TBD Meeting (3060-20)

Teprotumumab (Tepezza, Horizon Therapeutics), the first-ever medication approved specifically to treat thyroid eye disease, works in patients regardless of age, gender, and smoking status, new research finds.

The data were presented on March 31 by Raymond S. Douglas, MD, director of the thyroid eye disease program at Cedars-Sinai Medical Center, Los Angeles, during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

Thyroid eye disease occurs in up to 50% of people with Graves disease, causing a variety of symptoms, such as eye pain, double vision, light sensitivity or difficulty closing the eye, as well as proptosis, or bulging of the eye, and vision-threatening complications. It affects more women than men, and the symptoms can lead to the progressive inability to perform important daily activities, such as driving or working.

Teprotumumab is a fully human monoclonal antibody inhibitor of the insulin-like growth factor-1 (IGF-1) receptor and was approved by the US Food and Drug Administration in January 2020. Prior to that, therapy typically involved steroids or, in severe cases, surgery.

Blocking the IGF-1 receptor leads to reduced inflammation and reversal of retro-orbital tissue expansion and hyaluronan production in the eye orbit. Teprotumumab is given as an infusion once every 3 weeks for a total of eight infusions.
 

“Exciting to have an agent” that reduces proptosis to this degree

Previously reported pooled phase 2 and phase 3 data from the randomized, placebo-controlled OPTIC trial involving 171 patients showed significantly greater reductions in proptosis, as well as diplopia, and clinical symptoms of inflammation with teprotumumab versus placebo.

“This has really been unheralded in comparison to other medical therapies previously offered,” Dr. Douglas said during the briefing.

Now, the new analysis shows that the drug works across patient subgroups, he added, highlighting in particular the fact that the agent seems to work equally well in smokers and nonsmokers. Smoking leads to a worse prognosis in thyroid eye disease.

Asked to comment, endocrinologist David C. Lieb, MD, of Eastern Virginia Medical School, Norfolk, said in an interview, “It’s reassuring that this drug appears to have benefits in reducing proptosis across multiple age groups, in both genders, and that there are also benefits seen in patients who smoke and who don’t.”

So far Dr. Lieb has two patients who have been prescribed teprotumumab by their ophthalmologists, but it’s too soon to know how they’ll respond.

“I have no first-hand experience yet, but it’s very exciting to have something to offer patients with active Graves eye disease, which causes a lot of disability for people. It makes work difficult and driving difficult. It’s exciting to have an agent that reduces proptosis to the degree that this one does because we haven’t had anything like this before,” he said.

All patient subgroups benefited in combined analysis

A total of 79 patients completed phase 2 and 76 patients completed phase 3 of the OPTIC trial.

Overall, the proportions achieving proptosis reductions of at least 2 mm without deterioration in the fellow eye at week 24 were 77.4% with teprotumumab versus 14.9% with placebo in the intention-to-treat analysis (P < .001), respectively, and 84.8% versus 17.1% in the per-protocol analysis (P < .001). The number needed to treat was 1.6.

Similar results were achieved across all subgroups of patients: those aged 65 and older versus younger than aged 65 years; male versus female; tobacco user versus nonuser; and U.S. versus E.U. study centers (all P < .001).

Overall, the average decrease in proptosis was 3.1 mm, compared to just 0.4 mm with placebo (P < .001). By subgroup, those reductions ranged from 3.55 mm for those aged 65 and older to 2.93 mm for the U.S. group.

The average proptosis reductions with teprotumumab were 2.99 mm among smokers versus 3.20 mm in nonsmokers, but responses in both groups were significant when compared with placebo.

Smoking contributes to the severity of thyroid eye disease and is associated with more optic neuropathy, poorer response to anti-inflammatory treatment, and worse outcomes, Dr. Douglas said. “Smoking appears to preferentially cause fibroblasts in the orbit to increase proinflammatory cytokines. ... It’s reassuring that this medicine does work in smokers since most other medications are much less effective in reducing inflammatory signs in smoking versus nonsmoking patients.”
 

Most adverse reactions disappeared after infusion stopped

In the pooled studies overall there were no deaths, but there were seven severe adverse events in the teprotumumab group versus one in the placebo group. Two adverse events in the teprotumumab group – diarrhea and infusion-related reaction – were considered treatment-related and led to drug discontinuation. Another adverse event, Hashimoto’s encephalopathy, was deemed possibly related to the drug and also led to discontinuation.

Treatment-emergent adverse events occurred in 79.8% of patients treated with teprotumumab versus 69.8% with placebo. Those occurring in 5% or more of patients included muscle spasms (25% vs. 7%), nausea (17% vs. 9%), alopecia (13% vs. 8%), and diarrhea (12% vs. 8%). Most were well tolerated and tended to resolve after the infusions ended, Dr. Douglas noted, adding muscle spasms tended to occur at night, improved with massage, and were not accompanied by electrolyte abnormalities.

Antidrug antibodies were detected in two teprotumumab-treated patients, one at study day 1 and another at week 3 during the 24-week treatment period. The patient with antibodies at day 1 also tested positive at week 72. “[Antidrug] antibodies appeared to be very uncommon,” Dr. Douglas noted.

The trial was sponsored by Horizon Therapeutics. Dr. Douglas is a consultant for Horizon Therapeutics and Immunovant. Dr. Lieb has reported no relevant financial relationships. The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

This article first appeared on Medscape.com.

Teprotumumab (Tepezza, Horizon Therapeutics), the first-ever medication approved specifically to treat thyroid eye disease, works in patients regardless of age, gender, and smoking status, new research finds.

The data were presented on March 31 by Raymond S. Douglas, MD, director of the thyroid eye disease program at Cedars-Sinai Medical Center, Los Angeles, during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

Thyroid eye disease occurs in up to 50% of people with Graves disease, causing a variety of symptoms, such as eye pain, double vision, light sensitivity or difficulty closing the eye, as well as proptosis, or bulging of the eye, and vision-threatening complications. It affects more women than men, and the symptoms can lead to the progressive inability to perform important daily activities, such as driving or working.

Teprotumumab is a fully human monoclonal antibody inhibitor of the insulin-like growth factor-1 (IGF-1) receptor and was approved by the US Food and Drug Administration in January 2020. Prior to that, therapy typically involved steroids or, in severe cases, surgery.

Blocking the IGF-1 receptor leads to reduced inflammation and reversal of retro-orbital tissue expansion and hyaluronan production in the eye orbit. Teprotumumab is given as an infusion once every 3 weeks for a total of eight infusions.
 

“Exciting to have an agent” that reduces proptosis to this degree

Previously reported pooled phase 2 and phase 3 data from the randomized, placebo-controlled OPTIC trial involving 171 patients showed significantly greater reductions in proptosis, as well as diplopia, and clinical symptoms of inflammation with teprotumumab versus placebo.

“This has really been unheralded in comparison to other medical therapies previously offered,” Dr. Douglas said during the briefing.

Now, the new analysis shows that the drug works across patient subgroups, he added, highlighting in particular the fact that the agent seems to work equally well in smokers and nonsmokers. Smoking leads to a worse prognosis in thyroid eye disease.

Asked to comment, endocrinologist David C. Lieb, MD, of Eastern Virginia Medical School, Norfolk, said in an interview, “It’s reassuring that this drug appears to have benefits in reducing proptosis across multiple age groups, in both genders, and that there are also benefits seen in patients who smoke and who don’t.”

So far Dr. Lieb has two patients who have been prescribed teprotumumab by their ophthalmologists, but it’s too soon to know how they’ll respond.

“I have no first-hand experience yet, but it’s very exciting to have something to offer patients with active Graves eye disease, which causes a lot of disability for people. It makes work difficult and driving difficult. It’s exciting to have an agent that reduces proptosis to the degree that this one does because we haven’t had anything like this before,” he said.

All patient subgroups benefited in combined analysis

A total of 79 patients completed phase 2 and 76 patients completed phase 3 of the OPTIC trial.

Overall, the proportions achieving proptosis reductions of at least 2 mm without deterioration in the fellow eye at week 24 were 77.4% with teprotumumab versus 14.9% with placebo in the intention-to-treat analysis (P < .001), respectively, and 84.8% versus 17.1% in the per-protocol analysis (P < .001). The number needed to treat was 1.6.

Similar results were achieved across all subgroups of patients: those aged 65 and older versus younger than aged 65 years; male versus female; tobacco user versus nonuser; and U.S. versus E.U. study centers (all P < .001).

Overall, the average decrease in proptosis was 3.1 mm, compared to just 0.4 mm with placebo (P < .001). By subgroup, those reductions ranged from 3.55 mm for those aged 65 and older to 2.93 mm for the U.S. group.

The average proptosis reductions with teprotumumab were 2.99 mm among smokers versus 3.20 mm in nonsmokers, but responses in both groups were significant when compared with placebo.

Smoking contributes to the severity of thyroid eye disease and is associated with more optic neuropathy, poorer response to anti-inflammatory treatment, and worse outcomes, Dr. Douglas said. “Smoking appears to preferentially cause fibroblasts in the orbit to increase proinflammatory cytokines. ... It’s reassuring that this medicine does work in smokers since most other medications are much less effective in reducing inflammatory signs in smoking versus nonsmoking patients.”
 

Most adverse reactions disappeared after infusion stopped

In the pooled studies overall there were no deaths, but there were seven severe adverse events in the teprotumumab group versus one in the placebo group. Two adverse events in the teprotumumab group – diarrhea and infusion-related reaction – were considered treatment-related and led to drug discontinuation. Another adverse event, Hashimoto’s encephalopathy, was deemed possibly related to the drug and also led to discontinuation.

Treatment-emergent adverse events occurred in 79.8% of patients treated with teprotumumab versus 69.8% with placebo. Those occurring in 5% or more of patients included muscle spasms (25% vs. 7%), nausea (17% vs. 9%), alopecia (13% vs. 8%), and diarrhea (12% vs. 8%). Most were well tolerated and tended to resolve after the infusions ended, Dr. Douglas noted, adding muscle spasms tended to occur at night, improved with massage, and were not accompanied by electrolyte abnormalities.

Antidrug antibodies were detected in two teprotumumab-treated patients, one at study day 1 and another at week 3 during the 24-week treatment period. The patient with antibodies at day 1 also tested positive at week 72. “[Antidrug] antibodies appeared to be very uncommon,” Dr. Douglas noted.

The trial was sponsored by Horizon Therapeutics. Dr. Douglas is a consultant for Horizon Therapeutics and Immunovant. Dr. Lieb has reported no relevant financial relationships. The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

This article first appeared on Medscape.com.

Teprotumumab (Tepezza, Horizon Therapeutics), the first-ever medication approved specifically to treat thyroid eye disease, works in patients regardless of age, gender, and smoking status, new research finds.

The data were presented on March 31 by Raymond S. Douglas, MD, director of the thyroid eye disease program at Cedars-Sinai Medical Center, Los Angeles, during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

Thyroid eye disease occurs in up to 50% of people with Graves disease, causing a variety of symptoms, such as eye pain, double vision, light sensitivity or difficulty closing the eye, as well as proptosis, or bulging of the eye, and vision-threatening complications. It affects more women than men, and the symptoms can lead to the progressive inability to perform important daily activities, such as driving or working.

Teprotumumab is a fully human monoclonal antibody inhibitor of the insulin-like growth factor-1 (IGF-1) receptor and was approved by the US Food and Drug Administration in January 2020. Prior to that, therapy typically involved steroids or, in severe cases, surgery.

Blocking the IGF-1 receptor leads to reduced inflammation and reversal of retro-orbital tissue expansion and hyaluronan production in the eye orbit. Teprotumumab is given as an infusion once every 3 weeks for a total of eight infusions.
 

“Exciting to have an agent” that reduces proptosis to this degree

Previously reported pooled phase 2 and phase 3 data from the randomized, placebo-controlled OPTIC trial involving 171 patients showed significantly greater reductions in proptosis, as well as diplopia, and clinical symptoms of inflammation with teprotumumab versus placebo.

“This has really been unheralded in comparison to other medical therapies previously offered,” Dr. Douglas said during the briefing.

Now, the new analysis shows that the drug works across patient subgroups, he added, highlighting in particular the fact that the agent seems to work equally well in smokers and nonsmokers. Smoking leads to a worse prognosis in thyroid eye disease.

Asked to comment, endocrinologist David C. Lieb, MD, of Eastern Virginia Medical School, Norfolk, said in an interview, “It’s reassuring that this drug appears to have benefits in reducing proptosis across multiple age groups, in both genders, and that there are also benefits seen in patients who smoke and who don’t.”

So far Dr. Lieb has two patients who have been prescribed teprotumumab by their ophthalmologists, but it’s too soon to know how they’ll respond.

“I have no first-hand experience yet, but it’s very exciting to have something to offer patients with active Graves eye disease, which causes a lot of disability for people. It makes work difficult and driving difficult. It’s exciting to have an agent that reduces proptosis to the degree that this one does because we haven’t had anything like this before,” he said.

All patient subgroups benefited in combined analysis

A total of 79 patients completed phase 2 and 76 patients completed phase 3 of the OPTIC trial.

Overall, the proportions achieving proptosis reductions of at least 2 mm without deterioration in the fellow eye at week 24 were 77.4% with teprotumumab versus 14.9% with placebo in the intention-to-treat analysis (P < .001), respectively, and 84.8% versus 17.1% in the per-protocol analysis (P < .001). The number needed to treat was 1.6.

Similar results were achieved across all subgroups of patients: those aged 65 and older versus younger than aged 65 years; male versus female; tobacco user versus nonuser; and U.S. versus E.U. study centers (all P < .001).

Overall, the average decrease in proptosis was 3.1 mm, compared to just 0.4 mm with placebo (P < .001). By subgroup, those reductions ranged from 3.55 mm for those aged 65 and older to 2.93 mm for the U.S. group.

The average proptosis reductions with teprotumumab were 2.99 mm among smokers versus 3.20 mm in nonsmokers, but responses in both groups were significant when compared with placebo.

Smoking contributes to the severity of thyroid eye disease and is associated with more optic neuropathy, poorer response to anti-inflammatory treatment, and worse outcomes, Dr. Douglas said. “Smoking appears to preferentially cause fibroblasts in the orbit to increase proinflammatory cytokines. ... It’s reassuring that this medicine does work in smokers since most other medications are much less effective in reducing inflammatory signs in smoking versus nonsmoking patients.”
 

