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Food allergy testing for eczema in kids varies by specialty
Specialists vary on their opinion about the ordering of food allergy tests for children with eczema, a recent survey reveals.
A child with eczema is more likely to be given food allergy tests if seen by an allergist or a pediatrician and less likely to be given these tests if seen by a general practitioner or dermatologist.
“In our survey, we found evidence of variation in practice and a spectrum of opinion on what to do to treat eczema in children,” Matthew Ridd, MD, University of Bristol (England) said in an interview.
His clinician survey was sent to 155 health care providers. Findings were presented at the Food Allergy and Anaphylaxis Meeting–European Consortium on Application of Flow Cytometry in Allergy Congress, held virtually. They revealed big differences in the way physicians follow up on eczema. For a child with eczema with reported reactions to food, 20 of 22 (91%) allergists and 22 of 30 (73%) pediatricians always order food allergy tests.
But only 16 of 65 (25%) general practitioners and 3 of 12 (25%) dermatologists always order tests in the same situation.
A total of 155 health care practitioners responded to the survey, sent by a U.K. research team. Of those, 26 were unable to order allergy tests. Of the remaining 129, 65 (50%) specialized in general practice, 30 (23%) in pediatrics, 22 (17%) in the treatment of allergies, and 12 (9%) in dermatology.
Their opinions varied on when to order food allergy tests. For children with severe eczema who had no prior reaction to food, 8 of 22 (36%) practitioners specializing in allergy said they would order food allergy tests, as did 9 of 30 (30%) in pediatrics.
Of those surveyed, only 6 of 65 in general practice (9%) said they would request an allergy test for severe eczema for a patient with no allergy history, and no dermatologists (0%) would order the tests.
Only if a parent specifically requested a food allergy test would practitioners respond in a similar way. About two-thirds of all respondents said they would sometimes order the test if a parent asked (general practice, 75%; pediatrics, 63%; allergy, 68%; dermatology, 75%).
Dr. Ridd said in an interview that it’s not surprising there’s a wide variation in practice, inasmuch as the guidelines are quite convoluted and complex. “Eczema is a common problem, but we don’t have any good evidence to guide clinicians on when to consider food allergy as a possible cause.”
Current guidelines advise calling for allergy tests only when eczema is difficult to treat. “But this is a complex decision. We know that a third of children with eczema are at higher risk for food allergy,” Dr. Ridd said. A 2014 study published in Clinical and Experimental Allergy showed that infants with eczema are six times more likely to have egg allergy and 11 times more likely to have peanut allergy by 12 months than infants without eczema (Clin Exp Allergy. 2014;45:255-64).
Food allergy is a sticky subject, he said. “So we have to wonder, are general practitioners frightened to raise the question?
“We definitely see uncertainty around it.”
He suspects that parents may also be hesitant to bring it up. “They are likely thinking about it even if they don’t ask,” Dr. Ridd said. “I think it’s important to test for food allergy, to provide reassurance. Once we show it’s not an allergy, we can focus on topical treatment.”
Treating eczema with emollients may increase likelihood of food allergy
In a separate presentation at the FAAM-EUROBAT congress, Maeve Kelleher, MD, Imperial College London, said that, rather than help reduce eczema, emollients in infants probably cause an increase in the risk for skin infection and food allergy. Her research team performed a systematic review of 25,827 participants in randomized controlled trials of the use of skin care interventions in term infants for primary prevention of eczema and food allergy. The study focused especially on topical creams.
Dr. Kelleher reported that skin care interventions “probably don’t prevent eczema. They probably increase local skin infections and may increase food allergy.”
Other interventions need to be explored, she said. “Maybe prevention should be along the line of looking at the microbiome, or exposures on the skin when you’re younger.”
Dr. Ridd and Dr. Kelleher have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Specialists vary on their opinion about the ordering of food allergy tests for children with eczema, a recent survey reveals.
A child with eczema is more likely to be given food allergy tests if seen by an allergist or a pediatrician and less likely to be given these tests if seen by a general practitioner or dermatologist.
“In our survey, we found evidence of variation in practice and a spectrum of opinion on what to do to treat eczema in children,” Matthew Ridd, MD, University of Bristol (England) said in an interview.
His clinician survey was sent to 155 health care providers. Findings were presented at the Food Allergy and Anaphylaxis Meeting–European Consortium on Application of Flow Cytometry in Allergy Congress, held virtually. They revealed big differences in the way physicians follow up on eczema. For a child with eczema with reported reactions to food, 20 of 22 (91%) allergists and 22 of 30 (73%) pediatricians always order food allergy tests.
But only 16 of 65 (25%) general practitioners and 3 of 12 (25%) dermatologists always order tests in the same situation.
A total of 155 health care practitioners responded to the survey, sent by a U.K. research team. Of those, 26 were unable to order allergy tests. Of the remaining 129, 65 (50%) specialized in general practice, 30 (23%) in pediatrics, 22 (17%) in the treatment of allergies, and 12 (9%) in dermatology.
Their opinions varied on when to order food allergy tests. For children with severe eczema who had no prior reaction to food, 8 of 22 (36%) practitioners specializing in allergy said they would order food allergy tests, as did 9 of 30 (30%) in pediatrics.
Of those surveyed, only 6 of 65 in general practice (9%) said they would request an allergy test for severe eczema for a patient with no allergy history, and no dermatologists (0%) would order the tests.
Only if a parent specifically requested a food allergy test would practitioners respond in a similar way. About two-thirds of all respondents said they would sometimes order the test if a parent asked (general practice, 75%; pediatrics, 63%; allergy, 68%; dermatology, 75%).
Dr. Ridd said in an interview that it’s not surprising there’s a wide variation in practice, inasmuch as the guidelines are quite convoluted and complex. “Eczema is a common problem, but we don’t have any good evidence to guide clinicians on when to consider food allergy as a possible cause.”
Current guidelines advise calling for allergy tests only when eczema is difficult to treat. “But this is a complex decision. We know that a third of children with eczema are at higher risk for food allergy,” Dr. Ridd said. A 2014 study published in Clinical and Experimental Allergy showed that infants with eczema are six times more likely to have egg allergy and 11 times more likely to have peanut allergy by 12 months than infants without eczema (Clin Exp Allergy. 2014;45:255-64).
Food allergy is a sticky subject, he said. “So we have to wonder, are general practitioners frightened to raise the question?
“We definitely see uncertainty around it.”
He suspects that parents may also be hesitant to bring it up. “They are likely thinking about it even if they don’t ask,” Dr. Ridd said. “I think it’s important to test for food allergy, to provide reassurance. Once we show it’s not an allergy, we can focus on topical treatment.”
Treating eczema with emollients may increase likelihood of food allergy
In a separate presentation at the FAAM-EUROBAT congress, Maeve Kelleher, MD, Imperial College London, said that, rather than help reduce eczema, emollients in infants probably cause an increase in the risk for skin infection and food allergy. Her research team performed a systematic review of 25,827 participants in randomized controlled trials of the use of skin care interventions in term infants for primary prevention of eczema and food allergy. The study focused especially on topical creams.
Dr. Kelleher reported that skin care interventions “probably don’t prevent eczema. They probably increase local skin infections and may increase food allergy.”
Other interventions need to be explored, she said. “Maybe prevention should be along the line of looking at the microbiome, or exposures on the skin when you’re younger.”
Dr. Ridd and Dr. Kelleher have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Specialists vary on their opinion about the ordering of food allergy tests for children with eczema, a recent survey reveals.
A child with eczema is more likely to be given food allergy tests if seen by an allergist or a pediatrician and less likely to be given these tests if seen by a general practitioner or dermatologist.
“In our survey, we found evidence of variation in practice and a spectrum of opinion on what to do to treat eczema in children,” Matthew Ridd, MD, University of Bristol (England) said in an interview.
His clinician survey was sent to 155 health care providers. Findings were presented at the Food Allergy and Anaphylaxis Meeting–European Consortium on Application of Flow Cytometry in Allergy Congress, held virtually. They revealed big differences in the way physicians follow up on eczema. For a child with eczema with reported reactions to food, 20 of 22 (91%) allergists and 22 of 30 (73%) pediatricians always order food allergy tests.
But only 16 of 65 (25%) general practitioners and 3 of 12 (25%) dermatologists always order tests in the same situation.
A total of 155 health care practitioners responded to the survey, sent by a U.K. research team. Of those, 26 were unable to order allergy tests. Of the remaining 129, 65 (50%) specialized in general practice, 30 (23%) in pediatrics, 22 (17%) in the treatment of allergies, and 12 (9%) in dermatology.
Their opinions varied on when to order food allergy tests. For children with severe eczema who had no prior reaction to food, 8 of 22 (36%) practitioners specializing in allergy said they would order food allergy tests, as did 9 of 30 (30%) in pediatrics.
