX, a large U.S. claims database that includes millions of patients.
 

Key findings

The propensity matched study revealed that adults with IBD on biologics had a significantly lower risk for coronary artery disease (adjusted odds ratio, 0.69; 95% confidence interval, 0.66-0.72; P < .0001), myocardial infarction (aOR, 0.66; 95% CI, 0.61-0.72; P < .0001) or stroke (aOR, 0.71; 95% CI, 0.65-0.77; P < .0001), compared with IBD patients not on biological therapy.

The researchers also found a lower risk for venous thromboembolism associated with biologics (aOR, 0.85; 95% CI, 0.81-0.89; P < .0001).

Dr. Regueiro said that active inflammation in the bowel or anywhere in the body is associated with higher rates of blood clot formation. “The thought is that decreasing inflammation with treatment may actually decrease the rates of blood clots. So, in essence, we think that biologics may actually decrease MACE.”

IBD patients receiving an oral small molecule did not have a significantly increased risk for coronary artery disease (aOR, 1.05; 95% CI, 0.82-1.33; P = .7148) or myocardial infarction (aOR, 1.04; 95% CI, 0.60-1.78; P = .8903). The risk of stroke was lower but not significantly different (aOR, 0.87; 95% CI, 0.57-1.33; P = .5148).

In addition, there was no significant change in risk for venous thromboembolism (aOR 1.07; 95% CI, 0.83-1.39; P = .5957).

All cohorts were matched for age, race, sex, cardiovascular risk factors, and medications including immunomodulators, 5-aminosalicylic acids, and steroids. MACE and VTE were noted by ICD-10 codes at least 30 days after starting treatment.

Strengths of the study included large sample size, diverse cohorts, and propensity score matching. Limitations included the study’s retrospective design.
 

Difference in IBD and rheumatoid arthritis populations

The authors noted: “Although further study is needed, it is possible that adequate treatment of bowel inflammation in IBD patients results in a decreased risk of MACE.”

Dr. Regueiro and colleagues are updating and expanding the research to increase the number of patients. They are also planning to evaluate the long-term extension data with individual biologics and small molecules to assess the consistency of their findings. “On preliminary glance, we believe that our results will be consistent with future study.”

“When you look at the studies, the increase in cardiac risk issues we’re seeing are in rheumatoid arthritis. And when we look at the patients with inflammatory bowel disease, we don’t see it,” session co-moderator John Leighton, MD, said when asked to comment. “So we think that there is a difference in the two populations, and this study gives further credence to that.”

“There are probably some high-risk populations that we still want to be careful with,” added Dr. Leighton, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix. “But the risk is not as great as they initially saw in the rheumatoid [arthritis] patients – and it’s a good thing because these drugs work very well.”

The study was independently supported. Lead author Dr. Qapaja had no relevant financial relationships. Dr. Regueiro is an advisory committee or board member and consultant for Alfasigma, Allergan, Amgen, Eli Lilly, Miraca Labs, Prometheus, Salix, Seres, and Target RWE. He serves in these roles and receives unrestricted educational grants from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB. He also receives royalties from Wolters Kluwer Health. Dr. Leighton is an advisory committee/board member for Braintree.

A version of this article first appeared on Medscape.com.

VANCOUVER – In contrast to some previous research, investigators found no significant correlation between common biologic and oral small molecule treatments for inflammatory bowel disease (IBD) and an increased risk of major adverse cardiovascular events (MACE).

In addition, biologics such as infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab, and ustekinumab not only did not increase risk, but they were also linked to a significantly lower risk of major cardiovascular and thromboembolic events.

Risk reduction with biologics ranged from 15% for venous thromboembolism to 34% for myocardial infarction.

“The decrease in MACE with biologics was significant – and a bit surprising – but it correlates with the theory that by decreasing inflammation, there is a decrease in MACE,” said Miguel Regueiro, MD, chief of the Digestive Disease Institute at Cleveland Clinic, and senior author of the study.

“Our thought was that we would not see an increase in MACE and it would be equivalent between patients with IBD treated with advanced therapies and patients not treated with advanced therapies,” he told this news organization.

The findings “are consistent with some of the emerging long-term extension data from IBD clinical trials,” Dr. Regueiro reported at the ACG: American College of Gastroenterology annual scientific meeting. “And I’ll make an editorial comment for those that treat and practice in inflammatory bowel disease: I think these data continue to support, affirm, and hopefully comfort us.”
 

Therapies previously implicated in increased MACE risk

IBD itself is associated with increased MACE risk, likely because of chronic inflammation and endothelial dysfunction, the researchers note. While biologic and small molecule therapies are effective IBD treatments, some therapies have been implicated in an increased risk for MACE.

The Oral Surveillance postmarketing safety study of tofacitinib in rheumatoid arthritis, for example, linked the agent to higher MACE and venous thromboembolism rates vs. a TNF inhibitor. As a result, the FDA restricted the JAK inhibitor drug class that includes tofacitinib.

While long-term extension studies in IBD have not linked oral small molecules to increases in MACE, the sample sizes and duration of follow-up have been limited, the authors noted. For this reason, Dr. Regueiro and colleagues decided to further evaluate the potential associations in people with IBD.

The cohorts included 67,607 adults with IBD taking a biologic and another 67,607 with IBD not receiving a biologic between January 2021 and June 2023. The researchers also compared 3,194 adults with IBD taking an oral small molecule treatment vs. another 3,194 people with IBD not receiving these medications. These large sample sizes were possible through use of TriNetX, a large U.S. claims database that includes millions of patients.
 

Key findings

The propensity matched study revealed that adults with IBD on biologics had a significantly lower risk for coronary artery disease (adjusted odds ratio, 0.69; 95% confidence interval, 0.66-0.72; P < .0001), myocardial infarction (aOR, 0.66; 95% CI, 0.61-0.72; P < .0001) or stroke (aOR, 0.71; 95% CI, 0.65-0.77; P < .0001), compared with IBD patients not on biological therapy.

The researchers also found a lower risk for venous thromboembolism associated with biologics (aOR, 0.85; 95% CI, 0.81-0.89; P < .0001).

Dr. Regueiro said that active inflammation in the bowel or anywhere in the body is associated with higher rates of blood clot formation. “The thought is that decreasing inflammation with treatment may actually decrease the rates of blood clots. So, in essence, we think that biologics may actually decrease MACE.”

IBD patients receiving an oral small molecule did not have a significantly increased risk for coronary artery disease (aOR, 1.05; 95% CI, 0.82-1.33; P = .7148) or myocardial infarction (aOR, 1.04; 95% CI, 0.60-1.78; P = .8903). The risk of stroke was lower but not significantly different (aOR, 0.87; 95% CI, 0.57-1.33; P = .5148).

In addition, there was no significant change in risk for venous thromboembolism (aOR 1.07; 95% CI, 0.83-1.39; P = .5957).

All cohorts were matched for age, race, sex, cardiovascular risk factors, and medications including immunomodulators, 5-aminosalicylic acids, and steroids. MACE and VTE were noted by ICD-10 codes at least 30 days after starting treatment.

Strengths of the study included large sample size, diverse cohorts, and propensity score matching. Limitations included the study’s retrospective design.
 

Difference in IBD and rheumatoid arthritis populations

The authors noted: “Although further study is needed, it is possible that adequate treatment of bowel inflammation in IBD patients results in a decreased risk of MACE.”

Dr. Regueiro and colleagues are updating and expanding the research to increase the number of patients. They are also planning to evaluate the long-term extension data with individual biologics and small molecules to assess the consistency of their findings. “On preliminary glance, we believe that our results will be consistent with future study.”

“When you look at the studies, the increase in cardiac risk issues we’re seeing are in rheumatoid arthritis. And when we look at the patients with inflammatory bowel disease, we don’t see it,” session co-moderator John Leighton, MD, said when asked to comment. “So we think that there is a difference in the two populations, and this study gives further credence to that.”

“There are probably some high-risk populations that we still want to be careful with,” added Dr. Leighton, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix. “But the risk is not as great as they initially saw in the rheumatoid [arthritis] patients – and it’s a good thing because these drugs work very well.”

