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Midodrine reduces fainting in young patients
.
Vasovagal syncope is the most common cause of fainting and is often triggered by dehydration and upright posture, according to Johns Hopkins Medicine. But it can also be caused by stimuli like the sight of blood or sudden emotional distress. The stimulus causes the heart rate and blood pressure to drop rapidly, according to the Mayo Clinic.
The randomized, placebo-controlled, double-blind trial included 133 patients with recurrent vasovagal syncope and was published in Annals of Internal Medicine. Those that received midodrine were less likely to have one syncope episode (28 of 66 [42%]), compared with those that took the placebo (41 of 67 [61%]). The absolute risk reduction for vasovagal syncope was 19 percentage points (95% confidence interval, 2-36 percentage points).
The study included patients from 25 university hospitals in Canada, the United States, Mexico, and the United Kingdom, who were followed for 12 months. The trial participants were highly symptomatic for vasovagal syncope, having experienced a median of 23 episodes in their lifetime and 5 syncope episodes in the last year, and they had no comorbid conditions.
“We don’t have many arrows in our quiver,” said Robert Sheldon, MD, PhD, a cardiologist at University of Calgary (Alta.) and lead author of the study, referring to the lack of evidence-based treatments for syncope.
For 20 years Dr. Sheldon’s lab has been testing drugs that showed some potential. While a previous study of fludrocortisone (Florinef ) showed some benefit, “[midodrine] was the first to be unequivocally, slam-dunk positive,” he said in an interview.
Earlier trials of midodrine
Other studies have shown midodrine to prevent syncope on tilt tests. There have been two randomized trials where midodrine significantly reduced vasovagal syncope, but one of these was short and in children, and the other one was open label with no placebo control.
“Risk reduction was very high in previous studies,” Dr. Sheldon said in an interview. But, because they were open label, there was a huge placebo effect, he noted.
“There were no adequately done, adequately powered [studies] that have been positive,” Dr. Sheldon added.
New study methods and outcomes
The study published in Annals of Internal Medicine this week included patients over 18 years of age with a Calgary Syncope Symptom Score of at least 2. All were educated on lifestyle measures that can prevent syncopes before beginning to take 5 mg of study drug or placebo three times daily, 4 hours apart.
In these cases, the study authors wrote, “taking medication three times a day seems worth the effort.” But in patients with a lower frequency of episodes, midodrine might not have an adequate payoff.
These results are “impressive,” said Roopinder K. Sandhu, MD, MPH, clinical electrophysiologist at Cedar-Sinai in Los Angeles. “This study demonstrated that midodrine is the first medical therapy, in addition to education and lifestyle measures, to unequivocally pass the scrutiny of an international, placebo-controlled, RCT to show a significant reduction in syncope recurrence in a younger population with frequent syncope events.”
“[Taking midodrine] doesn’t carry the long-term consequence of pacemakers,” she added.
Study limitations
Limitations of the new study include its small size and short observation period, the authors wrote. Additionally, a large proportion of patients enrolled were also from a single center in Calgary that specializes in syncope care. Twenty-seven patients in the trial stopped taking their assigned medication during the year observation period, but the authors concluded these participants “likely would bias the results against midodrine.”
For doctors considering midodrine for their patients, it’s critical to confirm the diagnosis and to try patient education first, Dr. Sheldon advised.
Lifestyle factors like hydration, adequate sodium intake, and squatting or lying down when the syncope is coming on can sufficiently suppress syncopes in two-thirds of patients, he noted.
This is a treatment for young people, Dr. Sandhu said. The median age in the trial was 35, so patients taking midodrine should be younger than 50. Midodrine is also not effective in patients with high blood pressure or heart failure, she said.
“[Midodrine] is easy to use but kind of a pain at first,” Dr. Sheldon noted. Every patient should start out taking 5 mg doses, three times a day – during waking hours. But then you have to adjust the dosage, “and it’s tricky,” he said.
If a patient experiences goosebumps or the sensation of worms crawling in the hair, the dose might be too much, Dr. Sheldon noted.
If the patient is still fainting, first consider when they are fainting, he said. If it’s around the time they should take another dose, it might be trough effect.
Dr. Sandhu was not involved in the study, but Cedar Sinai was a participating center, and she considers Dr. Sheldon to be a mentor. Dr. Sandhu also noted that she has published papers with Dr. Sheldon, who reported no conflicts.
.