Of those surveyed, only 6 of 65 in general practice (9%) said they would request an allergy test for severe eczema for a patient with no allergy history, and no dermatologists (0%) would order the tests.
Only if a parent specifically requested a food allergy test would practitioners respond in a similar way. About two-thirds of all respondents said they would sometimes order the test if a parent asked (general practice, 75%; pediatrics, 63%; allergy, 68%; dermatology, 75%).
Dr. Ridd said in an interview that it’s not surprising there’s a wide variation in practice, inasmuch as the guidelines are quite convoluted and complex. “Eczema is a common problem, but we don’t have any good evidence to guide clinicians on when to consider food allergy as a possible cause.”
Current guidelines advise calling for allergy tests only when eczema is difficult to treat. “But this is a complex decision. We know that a third of children with eczema are at higher risk for food allergy,” Dr. Ridd said. A 2014 study published in Clinical and Experimental Allergy showed that infants with eczema are six times more likely to have egg allergy and 11 times more likely to have peanut allergy by 12 months than infants without eczema (Clin Exp Allergy. 2014;45:255-64).
Food allergy is a sticky subject, he said. “So we have to wonder, are general practitioners frightened to raise the question?
“We definitely see uncertainty around it.”
He suspects that parents may also be hesitant to bring it up. “They are likely thinking about it even if they don’t ask,” Dr. Ridd said. “I think it’s important to test for food allergy, to provide reassurance. Once we show it’s not an allergy, we can focus on topical treatment.”
Treating eczema with emollients may increase likelihood of food allergy
In a separate presentation at the FAAM-EUROBAT congress, Maeve Kelleher, MD, Imperial College London, said that, rather than help reduce eczema, emollients in infants probably cause an increase in the risk for skin infection and food allergy. Her research team performed a systematic review of 25,827 participants in randomized controlled trials of the use of skin care interventions in term infants for primary prevention of eczema and food allergy. The study focused especially on topical creams.
Dr. Kelleher reported that skin care interventions “probably don’t prevent eczema. They probably increase local skin infections and may increase food allergy.”
Other interventions need to be explored, she said. “Maybe prevention should be along the line of looking at the microbiome, or exposures on the skin when you’re younger.”
Dr. Ridd and Dr. Kelleher have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Teenage bone density declines following sleeve gastrectomy
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Radiofrequency ablation blocks hip, shoulder arthritis pain
Osteoarthritis patients report significant pain relief after treatment with cooled radiofrequency ablation, a new technique that “stuns” sensory nerves in shoulder and hip joints to reduce – and sometimes eliminate – pain.
“We send a small current to the sensory nerve to heat up the tissue and disrupt the fibers,” study lead author Felix Gonzalez, MD, of Emory University, Atlanta, said in an interview. “The effect is that the transmission of pain is significantly slowed or halted altogether.
“We damage something to fix something,” Dr. Gonzalez continued. “We target only the problematic nerve and get a very localized effect.”
Two-phase treatment
The treatment is performed in two phases. First, patients with shoulder pain are given an anesthetic to block their suprascapular, lateral pectoral, and axillary sensory articular nerves. Patients with hip pain have their obturator and femoral sensory articular nerves blocked.
A week or two later, the same nerves are treated with cooled radiofrequency ablation. Guided by x-ray imaging, a clinician heats up the affected nerve tissue using the tip of a needle, which is pointed at the nerve. “It’s a 22-gauge needle, slightly thicker than an acupuncture needle,” Dr. Gonzalez explained. “We heat up the nerve for about 2 minutes to about 60 degrees Celsius – it stuns the nerve,” he said.
“The result disrupts or slows down pain transmission while leaving the nerve intact.”
To test the efficacy of the technique, researchers treated 12 shoulders in patients with an average age of 61 years, and 11 hips in patients with an average age of 62 years.
Three months after treatment, patients with hip pain reported improvement in Hip Disability and Osteoarthritis Outcome Score (HOOS) from a baseline of 17.0 to 52.9 (P < .0001).
Shoulder pain was also reduced significantly. Using the American Shoulder and Elbow Surgeons (ASES) score, researchers reported an improvement from 17.2 (±6.6) at baseline to 65.7 (±5.9) at 3 months (P < .0001).
“We are targeting a subset of patients for this that don’t qualify for surgery,” Dr. Gonzalez noted. For patients with a body mass index above 35, or a history of hypertension, heart disease, or multiple strokes, opioids are the most common treatment, he said.
These patients “fall through the cracks,” he explained. Those who have mild to moderate pain are managed with physical therapy and injections, and those with severe pain go into surgery. “But what about the ones in the middle ... who are not eligible for surgery? They are at risk for opioid overuse,” he said. “So this treatment is a good option for them.”
Treats the symptoms, not the cause
“This study shows the efficacy of this method in taking care of shoulder and hip pain,” Luca Maria Sconfienza, MD, PhD, of Galeazzi Orthopedic Hospital in Milan, said in an interview. Dr. Sconfienza was not involved in Dr. Gonzalez’s study.
However, like corticosteroid injections, “the drawback of radiofrequency ablation is the fact that it only treats the symptoms and not the cause, and efficacy is usually limited over time,” she said.
Dr. Sconfienza said this study leaves her with three pertinent questions. “First, whether pain control extends beyond the 3-month follow-up reported by authors in the abstract; second, [what] is the efficacy of this method compared to other interventions (e.g., physical therapy, injections) or to doing nothing; and last, radiofrequency ablation is usually not a cheap treatment, thus a cost-efficacy analysis would be desirable, especially in comparison to other procedures.”
Dr. Gonzalez and Dr. Sconfienza have nothing relevant to disclose.
A version of this article originally appeared on Medscape.com.
Osteoarthritis patients report significant pain relief after treatment with cooled radiofrequency ablation, a new technique that “stuns” sensory nerves in shoulder and hip joints to reduce – and sometimes eliminate – pain.
“We send a small current to the sensory nerve to heat up the tissue and disrupt the fibers,” study lead author Felix Gonzalez, MD, of Emory University, Atlanta, said in an interview. “The effect is that the transmission of pain is significantly slowed or halted altogether.
“We damage something to fix something,” Dr. Gonzalez continued. “We target only the problematic nerve and get a very localized effect.”
Two-phase treatment
The treatment is performed in two phases. First, patients with shoulder pain are given an anesthetic to block their suprascapular, lateral pectoral, and axillary sensory articular nerves. Patients with hip pain have their obturator and femoral sensory articular nerves blocked.
A week or two later, the same nerves are treated with cooled radiofrequency ablation. Guided by x-ray imaging, a clinician heats up the affected nerve tissue using the tip of a needle, which is pointed at the nerve. “It’s a 22-gauge needle, slightly thicker than an acupuncture needle,” Dr. Gonzalez explained. “We heat up the nerve for about 2 minutes to about 60 degrees Celsius – it stuns the nerve,” he said.
“The result disrupts or slows down pain transmission while leaving the nerve intact.”
To test the efficacy of the technique, researchers treated 12 shoulders in patients with an average age of 61 years, and 11 hips in patients with an average age of 62 years.
Three months after treatment, patients with hip pain reported improvement in Hip Disability and Osteoarthritis Outcome Score (HOOS) from a baseline of 17.0 to 52.9 (P < .0001).
Shoulder pain was also reduced significantly. Using the American Shoulder and Elbow Surgeons (ASES) score, researchers reported an improvement from 17.2 (±6.6) at baseline to 65.7 (±5.9) at 3 months (P < .0001).
“We are targeting a subset of patients for this that don’t qualify for surgery,” Dr. Gonzalez noted. For patients with a body mass index above 35, or a history of hypertension, heart disease, or multiple strokes, opioids are the most common treatment, he said.
These patients “fall through the cracks,” he explained. Those who have mild to moderate pain are managed with physical therapy and injections, and those with severe pain go into surgery. “But what about the ones in the middle ... who are not eligible for surgery? They are at risk for opioid overuse,” he said. “So this treatment is a good option for them.”
Treats the symptoms, not the cause
“This study shows the efficacy of this method in taking care of shoulder and hip pain,” Luca Maria Sconfienza, MD, PhD, of Galeazzi Orthopedic Hospital in Milan, said in an interview. Dr. Sconfienza was not involved in Dr. Gonzalez’s study.
However, like corticosteroid injections, “the drawback of radiofrequency ablation is the fact that it only treats the symptoms and not the cause, and efficacy is usually limited over time,” she said.
Dr. Sconfienza said this study leaves her with three pertinent questions. “First, whether pain control extends beyond the 3-month follow-up reported by authors in the abstract; second, [what] is the efficacy of this method compared to other interventions (e.g., physical therapy, injections) or to doing nothing; and last, radiofrequency ablation is usually not a cheap treatment, thus a cost-efficacy analysis would be desirable, especially in comparison to other procedures.”
Dr. Gonzalez and Dr. Sconfienza have nothing relevant to disclose.
A version of this article originally appeared on Medscape.com.