The study was independently supported. Lead author Dr. Qapaja had no relevant financial relationships. Dr. Regueiro is an advisory committee or board member and consultant for Alfasigma, Allergan, Amgen, Eli Lilly, Miraca Labs, Prometheus, Salix, Seres, and Target RWE. He serves in these roles and receives unrestricted educational grants from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB. He also receives royalties from Wolters Kluwer Health. Dr. Leighton is an advisory committee/board member for Braintree.

A version of this article first appeared on Medscape.com.

VANCOUVER – In contrast to some previous research, investigators found no significant correlation between common biologic and oral small molecule treatments for inflammatory bowel disease (IBD) and an increased risk of major adverse cardiovascular events (MACE).

In addition, biologics such as infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab, and ustekinumab not only did not increase risk, but they were also linked to a significantly lower risk of major cardiovascular and thromboembolic events.

Risk reduction with biologics ranged from 15% for venous thromboembolism to 34% for myocardial infarction.

“The decrease in MACE with biologics was significant – and a bit surprising – but it correlates with the theory that by decreasing inflammation, there is a decrease in MACE,” said Miguel Regueiro, MD, chief of the Digestive Disease Institute at Cleveland Clinic, and senior author of the study.

“Our thought was that we would not see an increase in MACE and it would be equivalent between patients with IBD treated with advanced therapies and patients not treated with advanced therapies,” he told this news organization.

The findings “are consistent with some of the emerging long-term extension data from IBD clinical trials,” Dr. Regueiro reported at the ACG: American College of Gastroenterology annual scientific meeting. “And I’ll make an editorial comment for those that treat and practice in inflammatory bowel disease: I think these data continue to support, affirm, and hopefully comfort us.”
 

Therapies previously implicated in increased MACE risk

IBD itself is associated with increased MACE risk, likely because of chronic inflammation and endothelial dysfunction, the researchers note. While biologic and small molecule therapies are effective IBD treatments, some therapies have been implicated in an increased risk for MACE.

The Oral Surveillance postmarketing safety study of tofacitinib in rheumatoid arthritis, for example, linked the agent to higher MACE and venous thromboembolism rates vs. a TNF inhibitor. As a result, the FDA restricted the JAK inhibitor drug class that includes tofacitinib.

While long-term extension studies in IBD have not linked oral small molecules to increases in MACE, the sample sizes and duration of follow-up have been limited, the authors noted. For this reason, Dr. Regueiro and colleagues decided to further evaluate the potential associations in people with IBD.

The cohorts included 67,607 adults with IBD taking a biologic and another 67,607 with IBD not receiving a biologic between January 2021 and June 2023. The researchers also compared 3,194 adults with IBD taking an oral small molecule treatment vs. another 3,194 people with IBD not receiving these medications. These large sample sizes were possible through use of TriNetX, a large U.S. claims database that includes millions of patients.
 

Key findings

The propensity matched study revealed that adults with IBD on biologics had a significantly lower risk for coronary artery disease (adjusted odds ratio, 0.69; 95% confidence interval, 0.66-0.72; P < .0001), myocardial infarction (aOR, 0.66; 95% CI, 0.61-0.72; P < .0001) or stroke (aOR, 0.71; 95% CI, 0.65-0.77; P < .0001), compared with IBD patients not on biological therapy.

The researchers also found a lower risk for venous thromboembolism associated with biologics (aOR, 0.85; 95% CI, 0.81-0.89; P < .0001).

Dr. Regueiro said that active inflammation in the bowel or anywhere in the body is associated with higher rates of blood clot formation. “The thought is that decreasing inflammation with treatment may actually decrease the rates of blood clots. So, in essence, we think that biologics may actually decrease MACE.”

IBD patients receiving an oral small molecule did not have a significantly increased risk for coronary artery disease (aOR, 1.05; 95% CI, 0.82-1.33; P = .7148) or myocardial infarction (aOR, 1.04; 95% CI, 0.60-1.78; P = .8903). The risk of stroke was lower but not significantly different (aOR, 0.87; 95% CI, 0.57-1.33; P = .5148).

In addition, there was no significant change in risk for venous thromboembolism (aOR 1.07; 95% CI, 0.83-1.39; P = .5957).

All cohorts were matched for age, race, sex, cardiovascular risk factors, and medications including immunomodulators, 5-aminosalicylic acids, and steroids. MACE and VTE were noted by ICD-10 codes at least 30 days after starting treatment.

Strengths of the study included large sample size, diverse cohorts, and propensity score matching. Limitations included the study’s retrospective design.
 

Difference in IBD and rheumatoid arthritis populations

The authors noted: “Although further study is needed, it is possible that adequate treatment of bowel inflammation in IBD patients results in a decreased risk of MACE.”

Dr. Regueiro and colleagues are updating and expanding the research to increase the number of patients. They are also planning to evaluate the long-term extension data with individual biologics and small molecules to assess the consistency of their findings. “On preliminary glance, we believe that our results will be consistent with future study.”

“When you look at the studies, the increase in cardiac risk issues we’re seeing are in rheumatoid arthritis. And when we look at the patients with inflammatory bowel disease, we don’t see it,” session co-moderator John Leighton, MD, said when asked to comment. “So we think that there is a difference in the two populations, and this study gives further credence to that.”

“There are probably some high-risk populations that we still want to be careful with,” added Dr. Leighton, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix. “But the risk is not as great as they initially saw in the rheumatoid [arthritis] patients – and it’s a good thing because these drugs work very well.”

The study was independently supported. Lead author Dr. Qapaja had no relevant financial relationships. Dr. Regueiro is an advisory committee or board member and consultant for Alfasigma, Allergan, Amgen, Eli Lilly, Miraca Labs, Prometheus, Salix, Seres, and Target RWE. He serves in these roles and receives unrestricted educational grants from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB. He also receives royalties from Wolters Kluwer Health. Dr. Leighton is an advisory committee/board member for Braintree.

A version of this article first appeared on Medscape.com.

VANCOUVER – Two multitarget stool tests in development compare favorably for colorectal cancer (CRC) screening in average-risk people, suggest two new studies.

In a blinded, prospective, cross-sectional study, researchers assessed a multitarget stool RNA test (mt-sRNA; Colosense, Geneoscopy) vs. colonoscopy for detection of advanced adenomas and CRC in average-risk individuals aged 45 years and older.

In a prospective, cross-sectional study, investigators evaluated the clinical performance of a next-generation multitarget stool DNA (mt-sDNA; Cologuard, Exact Sciences) and fecal hemoglobin assay for CRC screening in adults aged 40 years and older.

Both studies were presented at the ACG: American College of Gastroenterology 2023 Annual Scientific Meeting.
 

RNA as a biomarker

For CRC-PREVENT, which evaluated the mt-sRNA test, David Lieberman, MD, professor of medicine and former chief of the division of gastroenterology and hepatology at the Oregon Health & Science University, Portland, and colleagues recruited a diverse group of 8,289 adults undergoing colonoscopy at one of more than 3,800 endoscopy centers nationwide. Recruitment included outreach through social media, which could be used to improve future screening rates, Dr. Lieberman said.

The full study findings of CRC-PREVENT were also published online in the Journal of the American Medical Association.

Participants provided stool samples before colonoscopy. Colosense includes a commercially available fecal immunochemical test (FIT) and tests for eight different strands of RNA. The mt-sRNA test results were compared with the colonoscopy results.

The mt-sRNA test had 100% sensitivity for early, stage I cancers, which were detected in 12 patients. Advanced adenomas were detected with an overall sensitivity of 45%. When the advanced adenomas were ≥ 2 cm, sensitivity increased to 51%.

Specificity was 87% among patients with negative findings for hyperplastic polyps or lesions.

The mt-sRNA test showed significant improvements in sensitivity for CRC (94% vs. 77%; P = .029) and advanced adenomas (45% vs 29%; P < .001), when compared with the FIT results alone.

“This is the first large study to include the 45- to 49-year-old population, for whom screening is now recommended,” Dr. Lieberman told this news organization.

Results show a sensitivity of 100% for detecting CRC and 44% for advanced adenomas in this younger age group. That performance is “excellent,” said Dr. Lieberman.

Results also were reliable across all ages.

“The consistent performance across all age groups for whom screening is recommended is a key finding and was totally unknown” before this study, Dr. Lieberman said.