Most adverse reactions disappeared after infusion stopped

In the pooled studies overall there were no deaths, but there were seven severe adverse events in the teprotumumab group versus one in the placebo group. Two adverse events in the teprotumumab group – diarrhea and infusion-related reaction – were considered treatment-related and led to drug discontinuation. Another adverse event, Hashimoto’s encephalopathy, was deemed possibly related to the drug and also led to discontinuation.

Treatment-emergent adverse events occurred in 79.8% of patients treated with teprotumumab versus 69.8% with placebo. Those occurring in 5% or more of patients included muscle spasms (25% vs. 7%), nausea (17% vs. 9%), alopecia (13% vs. 8%), and diarrhea (12% vs. 8%). Most were well tolerated and tended to resolve after the infusions ended, Dr. Douglas noted, adding muscle spasms tended to occur at night, improved with massage, and were not accompanied by electrolyte abnormalities.

Antidrug antibodies were detected in two teprotumumab-treated patients, one at study day 1 and another at week 3 during the 24-week treatment period. The patient with antibodies at day 1 also tested positive at week 72. “[Antidrug] antibodies appeared to be very uncommon,” Dr. Douglas noted.

The trial was sponsored by Horizon Therapeutics. Dr. Douglas is a consultant for Horizon Therapeutics and Immunovant. Dr. Lieb has reported no relevant financial relationships. The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

This article first appeared on Medscape.com.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

Bone fracture in older adults is associated with greater mortality risk, but the location of the break may be a key factor, according to a new study of outcomes in a Danish database.

Over the follow-up period, those with proximal fractures – breaks in the hip, femur, pelvis, rib, clavicle, and humerus – were more likely to be hospitalized and to die, compared with their matched controls, than were those were with distal fractures in regions like the ankle, forearm, hand, or foot, where the mortality was similar to the matched controls.

“Compared with someone with similar comorbidities without a proximal fracture, there seemed to be an increased hospitalization rate for things like diabetes, heart disease, and lung disease, and then for some of those hospitalizations, there seemed to be an increased mortality, compared with people who hadn’t fractured who were hospitalized,” said Jacqueline Center, MBBS, PhD, of the Garvan Institute of Medical Research, Sydney, in an interview. The study abstract was released online by the Endocrine Society. It had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.*

The study included 212,498 women and 95,372 men aged over 50 years who had a fragility fracture between 2001 and 2014. The researchers excluded high-trauma fractures. They matched each fracture patient with four nonfracture patients, based on sex, age, and comorbidity status. There were 30,677 deaths among women over 384,995 person-years of follow-up, and 19,519 deaths in men over 163,482 person-years of follow-up. Women were a mean age of 72 at the time of fracture, while men were a mean age of 75.

The researchers found that proximal fractures were associated with increased risk of mortality, compared with nonfractured controls, with hazard ratios ranging between 1.5 and 4.0. Distal fractures were not associated with any increased mortality risk.

Comorbidities were common in the study population, with 75% of men and 60% of women having at least one. The risk of mortality increased with increasing numbers of comorbidities in each fracture type, but only proximal fractures were associated with an independent increase in mortality risk over and above comorbidity status.

In the 2 years following fracture, compared with matched controls, proximal fractures were associated with a greater risk of major hospital admission for conditions like cardiovascular disease, cancer, stroke, diabetes, pneumonia, and pulmonary disease. There was no significant difference between controls and those with distal fractures in hospital admission rate. The 2-year mortality risk was higher among subjects with proximal fractures, compared with patients in the no-fracture control group, regardless of whether they were admitted to the hospital, but there was no significant difference in those with distal fractures.

The differing clinical trajectories between those with proximal and distal fractures is a key finding, according to Dr. Center. The cause still isn’t clear, but she suspects that, in those patients who do badly, the fractures are either a signal that something is happening with existing comorbidities of the underlying frailty or that it may exacerbate them. Comorbidity independently and additively contributes to mortality, so that someone with a hip fracture and no comorbidities might have a similar mortality risk as someone with an upper-arm fracture and a couple of comorbidities. “I think it tells us that the person has to be treated as a whole. We need to treat the fracture to treat the underlying osteoporosis, but we also need to look closely at the person with the fracture and treat their comorbidities as well, because they seem to be more vulnerable,” Dr. Center said.

Although patients and clinicians are attuned to the concerns over hip fractures, other fractures should also be noted, according to Nelson Watts, MD, who is director of osteoporosis and bone-health services at Mercy Health in Cincinnati and was not involved in the research. “I think the message for clinicians and patients is that all of these [proximal] fractures need to be taken seriously. The good news is that that we have medications that can cut the risk of further fractures by 50%-70%,” he said in an interview.

Dr. Center has been on an advisory board for Amgen. Dr. Watts has been a speaker for Amgen and Radius and has conducted numerous clinical trials of osteoporosis drugs.

In addition to a series of news conferences, the Endocrine Society is also planning to host ENDO Online 2020 during June 8-22, which will feature on-demand and live programming for clinicians and researchers.

SOURCE: Center J et al. ENDO 2020, Abstract OR13-03.

Correction, 4/21/20: An earlier version of this article misstated when the interview with Dr. Center took place.

Bone fracture in older adults is associated with greater mortality risk, but the location of the break may be a key factor, according to a new study of outcomes in a Danish database.

Over the follow-up period, those with proximal fractures – breaks in the hip, femur, pelvis, rib, clavicle, and humerus – were more likely to be hospitalized and to die, compared with their matched controls, than were those were with distal fractures in regions like the ankle, forearm, hand, or foot, where the mortality was similar to the matched controls.

“Compared with someone with similar comorbidities without a proximal fracture, there seemed to be an increased hospitalization rate for things like diabetes, heart disease, and lung disease, and then for some of those hospitalizations, there seemed to be an increased mortality, compared with people who hadn’t fractured who were hospitalized,” said Jacqueline Center, MBBS, PhD, of the Garvan Institute of Medical Research, Sydney, in an interview. The study abstract was released online by the Endocrine Society. It had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.*

The study included 212,498 women and 95,372 men aged over 50 years who had a fragility fracture between 2001 and 2014. The researchers excluded high-trauma fractures. They matched each fracture patient with four nonfracture patients, based on sex, age, and comorbidity status. There were 30,677 deaths among women over 384,995 person-years of follow-up, and 19,519 deaths in men over 163,482 person-years of follow-up. Women were a mean age of 72 at the time of fracture, while men were a mean age of 75.

The researchers found that proximal fractures were associated with increased risk of mortality, compared with nonfractured controls, with hazard ratios ranging between 1.5 and 4.0. Distal fractures were not associated with any increased mortality risk.

Comorbidities were common in the study population, with 75% of men and 60% of women having at least one. The risk of mortality increased with increasing numbers of comorbidities in each fracture type, but only proximal fractures were associated with an independent increase in mortality risk over and above comorbidity status.

In the 2 years following fracture, compared with matched controls, proximal fractures were associated with a greater risk of major hospital admission for conditions like cardiovascular disease, cancer, stroke, diabetes, pneumonia, and pulmonary disease. There was no significant difference between controls and those with distal fractures in hospital admission rate. The 2-year mortality risk was higher among subjects with proximal fractures, compared with patients in the no-fracture control group, regardless of whether they were admitted to the hospital, but there was no significant difference in those with distal fractures.

The differing clinical trajectories between those with proximal and distal fractures is a key finding, according to Dr. Center. The cause still isn’t clear, but she suspects that, in those patients who do badly, the fractures are either a signal that something is happening with existing comorbidities of the underlying frailty or that it may exacerbate them. Comorbidity independently and additively contributes to mortality, so that someone with a hip fracture and no comorbidities might have a similar mortality risk as someone with an upper-arm fracture and a couple of comorbidities. “I think it tells us that the person has to be treated as a whole. We need to treat the fracture to treat the underlying osteoporosis, but we also need to look closely at the person with the fracture and treat their comorbidities as well, because they seem to be more vulnerable,” Dr. Center said.

Although patients and clinicians are attuned to the concerns over hip fractures, other fractures should also be noted, according to Nelson Watts, MD, who is director of osteoporosis and bone-health services at Mercy Health in Cincinnati and was not involved in the research. “I think the message for clinicians and patients is that all of these [proximal] fractures need to be taken seriously. The good news is that that we have medications that can cut the risk of further fractures by 50%-70%,” he said in an interview.

Dr. Center has been on an advisory board for Amgen. Dr. Watts has been a speaker for Amgen and Radius and has conducted numerous clinical trials of osteoporosis drugs.

In addition to a series of news conferences, the Endocrine Society is also planning to host ENDO Online 2020 during June 8-22, which will feature on-demand and live programming for clinicians and researchers.

SOURCE: Center J et al. ENDO 2020, Abstract OR13-03.

Correction, 4/21/20: An earlier version of this article misstated when the interview with Dr. Center took place.

Bone fracture in older adults is associated with greater mortality risk, but the location of the break may be a key factor, according to a new study of outcomes in a Danish database.

Over the follow-up period, those with proximal fractures – breaks in the hip, femur, pelvis, rib, clavicle, and humerus – were more likely to be hospitalized and to die, compared with their matched controls, than were those were with distal fractures in regions like the ankle, forearm, hand, or foot, where the mortality was similar to the matched controls.

“Compared with someone with similar comorbidities without a proximal fracture, there seemed to be an increased hospitalization rate for things like diabetes, heart disease, and lung disease, and then for some of those hospitalizations, there seemed to be an increased mortality, compared with people who hadn’t fractured who were hospitalized,” said Jacqueline Center, MBBS, PhD, of the Garvan Institute of Medical Research, Sydney, in an interview. The study abstract was released online by the Endocrine Society. It had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.*

The study included 212,498 women and 95,372 men aged over 50 years who had a fragility fracture between 2001 and 2014. The researchers excluded high-trauma fractures. They matched each fracture patient with four nonfracture patients, based on sex, age, and comorbidity status. There were 30,677 deaths among women over 384,995 person-years of follow-up, and 19,519 deaths in men over 163,482 person-years of follow-up. Women were a mean age of 72 at the time of fracture, while men were a mean age of 75.

The researchers found that proximal fractures were associated with increased risk of mortality, compared with nonfractured controls, with hazard ratios ranging between 1.5 and 4.0. Distal fractures were not associated with any increased mortality risk.

Comorbidities were common in the study population, with 75% of men and 60% of women having at least one. The risk of mortality increased with increasing numbers of comorbidities in each fracture type, but only proximal fractures were associated with an independent increase in mortality risk over and above comorbidity status.

In the 2 years following fracture, compared with matched controls, proximal fractures were associated with a greater risk of major hospital admission for conditions like cardiovascular disease, cancer, stroke, diabetes, pneumonia, and pulmonary disease. There was no significant difference between controls and those with distal fractures in hospital admission rate. The 2-year mortality risk was higher among subjects with proximal fractures, compared with patients in the no-fracture control group, regardless of whether they were admitted to the hospital, but there was no significant difference in those with distal fractures.

The differing clinical trajectories between those with proximal and distal fractures is a key finding, according to Dr. Center. The cause still isn’t clear, but she suspects that, in those patients who do badly, the fractures are either a signal that something is happening with existing comorbidities of the underlying frailty or that it may exacerbate them. Comorbidity independently and additively contributes to mortality, so that someone with a hip fracture and no comorbidities might have a similar mortality risk as someone with an upper-arm fracture and a couple of comorbidities. “I think it tells us that the person has to be treated as a whole. We need to treat the fracture to treat the underlying osteoporosis, but we also need to look closely at the person with the fracture and treat their comorbidities as well, because they seem to be more vulnerable,” Dr. Center said.

Although patients and clinicians are attuned to the concerns over hip fractures, other fractures should also be noted, according to Nelson Watts, MD, who is director of osteoporosis and bone-health services at Mercy Health in Cincinnati and was not involved in the research. “I think the message for clinicians and patients is that all of these [proximal] fractures need to be taken seriously. The good news is that that we have medications that can cut the risk of further fractures by 50%-70%,” he said in an interview.

Dr. Center has been on an advisory board for Amgen. Dr. Watts has been a speaker for Amgen and Radius and has conducted numerous clinical trials of osteoporosis drugs.

In addition to a series of news conferences, the Endocrine Society is also planning to host ENDO Online 2020 during June 8-22, which will feature on-demand and live programming for clinicians and researchers.

SOURCE: Center J et al. ENDO 2020, Abstract OR13-03.

Correction, 4/21/20: An earlier version of this article misstated when the interview with Dr. Center took place.

Erectile dysfunction may be an early warning sign of broader health problems. That’s the suggestion from a new retrospective analysis of European men, which found that erectile dysfunction and other sexual symptoms were associated with a greater risk of death, independent of testosterone levels.

Similar studies have shown links between mortality and sexual dysfunction, or between mortality and testosterone level, but the current study is unique, Leen Antonio, MD, PhD, assistant professor of endocrinology at Katholieke Universiteit Leuven (Belgium), said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“It’s the first time we have put both together in the same group of people, and we can say that it’s mostly the sexual symptoms that are predicting the mortality risk, independent of the testosterone levels of these men,” Dr. Antonio said in an interview.

“We can regard sexual symptoms as a marker for adverse health status in general. It’s like a warning signal that you’re at risk for more severe problems,” Dr. Antonio added.

Dr. Antonio advised clinicians to test blood pressure and cholesterol levels in men presenting with sexual dysfunction and to counsel lifestyle changes, such as physical activity and weight management. “These can be beneficial for sexual symptoms and for general health and the risk for cardiovascular disease in the future.”

Although the study could not identify a reason for the relationship between sexual dysfunction and mortality, Dr. Antonio hypothesized that the narrow penile artery may be more likely to suffer noticeable effects in the early stages of atherosclerosis, before clinical effects occur in the coronary artery.

Michael Blaha, MD, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Heart Disease at Johns Hopkins University, Baltimore, who has studied erectile dysfunction (ED) and its association with cardiovascular disease, said that the study is further evidence that ED is an important and independent risk factor for cardiovascular disease and other health risks. He would like to see a move toward establishing men’s health clinics, where risk factors can be identified and mitigated through lifestyle changes and therapies.

“There needs to be a complete rethink of the way we approach the whole group of patients who present with erectile dysfunction to various specialists,” he said in an interview, noting that middle-aged men often present to ED specialists after years of not having any contact with the health system. In that group, ED can be an early warning sign that could trigger broader interventions.

“This points to the need for more men’s health clinics that are focused on the early detection of risk factors, and treating erectile dysfunction and other risk factors in a more comprehensive way,” said Dr. Blaha, who was not associated with the study.