Osteoarthritis patients report significant pain relief after treatment with cooled radiofrequency ablation, a new technique that “stuns” sensory nerves in shoulder and hip joints to reduce – and sometimes eliminate – pain.
“We send a small current to the sensory nerve to heat up the tissue and disrupt the fibers,” study lead author Felix Gonzalez, MD, of Emory University, Atlanta, said in an interview. “The effect is that the transmission of pain is significantly slowed or halted altogether.
“We damage something to fix something,” Dr. Gonzalez continued. “We target only the problematic nerve and get a very localized effect.”
Two-phase treatment
The treatment is performed in two phases. First, patients with shoulder pain are given an anesthetic to block their suprascapular, lateral pectoral, and axillary sensory articular nerves. Patients with hip pain have their obturator and femoral sensory articular nerves blocked.
A week or two later, the same nerves are treated with cooled radiofrequency ablation. Guided by x-ray imaging, a clinician heats up the affected nerve tissue using the tip of a needle, which is pointed at the nerve. “It’s a 22-gauge needle, slightly thicker than an acupuncture needle,” Dr. Gonzalez explained. “We heat up the nerve for about 2 minutes to about 60 degrees Celsius – it stuns the nerve,” he said.
“The result disrupts or slows down pain transmission while leaving the nerve intact.”
To test the efficacy of the technique, researchers treated 12 shoulders in patients with an average age of 61 years, and 11 hips in patients with an average age of 62 years.
Three months after treatment, patients with hip pain reported improvement in Hip Disability and Osteoarthritis Outcome Score (HOOS) from a baseline of 17.0 to 52.9 (P < .0001).
Shoulder pain was also reduced significantly. Using the American Shoulder and Elbow Surgeons (ASES) score, researchers reported an improvement from 17.2 (±6.6) at baseline to 65.7 (±5.9) at 3 months (P < .0001).
“We are targeting a subset of patients for this that don’t qualify for surgery,” Dr. Gonzalez noted. For patients with a body mass index above 35, or a history of hypertension, heart disease, or multiple strokes, opioids are the most common treatment, he said.
These patients “fall through the cracks,” he explained. Those who have mild to moderate pain are managed with physical therapy and injections, and those with severe pain go into surgery. “But what about the ones in the middle ... who are not eligible for surgery? They are at risk for opioid overuse,” he said. “So this treatment is a good option for them.”
Treats the symptoms, not the cause
“This study shows the efficacy of this method in taking care of shoulder and hip pain,” Luca Maria Sconfienza, MD, PhD, of Galeazzi Orthopedic Hospital in Milan, said in an interview. Dr. Sconfienza was not involved in Dr. Gonzalez’s study.
However, like corticosteroid injections, “the drawback of radiofrequency ablation is the fact that it only treats the symptoms and not the cause, and efficacy is usually limited over time,” she said.
Dr. Sconfienza said this study leaves her with three pertinent questions. “First, whether pain control extends beyond the 3-month follow-up reported by authors in the abstract; second, [what] is the efficacy of this method compared to other interventions (e.g., physical therapy, injections) or to doing nothing; and last, radiofrequency ablation is usually not a cheap treatment, thus a cost-efficacy analysis would be desirable, especially in comparison to other procedures.”
Dr. Gonzalez and Dr. Sconfienza have nothing relevant to disclose.
A version of this article originally appeared on Medscape.com.
Blood vessels in the eye may diagnose Parkinson’s disease
new research shows. Using an advanced machine-learning algorithm and fundus eye images, which depict the small blood vessels and more at the back of the eye, investigators are able to classify patients with Parkinson’s disease compared against a control group. “We discovered that micro blood vessels decreased in both size and number in patients with Parkinson’s disease,” said Maximillian Diaz, a PhD student at the University of Florida, Gainesville.
The simple eye examination may offer a way to diagnose Parkinson’s early in the disease progression.
Mr. Diaz said the test could be incorporated to a patient’s annual physical examination not only to look for Parkinson’s disease but also for other neurological diseases. Researchers at the University of Florida are also looking at whether the same technique can diagnose Alzheimer’s disease.
The beauty of this is that “the technique is simple,” he said. “What surprised us is that we can do this with fundus images, which can be taken in a clinical setting with a lens that attaches to your smartphone. It’s affordable and portable and it takes less than a minute.”
Machine learning on fundus eye images
Researchers, under the direction of Ruogu Fang, PhD, director of the J. Crayton Pruitt Department of Biomedical Engineering’s Smart Medical Informatics Learning and Evaluation Lab (SMILE) at the University of Florida, Gainesville, collected fundus eye images from 476 age- and gender-matched individuals, 238 diagnosed with Parkinson’s disease and 238 control group images. Another set of 100 images were collected from the University of Florida database using green color channels (UKB-Green and UF-UKB Green) and used to improve vessel segmentation. Of these, 28 were controls and 72 from patients with Parkinson’s disease. Researchers added 44 more control images from the U.K. Biobank to complete the second age- and gender-matched dataset.
“We used 80% of the images to develop the machine-learning network,” Mr. Diaz said. The other 20% of images, which were new to the algorithm, were used to test it, to determine true or false, Parkinson’s disease or control?
“We were able to achieve an accuracy of 85%,” Mr. Diaz said. Currently, there are no biomarkers to diagnose Parkinson’s disease. The disease is only recognizable once 80% of dopaminergic cells have already decayed. “Clinically, there’s no way to tell how long someone has had it,” Mr. Diaz said. He hopes that by doing additional research and testing earlier – with a longitudinal study of images – a pattern may be detected to better predict disease.
Eye vasculature reveals disease
“This concept [studying eye vasculature] is getting a lot of interest right now,” said Anant Madabhushi, PhD, Case Western Reserve University, Cleveland. “The eye is the proverbial window to the soul, and in this case, shows what’s happening in rest of the body.”
Dr. Madabhushi, who was not involved in the Parkinson’s research, has also been working with a team in Cleveland to look at how vessels in the eye predict response to drug therapies in diabetic macular edema, including treatment durability. “What we’ve found is the more twisted the vessels, the more constricted, and the less likely the person would respond to therapy,” he said, adding that studying the pathology of the eye makes a lot of sense. “The arrangement of vessels in the eye are likely to have implications in all kinds of diseases.”
Since Parkinson’s disease does not have any biomarkers, this technology could be very useful in diagnosis. “With specific quantitative measurements, we could have computational imaging biomarkers to predict the risk of onset of Parkinson’s, and the prognosis of disease. That’s the true utility of this approach,” he said.
Mr. Diaz disclosed no relevant financial relationships. Dr. Madabhushi has consulted for Aiforia and has had research sponsored by AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim.
A version of this article originally appeared on Medscape.com.
new research shows. Using an advanced machine-learning algorithm and fundus eye images, which depict the small blood vessels and more at the back of the eye, investigators are able to classify patients with Parkinson’s disease compared against a control group. “We discovered that micro blood vessels decreased in both size and number in patients with Parkinson’s disease,” said Maximillian Diaz, a PhD student at the University of Florida, Gainesville.
The simple eye examination may offer a way to diagnose Parkinson’s early in the disease progression.
Mr. Diaz said the test could be incorporated to a patient’s annual physical examination not only to look for Parkinson’s disease but also for other neurological diseases. Researchers at the University of Florida are also looking at whether the same technique can diagnose Alzheimer’s disease.
The beauty of this is that “the technique is simple,” he said. “What surprised us is that we can do this with fundus images, which can be taken in a clinical setting with a lens that attaches to your smartphone. It’s affordable and portable and it takes less than a minute.”
Machine learning on fundus eye images
Researchers, under the direction of Ruogu Fang, PhD, director of the J. Crayton Pruitt Department of Biomedical Engineering’s Smart Medical Informatics Learning and Evaluation Lab (SMILE) at the University of Florida, Gainesville, collected fundus eye images from 476 age- and gender-matched individuals, 238 diagnosed with Parkinson’s disease and 238 control group images. Another set of 100 images were collected from the University of Florida database using green color channels (UKB-Green and UF-UKB Green) and used to improve vessel segmentation. Of these, 28 were controls and 72 from patients with Parkinson’s disease. Researchers added 44 more control images from the U.K. Biobank to complete the second age- and gender-matched dataset.
“We used 80% of the images to develop the machine-learning network,” Mr. Diaz said. The other 20% of images, which were new to the algorithm, were used to test it, to determine true or false, Parkinson’s disease or control?
“We were able to achieve an accuracy of 85%,” Mr. Diaz said. Currently, there are no biomarkers to diagnose Parkinson’s disease. The disease is only recognizable once 80% of dopaminergic cells have already decayed. “Clinically, there’s no way to tell how long someone has had it,” Mr. Diaz said. He hopes that by doing additional research and testing earlier – with a longitudinal study of images – a pattern may be detected to better predict disease.