RNA-based testing may have an advantage over DNA biomarker tests, which can be prone to age-related DNA methylation changes, he added.
 

Detection by DNA

Thomas Imperiale, MD, distinguished professor of medicine at Indiana University, Indianapolis, and colleagues conducted the BLUE-C trial to validate the next-generation mt-sDNA test for CRC screening.

The mt-sDNA assay tests for three novel methylated DNA markers and fecal hemoglobin.

Dr. Imperiale and colleagues studied 20,176 adults (mean age, 63 years) scheduled for screening colonoscopy at one of 186 U.S. sites. Participants provided a stool sample for the mt-sDNA test and comparator FIT prior to colonoscopy preparation. They compared results to colonoscopy and FIT findings.

Colonoscopy revealed 98 people with CRC, 2,144 with advanced precancerous lesions, and 17,934 with no advanced neoplasia.

Sensitivity of the mt-sDNA test for detecting CRC was 93.9% (95% confidence interval, 87.1-97.7), advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6), and advanced precancerous lesions with high-grade dysplasia was 74.6% (95% CI, 65.6-82.3).

Sensitivities of the mt-sDNA test for detecting CRC and advanced precancerous lesions were significantly higher than FIT (P < .0001).

In terms of specificity, the mt-sDNA test had a specificity of 90.6% (95% CI, 90.1-91.0) for the absence of advanced neoplasia. Specificity for non-neoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1).

The mt-sDNA test demonstrated high specificity and high CRC and advanced precancerous lesion sensitivity. The test outperformed FIT for these factors on sensitivity but not specificity, the authors noted.

Improved specificity was a goal of developing this next-generation assay. The BLUE-C trial demonstrated a 30% improvement in specificity that “will decrease the number of unnecessary colonoscopies performed for false-positive results,” said Dr. Imperiale.

“I was pleased to see the robust results support this new battery of markers,” Dr. Imperiale added. Improvements associated with this next-generation test could “help further reduce the incidence of and mortality from colorectal cancer.”
 

Tests to provide more noninvasive options

Both are “important studies” that look at a large, average-risk screening population in the United States, said Aasma Shaukat, MD, MPH, who was not affiliated with the research. “Both show high sensitivity for detecting CRC and decent specificity for advanced adenomas.”

While we will have to wait for the full publications, U.S. Food and Drug Administration approvals, and insurance coverage, gastroenterologists can expect to see these tests in clinical use in the near future, added Dr. Shaukat, professor of medicine and population health at NYU Langone Health, New York, and lead author of the ACG 2021 Colorectal Cancer Screening Guidelines.

These tests provide more noninvasive options for CRC screening and are more accurate, which hopefully will translate into increased screening and a reduced burden of CRC, she said.

“We are always looking for ways to increase colon cancer screening uptake,” said Brooks Cash, MD, professor and chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston, who also was not affiliated with the research.

Certainly, the multitarget stool DNA is not a new concept with Cologuard, but it is a new assay, Dr. Cash said.

“It’s significantly different than their previous version, and they were able to show improved sensitivity as well as specificity, which has been one of the concerns,” he said.

The multitarget stool RNA test “shows very similar results,” Dr. Cash added. “Their predicate is that it’s slightly different and actually may return very good sensitivity for older patients, where you don’t have the same methylation issues with the DNA.”

“It will be interesting to see how they play out,” he added.

“The critical part to all of these tests is that if a patient has a positive test, they need to get a colonoscopy. That doesn’t always happen,” Dr. Cash said. “We have to make sure that there’s appropriate education for not only patients but also providers, many of whom will not be gastroenterologists.”

Geneoscopy funded the CRC-PREVENT trial. Exact Sciences funded the BLUE-C trial. Dr. Lieberman is an advisor or review panel member for Geneoscopy. Dr. Imperiale receives grant or research support from Exact Sciences. Dr. Shaukat reports no relevant financial relationships. Dr. Cash is on the advisory board for Exact Sciences.

A version of this article first appeared on Medscape.com.

VANCOUVER – Two multitarget stool tests in development compare favorably for colorectal cancer (CRC) screening in average-risk people, suggest two new studies.

In a blinded, prospective, cross-sectional study, researchers assessed a multitarget stool RNA test (mt-sRNA; Colosense, Geneoscopy) vs. colonoscopy for detection of advanced adenomas and CRC in average-risk individuals aged 45 years and older.

In a prospective, cross-sectional study, investigators evaluated the clinical performance of a next-generation multitarget stool DNA (mt-sDNA; Cologuard, Exact Sciences) and fecal hemoglobin assay for CRC screening in adults aged 40 years and older.

Both studies were presented at the ACG: American College of Gastroenterology 2023 Annual Scientific Meeting.
 

RNA as a biomarker

For CRC-PREVENT, which evaluated the mt-sRNA test, David Lieberman, MD, professor of medicine and former chief of the division of gastroenterology and hepatology at the Oregon Health & Science University, Portland, and colleagues recruited a diverse group of 8,289 adults undergoing colonoscopy at one of more than 3,800 endoscopy centers nationwide. Recruitment included outreach through social media, which could be used to improve future screening rates, Dr. Lieberman said.

The full study findings of CRC-PREVENT were also published online in the Journal of the American Medical Association.

Participants provided stool samples before colonoscopy. Colosense includes a commercially available fecal immunochemical test (FIT) and tests for eight different strands of RNA. The mt-sRNA test results were compared with the colonoscopy results.

The mt-sRNA test had 100% sensitivity for early, stage I cancers, which were detected in 12 patients. Advanced adenomas were detected with an overall sensitivity of 45%. When the advanced adenomas were ≥ 2 cm, sensitivity increased to 51%.

Specificity was 87% among patients with negative findings for hyperplastic polyps or lesions.

The mt-sRNA test showed significant improvements in sensitivity for CRC (94% vs. 77%; P = .029) and advanced adenomas (45% vs 29%; P < .001), when compared with the FIT results alone.

“This is the first large study to include the 45- to 49-year-old population, for whom screening is now recommended,” Dr. Lieberman told this news organization.

Results show a sensitivity of 100% for detecting CRC and 44% for advanced adenomas in this younger age group. That performance is “excellent,” said Dr. Lieberman.

Results also were reliable across all ages.

“The consistent performance across all age groups for whom screening is recommended is a key finding and was totally unknown” before this study, Dr. Lieberman said.

RNA-based testing may have an advantage over DNA biomarker tests, which can be prone to age-related DNA methylation changes, he added.
 

Detection by DNA

Thomas Imperiale, MD, distinguished professor of medicine at Indiana University, Indianapolis, and colleagues conducted the BLUE-C trial to validate the next-generation mt-sDNA test for CRC screening.

The mt-sDNA assay tests for three novel methylated DNA markers and fecal hemoglobin.

Dr. Imperiale and colleagues studied 20,176 adults (mean age, 63 years) scheduled for screening colonoscopy at one of 186 U.S. sites. Participants provided a stool sample for the mt-sDNA test and comparator FIT prior to colonoscopy preparation. They compared results to colonoscopy and FIT findings.

Colonoscopy revealed 98 people with CRC, 2,144 with advanced precancerous lesions, and 17,934 with no advanced neoplasia.

Sensitivity of the mt-sDNA test for detecting CRC was 93.9% (95% confidence interval, 87.1-97.7), advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6), and advanced precancerous lesions with high-grade dysplasia was 74.6% (95% CI, 65.6-82.3).

Sensitivities of the mt-sDNA test for detecting CRC and advanced precancerous lesions were significantly higher than FIT (P < .0001).

In terms of specificity, the mt-sDNA test had a specificity of 90.6% (95% CI, 90.1-91.0) for the absence of advanced neoplasia. Specificity for non-neoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1).

The mt-sDNA test demonstrated high specificity and high CRC and advanced precancerous lesion sensitivity. The test outperformed FIT for these factors on sensitivity but not specificity, the authors noted.

Improved specificity was a goal of developing this next-generation assay. The BLUE-C trial demonstrated a 30% improvement in specificity that “will decrease the number of unnecessary colonoscopies performed for false-positive results,” said Dr. Imperiale.