Dr. Antonio and colleagues studied 1,913 community-dwelling men, who participated in the European Male Ageing Study. Baseline information on sexual function and testosterone levels was collected between 2003 and 2005. The men were aged 40-79 years at study entry, and “because of the wide age range at study entry, age was used as time scale, instead of years since inclusion adjusting for age,” the researchers explained.

Over a mean follow-up of 12.4 years, 25.3% of participants died. Body mass index was higher in men who died (P = .002), but there was no significant difference in smoking status. Both groups had similar levels of total testosterone, but free testosterone was lower in the deceased population (270 pmol/L vs. 312 pmol/L; P < .001), whereas luteinizing hormone levels were higher (7.8 units/L vs. 5.7 units/L; P < .001).

The lowest quartile of free testosterone level was associated with higher mortality risk (hazard ratio, 1.43; P = .021), whereas the highest quartile of follicle-stimulating hormone was associated with greater mortality risk (HR, 1.38; P = .036). There was no association between mortality risk and total testosterone or estradiol.

Men reporting three sexual symptoms at baseline had a higher mortality risk than those reporting no symptoms (HR, 1.77; P < .001). There was an association between mortality risk and ED (HR, 1.40; P = .001) and poor morning erections (HR, 1.30; P = .012), but not low libido.

The associations were not affected after adjustment for total testosterone or free testosterone. Among men with normal total testosterone (>12 nmol/L), sexual symptoms were associated with heightened mortality risk (HR, 1.51; P = .003), and the same was true in men with total testosterone levels of less than 8 nmol, compared with men with normal total testosterone who reported no sexual symptoms (HR, 1.92; P = .035).

The European Male Ageing Study received support from the European Union. Dr. Antonio has no relevant financial disclosures. Dr. Blaha has received grants from Amgen and is on advisory boards for Amgen and other pharmaceutical firms.

Dr. Antonio and her team’s research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Antonio L et al. ENDO 2020, Abstract OR02-06.

This article was upadted on 4/17/2020.

Erectile dysfunction may be an early warning sign of broader health problems. That’s the suggestion from a new retrospective analysis of European men, which found that erectile dysfunction and other sexual symptoms were associated with a greater risk of death, independent of testosterone levels.

Similar studies have shown links between mortality and sexual dysfunction, or between mortality and testosterone level, but the current study is unique, Leen Antonio, MD, PhD, assistant professor of endocrinology at Katholieke Universiteit Leuven (Belgium), said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“It’s the first time we have put both together in the same group of people, and we can say that it’s mostly the sexual symptoms that are predicting the mortality risk, independent of the testosterone levels of these men,” Dr. Antonio said in an interview.

“We can regard sexual symptoms as a marker for adverse health status in general. It’s like a warning signal that you’re at risk for more severe problems,” Dr. Antonio added.

Dr. Antonio advised clinicians to test blood pressure and cholesterol levels in men presenting with sexual dysfunction and to counsel lifestyle changes, such as physical activity and weight management. “These can be beneficial for sexual symptoms and for general health and the risk for cardiovascular disease in the future.”

Although the study could not identify a reason for the relationship between sexual dysfunction and mortality, Dr. Antonio hypothesized that the narrow penile artery may be more likely to suffer noticeable effects in the early stages of atherosclerosis, before clinical effects occur in the coronary artery.

Michael Blaha, MD, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Heart Disease at Johns Hopkins University, Baltimore, who has studied erectile dysfunction (ED) and its association with cardiovascular disease, said that the study is further evidence that ED is an important and independent risk factor for cardiovascular disease and other health risks. He would like to see a move toward establishing men’s health clinics, where risk factors can be identified and mitigated through lifestyle changes and therapies.

“There needs to be a complete rethink of the way we approach the whole group of patients who present with erectile dysfunction to various specialists,” he said in an interview, noting that middle-aged men often present to ED specialists after years of not having any contact with the health system. In that group, ED can be an early warning sign that could trigger broader interventions.

“This points to the need for more men’s health clinics that are focused on the early detection of risk factors, and treating erectile dysfunction and other risk factors in a more comprehensive way,” said Dr. Blaha, who was not associated with the study.

Dr. Antonio and colleagues studied 1,913 community-dwelling men, who participated in the European Male Ageing Study. Baseline information on sexual function and testosterone levels was collected between 2003 and 2005. The men were aged 40-79 years at study entry, and “because of the wide age range at study entry, age was used as time scale, instead of years since inclusion adjusting for age,” the researchers explained.

Over a mean follow-up of 12.4 years, 25.3% of participants died. Body mass index was higher in men who died (P = .002), but there was no significant difference in smoking status. Both groups had similar levels of total testosterone, but free testosterone was lower in the deceased population (270 pmol/L vs. 312 pmol/L; P < .001), whereas luteinizing hormone levels were higher (7.8 units/L vs. 5.7 units/L; P < .001).

The lowest quartile of free testosterone level was associated with higher mortality risk (hazard ratio, 1.43; P = .021), whereas the highest quartile of follicle-stimulating hormone was associated with greater mortality risk (HR, 1.38; P = .036). There was no association between mortality risk and total testosterone or estradiol.

Men reporting three sexual symptoms at baseline had a higher mortality risk than those reporting no symptoms (HR, 1.77; P < .001). There was an association between mortality risk and ED (HR, 1.40; P = .001) and poor morning erections (HR, 1.30; P = .012), but not low libido.

The associations were not affected after adjustment for total testosterone or free testosterone. Among men with normal total testosterone (>12 nmol/L), sexual symptoms were associated with heightened mortality risk (HR, 1.51; P = .003), and the same was true in men with total testosterone levels of less than 8 nmol, compared with men with normal total testosterone who reported no sexual symptoms (HR, 1.92; P = .035).

The European Male Ageing Study received support from the European Union. Dr. Antonio has no relevant financial disclosures. Dr. Blaha has received grants from Amgen and is on advisory boards for Amgen and other pharmaceutical firms.

Dr. Antonio and her team’s research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Antonio L et al. ENDO 2020, Abstract OR02-06.

This article was upadted on 4/17/2020.

Erectile dysfunction may be an early warning sign of broader health problems. That’s the suggestion from a new retrospective analysis of European men, which found that erectile dysfunction and other sexual symptoms were associated with a greater risk of death, independent of testosterone levels.

Similar studies have shown links between mortality and sexual dysfunction, or between mortality and testosterone level, but the current study is unique, Leen Antonio, MD, PhD, assistant professor of endocrinology at Katholieke Universiteit Leuven (Belgium), said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“It’s the first time we have put both together in the same group of people, and we can say that it’s mostly the sexual symptoms that are predicting the mortality risk, independent of the testosterone levels of these men,” Dr. Antonio said in an interview.

“We can regard sexual symptoms as a marker for adverse health status in general. It’s like a warning signal that you’re at risk for more severe problems,” Dr. Antonio added.

Dr. Antonio advised clinicians to test blood pressure and cholesterol levels in men presenting with sexual dysfunction and to counsel lifestyle changes, such as physical activity and weight management. “These can be beneficial for sexual symptoms and for general health and the risk for cardiovascular disease in the future.”

Although the study could not identify a reason for the relationship between sexual dysfunction and mortality, Dr. Antonio hypothesized that the narrow penile artery may be more likely to suffer noticeable effects in the early stages of atherosclerosis, before clinical effects occur in the coronary artery.

Michael Blaha, MD, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Heart Disease at Johns Hopkins University, Baltimore, who has studied erectile dysfunction (ED) and its association with cardiovascular disease, said that the study is further evidence that ED is an important and independent risk factor for cardiovascular disease and other health risks. He would like to see a move toward establishing men’s health clinics, where risk factors can be identified and mitigated through lifestyle changes and therapies.

“There needs to be a complete rethink of the way we approach the whole group of patients who present with erectile dysfunction to various specialists,” he said in an interview, noting that middle-aged men often present to ED specialists after years of not having any contact with the health system. In that group, ED can be an early warning sign that could trigger broader interventions.

“This points to the need for more men’s health clinics that are focused on the early detection of risk factors, and treating erectile dysfunction and other risk factors in a more comprehensive way,” said Dr. Blaha, who was not associated with the study.

Dr. Antonio and colleagues studied 1,913 community-dwelling men, who participated in the European Male Ageing Study. Baseline information on sexual function and testosterone levels was collected between 2003 and 2005. The men were aged 40-79 years at study entry, and “because of the wide age range at study entry, age was used as time scale, instead of years since inclusion adjusting for age,” the researchers explained.

Over a mean follow-up of 12.4 years, 25.3% of participants died. Body mass index was higher in men who died (P = .002), but there was no significant difference in smoking status. Both groups had similar levels of total testosterone, but free testosterone was lower in the deceased population (270 pmol/L vs. 312 pmol/L; P < .001), whereas luteinizing hormone levels were higher (7.8 units/L vs. 5.7 units/L; P < .001).

The lowest quartile of free testosterone level was associated with higher mortality risk (hazard ratio, 1.43; P = .021), whereas the highest quartile of follicle-stimulating hormone was associated with greater mortality risk (HR, 1.38; P = .036). There was no association between mortality risk and total testosterone or estradiol.

Men reporting three sexual symptoms at baseline had a higher mortality risk than those reporting no symptoms (HR, 1.77; P < .001). There was an association between mortality risk and ED (HR, 1.40; P = .001) and poor morning erections (HR, 1.30; P = .012), but not low libido.

The associations were not affected after adjustment for total testosterone or free testosterone. Among men with normal total testosterone (>12 nmol/L), sexual symptoms were associated with heightened mortality risk (HR, 1.51; P = .003), and the same was true in men with total testosterone levels of less than 8 nmol, compared with men with normal total testosterone who reported no sexual symptoms (HR, 1.92; P = .035).

The European Male Ageing Study received support from the European Union. Dr. Antonio has no relevant financial disclosures. Dr. Blaha has received grants from Amgen and is on advisory boards for Amgen and other pharmaceutical firms.

Dr. Antonio and her team’s research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Antonio L et al. ENDO 2020, Abstract OR02-06.

This article was upadted on 4/17/2020.

After a year of planning, researchers sent a drone flight off the coast of western Ireland to the Aran Islands, delivering insulin and glucagon and retrieving a blood sample from the first patient to receive insulin successfully by autonomous drone delivery.

The nuts and bolts of arranging the drop and retrieval, which occurred in September 2019, were detailed by Spyridoula Maraka, MD, during a virtual news conference held by the Endocrine Society. The study had been slated for presentaion during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“There are multiple medical drone delivery opportunities that could be lifesaving during sentinel events such as hurricanes, earthquakes, and, of course, pandemics like the one we are currently experiencing,” said Dr. Maraka. “Medications and blood samples are ideal [drone] payload cargo because of their low weight and high value.”

Drones, or unmanned aerial vehicles, are popular for recreational use and in some commercial applications – notably photography – but they are largely untapped as a medical resource, said Dr. Maraka, a collaborator on the project and an endocrinologist at the University of Arkansas for Medical Sciences, Little Rock.

Most of the exploration of drones for medical purposes has been in countries with emerging economies, such as Ghana and Rwanda in Africa, where the unmanned vehicles have been used by the U.S. medical product delivery company Zipline since 2016 to deliver blood.

The autonomous drone delivery of insulin originated in Galway, where the project’s lead investigator, Derek O’Keefe, MD, PhD, is an endocrinologist and professor of medical device technology at the National University of Ireland.

In 2017, Ireland was pummeled by Ophelia, a category 3 hurricane, and a year later by Storm Emma, a winter blizzard, said Dr. Maraka. Those extreme weather events trapped patients in their homes, made streets impassable for days on end, and interrupted the delivery of essential medical supplies, including insulin.

Until then, Ireland’s medical management plan had been passive and rested on the assumption that any weather-related interruptions would be relatively brief and not result in large-scale disruption of care and supply delivery for geographically isolated patients, said Dr. Maraka. But the two extreme and disruptive weather events in relatively quick succession prompted a reassessment of emergency medical management plans.

“We realized that [the prevailing plans were] not good enough,” said Dr. Maraka. “Medicine has a track record of practicing for emergencies before they actually happen,” to make sure that necessary resources are available and protocols in place in case of an emergency. The researchers extrapolated this preparedness mindset to medication delivery and realized that drones could be used both for a medication drop and to bring blood or other samples back from patients for testing.

Ireland’s Aran Islands came to mind as a location that was at risk of being cut off from services, but that was reachable by drone from Galway. “We quickly realized that this project would be very challenging, as no one in the developed world had done drone deliveries beyond the visual line of sight,” said Dr. Maraka, adding that flight operations had significant regulatory constraints.

The cross-disciplinary team that was pulled together to run the Diabetes Drone Mission, as the project was dubbed, included physicians and experts from pharmacies and pharmaceutical companies. To address drone operation specifically, a drone manufacturer, a flight operations firm, and a telecommunications company were also engaged. Drone pilots had to be licensed for beyond-the-visual-line-of-sight (BVLOS) operation, and Irish and European aviation regulators were consulted.

It took a full year to pull the pieces together for the inaugural flight. “One of the first challenges we faced was that we wanted to perform a civilian drone flight covering more than 40 kilometers,” said Dr. Maraka, whereas most drones flights are in the range of 1-10 km (0.6-6.2 miles). This long-range BVLOS flight required the drone to send live camera feed for the flight duration, which necessitated uninterrupted 4G wireless connectivity with satellite telecommunications as backup.

The Wingcopter 178 drone that was eventually chosen has a wingspan of 178 cm (about 70 inches) and can reach a top speed of 130 km/hr (about 81 mph) in fixed-wing mode.

“We had to comply with medication-dispensing legislation ... and we had to comply with medication transportation cold-chain legislation,” said Dr. Maraka. In other words, the insulin could not be loaded and delivered without the usual prescribing, dispensing, and chain-of-custody procedures being met.

In the end, the successful proof-of-concept flight saw the drone covering 43.3 km (26.9 miles) in a 32-minute flight to deliver insulin and glucagon and return a blood sample for hemoglobin A_1c testing.

Dr. Maraka said she and her collaborators have an active collaboration with United Parcel Service and drone suppliers to expand into regular medical supply deliveries.

Dr. Maraka reported no conflicts of interest.

The report will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Maraka S et al. ENDO 2020, Abstract OR30-04.

This article was updated on 4/17/2020.

After a year of planning, researchers sent a drone flight off the coast of western Ireland to the Aran Islands, delivering insulin and glucagon and retrieving a blood sample from the first patient to receive insulin successfully by autonomous drone delivery.