Eye vasculature reveals disease
“This concept [studying eye vasculature] is getting a lot of interest right now,” said Anant Madabhushi, PhD, Case Western Reserve University, Cleveland. “The eye is the proverbial window to the soul, and in this case, shows what’s happening in rest of the body.”
Dr. Madabhushi, who was not involved in the Parkinson’s research, has also been working with a team in Cleveland to look at how vessels in the eye predict response to drug therapies in diabetic macular edema, including treatment durability. “What we’ve found is the more twisted the vessels, the more constricted, and the less likely the person would respond to therapy,” he said, adding that studying the pathology of the eye makes a lot of sense. “The arrangement of vessels in the eye are likely to have implications in all kinds of diseases.”
Since Parkinson’s disease does not have any biomarkers, this technology could be very useful in diagnosis. “With specific quantitative measurements, we could have computational imaging biomarkers to predict the risk of onset of Parkinson’s, and the prognosis of disease. That’s the true utility of this approach,” he said.
Mr. Diaz disclosed no relevant financial relationships. Dr. Madabhushi has consulted for Aiforia and has had research sponsored by AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim.
A version of this article originally appeared on Medscape.com.
new research shows. Using an advanced machine-learning algorithm and fundus eye images, which depict the small blood vessels and more at the back of the eye, investigators are able to classify patients with Parkinson’s disease compared against a control group. “We discovered that micro blood vessels decreased in both size and number in patients with Parkinson’s disease,” said Maximillian Diaz, a PhD student at the University of Florida, Gainesville.
The simple eye examination may offer a way to diagnose Parkinson’s early in the disease progression.
Mr. Diaz said the test could be incorporated to a patient’s annual physical examination not only to look for Parkinson’s disease but also for other neurological diseases. Researchers at the University of Florida are also looking at whether the same technique can diagnose Alzheimer’s disease.
The beauty of this is that “the technique is simple,” he said. “What surprised us is that we can do this with fundus images, which can be taken in a clinical setting with a lens that attaches to your smartphone. It’s affordable and portable and it takes less than a minute.”
Machine learning on fundus eye images
Researchers, under the direction of Ruogu Fang, PhD, director of the J. Crayton Pruitt Department of Biomedical Engineering’s Smart Medical Informatics Learning and Evaluation Lab (SMILE) at the University of Florida, Gainesville, collected fundus eye images from 476 age- and gender-matched individuals, 238 diagnosed with Parkinson’s disease and 238 control group images. Another set of 100 images were collected from the University of Florida database using green color channels (UKB-Green and UF-UKB Green) and used to improve vessel segmentation. Of these, 28 were controls and 72 from patients with Parkinson’s disease. Researchers added 44 more control images from the U.K. Biobank to complete the second age- and gender-matched dataset.
“We used 80% of the images to develop the machine-learning network,” Mr. Diaz said. The other 20% of images, which were new to the algorithm, were used to test it, to determine true or false, Parkinson’s disease or control?
“We were able to achieve an accuracy of 85%,” Mr. Diaz said. Currently, there are no biomarkers to diagnose Parkinson’s disease. The disease is only recognizable once 80% of dopaminergic cells have already decayed. “Clinically, there’s no way to tell how long someone has had it,” Mr. Diaz said. He hopes that by doing additional research and testing earlier – with a longitudinal study of images – a pattern may be detected to better predict disease.
Eye vasculature reveals disease
“This concept [studying eye vasculature] is getting a lot of interest right now,” said Anant Madabhushi, PhD, Case Western Reserve University, Cleveland. “The eye is the proverbial window to the soul, and in this case, shows what’s happening in rest of the body.”
Dr. Madabhushi, who was not involved in the Parkinson’s research, has also been working with a team in Cleveland to look at how vessels in the eye predict response to drug therapies in diabetic macular edema, including treatment durability. “What we’ve found is the more twisted the vessels, the more constricted, and the less likely the person would respond to therapy,” he said, adding that studying the pathology of the eye makes a lot of sense. “The arrangement of vessels in the eye are likely to have implications in all kinds of diseases.”
Since Parkinson’s disease does not have any biomarkers, this technology could be very useful in diagnosis. “With specific quantitative measurements, we could have computational imaging biomarkers to predict the risk of onset of Parkinson’s, and the prognosis of disease. That’s the true utility of this approach,” he said.
Mr. Diaz disclosed no relevant financial relationships. Dr. Madabhushi has consulted for Aiforia and has had research sponsored by AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim.
A version of this article originally appeared on Medscape.com.
FDA-approved peanut immunotherapy protocol comes with a cost
Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.
A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.
But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.
“Finally we have another treatment option,” said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, N.C. “This is what we were waiting for. It’s not cowboy stuff; this works.”
In January, the FDA approved peanut allergen powder (Palforzia) for patients 4-17 years of age, as reported by Medscape Medical News.
The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300 mg (about one peanut) and a black-box warning about anaphylaxis risk.
And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.
“That may scare some away,” said Dr. Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.
Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.
“People make the argument that there is a difference” between an expected allergic reaction – such as one that occurs after the administration of immunotherapy – and an unexpected reaction, he said. Because an expected reaction can be treated quickly, “some feel these expected reactions don’t matter so much.”
“Others say a reaction is a reaction” and argue that if, a treatment causes reaction, then it doesn’t make sense, he explained.
It comes down to patients – they must be willing to take a risk to develop tolerance and improve their quality of life – and the allergists willing to treat them.
The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. “Not everyone will want to do this,” said Dr. Kim.
The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day 1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300-mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.
The drug cost alone is about $4,200 a year, according to Institute for Clinical and Economic Review. Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.
“This product offers some reassurance, and that matters,” Dr. Kim said.
It’s good to have more options for food allergy treatment. “We need a more proactive way to treat food allergy; avoidance is not good enough,” he explained. “And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills.”
The art of medicine
But not all allergists will be able to make the protocol work. And it’s not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that “the product leaves little room for ‘the art of medicine,’ ” Kim said.
That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it’s backed by a rigid home-grown protocol.
Since 2010, he has treated 1,800 patients for peanut allergy, updosing slowly to a tolerance of 3,000 mg of peanut, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1,200 mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.
“We aim for full sensitization,” Dr. Elizur said in an interview.
The peanut pill is “a big step forward” for immunotherapy, he said. It is “a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians.”
But, he pointed out, “it’s expensive.” And it’s only for peanut. “There are millions of food-allergic patients around the world dying from adverse reactions to many different kinds of food. We don’t want to wait for years for a product for all of them. We can use the actual food.”
He questions the lifelong maintenance protocol with a daily 300-mg pill. “If you can’t eat a peanut, why would you buy a drug that’s a peanut?” he asked.
He also said he’s disappointed that the product is not indicated for adults.
At the Shamir clinic, reactions are closely monitored. “Some are mild, others we treat with autoinjectors, epinephrine,” he reported. “Those are the most undesirable.”
Data from his center show that reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 80% of his adult patients to full sensitization.
But it’s not for all patients or for all clinics, he acknowledged. “We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality of life threshold.”
Treatment that involves “native food” is “a lot of work” and requires “a lot of investment,” Dr. Elizur said. His center uses a web reporting system to maintain a 24/7 dialogue with patients, “and we look at the reports every day.” They also have a physician on call at all times. “Not everyone can commit to providing care throughout the day and night.”
His center charges the equivalent of $US3,000 per food allergy treated. “That’s whether it takes 6 months or 2 years,” he said.
There are more than 1,000 people on his 3-year waiting list.
“This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a pro–con debate on oral immunotherapy,” Dr. Kim pointed out. “We have a therapy now.”
However, the pandemic has slowed treatment uptake. “Immunotherapy is not easy to do, whether it’s FDA approved or not,” he explained. With at least 11 doctor visits in the first 6 months – each visit is between 30 minutes and 2-3 hours long – it hasn’t been possible to set up this year. “It’s not ideal.”
It will be interesting to see “how this will roll out and how it will be adopted,” Dr. Kim said. “From a food allergy point of view, the next 12 months are going to be very interesting.”
Dr. Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for Aimmune, Allakos, Allergenis, DBV, Duke Clinical Research Institute, Ukko Incorporated, Vibrant America, and Kenota Health. Dr. Elizur has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.
A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.
But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.
“Finally we have another treatment option,” said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, N.C. “This is what we were waiting for. It’s not cowboy stuff; this works.”
In January, the FDA approved peanut allergen powder (Palforzia) for patients 4-17 years of age, as reported by Medscape Medical News.
The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300 mg (about one peanut) and a black-box warning about anaphylaxis risk.
And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.
“That may scare some away,” said Dr. Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.
Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.
“People make the argument that there is a difference” between an expected allergic reaction – such as one that occurs after the administration of immunotherapy – and an unexpected reaction, he said. Because an expected reaction can be treated quickly, “some feel these expected reactions don’t matter so much.”