“I was pleased to see the robust results support this new battery of markers,” Dr. Imperiale added. Improvements associated with this next-generation test could “help further reduce the incidence of and mortality from colorectal cancer.”
 

Tests to provide more noninvasive options

Both are “important studies” that look at a large, average-risk screening population in the United States, said Aasma Shaukat, MD, MPH, who was not affiliated with the research. “Both show high sensitivity for detecting CRC and decent specificity for advanced adenomas.”

While we will have to wait for the full publications, U.S. Food and Drug Administration approvals, and insurance coverage, gastroenterologists can expect to see these tests in clinical use in the near future, added Dr. Shaukat, professor of medicine and population health at NYU Langone Health, New York, and lead author of the ACG 2021 Colorectal Cancer Screening Guidelines.

These tests provide more noninvasive options for CRC screening and are more accurate, which hopefully will translate into increased screening and a reduced burden of CRC, she said.

“We are always looking for ways to increase colon cancer screening uptake,” said Brooks Cash, MD, professor and chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston, who also was not affiliated with the research.

Certainly, the multitarget stool DNA is not a new concept with Cologuard, but it is a new assay, Dr. Cash said.

“It’s significantly different than their previous version, and they were able to show improved sensitivity as well as specificity, which has been one of the concerns,” he said.

The multitarget stool RNA test “shows very similar results,” Dr. Cash added. “Their predicate is that it’s slightly different and actually may return very good sensitivity for older patients, where you don’t have the same methylation issues with the DNA.”

“It will be interesting to see how they play out,” he added.

“The critical part to all of these tests is that if a patient has a positive test, they need to get a colonoscopy. That doesn’t always happen,” Dr. Cash said. “We have to make sure that there’s appropriate education for not only patients but also providers, many of whom will not be gastroenterologists.”

Geneoscopy funded the CRC-PREVENT trial. Exact Sciences funded the BLUE-C trial. Dr. Lieberman is an advisor or review panel member for Geneoscopy. Dr. Imperiale receives grant or research support from Exact Sciences. Dr. Shaukat reports no relevant financial relationships. Dr. Cash is on the advisory board for Exact Sciences.

A version of this article first appeared on Medscape.com.

VANCOUVER – Two multitarget stool tests in development compare favorably for colorectal cancer (CRC) screening in average-risk people, suggest two new studies.

In a blinded, prospective, cross-sectional study, researchers assessed a multitarget stool RNA test (mt-sRNA; Colosense, Geneoscopy) vs. colonoscopy for detection of advanced adenomas and CRC in average-risk individuals aged 45 years and older.

In a prospective, cross-sectional study, investigators evaluated the clinical performance of a next-generation multitarget stool DNA (mt-sDNA; Cologuard, Exact Sciences) and fecal hemoglobin assay for CRC screening in adults aged 40 years and older.

Both studies were presented at the ACG: American College of Gastroenterology 2023 Annual Scientific Meeting.
 

RNA as a biomarker

For CRC-PREVENT, which evaluated the mt-sRNA test, David Lieberman, MD, professor of medicine and former chief of the division of gastroenterology and hepatology at the Oregon Health & Science University, Portland, and colleagues recruited a diverse group of 8,289 adults undergoing colonoscopy at one of more than 3,800 endoscopy centers nationwide. Recruitment included outreach through social media, which could be used to improve future screening rates, Dr. Lieberman said.

The full study findings of CRC-PREVENT were also published online in the Journal of the American Medical Association.

Participants provided stool samples before colonoscopy. Colosense includes a commercially available fecal immunochemical test (FIT) and tests for eight different strands of RNA. The mt-sRNA test results were compared with the colonoscopy results.

The mt-sRNA test had 100% sensitivity for early, stage I cancers, which were detected in 12 patients. Advanced adenomas were detected with an overall sensitivity of 45%. When the advanced adenomas were ≥ 2 cm, sensitivity increased to 51%.

Specificity was 87% among patients with negative findings for hyperplastic polyps or lesions.

The mt-sRNA test showed significant improvements in sensitivity for CRC (94% vs. 77%; P = .029) and advanced adenomas (45% vs 29%; P < .001), when compared with the FIT results alone.

“This is the first large study to include the 45- to 49-year-old population, for whom screening is now recommended,” Dr. Lieberman told this news organization.

Results show a sensitivity of 100% for detecting CRC and 44% for advanced adenomas in this younger age group. That performance is “excellent,” said Dr. Lieberman.

Results also were reliable across all ages.

“The consistent performance across all age groups for whom screening is recommended is a key finding and was totally unknown” before this study, Dr. Lieberman said.

RNA-based testing may have an advantage over DNA biomarker tests, which can be prone to age-related DNA methylation changes, he added.
 

Detection by DNA

Thomas Imperiale, MD, distinguished professor of medicine at Indiana University, Indianapolis, and colleagues conducted the BLUE-C trial to validate the next-generation mt-sDNA test for CRC screening.

The mt-sDNA assay tests for three novel methylated DNA markers and fecal hemoglobin.

Dr. Imperiale and colleagues studied 20,176 adults (mean age, 63 years) scheduled for screening colonoscopy at one of 186 U.S. sites. Participants provided a stool sample for the mt-sDNA test and comparator FIT prior to colonoscopy preparation. They compared results to colonoscopy and FIT findings.

Colonoscopy revealed 98 people with CRC, 2,144 with advanced precancerous lesions, and 17,934 with no advanced neoplasia.

Sensitivity of the mt-sDNA test for detecting CRC was 93.9% (95% confidence interval, 87.1-97.7), advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6), and advanced precancerous lesions with high-grade dysplasia was 74.6% (95% CI, 65.6-82.3).

Sensitivities of the mt-sDNA test for detecting CRC and advanced precancerous lesions were significantly higher than FIT (P < .0001).

In terms of specificity, the mt-sDNA test had a specificity of 90.6% (95% CI, 90.1-91.0) for the absence of advanced neoplasia. Specificity for non-neoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1).

The mt-sDNA test demonstrated high specificity and high CRC and advanced precancerous lesion sensitivity. The test outperformed FIT for these factors on sensitivity but not specificity, the authors noted.

Improved specificity was a goal of developing this next-generation assay. The BLUE-C trial demonstrated a 30% improvement in specificity that “will decrease the number of unnecessary colonoscopies performed for false-positive results,” said Dr. Imperiale.

“I was pleased to see the robust results support this new battery of markers,” Dr. Imperiale added. Improvements associated with this next-generation test could “help further reduce the incidence of and mortality from colorectal cancer.”
 

Tests to provide more noninvasive options

Both are “important studies” that look at a large, average-risk screening population in the United States, said Aasma Shaukat, MD, MPH, who was not affiliated with the research. “Both show high sensitivity for detecting CRC and decent specificity for advanced adenomas.”

While we will have to wait for the full publications, U.S. Food and Drug Administration approvals, and insurance coverage, gastroenterologists can expect to see these tests in clinical use in the near future, added Dr. Shaukat, professor of medicine and population health at NYU Langone Health, New York, and lead author of the ACG 2021 Colorectal Cancer Screening Guidelines.

These tests provide more noninvasive options for CRC screening and are more accurate, which hopefully will translate into increased screening and a reduced burden of CRC, she said.

“We are always looking for ways to increase colon cancer screening uptake,” said Brooks Cash, MD, professor and chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston, who also was not affiliated with the research.

Certainly, the multitarget stool DNA is not a new concept with Cologuard, but it is a new assay, Dr. Cash said.

“It’s significantly different than their previous version, and they were able to show improved sensitivity as well as specificity, which has been one of the concerns,” he said.

The multitarget stool RNA test “shows very similar results,” Dr. Cash added. “Their predicate is that it’s slightly different and actually may return very good sensitivity for older patients, where you don’t have the same methylation issues with the DNA.”

“It will be interesting to see how they play out,” he added.

“The critical part to all of these tests is that if a patient has a positive test, they need to get a colonoscopy. That doesn’t always happen,” Dr. Cash said. “We have to make sure that there’s appropriate education for not only patients but also providers, many of whom will not be gastroenterologists.”