Vasovagal syncope is the most common cause of fainting and is often triggered by dehydration and upright posture, according to Johns Hopkins Medicine. But it can also be caused by stimuli like the sight of blood or sudden emotional distress. The stimulus causes the heart rate and blood pressure to drop rapidly, according to the Mayo Clinic.
The randomized, placebo-controlled, double-blind trial included 133 patients with recurrent vasovagal syncope and was published in Annals of Internal Medicine. Those that received midodrine were less likely to have one syncope episode (28 of 66 [42%]), compared with those that took the placebo (41 of 67 [61%]). The absolute risk reduction for vasovagal syncope was 19 percentage points (95% confidence interval, 2-36 percentage points).
The study included patients from 25 university hospitals in Canada, the United States, Mexico, and the United Kingdom, who were followed for 12 months. The trial participants were highly symptomatic for vasovagal syncope, having experienced a median of 23 episodes in their lifetime and 5 syncope episodes in the last year, and they had no comorbid conditions.
“We don’t have many arrows in our quiver,” said Robert Sheldon, MD, PhD, a cardiologist at University of Calgary (Alta.) and lead author of the study, referring to the lack of evidence-based treatments for syncope.
For 20 years Dr. Sheldon’s lab has been testing drugs that showed some potential. While a previous study of fludrocortisone (Florinef ) showed some benefit, “[midodrine] was the first to be unequivocally, slam-dunk positive,” he said in an interview.
Earlier trials of midodrine
Other studies have shown midodrine to prevent syncope on tilt tests. There have been two randomized trials where midodrine significantly reduced vasovagal syncope, but one of these was short and in children, and the other one was open label with no placebo control.
“Risk reduction was very high in previous studies,” Dr. Sheldon said in an interview. But, because they were open label, there was a huge placebo effect, he noted.
“There were no adequately done, adequately powered [studies] that have been positive,” Dr. Sheldon added.
New study methods and outcomes
The study published in Annals of Internal Medicine this week included patients over 18 years of age with a Calgary Syncope Symptom Score of at least 2. All were educated on lifestyle measures that can prevent syncopes before beginning to take 5 mg of study drug or placebo three times daily, 4 hours apart.
In these cases, the study authors wrote, “taking medication three times a day seems worth the effort.” But in patients with a lower frequency of episodes, midodrine might not have an adequate payoff.
These results are “impressive,” said Roopinder K. Sandhu, MD, MPH, clinical electrophysiologist at Cedar-Sinai in Los Angeles. “This study demonstrated that midodrine is the first medical therapy, in addition to education and lifestyle measures, to unequivocally pass the scrutiny of an international, placebo-controlled, RCT to show a significant reduction in syncope recurrence in a younger population with frequent syncope events.”
“[Taking midodrine] doesn’t carry the long-term consequence of pacemakers,” she added.
Study limitations
Limitations of the new study include its small size and short observation period, the authors wrote. Additionally, a large proportion of patients enrolled were also from a single center in Calgary that specializes in syncope care. Twenty-seven patients in the trial stopped taking their assigned medication during the year observation period, but the authors concluded these participants “likely would bias the results against midodrine.”
For doctors considering midodrine for their patients, it’s critical to confirm the diagnosis and to try patient education first, Dr. Sheldon advised.
Lifestyle factors like hydration, adequate sodium intake, and squatting or lying down when the syncope is coming on can sufficiently suppress syncopes in two-thirds of patients, he noted.
This is a treatment for young people, Dr. Sandhu said. The median age in the trial was 35, so patients taking midodrine should be younger than 50. Midodrine is also not effective in patients with high blood pressure or heart failure, she said.
“[Midodrine] is easy to use but kind of a pain at first,” Dr. Sheldon noted. Every patient should start out taking 5 mg doses, three times a day – during waking hours. But then you have to adjust the dosage, “and it’s tricky,” he said.
If a patient experiences goosebumps or the sensation of worms crawling in the hair, the dose might be too much, Dr. Sheldon noted.
If the patient is still fainting, first consider when they are fainting, he said. If it’s around the time they should take another dose, it might be trough effect.
Dr. Sandhu was not involved in the study, but Cedar Sinai was a participating center, and she considers Dr. Sheldon to be a mentor. Dr. Sandhu also noted that she has published papers with Dr. Sheldon, who reported no conflicts.
.
Vasovagal syncope is the most common cause of fainting and is often triggered by dehydration and upright posture, according to Johns Hopkins Medicine. But it can also be caused by stimuli like the sight of blood or sudden emotional distress. The stimulus causes the heart rate and blood pressure to drop rapidly, according to the Mayo Clinic.