“Others say a reaction is a reaction” and argue that if, a treatment causes reaction, then it doesn’t make sense, he explained.
It comes down to patients – they must be willing to take a risk to develop tolerance and improve their quality of life – and the allergists willing to treat them.
The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. “Not everyone will want to do this,” said Dr. Kim.
The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day 1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300-mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.
The drug cost alone is about $4,200 a year, according to Institute for Clinical and Economic Review. Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.
“This product offers some reassurance, and that matters,” Dr. Kim said.
It’s good to have more options for food allergy treatment. “We need a more proactive way to treat food allergy; avoidance is not good enough,” he explained. “And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills.”
The art of medicine
But not all allergists will be able to make the protocol work. And it’s not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that “the product leaves little room for ‘the art of medicine,’ ” Kim said.
That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it’s backed by a rigid home-grown protocol.
Since 2010, he has treated 1,800 patients for peanut allergy, updosing slowly to a tolerance of 3,000 mg of peanut, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1,200 mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.
“We aim for full sensitization,” Dr. Elizur said in an interview.
The peanut pill is “a big step forward” for immunotherapy, he said. It is “a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians.”
But, he pointed out, “it’s expensive.” And it’s only for peanut. “There are millions of food-allergic patients around the world dying from adverse reactions to many different kinds of food. We don’t want to wait for years for a product for all of them. We can use the actual food.”
He questions the lifelong maintenance protocol with a daily 300-mg pill. “If you can’t eat a peanut, why would you buy a drug that’s a peanut?” he asked.
He also said he’s disappointed that the product is not indicated for adults.
At the Shamir clinic, reactions are closely monitored. “Some are mild, others we treat with autoinjectors, epinephrine,” he reported. “Those are the most undesirable.”
Data from his center show that reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 80% of his adult patients to full sensitization.
But it’s not for all patients or for all clinics, he acknowledged. “We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality of life threshold.”
Treatment that involves “native food” is “a lot of work” and requires “a lot of investment,” Dr. Elizur said. His center uses a web reporting system to maintain a 24/7 dialogue with patients, “and we look at the reports every day.” They also have a physician on call at all times. “Not everyone can commit to providing care throughout the day and night.”
His center charges the equivalent of $US3,000 per food allergy treated. “That’s whether it takes 6 months or 2 years,” he said.
There are more than 1,000 people on his 3-year waiting list.
“This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a pro–con debate on oral immunotherapy,” Dr. Kim pointed out. “We have a therapy now.”
However, the pandemic has slowed treatment uptake. “Immunotherapy is not easy to do, whether it’s FDA approved or not,” he explained. With at least 11 doctor visits in the first 6 months – each visit is between 30 minutes and 2-3 hours long – it hasn’t been possible to set up this year. “It’s not ideal.”
It will be interesting to see “how this will roll out and how it will be adopted,” Dr. Kim said. “From a food allergy point of view, the next 12 months are going to be very interesting.”
Dr. Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for Aimmune, Allakos, Allergenis, DBV, Duke Clinical Research Institute, Ukko Incorporated, Vibrant America, and Kenota Health. Dr. Elizur has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.
A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.
But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.
“Finally we have another treatment option,” said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, N.C. “This is what we were waiting for. It’s not cowboy stuff; this works.”
In January, the FDA approved peanut allergen powder (Palforzia) for patients 4-17 years of age, as reported by Medscape Medical News.
The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300 mg (about one peanut) and a black-box warning about anaphylaxis risk.
And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.
“That may scare some away,” said Dr. Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.
Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.
“People make the argument that there is a difference” between an expected allergic reaction – such as one that occurs after the administration of immunotherapy – and an unexpected reaction, he said. Because an expected reaction can be treated quickly, “some feel these expected reactions don’t matter so much.”
“Others say a reaction is a reaction” and argue that if, a treatment causes reaction, then it doesn’t make sense, he explained.
It comes down to patients – they must be willing to take a risk to develop tolerance and improve their quality of life – and the allergists willing to treat them.
The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. “Not everyone will want to do this,” said Dr. Kim.
The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day 1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300-mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.
The drug cost alone is about $4,200 a year, according to Institute for Clinical and Economic Review. Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.
“This product offers some reassurance, and that matters,” Dr. Kim said.
It’s good to have more options for food allergy treatment. “We need a more proactive way to treat food allergy; avoidance is not good enough,” he explained. “And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills.”
The art of medicine
But not all allergists will be able to make the protocol work. And it’s not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that “the product leaves little room for ‘the art of medicine,’ ” Kim said.
That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it’s backed by a rigid home-grown protocol.
Since 2010, he has treated 1,800 patients for peanut allergy, updosing slowly to a tolerance of 3,000 mg of peanut, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1,200 mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.
“We aim for full sensitization,” Dr. Elizur said in an interview.
The peanut pill is “a big step forward” for immunotherapy, he said. It is “a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians.”
But, he pointed out, “it’s expensive.” And it’s only for peanut. “There are millions of food-allergic patients around the world dying from adverse reactions to many different kinds of food. We don’t want to wait for years for a product for all of them. We can use the actual food.”
He questions the lifelong maintenance protocol with a daily 300-mg pill. “If you can’t eat a peanut, why would you buy a drug that’s a peanut?” he asked.
He also said he’s disappointed that the product is not indicated for adults.
At the Shamir clinic, reactions are closely monitored. “Some are mild, others we treat with autoinjectors, epinephrine,” he reported. “Those are the most undesirable.”
Data from his center show that reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 80% of his adult patients to full sensitization.
But it’s not for all patients or for all clinics, he acknowledged. “We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality of life threshold.”
Treatment that involves “native food” is “a lot of work” and requires “a lot of investment,” Dr. Elizur said. His center uses a web reporting system to maintain a 24/7 dialogue with patients, “and we look at the reports every day.” They also have a physician on call at all times. “Not everyone can commit to providing care throughout the day and night.”
His center charges the equivalent of $US3,000 per food allergy treated. “That’s whether it takes 6 months or 2 years,” he said.
There are more than 1,000 people on his 3-year waiting list.
“This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a pro–con debate on oral immunotherapy,” Dr. Kim pointed out. “We have a therapy now.”
However, the pandemic has slowed treatment uptake. “Immunotherapy is not easy to do, whether it’s FDA approved or not,” he explained. With at least 11 doctor visits in the first 6 months – each visit is between 30 minutes and 2-3 hours long – it hasn’t been possible to set up this year. “It’s not ideal.”
It will be interesting to see “how this will roll out and how it will be adopted,” Dr. Kim said. “From a food allergy point of view, the next 12 months are going to be very interesting.”
Dr. Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for Aimmune, Allakos, Allergenis, DBV, Duke Clinical Research Institute, Ukko Incorporated, Vibrant America, and Kenota Health. Dr. Elizur has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
No evidence to guide selection of biologic for severe asthma
Although “biologics have been really revolutionary for the treatment of severe uncontrolled asthma, we still don’t have evidence to know the right drug for the right patient,” said Wendy Moore, MD, of Wake Forest University, Winston-Salem, N.C.
“You start with your best guess and then switch,” she said in an interview.
There are no real-world contemporary measurements of biologic therapy in the United States at this time, Dr. Moore explained during her presentation of findings from the CHRONICLE trial at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The agents have different targets: omalizumab targets immunoglobulin E, mepolizumab and reslizumab target interleukin (IL)-5, benralizumab targets the IL-5 receptor, and dupilumab targets the common receptor IL-4 receptor A for IL-4 and IL-13.
When the starting biologic doesn’t get the desired results, there is no evidence to show whether another will work better. What we say is, “This one is not working as well as I’d like, let’s try something new?” said Dr. Moore.
However, when looking at data on patients with severe asthma who change from one biologic to another, “I was actually pleased to see that only 10% are switching,” she said in an interview.
But, she added, “if you add that up with the 8% who are stopping, that means that almost 20% don’t get the clinical response they want.”
CHRONICLE trial
In the ongoing observational CHRONICLE trial, Dr. Moore and colleagues assessed biologic initiations, discontinuations, and switches to a different agent.
All 1,884 study participants had a diagnosis of severe asthma and were being treated by an allergist/immunologist or a pulmonologist. All were taking high-dose inhaled corticosteroids and additional controllers, or had received an Food and Drug Administration–approved monoclonal antibody, systemic corticosteroid, or another systemic immunosuppressant for at least half of the previous 12 months.
In the study cohort, 1,219 participants were receiving one biologic and 27 were receiving two.
Before November 2018, “it was almost universally all benralizumab being prescribed.” An earlier preference was omalizumab, which was prescribed to 99% of patients before November 2015 and to 45% from November 2017 to November 2018.
“As new drugs were introduced, patients were switched if the desired outcome was not achieved,” Dr. Moore explained.
Over the 2-year period from February 2018 to February 2020, 134 patients – about 10% of all participants taking a biologic – made 148 switches to another biologic.