Geneoscopy funded the CRC-PREVENT trial. Exact Sciences funded the BLUE-C trial. Dr. Lieberman is an advisor or review panel member for Geneoscopy. Dr. Imperiale receives grant or research support from Exact Sciences. Dr. Shaukat reports no relevant financial relationships. Dr. Cash is on the advisory board for Exact Sciences.

A version of this article first appeared on Medscape.com.

People taking semaglutide or liraglutide for weight management are at a higher risk for rare but potentially serious gastrointestinal issues, compared with those taking naltrexone/bupropion, according to a large epidemiologic study.

Patients taking either of these glucagonlike peptide-1 (GLP-1) receptor agonists had a 9-fold elevation in risk for pancreatitis. They were also 4 times more likely to develop bowel obstruction and over 3.5 times more likely to experience gastroparesis.

The research letter was published online in JAMA.

Investigators say their findings are not about scaring people off the weight-loss drugs, but instead about increasing awareness that these potential adverse outcomes can happen.

“Given the wide use of these drugs, these adverse events, although rare, must be considered by patients thinking about using them for weight loss,” said lead author Mohit Sodhi, MSc, in a news release about the study. Mr. Sodhi is a graduate of the experimental medicine program at the University of British Columbia in Vancouver, and also a 4th-year medical student at UBC.

People taking a GLP-1 agonist to treat diabetes might be more willing to accept the risks, given their potential advantages, especially that of lowering the risk for heart problems, said Mahyar Etminan, PharmD, MSc, the study’s senior author and an expert in drug safety and pharmacoepidemiology at UBC. “But those who are otherwise healthy and just taking them for weight loss might want to be more careful in weighing the risk–benefit equation.”

People taking these drugs for weight loss have an approximately 1%-2% chance of experiencing these events, including a 1% risk for gastroparesis, Dr. Etminan said.
 

Key findings

The study included 4,144 people taking liraglutide, 613 taking semaglutide, and 654 taking naltrexone/bupropion based on medical records between 2006 and 2020.

They included patients with a recent history of obesity but excluded those with diabetes or who had been prescribed another diabetes medication.

The use of GLP-1 agonists, compared with naltrexone/bupropion, was associated with an increased risk for pancreatitis (adjusted hazard ratio, 9.09; 95% confidence interval, 1.25-66.00), bowel obstruction (HR, 4.22; 95% CI, 1.02-17.40), and gastroparesis (HR, 3.67; 95% CI, 1.15-11.90).

The study also found a higher incidence of biliary disease, but the difference was not statistically significant (HR, 1.50; 95% CI, 0.89-2.53). The incidence of biliary disease (per 1,000 person-years) was 11.7 for semaglutide, 18.6 for liraglutide, and 12.6 for naltrexone/bupropion.
 

Not the first report of GI issues

“This important paper confirms the safety signals hinted at in previous randomized controlled trials,” said Carel Le Roux, MBChB, PhD, professor of metabolic medicine, Ulster University, Coleraine, Ireland, and professor of experimental pathology at University College Dublin.

“The limitations of the paper are acknowledged but do not detract from the value of the robust data,” Dr. Le Roux said. “Patients should be informed of the low risk of serious complications, such as pancreatitis, gastroparesis, and bowel obstruction, before they start semaglutide or liraglutide.”

This is not the first report of GI issues associated with GLP-1 agonists, but it’s one of the largest. Most reports have been anecdotal. The U.S. Food and Drug Administration announced on Sept. 28 that it would require manufacturers to include a warning about gastrointestinal ileus on the Ozempic (semaglutide) label.

“The results from this study highlight how important it is that patients access these drugs only through trusted medical professionals, and only with ongoing support and monitoring,” noted Simon Cork, PhD, senior lecturer in physiology, Anglia Ruskin University in Cambridge, England.

Dr. Cork added that “it’s important to look at this in the proper context.” Obesity significantly increases the risk for developing cardiovascular disease, type 2 diabetes, cancer, gallbladder disease, and stroke, risks that fall dramatically with clinically meaningful and sustained weight loss, he said.

“For the overwhelming majority of patients for whom these drugs are targeted (those with the most severe forms of obesity), the benefits of weight loss far outweigh the risks,” Dr. Cork said.

The study was independently supported. Mr. Sodhi, Dr. Etminan, and Dr. Cork report no relevant financial relationships. Dr. Le Roux is a consultant and has received research funding and reimbursement of travel expenses from Novo Nordisk.

A version of this article first appeared on Medscape.com.

People taking semaglutide or liraglutide for weight management are at a higher risk for rare but potentially serious gastrointestinal issues, compared with those taking naltrexone/bupropion, according to a large epidemiologic study.

Patients taking either of these glucagonlike peptide-1 (GLP-1) receptor agonists had a 9-fold elevation in risk for pancreatitis. They were also 4 times more likely to develop bowel obstruction and over 3.5 times more likely to experience gastroparesis.

The research letter was published online in JAMA.

Investigators say their findings are not about scaring people off the weight-loss drugs, but instead about increasing awareness that these potential adverse outcomes can happen.

“Given the wide use of these drugs, these adverse events, although rare, must be considered by patients thinking about using them for weight loss,” said lead author Mohit Sodhi, MSc, in a news release about the study. Mr. Sodhi is a graduate of the experimental medicine program at the University of British Columbia in Vancouver, and also a 4th-year medical student at UBC.

People taking a GLP-1 agonist to treat diabetes might be more willing to accept the risks, given their potential advantages, especially that of lowering the risk for heart problems, said Mahyar Etminan, PharmD, MSc, the study’s senior author and an expert in drug safety and pharmacoepidemiology at UBC. “But those who are otherwise healthy and just taking them for weight loss might want to be more careful in weighing the risk–benefit equation.”

People taking these drugs for weight loss have an approximately 1%-2% chance of experiencing these events, including a 1% risk for gastroparesis, Dr. Etminan said.
 

Key findings

The study included 4,144 people taking liraglutide, 613 taking semaglutide, and 654 taking naltrexone/bupropion based on medical records between 2006 and 2020.

They included patients with a recent history of obesity but excluded those with diabetes or who had been prescribed another diabetes medication.

The use of GLP-1 agonists, compared with naltrexone/bupropion, was associated with an increased risk for pancreatitis (adjusted hazard ratio, 9.09; 95% confidence interval, 1.25-66.00), bowel obstruction (HR, 4.22; 95% CI, 1.02-17.40), and gastroparesis (HR, 3.67; 95% CI, 1.15-11.90).

The study also found a higher incidence of biliary disease, but the difference was not statistically significant (HR, 1.50; 95% CI, 0.89-2.53). The incidence of biliary disease (per 1,000 person-years) was 11.7 for semaglutide, 18.6 for liraglutide, and 12.6 for naltrexone/bupropion.
 

Not the first report of GI issues

“This important paper confirms the safety signals hinted at in previous randomized controlled trials,” said Carel Le Roux, MBChB, PhD, professor of metabolic medicine, Ulster University, Coleraine, Ireland, and professor of experimental pathology at University College Dublin.

“The limitations of the paper are acknowledged but do not detract from the value of the robust data,” Dr. Le Roux said. “Patients should be informed of the low risk of serious complications, such as pancreatitis, gastroparesis, and bowel obstruction, before they start semaglutide or liraglutide.”

This is not the first report of GI issues associated with GLP-1 agonists, but it’s one of the largest. Most reports have been anecdotal. The U.S. Food and Drug Administration announced on Sept. 28 that it would require manufacturers to include a warning about gastrointestinal ileus on the Ozempic (semaglutide) label.

“The results from this study highlight how important it is that patients access these drugs only through trusted medical professionals, and only with ongoing support and monitoring,” noted Simon Cork, PhD, senior lecturer in physiology, Anglia Ruskin University in Cambridge, England.

Dr. Cork added that “it’s important to look at this in the proper context.” Obesity significantly increases the risk for developing cardiovascular disease, type 2 diabetes, cancer, gallbladder disease, and stroke, risks that fall dramatically with clinically meaningful and sustained weight loss, he said.

“For the overwhelming majority of patients for whom these drugs are targeted (those with the most severe forms of obesity), the benefits of weight loss far outweigh the risks,” Dr. Cork said.