The randomized, placebo-controlled, double-blind trial included 133 patients with recurrent vasovagal syncope and was published in Annals of Internal Medicine. Those that received midodrine were less likely to have one syncope episode (28 of 66 [42%]), compared with those that took the placebo (41 of 67 [61%]). The absolute risk reduction for vasovagal syncope was 19 percentage points (95% confidence interval, 2-36 percentage points).
The study included patients from 25 university hospitals in Canada, the United States, Mexico, and the United Kingdom, who were followed for 12 months. The trial participants were highly symptomatic for vasovagal syncope, having experienced a median of 23 episodes in their lifetime and 5 syncope episodes in the last year, and they had no comorbid conditions.
“We don’t have many arrows in our quiver,” said Robert Sheldon, MD, PhD, a cardiologist at University of Calgary (Alta.) and lead author of the study, referring to the lack of evidence-based treatments for syncope.
For 20 years Dr. Sheldon’s lab has been testing drugs that showed some potential. While a previous study of fludrocortisone (Florinef ) showed some benefit, “[midodrine] was the first to be unequivocally, slam-dunk positive,” he said in an interview.
Earlier trials of midodrine
Other studies have shown midodrine to prevent syncope on tilt tests. There have been two randomized trials where midodrine significantly reduced vasovagal syncope, but one of these was short and in children, and the other one was open label with no placebo control.
“Risk reduction was very high in previous studies,” Dr. Sheldon said in an interview. But, because they were open label, there was a huge placebo effect, he noted.
“There were no adequately done, adequately powered [studies] that have been positive,” Dr. Sheldon added.
New study methods and outcomes
The study published in Annals of Internal Medicine this week included patients over 18 years of age with a Calgary Syncope Symptom Score of at least 2. All were educated on lifestyle measures that can prevent syncopes before beginning to take 5 mg of study drug or placebo three times daily, 4 hours apart.
In these cases, the study authors wrote, “taking medication three times a day seems worth the effort.” But in patients with a lower frequency of episodes, midodrine might not have an adequate payoff.
These results are “impressive,” said Roopinder K. Sandhu, MD, MPH, clinical electrophysiologist at Cedar-Sinai in Los Angeles. “This study demonstrated that midodrine is the first medical therapy, in addition to education and lifestyle measures, to unequivocally pass the scrutiny of an international, placebo-controlled, RCT to show a significant reduction in syncope recurrence in a younger population with frequent syncope events.”
“[Taking midodrine] doesn’t carry the long-term consequence of pacemakers,” she added.
Study limitations
Limitations of the new study include its small size and short observation period, the authors wrote. Additionally, a large proportion of patients enrolled were also from a single center in Calgary that specializes in syncope care. Twenty-seven patients in the trial stopped taking their assigned medication during the year observation period, but the authors concluded these participants “likely would bias the results against midodrine.”
For doctors considering midodrine for their patients, it’s critical to confirm the diagnosis and to try patient education first, Dr. Sheldon advised.
Lifestyle factors like hydration, adequate sodium intake, and squatting or lying down when the syncope is coming on can sufficiently suppress syncopes in two-thirds of patients, he noted.
This is a treatment for young people, Dr. Sandhu said. The median age in the trial was 35, so patients taking midodrine should be younger than 50. Midodrine is also not effective in patients with high blood pressure or heart failure, she said.
“[Midodrine] is easy to use but kind of a pain at first,” Dr. Sheldon noted. Every patient should start out taking 5 mg doses, three times a day – during waking hours. But then you have to adjust the dosage, “and it’s tricky,” he said.
If a patient experiences goosebumps or the sensation of worms crawling in the hair, the dose might be too much, Dr. Sheldon noted.
If the patient is still fainting, first consider when they are fainting, he said. If it’s around the time they should take another dose, it might be trough effect.
Dr. Sandhu was not involved in the study, but Cedar Sinai was a participating center, and she considers Dr. Sheldon to be a mentor. Dr. Sandhu also noted that she has published papers with Dr. Sheldon, who reported no conflicts.
FROM ANNALS OF INTERNAL MEDICINE
Diabetes drug’s new weight-loss indication fuels cost-benefit debate
The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.
So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.
One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.
Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.
“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.
But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.
Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.
The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.
“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”
Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.
New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.
Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.
Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.
Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.
Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.
Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.
Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?
Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.
Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.
“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.
The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.
Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.
“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.
The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.
After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.
Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.
He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.
Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.