The nuts and bolts of arranging the drop and retrieval, which occurred in September 2019, were detailed by Spyridoula Maraka, MD, during a virtual news conference held by the Endocrine Society. The study had been slated for presentaion during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“There are multiple medical drone delivery opportunities that could be lifesaving during sentinel events such as hurricanes, earthquakes, and, of course, pandemics like the one we are currently experiencing,” said Dr. Maraka. “Medications and blood samples are ideal [drone] payload cargo because of their low weight and high value.”

Drones, or unmanned aerial vehicles, are popular for recreational use and in some commercial applications – notably photography – but they are largely untapped as a medical resource, said Dr. Maraka, a collaborator on the project and an endocrinologist at the University of Arkansas for Medical Sciences, Little Rock.

Most of the exploration of drones for medical purposes has been in countries with emerging economies, such as Ghana and Rwanda in Africa, where the unmanned vehicles have been used by the U.S. medical product delivery company Zipline since 2016 to deliver blood.

The autonomous drone delivery of insulin originated in Galway, where the project’s lead investigator, Derek O’Keefe, MD, PhD, is an endocrinologist and professor of medical device technology at the National University of Ireland.

In 2017, Ireland was pummeled by Ophelia, a category 3 hurricane, and a year later by Storm Emma, a winter blizzard, said Dr. Maraka. Those extreme weather events trapped patients in their homes, made streets impassable for days on end, and interrupted the delivery of essential medical supplies, including insulin.

Until then, Ireland’s medical management plan had been passive and rested on the assumption that any weather-related interruptions would be relatively brief and not result in large-scale disruption of care and supply delivery for geographically isolated patients, said Dr. Maraka. But the two extreme and disruptive weather events in relatively quick succession prompted a reassessment of emergency medical management plans.

“We realized that [the prevailing plans were] not good enough,” said Dr. Maraka. “Medicine has a track record of practicing for emergencies before they actually happen,” to make sure that necessary resources are available and protocols in place in case of an emergency. The researchers extrapolated this preparedness mindset to medication delivery and realized that drones could be used both for a medication drop and to bring blood or other samples back from patients for testing.

Ireland’s Aran Islands came to mind as a location that was at risk of being cut off from services, but that was reachable by drone from Galway. “We quickly realized that this project would be very challenging, as no one in the developed world had done drone deliveries beyond the visual line of sight,” said Dr. Maraka, adding that flight operations had significant regulatory constraints.

The cross-disciplinary team that was pulled together to run the Diabetes Drone Mission, as the project was dubbed, included physicians and experts from pharmacies and pharmaceutical companies. To address drone operation specifically, a drone manufacturer, a flight operations firm, and a telecommunications company were also engaged. Drone pilots had to be licensed for beyond-the-visual-line-of-sight (BVLOS) operation, and Irish and European aviation regulators were consulted.

It took a full year to pull the pieces together for the inaugural flight. “One of the first challenges we faced was that we wanted to perform a civilian drone flight covering more than 40 kilometers,” said Dr. Maraka, whereas most drones flights are in the range of 1-10 km (0.6-6.2 miles). This long-range BVLOS flight required the drone to send live camera feed for the flight duration, which necessitated uninterrupted 4G wireless connectivity with satellite telecommunications as backup.

The Wingcopter 178 drone that was eventually chosen has a wingspan of 178 cm (about 70 inches) and can reach a top speed of 130 km/hr (about 81 mph) in fixed-wing mode.

“We had to comply with medication-dispensing legislation ... and we had to comply with medication transportation cold-chain legislation,” said Dr. Maraka. In other words, the insulin could not be loaded and delivered without the usual prescribing, dispensing, and chain-of-custody procedures being met.

In the end, the successful proof-of-concept flight saw the drone covering 43.3 km (26.9 miles) in a 32-minute flight to deliver insulin and glucagon and return a blood sample for hemoglobin A_1c testing.

Dr. Maraka said she and her collaborators have an active collaboration with United Parcel Service and drone suppliers to expand into regular medical supply deliveries.

Dr. Maraka reported no conflicts of interest.

The report will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Maraka S et al. ENDO 2020, Abstract OR30-04.

This article was updated on 4/17/2020.

After a year of planning, researchers sent a drone flight off the coast of western Ireland to the Aran Islands, delivering insulin and glucagon and retrieving a blood sample from the first patient to receive insulin successfully by autonomous drone delivery.

The nuts and bolts of arranging the drop and retrieval, which occurred in September 2019, were detailed by Spyridoula Maraka, MD, during a virtual news conference held by the Endocrine Society. The study had been slated for presentaion during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“There are multiple medical drone delivery opportunities that could be lifesaving during sentinel events such as hurricanes, earthquakes, and, of course, pandemics like the one we are currently experiencing,” said Dr. Maraka. “Medications and blood samples are ideal [drone] payload cargo because of their low weight and high value.”

Drones, or unmanned aerial vehicles, are popular for recreational use and in some commercial applications – notably photography – but they are largely untapped as a medical resource, said Dr. Maraka, a collaborator on the project and an endocrinologist at the University of Arkansas for Medical Sciences, Little Rock.

Most of the exploration of drones for medical purposes has been in countries with emerging economies, such as Ghana and Rwanda in Africa, where the unmanned vehicles have been used by the U.S. medical product delivery company Zipline since 2016 to deliver blood.

The autonomous drone delivery of insulin originated in Galway, where the project’s lead investigator, Derek O’Keefe, MD, PhD, is an endocrinologist and professor of medical device technology at the National University of Ireland.

In 2017, Ireland was pummeled by Ophelia, a category 3 hurricane, and a year later by Storm Emma, a winter blizzard, said Dr. Maraka. Those extreme weather events trapped patients in their homes, made streets impassable for days on end, and interrupted the delivery of essential medical supplies, including insulin.

Until then, Ireland’s medical management plan had been passive and rested on the assumption that any weather-related interruptions would be relatively brief and not result in large-scale disruption of care and supply delivery for geographically isolated patients, said Dr. Maraka. But the two extreme and disruptive weather events in relatively quick succession prompted a reassessment of emergency medical management plans.

“We realized that [the prevailing plans were] not good enough,” said Dr. Maraka. “Medicine has a track record of practicing for emergencies before they actually happen,” to make sure that necessary resources are available and protocols in place in case of an emergency. The researchers extrapolated this preparedness mindset to medication delivery and realized that drones could be used both for a medication drop and to bring blood or other samples back from patients for testing.

Ireland’s Aran Islands came to mind as a location that was at risk of being cut off from services, but that was reachable by drone from Galway. “We quickly realized that this project would be very challenging, as no one in the developed world had done drone deliveries beyond the visual line of sight,” said Dr. Maraka, adding that flight operations had significant regulatory constraints.

The cross-disciplinary team that was pulled together to run the Diabetes Drone Mission, as the project was dubbed, included physicians and experts from pharmacies and pharmaceutical companies. To address drone operation specifically, a drone manufacturer, a flight operations firm, and a telecommunications company were also engaged. Drone pilots had to be licensed for beyond-the-visual-line-of-sight (BVLOS) operation, and Irish and European aviation regulators were consulted.

It took a full year to pull the pieces together for the inaugural flight. “One of the first challenges we faced was that we wanted to perform a civilian drone flight covering more than 40 kilometers,” said Dr. Maraka, whereas most drones flights are in the range of 1-10 km (0.6-6.2 miles). This long-range BVLOS flight required the drone to send live camera feed for the flight duration, which necessitated uninterrupted 4G wireless connectivity with satellite telecommunications as backup.

The Wingcopter 178 drone that was eventually chosen has a wingspan of 178 cm (about 70 inches) and can reach a top speed of 130 km/hr (about 81 mph) in fixed-wing mode.

“We had to comply with medication-dispensing legislation ... and we had to comply with medication transportation cold-chain legislation,” said Dr. Maraka. In other words, the insulin could not be loaded and delivered without the usual prescribing, dispensing, and chain-of-custody procedures being met.

In the end, the successful proof-of-concept flight saw the drone covering 43.3 km (26.9 miles) in a 32-minute flight to deliver insulin and glucagon and return a blood sample for hemoglobin A_1c testing.

Dr. Maraka said she and her collaborators have an active collaboration with United Parcel Service and drone suppliers to expand into regular medical supply deliveries.

Dr. Maraka reported no conflicts of interest.

The report will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Maraka S et al. ENDO 2020, Abstract OR30-04.

This article was updated on 4/17/2020.

A natural language processing algorithm, designed to scour emergency department records for fracture cases, has the potential to improve treatment of osteoporosis and prevent future, more severe fractures.

The approach led to a notable increase in referrals to the osteoporosis refracture prevention service at the Prince of Wales Hospital in Sydney, where the work was done.

The strongest predictor of a future fracture is a recent previous fracture, said Christopher White, MBBS, the hospital’s director of research, who presented results of an analysis at a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

“We have really effective therapies that can reduce the risk of [future] fractures by 50%, and yet 80% of osteoporotic patients leave the hospital untreated after fracture,” said Dr. White.

That, he explained, is because of a fundamental disconnect in fracture care – emergency department physicians tackle the immediate aftermath of a broken bone, but they are not tasked with treating the underlying condition. As a result, many patients who would be candidates for follow-up care are not referred.

The current work grew out of Dr. White’s frustration with not being able to recruit patients for osteoporosis clinical trials. In fact, he got so annoyed trying to recruit and not getting patients referred to him – even though he’d find they were actually in the hospital – that he decided “to start an AI [artificial intelligence] program that would read the radiology report and bypass the referrer,” he said.

To that end, with the help of an industry partner, he developed a software program called XRAIT (X-Ray Artificial Intelligence Tool), which analyzed the reports and, with Dr. White’s iterated guidance, learned to identify fractures.

The system performed a little too well. “You have to be careful what you wish for, because suddenly I went from 70 referrals to 339,” he said.

That influx is a potential downside, however, according to Angela Cheung, MD, PhD, director of the Centre of Excellence in Skeletal Health Assessment and Osteoporosis Program at the University of Toronto’s University Health Network. Natural language processing can help identify patients that a human reviewer would miss, because reviewers tend to focus on cases in which the fracture was the reason for the hospital visit, rather than on incidental findings. But not all incidental findings are clinically important. “A pneumonia patient might have had the fracture 30 years ago, falling off a tree as a college student. It may not pick up the highest-risk group in terms of fractures, because we know that recency of fractures matters,” Dr. Cheung, who was not associated with the research, said in an interview.

“It means the fracture liaison coordinator would need to review [more] numbers in trying to figure out whether the patient should get attention and whether they should be treated as well,” said Dr. Cheung, adding that more studies would need to be done to determine if the approach would be cost effective.

The researchers performed a technical evaluation of 2,445 nonfracture and 433 fracture reports, in which the tool performed with more than 99% sensitivity and specificity.

In a clinical validation, a fracture clinician and XRAIT reviewed 5,089 x-ray and computed tomography reports from ED patients who were older than 50 years. The ED referred 70 cases, leading to identification of 65 fractures. The combination of ED referral and a fracture clinician’s review of 224 cases revealed 98 fracture cases. By contrast, XRAIT nearly instantaneously analyzed 5,089 reports from 3,217 patients, and identified fractures in 349 patients – a nearly fivefold higher number than the manual case finding of 70. Of those 349 patients, results for 10 were false positives, leading to a total find of 339 patients.

In all, 57 cases were found both by XRAIT and the ED referral/fracture clinician, resulting in 282 unique cases identified by XRAIT alone. That translated to a 3.5-fold increase in cases that were identifiable using XRAIT.

In an external validation, the researchers tested the system on 327 reports from a subset of the Dubbo Osteoporosis Epidemiology Study, based in the city of Dubbo in New South Wales, Australia. In that cohort, XRAIT identified 97 positive cases, of which 87 were true fractures (10 false positives). Of 230 cases that it considered not to be fractures, there were 38 false negatives. Those numbers translated to a sensitivity of 69.6% and a specificity of 95.0%.

All of those hits have the potential to overwhelm osteoporosis services. “I now have to adjust to that, and further development will be to link the AI with clinical risk factors and treatment data to assist my fracture coordinators to target the right patients. We’ll increase the number of patients with osteoporosis on treatment, improve productivity and safety, and reduce the burden of care,” said Dr. White.

The study was funded by The Sydney Partnership for Health, Education, Research and Enterprise and the Musculoskeletal Consumer Advisory Group. The researchers reported no financial conflicts of interest, as did Dr. Cheung.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
 

A natural language processing algorithm, designed to scour emergency department records for fracture cases, has the potential to improve treatment of osteoporosis and prevent future, more severe fractures.

The approach led to a notable increase in referrals to the osteoporosis refracture prevention service at the Prince of Wales Hospital in Sydney, where the work was done.

The strongest predictor of a future fracture is a recent previous fracture, said Christopher White, MBBS, the hospital’s director of research, who presented results of an analysis at a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

“We have really effective therapies that can reduce the risk of [future] fractures by 50%, and yet 80% of osteoporotic patients leave the hospital untreated after fracture,” said Dr. White.

That, he explained, is because of a fundamental disconnect in fracture care – emergency department physicians tackle the immediate aftermath of a broken bone, but they are not tasked with treating the underlying condition. As a result, many patients who would be candidates for follow-up care are not referred.

The current work grew out of Dr. White’s frustration with not being able to recruit patients for osteoporosis clinical trials. In fact, he got so annoyed trying to recruit and not getting patients referred to him – even though he’d find they were actually in the hospital – that he decided “to start an AI [artificial intelligence] program that would read the radiology report and bypass the referrer,” he said.

To that end, with the help of an industry partner, he developed a software program called XRAIT (X-Ray Artificial Intelligence Tool), which analyzed the reports and, with Dr. White’s iterated guidance, learned to identify fractures.

The system performed a little too well. “You have to be careful what you wish for, because suddenly I went from 70 referrals to 339,” he said.

That influx is a potential downside, however, according to Angela Cheung, MD, PhD, director of the Centre of Excellence in Skeletal Health Assessment and Osteoporosis Program at the University of Toronto’s University Health Network. Natural language processing can help identify patients that a human reviewer would miss, because reviewers tend to focus on cases in which the fracture was the reason for the hospital visit, rather than on incidental findings. But not all incidental findings are clinically important. “A pneumonia patient might have had the fracture 30 years ago, falling off a tree as a college student. It may not pick up the highest-risk group in terms of fractures, because we know that recency of fractures matters,” Dr. Cheung, who was not associated with the research, said in an interview.