“The most common reasons reported for switching were lack of efficacy, worsening of asthma control, or waning efficacy,” Dr. Moore reported.
Of the 101 patients (8%) who discontinued 106 biologics, reasons cited were a worsening of asthma symptoms, a desire to change to a cheaper medication, and a waning of effectiveness.
“It seems that the biologic used depended on when you started and whether you were prescribed by an immunologist or pulmonologist,” said Dr. Moore. “I don’t think we understand the perfect patient for any one of these drugs.”
Large-population studies need to be done on each of the drugs. “You have to look at who’s the super responder, the partial responder, compared with the nonresponders, for each medication, but those comparative studies are unlikely to happen,” she said.
In her own practice, her 175 patients are “pretty evenly split between dupilumab, benralizumab, and mepolizumab.”
I have opinions on what works, said Dr. Moore, but none of it is evidence-based. “Those with upper airway involvement with chronic sinusitis tend to do better with mepolizumab than benralizumab. My opinion,” she emphasized.
“People with nasal problems may do better with dupilumab and mepolizumab,” she added. “Also in my opinion.
“But more likely, the issue is you have a partial responder who’s on a T2 high drug but has a T2 low problem too.”
PATHWAY study
Findings from the phase 2B PATHWAY study showed that tezepelumab reduced exacerbations in patients with uncontrolled asthma better than inhaled corticosteroids, and improved forced expiratory volume in 1 second.
“Adherence was monitored very carefully,” said investigator Jonathan Corren, MD, of the University of California, Los Angeles, who presented the PATHWAY data. This could explain, in part, why some patients in the control group “showed improvement from baseline.”
Before switching to a biologic, “we should always consider some of these issues that might contribute to better asthma control, like patient adherence or the inability to use an inhaler properly,” Dr. Corren said.
Some people have never been “shown how to use their inhalers properly,” said Moore. “Some of them come back fine when we show them.”
Dr. Moore has been on the advisory board for AstraZeneca, Genentech, GlaxoSmithKline (GSK), Regeneron, and Sanofi. Dr. Corren reports receiving honoraria from AstraZeneca.
A version of this article originally appeared on Medscape.com.
Although “biologics have been really revolutionary for the treatment of severe uncontrolled asthma, we still don’t have evidence to know the right drug for the right patient,” said Wendy Moore, MD, of Wake Forest University, Winston-Salem, N.C.
“You start with your best guess and then switch,” she said in an interview.
There are no real-world contemporary measurements of biologic therapy in the United States at this time, Dr. Moore explained during her presentation of findings from the CHRONICLE trial at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The agents have different targets: omalizumab targets immunoglobulin E, mepolizumab and reslizumab target interleukin (IL)-5, benralizumab targets the IL-5 receptor, and dupilumab targets the common receptor IL-4 receptor A for IL-4 and IL-13.
When the starting biologic doesn’t get the desired results, there is no evidence to show whether another will work better. What we say is, “This one is not working as well as I’d like, let’s try something new?” said Dr. Moore.
However, when looking at data on patients with severe asthma who change from one biologic to another, “I was actually pleased to see that only 10% are switching,” she said in an interview.
But, she added, “if you add that up with the 8% who are stopping, that means that almost 20% don’t get the clinical response they want.”
CHRONICLE trial
In the ongoing observational CHRONICLE trial, Dr. Moore and colleagues assessed biologic initiations, discontinuations, and switches to a different agent.
All 1,884 study participants had a diagnosis of severe asthma and were being treated by an allergist/immunologist or a pulmonologist. All were taking high-dose inhaled corticosteroids and additional controllers, or had received an Food and Drug Administration–approved monoclonal antibody, systemic corticosteroid, or another systemic immunosuppressant for at least half of the previous 12 months.
In the study cohort, 1,219 participants were receiving one biologic and 27 were receiving two.
Before November 2018, “it was almost universally all benralizumab being prescribed.” An earlier preference was omalizumab, which was prescribed to 99% of patients before November 2015 and to 45% from November 2017 to November 2018.
“As new drugs were introduced, patients were switched if the desired outcome was not achieved,” Dr. Moore explained.
Over the 2-year period from February 2018 to February 2020, 134 patients – about 10% of all participants taking a biologic – made 148 switches to another biologic.
“The most common reasons reported for switching were lack of efficacy, worsening of asthma control, or waning efficacy,” Dr. Moore reported.
Of the 101 patients (8%) who discontinued 106 biologics, reasons cited were a worsening of asthma symptoms, a desire to change to a cheaper medication, and a waning of effectiveness.
“It seems that the biologic used depended on when you started and whether you were prescribed by an immunologist or pulmonologist,” said Dr. Moore. “I don’t think we understand the perfect patient for any one of these drugs.”
Large-population studies need to be done on each of the drugs. “You have to look at who’s the super responder, the partial responder, compared with the nonresponders, for each medication, but those comparative studies are unlikely to happen,” she said.
In her own practice, her 175 patients are “pretty evenly split between dupilumab, benralizumab, and mepolizumab.”
I have opinions on what works, said Dr. Moore, but none of it is evidence-based. “Those with upper airway involvement with chronic sinusitis tend to do better with mepolizumab than benralizumab. My opinion,” she emphasized.
“People with nasal problems may do better with dupilumab and mepolizumab,” she added. “Also in my opinion.
“But more likely, the issue is you have a partial responder who’s on a T2 high drug but has a T2 low problem too.”
PATHWAY study
Findings from the phase 2B PATHWAY study showed that tezepelumab reduced exacerbations in patients with uncontrolled asthma better than inhaled corticosteroids, and improved forced expiratory volume in 1 second.
“Adherence was monitored very carefully,” said investigator Jonathan Corren, MD, of the University of California, Los Angeles, who presented the PATHWAY data. This could explain, in part, why some patients in the control group “showed improvement from baseline.”
Before switching to a biologic, “we should always consider some of these issues that might contribute to better asthma control, like patient adherence or the inability to use an inhaler properly,” Dr. Corren said.
Some people have never been “shown how to use their inhalers properly,” said Moore. “Some of them come back fine when we show them.”
Dr. Moore has been on the advisory board for AstraZeneca, Genentech, GlaxoSmithKline (GSK), Regeneron, and Sanofi. Dr. Corren reports receiving honoraria from AstraZeneca.
A version of this article originally appeared on Medscape.com.
Although “biologics have been really revolutionary for the treatment of severe uncontrolled asthma, we still don’t have evidence to know the right drug for the right patient,” said Wendy Moore, MD, of Wake Forest University, Winston-Salem, N.C.
“You start with your best guess and then switch,” she said in an interview.
There are no real-world contemporary measurements of biologic therapy in the United States at this time, Dr. Moore explained during her presentation of findings from the CHRONICLE trial at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The agents have different targets: omalizumab targets immunoglobulin E, mepolizumab and reslizumab target interleukin (IL)-5, benralizumab targets the IL-5 receptor, and dupilumab targets the common receptor IL-4 receptor A for IL-4 and IL-13.
When the starting biologic doesn’t get the desired results, there is no evidence to show whether another will work better. What we say is, “This one is not working as well as I’d like, let’s try something new?” said Dr. Moore.
However, when looking at data on patients with severe asthma who change from one biologic to another, “I was actually pleased to see that only 10% are switching,” she said in an interview.
But, she added, “if you add that up with the 8% who are stopping, that means that almost 20% don’t get the clinical response they want.”
CHRONICLE trial
In the ongoing observational CHRONICLE trial, Dr. Moore and colleagues assessed biologic initiations, discontinuations, and switches to a different agent.
All 1,884 study participants had a diagnosis of severe asthma and were being treated by an allergist/immunologist or a pulmonologist. All were taking high-dose inhaled corticosteroids and additional controllers, or had received an Food and Drug Administration–approved monoclonal antibody, systemic corticosteroid, or another systemic immunosuppressant for at least half of the previous 12 months.
In the study cohort, 1,219 participants were receiving one biologic and 27 were receiving two.
Before November 2018, “it was almost universally all benralizumab being prescribed.” An earlier preference was omalizumab, which was prescribed to 99% of patients before November 2015 and to 45% from November 2017 to November 2018.
“As new drugs were introduced, patients were switched if the desired outcome was not achieved,” Dr. Moore explained.
Over the 2-year period from February 2018 to February 2020, 134 patients – about 10% of all participants taking a biologic – made 148 switches to another biologic.
“The most common reasons reported for switching were lack of efficacy, worsening of asthma control, or waning efficacy,” Dr. Moore reported.
Of the 101 patients (8%) who discontinued 106 biologics, reasons cited were a worsening of asthma symptoms, a desire to change to a cheaper medication, and a waning of effectiveness.
“It seems that the biologic used depended on when you started and whether you were prescribed by an immunologist or pulmonologist,” said Dr. Moore. “I don’t think we understand the perfect patient for any one of these drugs.”