“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”
He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.
Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.
Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.
Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.
So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.
One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.
Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.
“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.
But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.
Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.
The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.
“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”
Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.
New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.
Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.
Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.
Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.
Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.
Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.
Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?
Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.
Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.
“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.
The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.
Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.
“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.
The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.
After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.
Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.
He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.
Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.
“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”
He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.
Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.
Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.
Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.
So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.
One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.
Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.
“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.
But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.
Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.
The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.
“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”
Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.
New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.
Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.
Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.
Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.
Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.
Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.
Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?
Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.
Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.
“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.
The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.
Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.
“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.
The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.
After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.
Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.
He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.
Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.
“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”
He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.
Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.
Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.
Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
MR elastography could predict cirrhosis in NAFLD
Liver stiffness measurement with magnetic resonance elastography (MRE) may prove predictive of future cirrhosis risk in patients with nonalcoholic fatty liver disease (NAFLD), according to researchers from the Mayo Clinic in Rochester, Minn.
“These data expand the role of MRE from an accurate diagnostic method to a prognostic noninvasive imaging biomarker that can risk-stratify patients with NAFLD and guide the timing of surveillance and further refine their clinical management,” wrote Tolga Gidener, MD, and colleagues. The study authors added that the research further expands “the role of MRE beyond liver fibrosis estimation by adding a predictive feature to improve individualized disease monitoring and patient counseling.” Their study was published in Clinical Gastroenterology and Hepatology.
Currently, there are no established noninvasive strategies that can effectively identify patients with NAFLD who are at high risk of progression to cirrhosis and liver-related complications. While fibrosis stage on histology may predict liver-associated outcomes in these patients, this approach is invasive, time consuming, and is generally not well tolerated by patients.
Although the technique has been noted for its high success rate and excellent levels of reliability and reproducibility, a possible limitation of MRE is its cost. That said, standalone MRE is reimbursed under Medicare Category I Current Procedural Terminology code 76391 with a cost of $240.02. However, there is also a lack of data on whether baseline liver stiffness measurement by MRE can predict progression of NAFLD to cirrhosis.
To gauge the role of baseline liver stiffness measurement by MRE, Dr. Gidener and colleagues performed a retrospective cohort study that evaluated hard liver–related outcomes in 829 adult patients with NAFLD with or without cirrhosis (median age, 58 years; 54% female) who underwent MRE during 2007-2019.
Patients in the study were followed from the first MRE until death, last clinical encounter, or the end of the study. Clinical outcomes assessed in individual chart review included cirrhosis, hepatic decompensation, and death.
At baseline, the median liver stiffness measurement was 2.8 kPa in 639 patients with NAFLD but without cirrhosis. Over a median 4-year follow-up period, a total of 20 patients developed cirrhosis, with an overall annual incidence rate of 1%.
Baseline liver stiffness measurement by MRE was significantly predictive of subsequent cirrhosis (hazard ratio, 2.93; 95% confidence interval, 1.86-4.62; P < .0001) per 1-kPa difference in liver stiffness measurement at baseline.
According to the researchers, the probability of future cirrhosis development can be ascertained using current liver stiffness measurement. As such, a greater than 1% probability threshold can be reached in 5 years in patients with a measurement of 2 kPa, 3 years in patients with a measurement of 3 kPA, and 1 year in patients with 4-5 kPa. “These time frames inform about estimated time to progression to hard outcomes and provide guidance for subsequent noninvasive monitoring for disease progression,” wrote the researchers.
The baseline liver stiffness measurement by MRE was also significantly predictive of future hepatic decompensation or death (HR, 1.32; 95% CI, 1.13-1.56; P = .0007) per 1-kPa increment in the liver stiffness measurement. Likewise, the 1-year probability of subsequent hepatic decompensation or death in patients with cirrhosis and baseline liver stiffness measurement of 5 kPa versus 8 kPa was 9% versus 20%, respectively. In terms of covariates, age was the only factor that increased the risk of hepatic decompensation or death.
While the current study offers a glimpse into the potential clinical implications of liver stiffness measurement by MRE in NAFLD, the researchers suggest the applicability of the findings are limited by the study’s small sample size, relatively short follow-up duration, and the small number of cirrhosis events.
The researchers received study funding from the National Institute of Diabetes and Digestive and Kidney Diseases, American College of Gastroenterology, National Institutes of Health, and the Department of Defense. The researchers disclosed no other relevant conflicts of interest.
Liver stiffness measurement with magnetic resonance elastography (MRE) may prove predictive of future cirrhosis risk in patients with nonalcoholic fatty liver disease (NAFLD), according to researchers from the Mayo Clinic in Rochester, Minn.