The study was independently supported. Mr. Sodhi, Dr. Etminan, and Dr. Cork report no relevant financial relationships. Dr. Le Roux is a consultant and has received research funding and reimbursement of travel expenses from Novo Nordisk.

A version of this article first appeared on Medscape.com.

People taking semaglutide or liraglutide for weight management are at a higher risk for rare but potentially serious gastrointestinal issues, compared with those taking naltrexone/bupropion, according to a large epidemiologic study.

Patients taking either of these glucagonlike peptide-1 (GLP-1) receptor agonists had a 9-fold elevation in risk for pancreatitis. They were also 4 times more likely to develop bowel obstruction and over 3.5 times more likely to experience gastroparesis.

The research letter was published online in JAMA.

Investigators say their findings are not about scaring people off the weight-loss drugs, but instead about increasing awareness that these potential adverse outcomes can happen.

“Given the wide use of these drugs, these adverse events, although rare, must be considered by patients thinking about using them for weight loss,” said lead author Mohit Sodhi, MSc, in a news release about the study. Mr. Sodhi is a graduate of the experimental medicine program at the University of British Columbia in Vancouver, and also a 4th-year medical student at UBC.

People taking a GLP-1 agonist to treat diabetes might be more willing to accept the risks, given their potential advantages, especially that of lowering the risk for heart problems, said Mahyar Etminan, PharmD, MSc, the study’s senior author and an expert in drug safety and pharmacoepidemiology at UBC. “But those who are otherwise healthy and just taking them for weight loss might want to be more careful in weighing the risk–benefit equation.”

People taking these drugs for weight loss have an approximately 1%-2% chance of experiencing these events, including a 1% risk for gastroparesis, Dr. Etminan said.
 

Key findings

The study included 4,144 people taking liraglutide, 613 taking semaglutide, and 654 taking naltrexone/bupropion based on medical records between 2006 and 2020.

They included patients with a recent history of obesity but excluded those with diabetes or who had been prescribed another diabetes medication.

The use of GLP-1 agonists, compared with naltrexone/bupropion, was associated with an increased risk for pancreatitis (adjusted hazard ratio, 9.09; 95% confidence interval, 1.25-66.00), bowel obstruction (HR, 4.22; 95% CI, 1.02-17.40), and gastroparesis (HR, 3.67; 95% CI, 1.15-11.90).

The study also found a higher incidence of biliary disease, but the difference was not statistically significant (HR, 1.50; 95% CI, 0.89-2.53). The incidence of biliary disease (per 1,000 person-years) was 11.7 for semaglutide, 18.6 for liraglutide, and 12.6 for naltrexone/bupropion.
 

Not the first report of GI issues

“This important paper confirms the safety signals hinted at in previous randomized controlled trials,” said Carel Le Roux, MBChB, PhD, professor of metabolic medicine, Ulster University, Coleraine, Ireland, and professor of experimental pathology at University College Dublin.

“The limitations of the paper are acknowledged but do not detract from the value of the robust data,” Dr. Le Roux said. “Patients should be informed of the low risk of serious complications, such as pancreatitis, gastroparesis, and bowel obstruction, before they start semaglutide or liraglutide.”

This is not the first report of GI issues associated with GLP-1 agonists, but it’s one of the largest. Most reports have been anecdotal. The U.S. Food and Drug Administration announced on Sept. 28 that it would require manufacturers to include a warning about gastrointestinal ileus on the Ozempic (semaglutide) label.

“The results from this study highlight how important it is that patients access these drugs only through trusted medical professionals, and only with ongoing support and monitoring,” noted Simon Cork, PhD, senior lecturer in physiology, Anglia Ruskin University in Cambridge, England.

Dr. Cork added that “it’s important to look at this in the proper context.” Obesity significantly increases the risk for developing cardiovascular disease, type 2 diabetes, cancer, gallbladder disease, and stroke, risks that fall dramatically with clinically meaningful and sustained weight loss, he said.

“For the overwhelming majority of patients for whom these drugs are targeted (those with the most severe forms of obesity), the benefits of weight loss far outweigh the risks,” Dr. Cork said.

The study was independently supported. Mr. Sodhi, Dr. Etminan, and Dr. Cork report no relevant financial relationships. Dr. Le Roux is a consultant and has received research funding and reimbursement of travel expenses from Novo Nordisk.

A version of this article first appeared on Medscape.com.

COVID-19 hospitalizations have been on the rise for weeks as summer nears its end, but how concerned should you be? SARS-CoV-2, the virus behind COVID, continues to evolve and surprise us. So COVID transmission, hospitalization, and death rates can be difficult to predict. 

This news organization turned to the experts for their take on the current circulating virus, asking them to predict if we’ll be masking up again anytime soon, and what this fall and winter might look like, especially now that testing and vaccinations are no longer free of charge.
 

Question 1: Are you expecting an end-of-summer COVID wave to be substantial?

Eric Topol, MD: “This wave won’t likely be substantial and could be more of a ‘wavelet.’ I’m not thinking that physicians are too concerned,” said Dr. Topol, founder and director of Scripps Research Translational Institute in La Jolla, Calif. 

Thomas Gut, DO: “It’s always impossible to predict the severity of COVID waves. Although the virus has generally mutated in ways that favor easier transmission and milder illness, there have been a handful of surprising mutations that were more dangerous and deadly than the preceding strain,” said Dr. Gut, associate chair of medicine at Staten Island University Hospital/Northwell Health in New York.

Robert Atmar, MD: “I’ll start with the caveat that prognosticating for SARS-CoV-2 is a bit hazardous as we remain in unknown territory for some aspects of its epidemiology and evolution,” said Dr. Atmar, a professor of infectious diseases at Baylor College of Medicine in Houston. “It depends on your definition of substantial. We, at least in Houston, are already in the midst of a substantial surge in the burden of infection, at least as monitored through wastewater surveillance. The amount of virus in the wastewater already exceeds the peak level we saw last winter. That said, the increased infection burden has not translated into large increases in hospitalizations for COVID-19. Most persons hospitalized in our hospital are admitted with infection, not for the consequences of infection.”

Stuart Campbell Ray, MD: “It looks like there is a rise in infections, but the proportional rise in hospitalizations from severe cases is lower than in the past, suggesting that folks are protected by the immunity we’ve gained over the past few years through vaccination and prior infections. Of course, we should be thinking about how that applies to each of us – how recently we had a vaccine or COVID-19, and whether we might see more severe infections as immunity wanes,” said Dr. Ray, who is a professor of medicine in the division of infectious diseases at Johns Hopkins University in Baltimore. 

Question 2: Is a return to masks or mask mandates coming this fall or winter?

Dr. Topol: “Mandating masks doesn’t work very well, but we may see wide use again if a descendant of [variant] BA.2.86 takes off.”

Dr. Gut: “It’s difficult to predict if there are any mask mandates returning at any point. Ever since the Omicron strains emerged, COVID has been relatively mild, compared to previous strains, so there probably won’t be any plan to start masking in public unless a more deadly strain appears.”

Dr. Atmar: “I do not think we will see a return to mask mandates this fall or winter for a variety of reasons. The primary one is that I don’t think the public will accept mask mandates. However, I think masking can continue to be an adjunctive measure to enhance protection from infection, along with booster vaccination.”

Dr. Ray: “Some people will choose to wear masks during a surge, particularly in situations like commuting where they don’t interfere with what they’re doing. They will wear masks particularly if they want to avoid infection due to concerns about others they care about, disruption of work or travel plans, or concerns about long-term consequences of repeated COVID-19.”

Question 3: Now that COVID testing and vaccinations are no longer free of charge, how might that affect their use?

Dr. Topol: “It was already low, and this will undoubtedly further compromise their uptake.”

Dr. Gut: “I do expect that testing will become less common now that tests are no longer free. I’m sure there will be a lower amount of detection in patients with milder or asymptomatic disease compared to what we had previously.”

Dr. Atmar: “If there are out-of-pocket costs for the SARS-CoV-2 vaccine, or if the administrative paperwork attached to getting a vaccine is increased, the uptake of SARS-CoV-2 vaccines will likely decrease. It will be important to communicate to the populations targeted for vaccination the potential benefits of such vaccination.”