“It means the fracture liaison coordinator would need to review [more] numbers in trying to figure out whether the patient should get attention and whether they should be treated as well,” said Dr. Cheung, adding that more studies would need to be done to determine if the approach would be cost effective.

The researchers performed a technical evaluation of 2,445 nonfracture and 433 fracture reports, in which the tool performed with more than 99% sensitivity and specificity.

In a clinical validation, a fracture clinician and XRAIT reviewed 5,089 x-ray and computed tomography reports from ED patients who were older than 50 years. The ED referred 70 cases, leading to identification of 65 fractures. The combination of ED referral and a fracture clinician’s review of 224 cases revealed 98 fracture cases. By contrast, XRAIT nearly instantaneously analyzed 5,089 reports from 3,217 patients, and identified fractures in 349 patients – a nearly fivefold higher number than the manual case finding of 70. Of those 349 patients, results for 10 were false positives, leading to a total find of 339 patients.

In all, 57 cases were found both by XRAIT and the ED referral/fracture clinician, resulting in 282 unique cases identified by XRAIT alone. That translated to a 3.5-fold increase in cases that were identifiable using XRAIT.

In an external validation, the researchers tested the system on 327 reports from a subset of the Dubbo Osteoporosis Epidemiology Study, based in the city of Dubbo in New South Wales, Australia. In that cohort, XRAIT identified 97 positive cases, of which 87 were true fractures (10 false positives). Of 230 cases that it considered not to be fractures, there were 38 false negatives. Those numbers translated to a sensitivity of 69.6% and a specificity of 95.0%.

All of those hits have the potential to overwhelm osteoporosis services. “I now have to adjust to that, and further development will be to link the AI with clinical risk factors and treatment data to assist my fracture coordinators to target the right patients. We’ll increase the number of patients with osteoporosis on treatment, improve productivity and safety, and reduce the burden of care,” said Dr. White.

The study was funded by The Sydney Partnership for Health, Education, Research and Enterprise and the Musculoskeletal Consumer Advisory Group. The researchers reported no financial conflicts of interest, as did Dr. Cheung.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
 

A natural language processing algorithm, designed to scour emergency department records for fracture cases, has the potential to improve treatment of osteoporosis and prevent future, more severe fractures.

The approach led to a notable increase in referrals to the osteoporosis refracture prevention service at the Prince of Wales Hospital in Sydney, where the work was done.

The strongest predictor of a future fracture is a recent previous fracture, said Christopher White, MBBS, the hospital’s director of research, who presented results of an analysis at a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

“We have really effective therapies that can reduce the risk of [future] fractures by 50%, and yet 80% of osteoporotic patients leave the hospital untreated after fracture,” said Dr. White.

That, he explained, is because of a fundamental disconnect in fracture care – emergency department physicians tackle the immediate aftermath of a broken bone, but they are not tasked with treating the underlying condition. As a result, many patients who would be candidates for follow-up care are not referred.

The current work grew out of Dr. White’s frustration with not being able to recruit patients for osteoporosis clinical trials. In fact, he got so annoyed trying to recruit and not getting patients referred to him – even though he’d find they were actually in the hospital – that he decided “to start an AI [artificial intelligence] program that would read the radiology report and bypass the referrer,” he said.

To that end, with the help of an industry partner, he developed a software program called XRAIT (X-Ray Artificial Intelligence Tool), which analyzed the reports and, with Dr. White’s iterated guidance, learned to identify fractures.

The system performed a little too well. “You have to be careful what you wish for, because suddenly I went from 70 referrals to 339,” he said.

That influx is a potential downside, however, according to Angela Cheung, MD, PhD, director of the Centre of Excellence in Skeletal Health Assessment and Osteoporosis Program at the University of Toronto’s University Health Network. Natural language processing can help identify patients that a human reviewer would miss, because reviewers tend to focus on cases in which the fracture was the reason for the hospital visit, rather than on incidental findings. But not all incidental findings are clinically important. “A pneumonia patient might have had the fracture 30 years ago, falling off a tree as a college student. It may not pick up the highest-risk group in terms of fractures, because we know that recency of fractures matters,” Dr. Cheung, who was not associated with the research, said in an interview.

“It means the fracture liaison coordinator would need to review [more] numbers in trying to figure out whether the patient should get attention and whether they should be treated as well,” said Dr. Cheung, adding that more studies would need to be done to determine if the approach would be cost effective.

The researchers performed a technical evaluation of 2,445 nonfracture and 433 fracture reports, in which the tool performed with more than 99% sensitivity and specificity.

In a clinical validation, a fracture clinician and XRAIT reviewed 5,089 x-ray and computed tomography reports from ED patients who were older than 50 years. The ED referred 70 cases, leading to identification of 65 fractures. The combination of ED referral and a fracture clinician’s review of 224 cases revealed 98 fracture cases. By contrast, XRAIT nearly instantaneously analyzed 5,089 reports from 3,217 patients, and identified fractures in 349 patients – a nearly fivefold higher number than the manual case finding of 70. Of those 349 patients, results for 10 were false positives, leading to a total find of 339 patients.

In all, 57 cases were found both by XRAIT and the ED referral/fracture clinician, resulting in 282 unique cases identified by XRAIT alone. That translated to a 3.5-fold increase in cases that were identifiable using XRAIT.

In an external validation, the researchers tested the system on 327 reports from a subset of the Dubbo Osteoporosis Epidemiology Study, based in the city of Dubbo in New South Wales, Australia. In that cohort, XRAIT identified 97 positive cases, of which 87 were true fractures (10 false positives). Of 230 cases that it considered not to be fractures, there were 38 false negatives. Those numbers translated to a sensitivity of 69.6% and a specificity of 95.0%.

All of those hits have the potential to overwhelm osteoporosis services. “I now have to adjust to that, and further development will be to link the AI with clinical risk factors and treatment data to assist my fracture coordinators to target the right patients. We’ll increase the number of patients with osteoporosis on treatment, improve productivity and safety, and reduce the burden of care,” said Dr. White.

The study was funded by The Sydney Partnership for Health, Education, Research and Enterprise and the Musculoskeletal Consumer Advisory Group. The researchers reported no financial conflicts of interest, as did Dr. Cheung.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
 

A retrospective study of patients at a minority-serving, safety-net hospital showed low uptake of diabetes technology among black patients with type 1 diabetes, compared with their white counterparts.

The researchers also found lower usage of the technology among Hispanic patients, but the difference, compared with their white counterparts, was not statistically significant after adjustments for language, insurance, age, and income. Patients who identified as “other” also were less likely than white patients to use the technology, which included continuous glucose monitors and continuous subcutaneous insulin infusion devices.

The data differes from other, similar studies of technology use in patients with type 1 diabetes, because the study population, drawn from the Boston University Medical Center, was more diverse than other studies, according to Kamonkiat Wirunsawanya, who is an endocrinology fellow at the medical center. The abstract had been slated for presentation at ENDO 2020, the Endocrine Society's annual meeting, which was canceled because of the COVID-19 pandemic.

Dr. Wirunsawanya and his colleagues are now using questionnaires to try to identify specific patient and physician factors that might explain the differences in technology use.

“Once we know which factors could be a barrier to using the technology, we’ll be able to implement a strategy to increase use in those patients,” Dr. Wirunsawanya said in an interview. The issue could be a two-way street, he noted, because some providers may be uncomfortable using the technology, or may perceive minorities as less adept at using technology.

The study included 227 adult patients who were seen at the medical center between October 2016 and September 2017. The mean age was 39 years, and 59% were men. The mean duration of type 1 diabetes was 21 years, and 30% of the patients were overweight, 22% were obese, 80% spoke English, and 50% were on government insurance. In all, 43% of the patients were white, 25% were black, 15% were Hispanic, 2% were Asian, and 15% identified as other.

Patients who used technology had lower mean levels of hemoglobin A_1c, compared with nonusers (8.27% vs. 9.49%, respectively). Those with government health insurance were less likely than those with private insurance to use technology (odds ratio, 0.43; 95% confidential interval, 0.25-0.74).

Overall, 26% of the patients used continuous subcutaneous insulin infusion devices. Of those, 43% were white, 10% black, 14% Hispanic, none were Asian, and 18% identified as other.

In addition, 30% of the patients used continuous glucose monitors; of those, 47% were white, 14% black, 23% Hispanic, 25% Asian, and none identified as other.

After adjustments for insurance and language, the researchers found that black patients were less likely to use technology than were the white patients (OR, 0.25; 95% CI, 0.11-0.53). The same was found for those who identified as other (OR, 0.33; 95% CI, 0.12-0.89). There was no significant differences in technology use between white and Asian patients. After adjustments, the researchers showed that fewer Hispanic patients used technology, compared with their white counterparts, but the difference was not statistically significant.

In a multivariable logistic regression model that adjusted for insurance and language, black patients had lower odds of using technology, compared with white patients (OR, 0.25; 95% CI, 0.11-0.53), as did those identifying as other (OR, 0.33; 95% CI, 0.12-0.89).

In an interview, Anne Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, said that the study highlights a common problem with introducing technology to underserved populations. “These study [findings are] not at all surprising. It’s something that is a puzzle for those of us who work in the field of diabetes management in patients from underserved communities. Even if you can get access to the technology, even when I get them tools and native Spanish-speaking educators and people who should be able to teach them how to use the technology, the adoption of the technology has been really much less than would be expected,” said Dr. Peters, who is also a professor of medicine at USC and was not involved in the research.

Part of the problem may be lack of contact with health care services, she said. White children with type 1 diabetes are treated from an early age and learn how to manage daily blood sugar levels. They often grow up to embrace technology, even enthusiastically. But in some minority communities, diabetes is viewed as something to be hidden away. That cultural difference is also a frustrating barrier.

“What happens in more affluent groups is that people learn from their peers, and they see that [managing their blood sugar] is possible. One of my big beliefs is that the answer has to come from [the community]. ... We need to get champions, people from the community who use these tools, to encourage others, and that’s hard to do because type 1 diabetes is such a small subset of the people with diabetes who are [black] or Latino,” said Dr. Peters.

Ultimately, the solution will require a shift in messaging by finding a way to help communities look differently at diabetes and its treatment. “There’s something that must come educationally and culturally that I’ve not figured out [yet]. I can get resources and fight for them, but we have to figure out how to make [technology] part of that culture, and I don’t know that we’ve done that,” she said.

Dr. Wirunsawanya reported no financial conflicts of interest. Dr. Peters has been on an advisory panel for Abbott Diabetes Care and has received research funding from Dexcom.

Dr. Wirunsawanya and colleagues’ research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Wirunsawanya K et al. ENDO 2020, Abstract OR30-03.

This article was updated on 4/17/2020.

A retrospective study of patients at a minority-serving, safety-net hospital showed low uptake of diabetes technology among black patients with type 1 diabetes, compared with their white counterparts.

The researchers also found lower usage of the technology among Hispanic patients, but the difference, compared with their white counterparts, was not statistically significant after adjustments for language, insurance, age, and income. Patients who identified as “other” also were less likely than white patients to use the technology, which included continuous glucose monitors and continuous subcutaneous insulin infusion devices.

The data differes from other, similar studies of technology use in patients with type 1 diabetes, because the study population, drawn from the Boston University Medical Center, was more diverse than other studies, according to Kamonkiat Wirunsawanya, who is an endocrinology fellow at the medical center. The abstract had been slated for presentation at ENDO 2020, the Endocrine Society's annual meeting, which was canceled because of the COVID-19 pandemic.

Dr. Wirunsawanya and his colleagues are now using questionnaires to try to identify specific patient and physician factors that might explain the differences in technology use.

“Once we know which factors could be a barrier to using the technology, we’ll be able to implement a strategy to increase use in those patients,” Dr. Wirunsawanya said in an interview. The issue could be a two-way street, he noted, because some providers may be uncomfortable using the technology, or may perceive minorities as less adept at using technology.

The study included 227 adult patients who were seen at the medical center between October 2016 and September 2017. The mean age was 39 years, and 59% were men. The mean duration of type 1 diabetes was 21 years, and 30% of the patients were overweight, 22% were obese, 80% spoke English, and 50% were on government insurance. In all, 43% of the patients were white, 25% were black, 15% were Hispanic, 2% were Asian, and 15% identified as other.

Patients who used technology had lower mean levels of hemoglobin A_1c, compared with nonusers (8.27% vs. 9.49%, respectively). Those with government health insurance were less likely than those with private insurance to use technology (odds ratio, 0.43; 95% confidential interval, 0.25-0.74).

Overall, 26% of the patients used continuous subcutaneous insulin infusion devices. Of those, 43% were white, 10% black, 14% Hispanic, none were Asian, and 18% identified as other.

In addition, 30% of the patients used continuous glucose monitors; of those, 47% were white, 14% black, 23% Hispanic, 25% Asian, and none identified as other.

After adjustments for insurance and language, the researchers found that black patients were less likely to use technology than were the white patients (OR, 0.25; 95% CI, 0.11-0.53). The same was found for those who identified as other (OR, 0.33; 95% CI, 0.12-0.89). There was no significant differences in technology use between white and Asian patients. After adjustments, the researchers showed that fewer Hispanic patients used technology, compared with their white counterparts, but the difference was not statistically significant.

In a multivariable logistic regression model that adjusted for insurance and language, black patients had lower odds of using technology, compared with white patients (OR, 0.25; 95% CI, 0.11-0.53), as did those identifying as other (OR, 0.33; 95% CI, 0.12-0.89).

In an interview, Anne Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, said that the study highlights a common problem with introducing technology to underserved populations. “These study [findings are] not at all surprising. It’s something that is a puzzle for those of us who work in the field of diabetes management in patients from underserved communities. Even if you can get access to the technology, even when I get them tools and native Spanish-speaking educators and people who should be able to teach them how to use the technology, the adoption of the technology has been really much less than would be expected,” said Dr. Peters, who is also a professor of medicine at USC and was not involved in the research.

Part of the problem may be lack of contact with health care services, she said. White children with type 1 diabetes are treated from an early age and learn how to manage daily blood sugar levels. They often grow up to embrace technology, even enthusiastically. But in some minority communities, diabetes is viewed as something to be hidden away. That cultural difference is also a frustrating barrier.

“What happens in more affluent groups is that people learn from their peers, and they see that [managing their blood sugar] is possible. One of my big beliefs is that the answer has to come from [the community]. ... We need to get champions, people from the community who use these tools, to encourage others, and that’s hard to do because type 1 diabetes is such a small subset of the people with diabetes who are [black] or Latino,” said Dr. Peters.