“These data expand the role of MRE from an accurate diagnostic method to a prognostic noninvasive imaging biomarker that can risk-stratify patients with NAFLD and guide the timing of surveillance and further refine their clinical management,” wrote Tolga Gidener, MD, and colleagues. The study authors added that the research further expands “the role of MRE beyond liver fibrosis estimation by adding a predictive feature to improve individualized disease monitoring and patient counseling.” Their study was published in Clinical Gastroenterology and Hepatology.
Currently, there are no established noninvasive strategies that can effectively identify patients with NAFLD who are at high risk of progression to cirrhosis and liver-related complications. While fibrosis stage on histology may predict liver-associated outcomes in these patients, this approach is invasive, time consuming, and is generally not well tolerated by patients.
Although the technique has been noted for its high success rate and excellent levels of reliability and reproducibility, a possible limitation of MRE is its cost. That said, standalone MRE is reimbursed under Medicare Category I Current Procedural Terminology code 76391 with a cost of $240.02. However, there is also a lack of data on whether baseline liver stiffness measurement by MRE can predict progression of NAFLD to cirrhosis.
To gauge the role of baseline liver stiffness measurement by MRE, Dr. Gidener and colleagues performed a retrospective cohort study that evaluated hard liver–related outcomes in 829 adult patients with NAFLD with or without cirrhosis (median age, 58 years; 54% female) who underwent MRE during 2007-2019.
Patients in the study were followed from the first MRE until death, last clinical encounter, or the end of the study. Clinical outcomes assessed in individual chart review included cirrhosis, hepatic decompensation, and death.
At baseline, the median liver stiffness measurement was 2.8 kPa in 639 patients with NAFLD but without cirrhosis. Over a median 4-year follow-up period, a total of 20 patients developed cirrhosis, with an overall annual incidence rate of 1%.
Baseline liver stiffness measurement by MRE was significantly predictive of subsequent cirrhosis (hazard ratio, 2.93; 95% confidence interval, 1.86-4.62; P < .0001) per 1-kPa difference in liver stiffness measurement at baseline.
According to the researchers, the probability of future cirrhosis development can be ascertained using current liver stiffness measurement. As such, a greater than 1% probability threshold can be reached in 5 years in patients with a measurement of 2 kPa, 3 years in patients with a measurement of 3 kPA, and 1 year in patients with 4-5 kPa. “These time frames inform about estimated time to progression to hard outcomes and provide guidance for subsequent noninvasive monitoring for disease progression,” wrote the researchers.
The baseline liver stiffness measurement by MRE was also significantly predictive of future hepatic decompensation or death (HR, 1.32; 95% CI, 1.13-1.56; P = .0007) per 1-kPa increment in the liver stiffness measurement. Likewise, the 1-year probability of subsequent hepatic decompensation or death in patients with cirrhosis and baseline liver stiffness measurement of 5 kPa versus 8 kPa was 9% versus 20%, respectively. In terms of covariates, age was the only factor that increased the risk of hepatic decompensation or death.
While the current study offers a glimpse into the potential clinical implications of liver stiffness measurement by MRE in NAFLD, the researchers suggest the applicability of the findings are limited by the study’s small sample size, relatively short follow-up duration, and the small number of cirrhosis events.
The researchers received study funding from the National Institute of Diabetes and Digestive and Kidney Diseases, American College of Gastroenterology, National Institutes of Health, and the Department of Defense. The researchers disclosed no other relevant conflicts of interest.
Liver stiffness measurement with magnetic resonance elastography (MRE) may prove predictive of future cirrhosis risk in patients with nonalcoholic fatty liver disease (NAFLD), according to researchers from the Mayo Clinic in Rochester, Minn.
“These data expand the role of MRE from an accurate diagnostic method to a prognostic noninvasive imaging biomarker that can risk-stratify patients with NAFLD and guide the timing of surveillance and further refine their clinical management,” wrote Tolga Gidener, MD, and colleagues. The study authors added that the research further expands “the role of MRE beyond liver fibrosis estimation by adding a predictive feature to improve individualized disease monitoring and patient counseling.” Their study was published in Clinical Gastroenterology and Hepatology.
Currently, there are no established noninvasive strategies that can effectively identify patients with NAFLD who are at high risk of progression to cirrhosis and liver-related complications. While fibrosis stage on histology may predict liver-associated outcomes in these patients, this approach is invasive, time consuming, and is generally not well tolerated by patients.