Large-population studies need to be done on each of the drugs. “You have to look at who’s the super responder, the partial responder, compared with the nonresponders, for each medication, but those comparative studies are unlikely to happen,” she said.
In her own practice, her 175 patients are “pretty evenly split between dupilumab, benralizumab, and mepolizumab.”
I have opinions on what works, said Dr. Moore, but none of it is evidence-based. “Those with upper airway involvement with chronic sinusitis tend to do better with mepolizumab than benralizumab. My opinion,” she emphasized.
“People with nasal problems may do better with dupilumab and mepolizumab,” she added. “Also in my opinion.
“But more likely, the issue is you have a partial responder who’s on a T2 high drug but has a T2 low problem too.”
PATHWAY study
Findings from the phase 2B PATHWAY study showed that tezepelumab reduced exacerbations in patients with uncontrolled asthma better than inhaled corticosteroids, and improved forced expiratory volume in 1 second.
“Adherence was monitored very carefully,” said investigator Jonathan Corren, MD, of the University of California, Los Angeles, who presented the PATHWAY data. This could explain, in part, why some patients in the control group “showed improvement from baseline.”
Before switching to a biologic, “we should always consider some of these issues that might contribute to better asthma control, like patient adherence or the inability to use an inhaler properly,” Dr. Corren said.
Some people have never been “shown how to use their inhalers properly,” said Moore. “Some of them come back fine when we show them.”
Dr. Moore has been on the advisory board for AstraZeneca, Genentech, GlaxoSmithKline (GSK), Regeneron, and Sanofi. Dr. Corren reports receiving honoraria from AstraZeneca.
A version of this article originally appeared on Medscape.com.
Unneeded meds at discharge could cause harm
A significant number of patients leave the hospital with inappropriate drugs because of a lack of medication reconciliation at discharge, new research shows.
Proton pump inhibitors – known to have adverse effects, such as fractures, osteoporosis, and progressive kidney disease – make up 30% of inappropriate prescriptions at discharge.
“These medications can have a significant toxic effect, especially in the long term,” said Harsh Patel, MD, from Medical City Healthcare in Fort Worth, Tex.
And “when we interviewed patients, they were unable to recall ever partaking in a pulmonary function test or endoscopy to warrant the medications,” he said in an interview.
For their retrospective chart review, Dr. Patel and colleagues assessed patients admitted to the ICU in 13 hospitals over a 6-month period in northern Texas. Of the 12,930 patients, 2,557 had not previously received but were prescribed during their hospital stay a bronchodilator, a proton pump inhibitor, or an H2 receptor agonist.
Of those 2,557 patients, 26.8% were discharged on a proton pump inhibitor, 8.4% on an H2 receptor agonist, and 5.49% on a bronchodilator.
There were no corresponding diseases or diagnoses to justify continued use, Dr. Patel said during his presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
Button fatigue
The problem stems from a technology disconnect when patients are transferred from the ICU to the general population.
Doctors expect that the medications will be reconciled at discharge, said one of the study investigators, Prashanth Reddy, MD, from Medical City Las Colinas (Tex.).
But in some instances, clinicians unfamiliar with the case click through the electronic health record to get the patient “out of the ICU to the floor,” he explained. “They don’t always know what medications to keep.”
“They may have button fatigue, so they just accept and continue,” Dr. Reddy said in an interviews.
In light of these findings, the team has kick-started a project to improve transition out of the ICU and minimize overprescription at discharge.
“This is the kind of a problem where we thought we could have some influence,” said Dr. Reddy.
One solution would be to put “stop orders” on potentially harmful medications. “But we don’t want to increase button fatigue even more, so we have to find a happy medium,” he said. “It’s going to take a while to formulate the best path on this.”
The inclusion of pharmacy residents in rounds could make a difference. “When we rounded with pharmacy residents, these issues got addressed,” Dr. Patel said. The pharmacy residents often asked: “Can we go over the meds? Does this person really need all this?”
Medication reconciliations not only have a positive effect on a patient’s health, they can also cut costs by eliminating unneeded drugs. And “patients are always happy to hear we’re taking them off a drug,” Dr. Patel added.
He said he remembers one of his mentors telling him that, if he could get his patients down to five medications, “then you’ve achieved success as a physician.”
“I’m still working toward that,” he said. “The end goal should sometimes be, less is more.”
COPD patients overprescribed home oxygen
In addition to medications, home oxygen therapy is often prescribed when patients are discharged from the hospital.
A study of 69 patients who were continued on home oxygen therapy after hospitalization for an exacerbation of chronic obstructive pulmonary disease was presented by Analisa Taylor, MD, from the University of Illinois at Chicago.
Despite guideline recommendations that patients be reassessed within 90 days of discharge, only 38 patients in the cohort were reassessed, and “28 were considered eligible for discontinuation,” she said during her presentation.
However, “of those, only four were ultimately discontinued,” she reported.
The reason for this gap needs to be examined, noted Dr. Taylor, suggesting that “perhaps clinical inertia plays a role in the continuation of previously prescribed therapy despite a lack of ongoing clinical benefit.”
A version of this article originally appeared on Medscape.com.
A significant number of patients leave the hospital with inappropriate drugs because of a lack of medication reconciliation at discharge, new research shows.
Proton pump inhibitors – known to have adverse effects, such as fractures, osteoporosis, and progressive kidney disease – make up 30% of inappropriate prescriptions at discharge.
“These medications can have a significant toxic effect, especially in the long term,” said Harsh Patel, MD, from Medical City Healthcare in Fort Worth, Tex.
And “when we interviewed patients, they were unable to recall ever partaking in a pulmonary function test or endoscopy to warrant the medications,” he said in an interview.
For their retrospective chart review, Dr. Patel and colleagues assessed patients admitted to the ICU in 13 hospitals over a 6-month period in northern Texas. Of the 12,930 patients, 2,557 had not previously received but were prescribed during their hospital stay a bronchodilator, a proton pump inhibitor, or an H2 receptor agonist.
Of those 2,557 patients, 26.8% were discharged on a proton pump inhibitor, 8.4% on an H2 receptor agonist, and 5.49% on a bronchodilator.
There were no corresponding diseases or diagnoses to justify continued use, Dr. Patel said during his presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
Button fatigue
The problem stems from a technology disconnect when patients are transferred from the ICU to the general population.
Doctors expect that the medications will be reconciled at discharge, said one of the study investigators, Prashanth Reddy, MD, from Medical City Las Colinas (Tex.).
But in some instances, clinicians unfamiliar with the case click through the electronic health record to get the patient “out of the ICU to the floor,” he explained. “They don’t always know what medications to keep.”
“They may have button fatigue, so they just accept and continue,” Dr. Reddy said in an interviews.
In light of these findings, the team has kick-started a project to improve transition out of the ICU and minimize overprescription at discharge.
“This is the kind of a problem where we thought we could have some influence,” said Dr. Reddy.
One solution would be to put “stop orders” on potentially harmful medications. “But we don’t want to increase button fatigue even more, so we have to find a happy medium,” he said. “It’s going to take a while to formulate the best path on this.”
The inclusion of pharmacy residents in rounds could make a difference. “When we rounded with pharmacy residents, these issues got addressed,” Dr. Patel said. The pharmacy residents often asked: “Can we go over the meds? Does this person really need all this?”
Medication reconciliations not only have a positive effect on a patient’s health, they can also cut costs by eliminating unneeded drugs. And “patients are always happy to hear we’re taking them off a drug,” Dr. Patel added.
He said he remembers one of his mentors telling him that, if he could get his patients down to five medications, “then you’ve achieved success as a physician.”
“I’m still working toward that,” he said. “The end goal should sometimes be, less is more.”
COPD patients overprescribed home oxygen
In addition to medications, home oxygen therapy is often prescribed when patients are discharged from the hospital.
A study of 69 patients who were continued on home oxygen therapy after hospitalization for an exacerbation of chronic obstructive pulmonary disease was presented by Analisa Taylor, MD, from the University of Illinois at Chicago.
Despite guideline recommendations that patients be reassessed within 90 days of discharge, only 38 patients in the cohort were reassessed, and “28 were considered eligible for discontinuation,” she said during her presentation.
However, “of those, only four were ultimately discontinued,” she reported.
The reason for this gap needs to be examined, noted Dr. Taylor, suggesting that “perhaps clinical inertia plays a role in the continuation of previously prescribed therapy despite a lack of ongoing clinical benefit.”
A version of this article originally appeared on Medscape.com.
A significant number of patients leave the hospital with inappropriate drugs because of a lack of medication reconciliation at discharge, new research shows.
Proton pump inhibitors – known to have adverse effects, such as fractures, osteoporosis, and progressive kidney disease – make up 30% of inappropriate prescriptions at discharge.
“These medications can have a significant toxic effect, especially in the long term,” said Harsh Patel, MD, from Medical City Healthcare in Fort Worth, Tex.