Ultimately, the solution will require a shift in messaging by finding a way to help communities look differently at diabetes and its treatment. “There’s something that must come educationally and culturally that I’ve not figured out [yet]. I can get resources and fight for them, but we have to figure out how to make [technology] part of that culture, and I don’t know that we’ve done that,” she said.

Dr. Wirunsawanya reported no financial conflicts of interest. Dr. Peters has been on an advisory panel for Abbott Diabetes Care and has received research funding from Dexcom.

Dr. Wirunsawanya and colleagues’ research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Wirunsawanya K et al. ENDO 2020, Abstract OR30-03.

This article was updated on 4/17/2020.

A retrospective study of patients at a minority-serving, safety-net hospital showed low uptake of diabetes technology among black patients with type 1 diabetes, compared with their white counterparts.

The researchers also found lower usage of the technology among Hispanic patients, but the difference, compared with their white counterparts, was not statistically significant after adjustments for language, insurance, age, and income. Patients who identified as “other” also were less likely than white patients to use the technology, which included continuous glucose monitors and continuous subcutaneous insulin infusion devices.

The data differes from other, similar studies of technology use in patients with type 1 diabetes, because the study population, drawn from the Boston University Medical Center, was more diverse than other studies, according to Kamonkiat Wirunsawanya, who is an endocrinology fellow at the medical center. The abstract had been slated for presentation at ENDO 2020, the Endocrine Society's annual meeting, which was canceled because of the COVID-19 pandemic.

Dr. Wirunsawanya and his colleagues are now using questionnaires to try to identify specific patient and physician factors that might explain the differences in technology use.

“Once we know which factors could be a barrier to using the technology, we’ll be able to implement a strategy to increase use in those patients,” Dr. Wirunsawanya said in an interview. The issue could be a two-way street, he noted, because some providers may be uncomfortable using the technology, or may perceive minorities as less adept at using technology.

The study included 227 adult patients who were seen at the medical center between October 2016 and September 2017. The mean age was 39 years, and 59% were men. The mean duration of type 1 diabetes was 21 years, and 30% of the patients were overweight, 22% were obese, 80% spoke English, and 50% were on government insurance. In all, 43% of the patients were white, 25% were black, 15% were Hispanic, 2% were Asian, and 15% identified as other.

Patients who used technology had lower mean levels of hemoglobin A_1c, compared with nonusers (8.27% vs. 9.49%, respectively). Those with government health insurance were less likely than those with private insurance to use technology (odds ratio, 0.43; 95% confidential interval, 0.25-0.74).

Overall, 26% of the patients used continuous subcutaneous insulin infusion devices. Of those, 43% were white, 10% black, 14% Hispanic, none were Asian, and 18% identified as other.

In addition, 30% of the patients used continuous glucose monitors; of those, 47% were white, 14% black, 23% Hispanic, 25% Asian, and none identified as other.

After adjustments for insurance and language, the researchers found that black patients were less likely to use technology than were the white patients (OR, 0.25; 95% CI, 0.11-0.53). The same was found for those who identified as other (OR, 0.33; 95% CI, 0.12-0.89). There was no significant differences in technology use between white and Asian patients. After adjustments, the researchers showed that fewer Hispanic patients used technology, compared with their white counterparts, but the difference was not statistically significant.

In a multivariable logistic regression model that adjusted for insurance and language, black patients had lower odds of using technology, compared with white patients (OR, 0.25; 95% CI, 0.11-0.53), as did those identifying as other (OR, 0.33; 95% CI, 0.12-0.89).

In an interview, Anne Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, said that the study highlights a common problem with introducing technology to underserved populations. “These study [findings are] not at all surprising. It’s something that is a puzzle for those of us who work in the field of diabetes management in patients from underserved communities. Even if you can get access to the technology, even when I get them tools and native Spanish-speaking educators and people who should be able to teach them how to use the technology, the adoption of the technology has been really much less than would be expected,” said Dr. Peters, who is also a professor of medicine at USC and was not involved in the research.

Part of the problem may be lack of contact with health care services, she said. White children with type 1 diabetes are treated from an early age and learn how to manage daily blood sugar levels. They often grow up to embrace technology, even enthusiastically. But in some minority communities, diabetes is viewed as something to be hidden away. That cultural difference is also a frustrating barrier.

“What happens in more affluent groups is that people learn from their peers, and they see that [managing their blood sugar] is possible. One of my big beliefs is that the answer has to come from [the community]. ... We need to get champions, people from the community who use these tools, to encourage others, and that’s hard to do because type 1 diabetes is such a small subset of the people with diabetes who are [black] or Latino,” said Dr. Peters.

Ultimately, the solution will require a shift in messaging by finding a way to help communities look differently at diabetes and its treatment. “There’s something that must come educationally and culturally that I’ve not figured out [yet]. I can get resources and fight for them, but we have to figure out how to make [technology] part of that culture, and I don’t know that we’ve done that,” she said.

Dr. Wirunsawanya reported no financial conflicts of interest. Dr. Peters has been on an advisory panel for Abbott Diabetes Care and has received research funding from Dexcom.

Dr. Wirunsawanya and colleagues’ research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Wirunsawanya K et al. ENDO 2020, Abstract OR30-03.

This article was updated on 4/17/2020.

Participants who had higher levels of fitness when beginning a behavioral weight-loss intervention kept off more weight over the course of an 18-month study, compared with those with lower levels of fitness at baseline.

Those with higher baseline fitness also were able to achieve higher levels of moderate to vigorous physical activity at the 18-month mark, Adnin Zaman, MD, said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“Our study really comes from an observation that we often see significant variability in how much weight participants lose during a behavioral weight-loss intervention study, said Dr. Zaman, an endocrinology research fellow at the University of Colorado at Denver, Aurora.

She and her colleagues wanted to look at baseline cardiovascular fitness as an individual-specific factor that could affect how much weight people lost when participating in a behavioral intervention.

“Very little is known about how cardiovascular fitness affects [people’s] ability to lose weight [or] to adhere to high levels of physical activity, which is a very common recommendation during a program for both weight loss and weight-loss maintenance,” she added.

Dr. Zaman and colleagues conducted a secondary analysis of data from an 18-month trial of behavioral interventions for weight loss. The trial randomized 170 participants 1:1 to receive either concurrent exercise and a dietary behavior modification intervention or sequential dietary and exercise interventions.

The 85 participants in the concurrent intervention arm received 18 months of combined dietary modifications (calorie-restricted diet and group-based behavioral support) and exercise (supervised for the first 6 months of the study, unsupervised for the final 12). Those participating in the sequential intervention arm received a diet-only intervention during the first 6 months of the study, after which supervised exercise was added to the dietary intervention for 6 months, followed by a final 6 months of unsupervised exercise.

Participants in both study arms worked up to 300 minutes a week of moderate to vigorous physical activity in the supervised exercise phase.

For the secondary analysis, Dr. Zaman and colleagues looked only at the 60 participants who received concurrent diet and exercise interventions and who completed the full 18-month study. The mean age in that group was 40 years, mean baseline body mass index (BMI) was 34.6 kg/m², and 80% of participants in the group were women.

Cardiovascular fitness as measured by VO_2max was assessed at baseline using a graded exercise test. Participants were designated as having either “very poor” or “poor or better” cardiovascular fitness (20 and 40 participants, respectively).

Participants in the original trial were inactive at baseline and had a BMI range of 27-42 kg/m². Among the subset of participants studied by Dr. Zaman and colleagues, those who were in the poor or better fitness category actually weighed less at baseline and had a lower BMI, compared with those in the very poor group (33.7 vs. 36.2, respectively), she said. Mean VO_2max for those with very poor fitness was 22.5 mL/kg per minute, compared with 25.6 mL/kg per minute for those with poor or better fitness.

“Despite those differences, it is interesting to note that, during the supervised exercise portion of the study ... everyone lost pretty much the same amount of weight in the first 6 months,” said Dr. Zaman. At the 6-month mark, those with very poor fitness had lost 9.2 kg (20.3 pounds), and those with poor or better fitness had lost 9.1 kg (20.1 pounds). However, weight regain was less likely in those with poor or better fitness, and those participants had a net loss of weight from baseline of 8.2 kg (18.1 pounds), compared with 4.4 kg (9.7 pounds) for those with very poor fitness.

Those with poor or better fitness were able to sustain a 33-minute bout of moderate to vigorous physical activity at baseline, whereas those with very poor fitness could achieve only about half of that. The difference in achievable physical activity between the two groups persisted throughout the study, with a peak at the 6-month mark, at about 60 minutes for the more fit participants and 38 minutes for those in the poor fitness group. By the end of the study, the less-fit participants achieved about 24 minutes of activity, whereas those who were more fit could sustain about 42 minutes of moderate to vigorous physical activity.

Physical activity levels were measured with a validated, wrist-worn device during a 1-week period at baseline and again at study months 6, 12, and 18.

Dr. Zaman noted that baseline weight may have confounded fitness categorization, because VO_2max includes body weight in its calculations. A newer method of calculating cardiorespiratory fitness that scales VO_2max to body weight may help minimize this potential confounder.

The investigators reported no outside sources of funding and reported that they had no financial conflicts of interest.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Zaman A et al. ENDO 2020, Abstract 575.

This article was updated on 4/17/2020.

Participants who had higher levels of fitness when beginning a behavioral weight-loss intervention kept off more weight over the course of an 18-month study, compared with those with lower levels of fitness at baseline.

Those with higher baseline fitness also were able to achieve higher levels of moderate to vigorous physical activity at the 18-month mark, Adnin Zaman, MD, said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“Our study really comes from an observation that we often see significant variability in how much weight participants lose during a behavioral weight-loss intervention study, said Dr. Zaman, an endocrinology research fellow at the University of Colorado at Denver, Aurora.

She and her colleagues wanted to look at baseline cardiovascular fitness as an individual-specific factor that could affect how much weight people lost when participating in a behavioral intervention.

“Very little is known about how cardiovascular fitness affects [people’s] ability to lose weight [or] to adhere to high levels of physical activity, which is a very common recommendation during a program for both weight loss and weight-loss maintenance,” she added.

Dr. Zaman and colleagues conducted a secondary analysis of data from an 18-month trial of behavioral interventions for weight loss. The trial randomized 170 participants 1:1 to receive either concurrent exercise and a dietary behavior modification intervention or sequential dietary and exercise interventions.

The 85 participants in the concurrent intervention arm received 18 months of combined dietary modifications (calorie-restricted diet and group-based behavioral support) and exercise (supervised for the first 6 months of the study, unsupervised for the final 12). Those participating in the sequential intervention arm received a diet-only intervention during the first 6 months of the study, after which supervised exercise was added to the dietary intervention for 6 months, followed by a final 6 months of unsupervised exercise.

Participants in both study arms worked up to 300 minutes a week of moderate to vigorous physical activity in the supervised exercise phase.

For the secondary analysis, Dr. Zaman and colleagues looked only at the 60 participants who received concurrent diet and exercise interventions and who completed the full 18-month study. The mean age in that group was 40 years, mean baseline body mass index (BMI) was 34.6 kg/m², and 80% of participants in the group were women.

Cardiovascular fitness as measured by VO_2max was assessed at baseline using a graded exercise test. Participants were designated as having either “very poor” or “poor or better” cardiovascular fitness (20 and 40 participants, respectively).

Participants in the original trial were inactive at baseline and had a BMI range of 27-42 kg/m². Among the subset of participants studied by Dr. Zaman and colleagues, those who were in the poor or better fitness category actually weighed less at baseline and had a lower BMI, compared with those in the very poor group (33.7 vs. 36.2, respectively), she said. Mean VO_2max for those with very poor fitness was 22.5 mL/kg per minute, compared with 25.6 mL/kg per minute for those with poor or better fitness.

“Despite those differences, it is interesting to note that, during the supervised exercise portion of the study ... everyone lost pretty much the same amount of weight in the first 6 months,” said Dr. Zaman. At the 6-month mark, those with very poor fitness had lost 9.2 kg (20.3 pounds), and those with poor or better fitness had lost 9.1 kg (20.1 pounds). However, weight regain was less likely in those with poor or better fitness, and those participants had a net loss of weight from baseline of 8.2 kg (18.1 pounds), compared with 4.4 kg (9.7 pounds) for those with very poor fitness.

Those with poor or better fitness were able to sustain a 33-minute bout of moderate to vigorous physical activity at baseline, whereas those with very poor fitness could achieve only about half of that. The difference in achievable physical activity between the two groups persisted throughout the study, with a peak at the 6-month mark, at about 60 minutes for the more fit participants and 38 minutes for those in the poor fitness group. By the end of the study, the less-fit participants achieved about 24 minutes of activity, whereas those who were more fit could sustain about 42 minutes of moderate to vigorous physical activity.

Physical activity levels were measured with a validated, wrist-worn device during a 1-week period at baseline and again at study months 6, 12, and 18.

Dr. Zaman noted that baseline weight may have confounded fitness categorization, because VO_2max includes body weight in its calculations. A newer method of calculating cardiorespiratory fitness that scales VO_2max to body weight may help minimize this potential confounder.

The investigators reported no outside sources of funding and reported that they had no financial conflicts of interest.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Zaman A et al. ENDO 2020, Abstract 575.

This article was updated on 4/17/2020.

Participants who had higher levels of fitness when beginning a behavioral weight-loss intervention kept off more weight over the course of an 18-month study, compared with those with lower levels of fitness at baseline.

Those with higher baseline fitness also were able to achieve higher levels of moderate to vigorous physical activity at the 18-month mark, Adnin Zaman, MD, said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

“Our study really comes from an observation that we often see significant variability in how much weight participants lose during a behavioral weight-loss intervention study, said Dr. Zaman, an endocrinology research fellow at the University of Colorado at Denver, Aurora.

She and her colleagues wanted to look at baseline cardiovascular fitness as an individual-specific factor that could affect how much weight people lost when participating in a behavioral intervention.

“Very little is known about how cardiovascular fitness affects [people’s] ability to lose weight [or] to adhere to high levels of physical activity, which is a very common recommendation during a program for both weight loss and weight-loss maintenance,” she added.

Dr. Zaman and colleagues conducted a secondary analysis of data from an 18-month trial of behavioral interventions for weight loss. The trial randomized 170 participants 1:1 to receive either concurrent exercise and a dietary behavior modification intervention or sequential dietary and exercise interventions.

The 85 participants in the concurrent intervention arm received 18 months of combined dietary modifications (calorie-restricted diet and group-based behavioral support) and exercise (supervised for the first 6 months of the study, unsupervised for the final 12). Those participating in the sequential intervention arm received a diet-only intervention during the first 6 months of the study, after which supervised exercise was added to the dietary intervention for 6 months, followed by a final 6 months of unsupervised exercise.