Dr. Ray: “A challenge with COVID-19, all along, has been disparities in access to care, and this will be worse without public support for prevention and testing. This applies to everyone but is especially burdensome for those who are often marginalized in our health care system and society in general. I hope that we’ll find ways to ensure that people who need tests and vaccinations are able to access them, as good health is in everyone’s interest.”

Question 4: Will the new vaccines against COVID work for the currently circulating variants?

Dr. Topol: “The XBB.1.5 boosters will be out Sept. 14. They should help versus EG.5.1 and FL.1.5.1. The FL.1.5.1 variant is gaining now.”

Dr. Gut: “In the next several weeks, we expect the newer monovalent XBB-based vaccines to be offered that offer good protection against current circulating COVID variants along with the new Eris variant.”

Dr. Atmar: “The vaccines are expected to induce immune responses to the currently circulating variants, most of which are strains that evolved from the vaccine strain. The vaccine is expected to be most effective in preventing severe illness and will likely be less effective in preventing infection and mild illness.”

Dr. Ray: “Yes, the updated vaccine design has a spike antigen (XBB.1.5) nearly identical to the current dominant variant (EG.5). Even as variants change, the boosters stimulate B cells and T cells to help protect in a way that is safer than getting COVID-19 infection.”

Question 5: Is there anything we should watch out for regarding the BA.2.86 variant in particular?

Dr. Topol: “The scenario could change if there are new functional mutations added to it.”

Dr. Gut: “BA.2.86 is still fairly uncommon and does not have much data to directly make any informed guesses. However, in general, people that have been exposed to more recent mutations of the COVID virus have been shown to have more protection from newer upcoming mutations. It’s fair to guess that people that have not had recent infection from COVID, or have not had a recent booster, are at higher risk for being infected by any XBB- or BA.2-based strains.”

Dr. Atmar: BA.2.86 has been designated as a variant under monitoring. We will want to see whether it becomes more common and if there are any unexpected characteristics associated with infection by this variant.”

Dr. Ray: “It’s still rare, but it’s been seen in geographically dispersed places, so it’s got legs. The question is how effectively it will bypass some of the immunity we’ve gained. T cells are likely to remain protective, because they target so many parts of the virus that change more slowly, but antibodies from B cells to spike protein may have more trouble recognizing BA.2.86, whether those antibodies were made to a vaccine or a prior variant.”

A version of this article first appeared on WebMD.com.

COVID-19 hospitalizations have been on the rise for weeks as summer nears its end, but how concerned should you be? SARS-CoV-2, the virus behind COVID, continues to evolve and surprise us. So COVID transmission, hospitalization, and death rates can be difficult to predict. 

This news organization turned to the experts for their take on the current circulating virus, asking them to predict if we’ll be masking up again anytime soon, and what this fall and winter might look like, especially now that testing and vaccinations are no longer free of charge.
 

Question 1: Are you expecting an end-of-summer COVID wave to be substantial?

Eric Topol, MD: “This wave won’t likely be substantial and could be more of a ‘wavelet.’ I’m not thinking that physicians are too concerned,” said Dr. Topol, founder and director of Scripps Research Translational Institute in La Jolla, Calif. 

Thomas Gut, DO: “It’s always impossible to predict the severity of COVID waves. Although the virus has generally mutated in ways that favor easier transmission and milder illness, there have been a handful of surprising mutations that were more dangerous and deadly than the preceding strain,” said Dr. Gut, associate chair of medicine at Staten Island University Hospital/Northwell Health in New York.

Robert Atmar, MD: “I’ll start with the caveat that prognosticating for SARS-CoV-2 is a bit hazardous as we remain in unknown territory for some aspects of its epidemiology and evolution,” said Dr. Atmar, a professor of infectious diseases at Baylor College of Medicine in Houston. “It depends on your definition of substantial. We, at least in Houston, are already in the midst of a substantial surge in the burden of infection, at least as monitored through wastewater surveillance. The amount of virus in the wastewater already exceeds the peak level we saw last winter. That said, the increased infection burden has not translated into large increases in hospitalizations for COVID-19. Most persons hospitalized in our hospital are admitted with infection, not for the consequences of infection.”

Stuart Campbell Ray, MD: “It looks like there is a rise in infections, but the proportional rise in hospitalizations from severe cases is lower than in the past, suggesting that folks are protected by the immunity we’ve gained over the past few years through vaccination and prior infections. Of course, we should be thinking about how that applies to each of us – how recently we had a vaccine or COVID-19, and whether we might see more severe infections as immunity wanes,” said Dr. Ray, who is a professor of medicine in the division of infectious diseases at Johns Hopkins University in Baltimore. 

Question 2: Is a return to masks or mask mandates coming this fall or winter?

Dr. Topol: “Mandating masks doesn’t work very well, but we may see wide use again if a descendant of [variant] BA.2.86 takes off.”

Dr. Gut: “It’s difficult to predict if there are any mask mandates returning at any point. Ever since the Omicron strains emerged, COVID has been relatively mild, compared to previous strains, so there probably won’t be any plan to start masking in public unless a more deadly strain appears.”

Dr. Atmar: “I do not think we will see a return to mask mandates this fall or winter for a variety of reasons. The primary one is that I don’t think the public will accept mask mandates. However, I think masking can continue to be an adjunctive measure to enhance protection from infection, along with booster vaccination.”

Dr. Ray: “Some people will choose to wear masks during a surge, particularly in situations like commuting where they don’t interfere with what they’re doing. They will wear masks particularly if they want to avoid infection due to concerns about others they care about, disruption of work or travel plans, or concerns about long-term consequences of repeated COVID-19.”

Question 3: Now that COVID testing and vaccinations are no longer free of charge, how might that affect their use?

Dr. Topol: “It was already low, and this will undoubtedly further compromise their uptake.”

Dr. Gut: “I do expect that testing will become less common now that tests are no longer free. I’m sure there will be a lower amount of detection in patients with milder or asymptomatic disease compared to what we had previously.”

Dr. Atmar: “If there are out-of-pocket costs for the SARS-CoV-2 vaccine, or if the administrative paperwork attached to getting a vaccine is increased, the uptake of SARS-CoV-2 vaccines will likely decrease. It will be important to communicate to the populations targeted for vaccination the potential benefits of such vaccination.”

Dr. Ray: “A challenge with COVID-19, all along, has been disparities in access to care, and this will be worse without public support for prevention and testing. This applies to everyone but is especially burdensome for those who are often marginalized in our health care system and society in general. I hope that we’ll find ways to ensure that people who need tests and vaccinations are able to access them, as good health is in everyone’s interest.”

Question 4: Will the new vaccines against COVID work for the currently circulating variants?

Dr. Topol: “The XBB.1.5 boosters will be out Sept. 14. They should help versus EG.5.1 and FL.1.5.1. The FL.1.5.1 variant is gaining now.”

Dr. Gut: “In the next several weeks, we expect the newer monovalent XBB-based vaccines to be offered that offer good protection against current circulating COVID variants along with the new Eris variant.”

Dr. Atmar: “The vaccines are expected to induce immune responses to the currently circulating variants, most of which are strains that evolved from the vaccine strain. The vaccine is expected to be most effective in preventing severe illness and will likely be less effective in preventing infection and mild illness.”

Dr. Ray: “Yes, the updated vaccine design has a spike antigen (XBB.1.5) nearly identical to the current dominant variant (EG.5). Even as variants change, the boosters stimulate B cells and T cells to help protect in a way that is safer than getting COVID-19 infection.”

Question 5: Is there anything we should watch out for regarding the BA.2.86 variant in particular?

Dr. Topol: “The scenario could change if there are new functional mutations added to it.”

Dr. Gut: “BA.2.86 is still fairly uncommon and does not have much data to directly make any informed guesses. However, in general, people that have been exposed to more recent mutations of the COVID virus have been shown to have more protection from newer upcoming mutations. It’s fair to guess that people that have not had recent infection from COVID, or have not had a recent booster, are at higher risk for being infected by any XBB- or BA.2-based strains.”

Dr. Atmar: BA.2.86 has been designated as a variant under monitoring. We will want to see whether it becomes more common and if there are any unexpected characteristics associated with infection by this variant.”