And “when we interviewed patients, they were unable to recall ever partaking in a pulmonary function test or endoscopy to warrant the medications,” he said in an interview.
For their retrospective chart review, Dr. Patel and colleagues assessed patients admitted to the ICU in 13 hospitals over a 6-month period in northern Texas. Of the 12,930 patients, 2,557 had not previously received but were prescribed during their hospital stay a bronchodilator, a proton pump inhibitor, or an H2 receptor agonist.
Of those 2,557 patients, 26.8% were discharged on a proton pump inhibitor, 8.4% on an H2 receptor agonist, and 5.49% on a bronchodilator.
There were no corresponding diseases or diagnoses to justify continued use, Dr. Patel said during his presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
Button fatigue
The problem stems from a technology disconnect when patients are transferred from the ICU to the general population.
Doctors expect that the medications will be reconciled at discharge, said one of the study investigators, Prashanth Reddy, MD, from Medical City Las Colinas (Tex.).
But in some instances, clinicians unfamiliar with the case click through the electronic health record to get the patient “out of the ICU to the floor,” he explained. “They don’t always know what medications to keep.”
“They may have button fatigue, so they just accept and continue,” Dr. Reddy said in an interviews.
In light of these findings, the team has kick-started a project to improve transition out of the ICU and minimize overprescription at discharge.
“This is the kind of a problem where we thought we could have some influence,” said Dr. Reddy.
One solution would be to put “stop orders” on potentially harmful medications. “But we don’t want to increase button fatigue even more, so we have to find a happy medium,” he said. “It’s going to take a while to formulate the best path on this.”
The inclusion of pharmacy residents in rounds could make a difference. “When we rounded with pharmacy residents, these issues got addressed,” Dr. Patel said. The pharmacy residents often asked: “Can we go over the meds? Does this person really need all this?”
Medication reconciliations not only have a positive effect on a patient’s health, they can also cut costs by eliminating unneeded drugs. And “patients are always happy to hear we’re taking them off a drug,” Dr. Patel added.
He said he remembers one of his mentors telling him that, if he could get his patients down to five medications, “then you’ve achieved success as a physician.”
“I’m still working toward that,” he said. “The end goal should sometimes be, less is more.”
COPD patients overprescribed home oxygen
In addition to medications, home oxygen therapy is often prescribed when patients are discharged from the hospital.
A study of 69 patients who were continued on home oxygen therapy after hospitalization for an exacerbation of chronic obstructive pulmonary disease was presented by Analisa Taylor, MD, from the University of Illinois at Chicago.
Despite guideline recommendations that patients be reassessed within 90 days of discharge, only 38 patients in the cohort were reassessed, and “28 were considered eligible for discontinuation,” she said during her presentation.
However, “of those, only four were ultimately discontinued,” she reported.
The reason for this gap needs to be examined, noted Dr. Taylor, suggesting that “perhaps clinical inertia plays a role in the continuation of previously prescribed therapy despite a lack of ongoing clinical benefit.”
A version of this article originally appeared on Medscape.com.
FROM CHEST 2020
Score predicts risk for ventilation in COVID-19 patients
A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.
The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2); and a positive troponin I level.
“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”
“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”
For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.
Ultimately, 54 of these patients required invasive mechanical ventilation.
On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.
Calibration of the model was good (Hosmer–Lemeshow score, 6.3; P = .39), as was predictive ability (area under the curve, 0.80).
The risk for invasive mechanical ventilation increased as the number of positive variables increased (P < .001), from 15.4% for those with one positive variable, to 29.0% for those with two, to 60.5% for those with three positive variables.
The team established cutoff points for each variable and developed a points-based scoring system to predict risk.
It was an initial surprise that troponin – a cardiac marker – would be a risk factor. “Originally, we thought COVID-19 only affects the lung,” Dr. Alnababteh explained during his presentation at CHEST 2020. Later studies, however, showed it can cause myocarditis symptoms.
The case for looking at cardiac markers was made when a study of young athletes who recovered from COVID-19 after experiencing mild or no symptoms showed that 15% had signs of myocarditis on cardiac MRI.
“If mild COVID disease in young patients caused cardiac injury, you can imagine what it can do to older patients with severe disease,” Alnababteh said.
This tool will help triage patients who are not sick enough for the ICU but are known to be at high risk for ventilation. “It’s one of the biggest decisions you have to make: Where do you send your patient? This score helps determine that,” he said.
The researchers are now working to validate the score and evaluate how it performs, he reported.
Existing scores evaluated for COVID-19 outcome prediction
The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.
A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.
Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.
The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.
“Further studies are required to validate this study in larger patient cohorts,” she added.
The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.
“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”
A version of this article originally appeared on Medscape.com.
A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.
The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2); and a positive troponin I level.
“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”
“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”
For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.
Ultimately, 54 of these patients required invasive mechanical ventilation.
On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.
Calibration of the model was good (Hosmer–Lemeshow score, 6.3; P = .39), as was predictive ability (area under the curve, 0.80).
The risk for invasive mechanical ventilation increased as the number of positive variables increased (P < .001), from 15.4% for those with one positive variable, to 29.0% for those with two, to 60.5% for those with three positive variables.
The team established cutoff points for each variable and developed a points-based scoring system to predict risk.
It was an initial surprise that troponin – a cardiac marker – would be a risk factor. “Originally, we thought COVID-19 only affects the lung,” Dr. Alnababteh explained during his presentation at CHEST 2020. Later studies, however, showed it can cause myocarditis symptoms.
The case for looking at cardiac markers was made when a study of young athletes who recovered from COVID-19 after experiencing mild or no symptoms showed that 15% had signs of myocarditis on cardiac MRI.
“If mild COVID disease in young patients caused cardiac injury, you can imagine what it can do to older patients with severe disease,” Alnababteh said.
This tool will help triage patients who are not sick enough for the ICU but are known to be at high risk for ventilation. “It’s one of the biggest decisions you have to make: Where do you send your patient? This score helps determine that,” he said.
The researchers are now working to validate the score and evaluate how it performs, he reported.
Existing scores evaluated for COVID-19 outcome prediction
The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.
A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.
Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.
The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.
“Further studies are required to validate this study in larger patient cohorts,” she added.
The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.
“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”
A version of this article originally appeared on Medscape.com.
A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.
The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2); and a positive troponin I level.
“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”
“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”
For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.
Ultimately, 54 of these patients required invasive mechanical ventilation.
On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.
Calibration of the model was good (Hosmer–Lemeshow score, 6.3; P = .39), as was predictive ability (area under the curve, 0.80).
The risk for invasive mechanical ventilation increased as the number of positive variables increased (P < .001), from 15.4% for those with one positive variable, to 29.0% for those with two, to 60.5% for those with three positive variables.
The team established cutoff points for each variable and developed a points-based scoring system to predict risk.
It was an initial surprise that troponin – a cardiac marker – would be a risk factor. “Originally, we thought COVID-19 only affects the lung,” Dr. Alnababteh explained during his presentation at CHEST 2020. Later studies, however, showed it can cause myocarditis symptoms.
The case for looking at cardiac markers was made when a study of young athletes who recovered from COVID-19 after experiencing mild or no symptoms showed that 15% had signs of myocarditis on cardiac MRI.
“If mild COVID disease in young patients caused cardiac injury, you can imagine what it can do to older patients with severe disease,” Alnababteh said.
This tool will help triage patients who are not sick enough for the ICU but are known to be at high risk for ventilation. “It’s one of the biggest decisions you have to make: Where do you send your patient? This score helps determine that,” he said.
The researchers are now working to validate the score and evaluate how it performs, he reported.
Existing scores evaluated for COVID-19 outcome prediction
The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.
A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.
Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.
The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.
“Further studies are required to validate this study in larger patient cohorts,” she added.
The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.
“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”
A version of this article originally appeared on Medscape.com.
Selexipag has no effect on daily activity in PAH patients
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Link between vitamin D and ICU outcomes unclear
We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.
“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.
Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.
We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”
Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?
When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.
In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.
“Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.
In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.
“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
Maintenance dose needed?
One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.
In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.
The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”
“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”
Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.
Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).
Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.
“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.
Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.
“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”
However, “we’re not really sure that it improves outcomes,” he said.
A chronic issue?
“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.
“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.
“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.
Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.
“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.
Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.
We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”
Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?
When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.
In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.
“Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.
In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.
“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
Maintenance dose needed?
One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.
In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.
The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”
“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”
Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.
Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).
Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.
“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.
Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.
“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”
However, “we’re not really sure that it improves outcomes,” he said.
A chronic issue?
“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.
“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.
“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.
Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.
“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.
Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.
We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”
Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?
When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.
In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.
“Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.
In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.
“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
Maintenance dose needed?
One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.
In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.
The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”
“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”
Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.
Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).
Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.
“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.
Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.
“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”
However, “we’re not really sure that it improves outcomes,” he said.
A chronic issue?
“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.
“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.
“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.
Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM CHEST 2020