Participants in both study arms worked up to 300 minutes a week of moderate to vigorous physical activity in the supervised exercise phase.

For the secondary analysis, Dr. Zaman and colleagues looked only at the 60 participants who received concurrent diet and exercise interventions and who completed the full 18-month study. The mean age in that group was 40 years, mean baseline body mass index (BMI) was 34.6 kg/m², and 80% of participants in the group were women.

Cardiovascular fitness as measured by VO_2max was assessed at baseline using a graded exercise test. Participants were designated as having either “very poor” or “poor or better” cardiovascular fitness (20 and 40 participants, respectively).

Participants in the original trial were inactive at baseline and had a BMI range of 27-42 kg/m². Among the subset of participants studied by Dr. Zaman and colleagues, those who were in the poor or better fitness category actually weighed less at baseline and had a lower BMI, compared with those in the very poor group (33.7 vs. 36.2, respectively), she said. Mean VO_2max for those with very poor fitness was 22.5 mL/kg per minute, compared with 25.6 mL/kg per minute for those with poor or better fitness.

“Despite those differences, it is interesting to note that, during the supervised exercise portion of the study ... everyone lost pretty much the same amount of weight in the first 6 months,” said Dr. Zaman. At the 6-month mark, those with very poor fitness had lost 9.2 kg (20.3 pounds), and those with poor or better fitness had lost 9.1 kg (20.1 pounds). However, weight regain was less likely in those with poor or better fitness, and those participants had a net loss of weight from baseline of 8.2 kg (18.1 pounds), compared with 4.4 kg (9.7 pounds) for those with very poor fitness.

Those with poor or better fitness were able to sustain a 33-minute bout of moderate to vigorous physical activity at baseline, whereas those with very poor fitness could achieve only about half of that. The difference in achievable physical activity between the two groups persisted throughout the study, with a peak at the 6-month mark, at about 60 minutes for the more fit participants and 38 minutes for those in the poor fitness group. By the end of the study, the less-fit participants achieved about 24 minutes of activity, whereas those who were more fit could sustain about 42 minutes of moderate to vigorous physical activity.

Physical activity levels were measured with a validated, wrist-worn device during a 1-week period at baseline and again at study months 6, 12, and 18.

Dr. Zaman noted that baseline weight may have confounded fitness categorization, because VO_2max includes body weight in its calculations. A newer method of calculating cardiorespiratory fitness that scales VO_2max to body weight may help minimize this potential confounder.

The investigators reported no outside sources of funding and reported that they had no financial conflicts of interest.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: Zaman A et al. ENDO 2020, Abstract 575.

This article was updated on 4/17/2020.

In utero exposure to bisphenol-A (BPA) analogs led to hypertension in female rats, findings in a new study have shown.

Researchers tested exposures to BPA, as well as bisphenol-S (BPS) and bisphenol-F (BPF), which have been introduced in recent years as BPA alternatives and are now increasingly detectable in human and animal tissues. BPS and BPF are often found in products labeled as “BPA free.”

BPS and BPF have similar physiochemical properties to BPA, and there is concern over their effects.

But their physiological impact is not yet clear, according to Puliyur MohanKumar, DVM, PhD, of the University of Georgia Regenerative Bioscience Center, Athens. “We are exposed to BPA and related compounds on a regular basis, and the important thing is that BPA and related compounds easily cross the placental barrier,” Dr. MohanKumar said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

Dr. MohanKumar and colleagues exposed pregnant rats to BPA, BPS, or BPF. When the offspring reached adulthood, the researchers implanted them with radiotelemetry devices to track systolic and diastolic blood pressure, which they measured every 10 minutes over a 24-hour period. This was repeated once a week for 11 weeks.

“The female offspring had elevated systolic as well as diastolic blood pressure, and this was an increase of about 8 mm [Hg] higher than the control animals. That was pretty significant. Keeping these animals at such a prehypertensive state for such a long period of time is going to [lead to] lots of cardiovascular issues later on,” said Dr. MohanKumar.

Robert Sargis, MD, PhD, professor of endocrinology, diabetes, and metabolism at the University of Illinois at Chicago, noted that, although animal studies don’t necessarily translate to similar outcomes in humans, the results are cause for concern.

“What’s particularly interesting, is that there is whole area of essential hypertension, where people develop hypertension and we don’t really know why. We just treat it,” he said in an interview. “But thinking about biological origins [of hypertension] is potentially interesting for a couple of reasons. These bisphenol compounds are really common. Most Americans are exposed to bisphenol A, and it’s been associated with other adverse metabolic effects, including alterations to body weight and glucose homeostasis.

“[These findings] feed into a whole series of studies that have begun to look at the BPA replacements and the fact that they may be, at best, as bad as BPA, and at worst, possibly slightly worse, depending on which outcomes you’re looking at,” Dr. Sargis added.

In the study, seven pregnant rats were orally exposed to saline, four pregnant rats to 5 mcg/kg BPA, four to 5 mcg/kg BPS, and five to 1 mcg/kg BPF during days 6-21 of pregnancy. The lower dose of BPF was used because a dose of 5 mcg/kg proved too toxic. When the offspring reached adulthood, the researchers implanted radiotelemetry devices in the offspring’s femoral artery.

Mean daytime systolic BP was highest in the BPA group (133.3 mg Hg; P < .05), followed by BPS (132.5 mm Hg; P < .05) and BPF (129.2 mm Hg; nonsignificant), compared with 125.2 mm Hg in controls. Nighttime systolic BP was again highest in the BPA group (134.2 mm Hg; P < .01), followed by BPS (133.2 mm Hg; P < .05) and BPF (129.6 mm Hg; nonsignificant), compared with 125.1 mm Hg in controls.

During the day, diastolic BP was highest in the BPS group (91.3 mm Hg; P < .01), followed by BPA (88.8 mm Hg; nonsignificant) and BPF (88.6 mm Hg; nonsignificant), compared with 84.1 mm Hg in controls. At night, diastolic BP was highest in the BPS group (89.7 mm Hg; P < .01), followed by BPA (89.6 mm Hg; P < .01) and BPF (88.6 mm Hg; P < .01), compared with 83.3 mm Hg in controls.

During the day, mean arterial pressure was highest in the BPA group (110.5 mm Hg; P < .01), followed by BPS (108.9 mm Hg; P < .01) and BPF (105.2 mm Hg; nonsignificant), compared with 102.6 mm Hg in controls. At night, mean arterial pressure was highest in BPS (108.6 mm Hg; P < .05), followed by BPA (107.5 mm Hg; nonsignificant) and BPF (105.7 mm Hg; nonsignificant), compared with 101.8 mm Hg in controls.

“These results indicate that prenatal exposure to low levels of BPA analogs has a profound effect on hypertension” in the offspring of pregnant rats exposed to bisphenols, Dr. MohanKumar and colleagues wrote in the abstract.

He noted during his presentation that he and his colleagues plan to repeat the study in male offspring to determine if there are sex differences.

Dr. MohanKumar and colleagues reported having no relevant financial disclosures. Dr. Sargis also reported no conflicts of interest.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: MohanKumar P et al. ENDO 2020, Abstract 719.

This article was updated on 4/17/2020.

In utero exposure to bisphenol-A (BPA) analogs led to hypertension in female rats, findings in a new study have shown.

Researchers tested exposures to BPA, as well as bisphenol-S (BPS) and bisphenol-F (BPF), which have been introduced in recent years as BPA alternatives and are now increasingly detectable in human and animal tissues. BPS and BPF are often found in products labeled as “BPA free.”

BPS and BPF have similar physiochemical properties to BPA, and there is concern over their effects.

But their physiological impact is not yet clear, according to Puliyur MohanKumar, DVM, PhD, of the University of Georgia Regenerative Bioscience Center, Athens. “We are exposed to BPA and related compounds on a regular basis, and the important thing is that BPA and related compounds easily cross the placental barrier,” Dr. MohanKumar said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

Dr. MohanKumar and colleagues exposed pregnant rats to BPA, BPS, or BPF. When the offspring reached adulthood, the researchers implanted them with radiotelemetry devices to track systolic and diastolic blood pressure, which they measured every 10 minutes over a 24-hour period. This was repeated once a week for 11 weeks.

“The female offspring had elevated systolic as well as diastolic blood pressure, and this was an increase of about 8 mm [Hg] higher than the control animals. That was pretty significant. Keeping these animals at such a prehypertensive state for such a long period of time is going to [lead to] lots of cardiovascular issues later on,” said Dr. MohanKumar.

Robert Sargis, MD, PhD, professor of endocrinology, diabetes, and metabolism at the University of Illinois at Chicago, noted that, although animal studies don’t necessarily translate to similar outcomes in humans, the results are cause for concern.

“What’s particularly interesting, is that there is whole area of essential hypertension, where people develop hypertension and we don’t really know why. We just treat it,” he said in an interview. “But thinking about biological origins [of hypertension] is potentially interesting for a couple of reasons. These bisphenol compounds are really common. Most Americans are exposed to bisphenol A, and it’s been associated with other adverse metabolic effects, including alterations to body weight and glucose homeostasis.

“[These findings] feed into a whole series of studies that have begun to look at the BPA replacements and the fact that they may be, at best, as bad as BPA, and at worst, possibly slightly worse, depending on which outcomes you’re looking at,” Dr. Sargis added.

In the study, seven pregnant rats were orally exposed to saline, four pregnant rats to 5 mcg/kg BPA, four to 5 mcg/kg BPS, and five to 1 mcg/kg BPF during days 6-21 of pregnancy. The lower dose of BPF was used because a dose of 5 mcg/kg proved too toxic. When the offspring reached adulthood, the researchers implanted radiotelemetry devices in the offspring’s femoral artery.

Mean daytime systolic BP was highest in the BPA group (133.3 mg Hg; P < .05), followed by BPS (132.5 mm Hg; P < .05) and BPF (129.2 mm Hg; nonsignificant), compared with 125.2 mm Hg in controls. Nighttime systolic BP was again highest in the BPA group (134.2 mm Hg; P < .01), followed by BPS (133.2 mm Hg; P < .05) and BPF (129.6 mm Hg; nonsignificant), compared with 125.1 mm Hg in controls.

During the day, diastolic BP was highest in the BPS group (91.3 mm Hg; P < .01), followed by BPA (88.8 mm Hg; nonsignificant) and BPF (88.6 mm Hg; nonsignificant), compared with 84.1 mm Hg in controls. At night, diastolic BP was highest in the BPS group (89.7 mm Hg; P < .01), followed by BPA (89.6 mm Hg; P < .01) and BPF (88.6 mm Hg; P < .01), compared with 83.3 mm Hg in controls.

During the day, mean arterial pressure was highest in the BPA group (110.5 mm Hg; P < .01), followed by BPS (108.9 mm Hg; P < .01) and BPF (105.2 mm Hg; nonsignificant), compared with 102.6 mm Hg in controls. At night, mean arterial pressure was highest in BPS (108.6 mm Hg; P < .05), followed by BPA (107.5 mm Hg; nonsignificant) and BPF (105.7 mm Hg; nonsignificant), compared with 101.8 mm Hg in controls.

“These results indicate that prenatal exposure to low levels of BPA analogs has a profound effect on hypertension” in the offspring of pregnant rats exposed to bisphenols, Dr. MohanKumar and colleagues wrote in the abstract.

He noted during his presentation that he and his colleagues plan to repeat the study in male offspring to determine if there are sex differences.

Dr. MohanKumar and colleagues reported having no relevant financial disclosures. Dr. Sargis also reported no conflicts of interest.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: MohanKumar P et al. ENDO 2020, Abstract 719.

This article was updated on 4/17/2020.

In utero exposure to bisphenol-A (BPA) analogs led to hypertension in female rats, findings in a new study have shown.

Researchers tested exposures to BPA, as well as bisphenol-S (BPS) and bisphenol-F (BPF), which have been introduced in recent years as BPA alternatives and are now increasingly detectable in human and animal tissues. BPS and BPF are often found in products labeled as “BPA free.”

BPS and BPF have similar physiochemical properties to BPA, and there is concern over their effects.

But their physiological impact is not yet clear, according to Puliyur MohanKumar, DVM, PhD, of the University of Georgia Regenerative Bioscience Center, Athens. “We are exposed to BPA and related compounds on a regular basis, and the important thing is that BPA and related compounds easily cross the placental barrier,” Dr. MohanKumar said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.

Dr. MohanKumar and colleagues exposed pregnant rats to BPA, BPS, or BPF. When the offspring reached adulthood, the researchers implanted them with radiotelemetry devices to track systolic and diastolic blood pressure, which they measured every 10 minutes over a 24-hour period. This was repeated once a week for 11 weeks.

“The female offspring had elevated systolic as well as diastolic blood pressure, and this was an increase of about 8 mm [Hg] higher than the control animals. That was pretty significant. Keeping these animals at such a prehypertensive state for such a long period of time is going to [lead to] lots of cardiovascular issues later on,” said Dr. MohanKumar.

Robert Sargis, MD, PhD, professor of endocrinology, diabetes, and metabolism at the University of Illinois at Chicago, noted that, although animal studies don’t necessarily translate to similar outcomes in humans, the results are cause for concern.

“What’s particularly interesting, is that there is whole area of essential hypertension, where people develop hypertension and we don’t really know why. We just treat it,” he said in an interview. “But thinking about biological origins [of hypertension] is potentially interesting for a couple of reasons. These bisphenol compounds are really common. Most Americans are exposed to bisphenol A, and it’s been associated with other adverse metabolic effects, including alterations to body weight and glucose homeostasis.

“[These findings] feed into a whole series of studies that have begun to look at the BPA replacements and the fact that they may be, at best, as bad as BPA, and at worst, possibly slightly worse, depending on which outcomes you’re looking at,” Dr. Sargis added.

In the study, seven pregnant rats were orally exposed to saline, four pregnant rats to 5 mcg/kg BPA, four to 5 mcg/kg BPS, and five to 1 mcg/kg BPF during days 6-21 of pregnancy. The lower dose of BPF was used because a dose of 5 mcg/kg proved too toxic. When the offspring reached adulthood, the researchers implanted radiotelemetry devices in the offspring’s femoral artery.

Mean daytime systolic BP was highest in the BPA group (133.3 mg Hg; P < .05), followed by BPS (132.5 mm Hg; P < .05) and BPF (129.2 mm Hg; nonsignificant), compared with 125.2 mm Hg in controls. Nighttime systolic BP was again highest in the BPA group (134.2 mm Hg; P < .01), followed by BPS (133.2 mm Hg; P < .05) and BPF (129.6 mm Hg; nonsignificant), compared with 125.1 mm Hg in controls.