Dr. Ray: “It’s still rare, but it’s been seen in geographically dispersed places, so it’s got legs. The question is how effectively it will bypass some of the immunity we’ve gained. T cells are likely to remain protective, because they target so many parts of the virus that change more slowly, but antibodies from B cells to spike protein may have more trouble recognizing BA.2.86, whether those antibodies were made to a vaccine or a prior variant.”

A version of this article first appeared on WebMD.com.

COVID-19 hospitalizations have been on the rise for weeks as summer nears its end, but how concerned should you be? SARS-CoV-2, the virus behind COVID, continues to evolve and surprise us. So COVID transmission, hospitalization, and death rates can be difficult to predict. 

This news organization turned to the experts for their take on the current circulating virus, asking them to predict if we’ll be masking up again anytime soon, and what this fall and winter might look like, especially now that testing and vaccinations are no longer free of charge.
 

Question 1: Are you expecting an end-of-summer COVID wave to be substantial?

Eric Topol, MD: “This wave won’t likely be substantial and could be more of a ‘wavelet.’ I’m not thinking that physicians are too concerned,” said Dr. Topol, founder and director of Scripps Research Translational Institute in La Jolla, Calif. 

Thomas Gut, DO: “It’s always impossible to predict the severity of COVID waves. Although the virus has generally mutated in ways that favor easier transmission and milder illness, there have been a handful of surprising mutations that were more dangerous and deadly than the preceding strain,” said Dr. Gut, associate chair of medicine at Staten Island University Hospital/Northwell Health in New York.

Robert Atmar, MD: “I’ll start with the caveat that prognosticating for SARS-CoV-2 is a bit hazardous as we remain in unknown territory for some aspects of its epidemiology and evolution,” said Dr. Atmar, a professor of infectious diseases at Baylor College of Medicine in Houston. “It depends on your definition of substantial. We, at least in Houston, are already in the midst of a substantial surge in the burden of infection, at least as monitored through wastewater surveillance. The amount of virus in the wastewater already exceeds the peak level we saw last winter. That said, the increased infection burden has not translated into large increases in hospitalizations for COVID-19. Most persons hospitalized in our hospital are admitted with infection, not for the consequences of infection.”

Stuart Campbell Ray, MD: “It looks like there is a rise in infections, but the proportional rise in hospitalizations from severe cases is lower than in the past, suggesting that folks are protected by the immunity we’ve gained over the past few years through vaccination and prior infections. Of course, we should be thinking about how that applies to each of us – how recently we had a vaccine or COVID-19, and whether we might see more severe infections as immunity wanes,” said Dr. Ray, who is a professor of medicine in the division of infectious diseases at Johns Hopkins University in Baltimore. 

Question 2: Is a return to masks or mask mandates coming this fall or winter?

Dr. Topol: “Mandating masks doesn’t work very well, but we may see wide use again if a descendant of [variant] BA.2.86 takes off.”

Dr. Gut: “It’s difficult to predict if there are any mask mandates returning at any point. Ever since the Omicron strains emerged, COVID has been relatively mild, compared to previous strains, so there probably won’t be any plan to start masking in public unless a more deadly strain appears.”

Dr. Atmar: “I do not think we will see a return to mask mandates this fall or winter for a variety of reasons. The primary one is that I don’t think the public will accept mask mandates. However, I think masking can continue to be an adjunctive measure to enhance protection from infection, along with booster vaccination.”

Dr. Ray: “Some people will choose to wear masks during a surge, particularly in situations like commuting where they don’t interfere with what they’re doing. They will wear masks particularly if they want to avoid infection due to concerns about others they care about, disruption of work or travel plans, or concerns about long-term consequences of repeated COVID-19.”

Question 3: Now that COVID testing and vaccinations are no longer free of charge, how might that affect their use?

Dr. Topol: “It was already low, and this will undoubtedly further compromise their uptake.”

Dr. Gut: “I do expect that testing will become less common now that tests are no longer free. I’m sure there will be a lower amount of detection in patients with milder or asymptomatic disease compared to what we had previously.”

Dr. Atmar: “If there are out-of-pocket costs for the SARS-CoV-2 vaccine, or if the administrative paperwork attached to getting a vaccine is increased, the uptake of SARS-CoV-2 vaccines will likely decrease. It will be important to communicate to the populations targeted for vaccination the potential benefits of such vaccination.”

Dr. Ray: “A challenge with COVID-19, all along, has been disparities in access to care, and this will be worse without public support for prevention and testing. This applies to everyone but is especially burdensome for those who are often marginalized in our health care system and society in general. I hope that we’ll find ways to ensure that people who need tests and vaccinations are able to access them, as good health is in everyone’s interest.”

Question 4: Will the new vaccines against COVID work for the currently circulating variants?

Dr. Topol: “The XBB.1.5 boosters will be out Sept. 14. They should help versus EG.5.1 and FL.1.5.1. The FL.1.5.1 variant is gaining now.”

Dr. Gut: “In the next several weeks, we expect the newer monovalent XBB-based vaccines to be offered that offer good protection against current circulating COVID variants along with the new Eris variant.”

Dr. Atmar: “The vaccines are expected to induce immune responses to the currently circulating variants, most of which are strains that evolved from the vaccine strain. The vaccine is expected to be most effective in preventing severe illness and will likely be less effective in preventing infection and mild illness.”

Dr. Ray: “Yes, the updated vaccine design has a spike antigen (XBB.1.5) nearly identical to the current dominant variant (EG.5). Even as variants change, the boosters stimulate B cells and T cells to help protect in a way that is safer than getting COVID-19 infection.”

Question 5: Is there anything we should watch out for regarding the BA.2.86 variant in particular?

Dr. Topol: “The scenario could change if there are new functional mutations added to it.”

Dr. Gut: “BA.2.86 is still fairly uncommon and does not have much data to directly make any informed guesses. However, in general, people that have been exposed to more recent mutations of the COVID virus have been shown to have more protection from newer upcoming mutations. It’s fair to guess that people that have not had recent infection from COVID, or have not had a recent booster, are at higher risk for being infected by any XBB- or BA.2-based strains.”

Dr. Atmar: BA.2.86 has been designated as a variant under monitoring. We will want to see whether it becomes more common and if there are any unexpected characteristics associated with infection by this variant.”

Dr. Ray: “It’s still rare, but it’s been seen in geographically dispersed places, so it’s got legs. The question is how effectively it will bypass some of the immunity we’ve gained. T cells are likely to remain protective, because they target so many parts of the virus that change more slowly, but antibodies from B cells to spike protein may have more trouble recognizing BA.2.86, whether those antibodies were made to a vaccine or a prior variant.”

A version of this article first appeared on WebMD.com.

More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.

Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July. 

A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation. 

Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
 

Cause for concern?

The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn. 

“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”

So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”

While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.

So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
 

What the official numbers say

The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.

But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000. 

“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle. 

“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.” 

For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing. 

So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited. 

It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States. 

In terms of other metrics: 

• On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%. 
• On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown. 
• The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.

What about new COVID vaccines?

As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter. 

“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University. 

In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”

Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”

Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September. 

His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.” 

Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”

Stay alert and stay realistic

Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said. 

“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”

While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”

A version of this article first appeared on WebMD.com.

More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.

Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July. 

A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation. 

Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
 

Cause for concern?

The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn. 

“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”

So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”

While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.

So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
 

What the official numbers say

The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.

But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000. 

“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle. 

“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.” 

For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing. 

So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited. 

It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States. 

In terms of other metrics: 

• On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%. 
• On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown. 
• The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.

What about new COVID vaccines?

As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter. 

“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University. 

In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”

Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”

Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September. 

His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.” 

Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”

Stay alert and stay realistic

Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said. 

“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”

While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”

A version of this article first appeared on WebMD.com.

More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.

Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July. 

A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation. 

Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
 

Cause for concern?

The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn. 

“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”

So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”

While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.

So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
 

What the official numbers say

The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.

But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000. 

“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle. 

“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.” 

For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing. 

So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited. 

It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States. 

In terms of other metrics: 

• On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%. 
• On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown. 
• The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.

What about new COVID vaccines?

As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter. 

“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University. 

In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”

Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”

Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September. 

His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.” 

Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”

Stay alert and stay realistic

Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said. 

“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”

While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”

A version of this article first appeared on WebMD.com.