During the day, diastolic BP was highest in the BPS group (91.3 mm Hg; P < .01), followed by BPA (88.8 mm Hg; nonsignificant) and BPF (88.6 mm Hg; nonsignificant), compared with 84.1 mm Hg in controls. At night, diastolic BP was highest in the BPS group (89.7 mm Hg; P < .01), followed by BPA (89.6 mm Hg; P < .01) and BPF (88.6 mm Hg; P < .01), compared with 83.3 mm Hg in controls.

During the day, mean arterial pressure was highest in the BPA group (110.5 mm Hg; P < .01), followed by BPS (108.9 mm Hg; P < .01) and BPF (105.2 mm Hg; nonsignificant), compared with 102.6 mm Hg in controls. At night, mean arterial pressure was highest in BPS (108.6 mm Hg; P < .05), followed by BPA (107.5 mm Hg; nonsignificant) and BPF (105.7 mm Hg; nonsignificant), compared with 101.8 mm Hg in controls.

“These results indicate that prenatal exposure to low levels of BPA analogs has a profound effect on hypertension” in the offspring of pregnant rats exposed to bisphenols, Dr. MohanKumar and colleagues wrote in the abstract.

He noted during his presentation that he and his colleagues plan to repeat the study in male offspring to determine if there are sex differences.

Dr. MohanKumar and colleagues reported having no relevant financial disclosures. Dr. Sargis also reported no conflicts of interest.

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

SOURCE: MohanKumar P et al. ENDO 2020, Abstract 719.

This article was updated on 4/17/2020.

Nearly one in five individuals with cancer who are treated with immune checkpoint inhibitors develop thyroid dysfunction, new research suggests.

Sebastian Kaulitzki/Fotolia

Immune checkpoint inhibitors have revolutionized the treatment of many different types of cancers, but can also trigger a variety of immune-related adverse effects. As these drugs become more widely used, rates of these events appear to be more common in the real-world compared with clinical trial settings.

In their new study, Zoe Quandt, MD, of the University of California, San Francisco (UCSF), and colleagues specifically looked at thyroid dysfunction in their own institution’s EHR data and found more than double the rate of hypothyroidism and more than triple the rate of hyperthyroidism, compared with rates in published trials.

Moreover, in contrast to previous studies that have found differences in thyroid dysfunction by checkpoint inhibitor type, Dr. Quandt and colleagues instead found significant differences by cancer type.

Dr. Quandt presented the findings during a virtual press briefing held March 31originally scheduled for ENDO 2020.

“Thyroid dysfunction following checkpoint inhibitor therapy appears to be much more common than was previously reported in clinical trials, and this is one of the first studies to show differences by cancer type rather than by checkpoint inhibitor type,” Dr. Quandt said during the presentation.

However, she also cautioned that there’s “a lot more research to be done to validate case definitions and validate these findings.”

Asked to comment, endocrinologist David C. Lieb, MD, associate professor of medicine at Eastern Virginia Medical School in Norfolk, said in an interview, “These drugs are becoming so much more commonly used, so it’s not surprising that we’re seeing more endocrine complications, especially thyroid disease.”

“Endocrinologists need to work closely with oncologists to make sure patients are being screened and followed appropriately.”

‘A much higher percentage than we were expecting’

Dr. Quandt’s study included 1,146 individuals treated with checkpoint inhibitors at UCSF during 2012-2018 who did not have thyroid cancer or preexisting thyroid dysfunction.

Pembrolizumab (Keytruda) was the most common treatment (45%), followed by nivolumab (Opdivo) (20%). Less than 10% of patients received atezolizumab (Tecentriq), durvalumab (Imfizi), ipilimumab (Yervoy) monotherapy, combined ipilimumab/nivolumab, or other combinations of checkpoint inhibitors.

A total of 19.1% developed thyroid disease, with 13.4% having hypothyroidism and 9.5% hyperthyroidism. These figures far exceed those found in a recent meta-analysis of 38 randomized clinical trials of checkpoint inhibitors that included 7551 patients.

“Using this approach, we found a much higher percentage of patients who developed thyroid dysfunction than we were expecting,” Dr. Quandt said.

In both cases, the two categories – hypothyroidism and hyperthyroidism – aren’t mutually exclusive as hypothyroidism can arise de novo or subsequent to hyperthyroidism.

Dr Lieb commented, “It would be interesting to see what the causes of hyperthyroidism are – thyroiditis or Graves disease.”

Dr. Quandt mentioned a possible reason for the large difference between clinical trial and real-world data.

“Once we’re actually using these drugs outside of clinical trials, some of the restrictions about using them in people with other autoimmune diseases have been lifted, so my guess is that as we give them to a broader population we’re seeing more of these [adverse effects],” she suggested.

Also, “In the initial trials, people weren’t quite as aware of the possibilities of these side effects, so now we’re doing many more labs. Patients get thyroid function tests with every infusion, so I think we’re probably catching more patients who develop disease.”
 

Differences by cancer type, not checkpoint inhibitor type

And in a new twist, Dr. Quandt found that, in contrast to the differences seen by checkpoint inhibitor type in randomized trials, “surprisingly, we found that this difference did not reach statistical significance.”

“Instead, we saw that cancer type was associated with development of thyroid dysfunction, even after taking checkpoint inhibitor type into account.”

The percentages of patients who developed thyroid dysfunction ranged from 9.7% of those with glioblastoma to 40.0% of those with renal cell carcinoma.

The reason for this is not clear, said Dr. Quandt in an interview.

One possibility relates to other treatments patients with cancer also receive. In renal cell carcinoma, for example, patients also are treated with tyrosine kinase inhibitors, which can also cause thyroid dysfunction, so they may be more susceptible. Or there may be shared antigens activating the immune system.

“That’s definitely one of the questions we’re looking at,” she said.

Dr. Quandt and Dr. Lieb have reported no relevant financial relationships.

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

Nearly one in five individuals with cancer who are treated with immune checkpoint inhibitors develop thyroid dysfunction, new research suggests.

Sebastian Kaulitzki/Fotolia

Immune checkpoint inhibitors have revolutionized the treatment of many different types of cancers, but can also trigger a variety of immune-related adverse effects. As these drugs become more widely used, rates of these events appear to be more common in the real-world compared with clinical trial settings.

In their new study, Zoe Quandt, MD, of the University of California, San Francisco (UCSF), and colleagues specifically looked at thyroid dysfunction in their own institution’s EHR data and found more than double the rate of hypothyroidism and more than triple the rate of hyperthyroidism, compared with rates in published trials.

Moreover, in contrast to previous studies that have found differences in thyroid dysfunction by checkpoint inhibitor type, Dr. Quandt and colleagues instead found significant differences by cancer type.

Dr. Quandt presented the findings during a virtual press briefing held March 31originally scheduled for ENDO 2020.

“Thyroid dysfunction following checkpoint inhibitor therapy appears to be much more common than was previously reported in clinical trials, and this is one of the first studies to show differences by cancer type rather than by checkpoint inhibitor type,” Dr. Quandt said during the presentation.

However, she also cautioned that there’s “a lot more research to be done to validate case definitions and validate these findings.”

Asked to comment, endocrinologist David C. Lieb, MD, associate professor of medicine at Eastern Virginia Medical School in Norfolk, said in an interview, “These drugs are becoming so much more commonly used, so it’s not surprising that we’re seeing more endocrine complications, especially thyroid disease.”

“Endocrinologists need to work closely with oncologists to make sure patients are being screened and followed appropriately.”

‘A much higher percentage than we were expecting’

Dr. Quandt’s study included 1,146 individuals treated with checkpoint inhibitors at UCSF during 2012-2018 who did not have thyroid cancer or preexisting thyroid dysfunction.

Pembrolizumab (Keytruda) was the most common treatment (45%), followed by nivolumab (Opdivo) (20%). Less than 10% of patients received atezolizumab (Tecentriq), durvalumab (Imfizi), ipilimumab (Yervoy) monotherapy, combined ipilimumab/nivolumab, or other combinations of checkpoint inhibitors.

A total of 19.1% developed thyroid disease, with 13.4% having hypothyroidism and 9.5% hyperthyroidism. These figures far exceed those found in a recent meta-analysis of 38 randomized clinical trials of checkpoint inhibitors that included 7551 patients.

“Using this approach, we found a much higher percentage of patients who developed thyroid dysfunction than we were expecting,” Dr. Quandt said.

In both cases, the two categories – hypothyroidism and hyperthyroidism – aren’t mutually exclusive as hypothyroidism can arise de novo or subsequent to hyperthyroidism.

Dr Lieb commented, “It would be interesting to see what the causes of hyperthyroidism are – thyroiditis or Graves disease.”

Dr. Quandt mentioned a possible reason for the large difference between clinical trial and real-world data.

“Once we’re actually using these drugs outside of clinical trials, some of the restrictions about using them in people with other autoimmune diseases have been lifted, so my guess is that as we give them to a broader population we’re seeing more of these [adverse effects],” she suggested.

Also, “In the initial trials, people weren’t quite as aware of the possibilities of these side effects, so now we’re doing many more labs. Patients get thyroid function tests with every infusion, so I think we’re probably catching more patients who develop disease.”
 

Differences by cancer type, not checkpoint inhibitor type

And in a new twist, Dr. Quandt found that, in contrast to the differences seen by checkpoint inhibitor type in randomized trials, “surprisingly, we found that this difference did not reach statistical significance.”

“Instead, we saw that cancer type was associated with development of thyroid dysfunction, even after taking checkpoint inhibitor type into account.”

The percentages of patients who developed thyroid dysfunction ranged from 9.7% of those with glioblastoma to 40.0% of those with renal cell carcinoma.

The reason for this is not clear, said Dr. Quandt in an interview.

One possibility relates to other treatments patients with cancer also receive. In renal cell carcinoma, for example, patients also are treated with tyrosine kinase inhibitors, which can also cause thyroid dysfunction, so they may be more susceptible. Or there may be shared antigens activating the immune system.

“That’s definitely one of the questions we’re looking at,” she said.

Dr. Quandt and Dr. Lieb have reported no relevant financial relationships.

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

Nearly one in five individuals with cancer who are treated with immune checkpoint inhibitors develop thyroid dysfunction, new research suggests.

Sebastian Kaulitzki/Fotolia

Immune checkpoint inhibitors have revolutionized the treatment of many different types of cancers, but can also trigger a variety of immune-related adverse effects. As these drugs become more widely used, rates of these events appear to be more common in the real-world compared with clinical trial settings.

In their new study, Zoe Quandt, MD, of the University of California, San Francisco (UCSF), and colleagues specifically looked at thyroid dysfunction in their own institution’s EHR data and found more than double the rate of hypothyroidism and more than triple the rate of hyperthyroidism, compared with rates in published trials.

Moreover, in contrast to previous studies that have found differences in thyroid dysfunction by checkpoint inhibitor type, Dr. Quandt and colleagues instead found significant differences by cancer type.

Dr. Quandt presented the findings during a virtual press briefing held March 31originally scheduled for ENDO 2020.

“Thyroid dysfunction following checkpoint inhibitor therapy appears to be much more common than was previously reported in clinical trials, and this is one of the first studies to show differences by cancer type rather than by checkpoint inhibitor type,” Dr. Quandt said during the presentation.

However, she also cautioned that there’s “a lot more research to be done to validate case definitions and validate these findings.”

Asked to comment, endocrinologist David C. Lieb, MD, associate professor of medicine at Eastern Virginia Medical School in Norfolk, said in an interview, “These drugs are becoming so much more commonly used, so it’s not surprising that we’re seeing more endocrine complications, especially thyroid disease.”

“Endocrinologists need to work closely with oncologists to make sure patients are being screened and followed appropriately.”

‘A much higher percentage than we were expecting’

Dr. Quandt’s study included 1,146 individuals treated with checkpoint inhibitors at UCSF during 2012-2018 who did not have thyroid cancer or preexisting thyroid dysfunction.

Pembrolizumab (Keytruda) was the most common treatment (45%), followed by nivolumab (Opdivo) (20%). Less than 10% of patients received atezolizumab (Tecentriq), durvalumab (Imfizi), ipilimumab (Yervoy) monotherapy, combined ipilimumab/nivolumab, or other combinations of checkpoint inhibitors.

A total of 19.1% developed thyroid disease, with 13.4% having hypothyroidism and 9.5% hyperthyroidism. These figures far exceed those found in a recent meta-analysis of 38 randomized clinical trials of checkpoint inhibitors that included 7551 patients.

“Using this approach, we found a much higher percentage of patients who developed thyroid dysfunction than we were expecting,” Dr. Quandt said.

In both cases, the two categories – hypothyroidism and hyperthyroidism – aren’t mutually exclusive as hypothyroidism can arise de novo or subsequent to hyperthyroidism.

Dr Lieb commented, “It would be interesting to see what the causes of hyperthyroidism are – thyroiditis or Graves disease.”

Dr. Quandt mentioned a possible reason for the large difference between clinical trial and real-world data.

“Once we’re actually using these drugs outside of clinical trials, some of the restrictions about using them in people with other autoimmune diseases have been lifted, so my guess is that as we give them to a broader population we’re seeing more of these [adverse effects],” she suggested.

Also, “In the initial trials, people weren’t quite as aware of the possibilities of these side effects, so now we’re doing many more labs. Patients get thyroid function tests with every infusion, so I think we’re probably catching more patients who develop disease.”
 

Differences by cancer type, not checkpoint inhibitor type

And in a new twist, Dr. Quandt found that, in contrast to the differences seen by checkpoint inhibitor type in randomized trials, “surprisingly, we found that this difference did not reach statistical significance.”

“Instead, we saw that cancer type was associated with development of thyroid dysfunction, even after taking checkpoint inhibitor type into account.”

The percentages of patients who developed thyroid dysfunction ranged from 9.7% of those with glioblastoma to 40.0% of those with renal cell carcinoma.

The reason for this is not clear, said Dr. Quandt in an interview.

One possibility relates to other treatments patients with cancer also receive. In renal cell carcinoma, for example, patients also are treated with tyrosine kinase inhibitors, which can also cause thyroid dysfunction, so they may be more susceptible. Or there may be shared antigens activating the immune system.

“That’s definitely one of the questions we’re looking at,” she said.

Dr. Quandt and Dr. Lieb have reported no relevant financial relationships.

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