Although the technique has been noted for its high success rate and excellent levels of reliability and reproducibility, a possible limitation of MRE is its cost. That said, standalone MRE is reimbursed under Medicare Category I Current Procedural Terminology code 76391 with a cost of $240.02. However, there is also a lack of data on whether baseline liver stiffness measurement by MRE can predict progression of NAFLD to cirrhosis.
To gauge the role of baseline liver stiffness measurement by MRE, Dr. Gidener and colleagues performed a retrospective cohort study that evaluated hard liver–related outcomes in 829 adult patients with NAFLD with or without cirrhosis (median age, 58 years; 54% female) who underwent MRE during 2007-2019.
Patients in the study were followed from the first MRE until death, last clinical encounter, or the end of the study. Clinical outcomes assessed in individual chart review included cirrhosis, hepatic decompensation, and death.
At baseline, the median liver stiffness measurement was 2.8 kPa in 639 patients with NAFLD but without cirrhosis. Over a median 4-year follow-up period, a total of 20 patients developed cirrhosis, with an overall annual incidence rate of 1%.
Baseline liver stiffness measurement by MRE was significantly predictive of subsequent cirrhosis (hazard ratio, 2.93; 95% confidence interval, 1.86-4.62; P < .0001) per 1-kPa difference in liver stiffness measurement at baseline.
According to the researchers, the probability of future cirrhosis development can be ascertained using current liver stiffness measurement. As such, a greater than 1% probability threshold can be reached in 5 years in patients with a measurement of 2 kPa, 3 years in patients with a measurement of 3 kPA, and 1 year in patients with 4-5 kPa. “These time frames inform about estimated time to progression to hard outcomes and provide guidance for subsequent noninvasive monitoring for disease progression,” wrote the researchers.
The baseline liver stiffness measurement by MRE was also significantly predictive of future hepatic decompensation or death (HR, 1.32; 95% CI, 1.13-1.56; P = .0007) per 1-kPa increment in the liver stiffness measurement. Likewise, the 1-year probability of subsequent hepatic decompensation or death in patients with cirrhosis and baseline liver stiffness measurement of 5 kPa versus 8 kPa was 9% versus 20%, respectively. In terms of covariates, age was the only factor that increased the risk of hepatic decompensation or death.
While the current study offers a glimpse into the potential clinical implications of liver stiffness measurement by MRE in NAFLD, the researchers suggest the applicability of the findings are limited by the study’s small sample size, relatively short follow-up duration, and the small number of cirrhosis events.
The researchers received study funding from the National Institute of Diabetes and Digestive and Kidney Diseases, American College of Gastroenterology, National Institutes of Health, and the Department of Defense. The researchers disclosed no other relevant conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
‘A few mutations away’: The threat of a vaccine-proof variant
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.
“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27.
A new, more elusive variant could be “just a few mutations away,” she said.
“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.
“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”
“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”
He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”
“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.
Dr. Nelson said.
If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
Technology to the rescue?
The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.
“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.
“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
Nothing appears certain
When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.
“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”
Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.
Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
Mutations not the only concern
Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.
Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.
“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”
“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
Protected, for now
Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.
On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.
“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27.
A new, more elusive variant could be “just a few mutations away,” she said.
“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.
“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”
“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”
He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”
“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.
Dr. Nelson said.
If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
Technology to the rescue?
The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.
“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.
“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
Nothing appears certain
When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.
“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”
Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.
Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
Mutations not the only concern
Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.
Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.
“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”
“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
Protected, for now
Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.
On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.
“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27.
A new, more elusive variant could be “just a few mutations away,” she said.
“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.
“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”
“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”
He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”
“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.
Dr. Nelson said.
If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
Technology to the rescue?
The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.
“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.
“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
Nothing appears certain
When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.
“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”
Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.
Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
Mutations not the only concern
Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.
Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.
“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”
“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
Protected, for now
Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.
On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”
A version of this article first appeared on Medscape.com.
Study highlights impact of acne in adult women on quality of life, mental health
results from a qualitative study demonstrated.
“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”
For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.
The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).
More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.
In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.
“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”
In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”
Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”
In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”
A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”
For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”
This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.
results from a qualitative study demonstrated.
“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”
For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.
The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).
More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.
In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.
“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”
In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”
Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”
In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”
A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”
For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”
This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.
results from a qualitative study demonstrated.
“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”
For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.
The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).
More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.
In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.
“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”
In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”
Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”
In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”
A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”
For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”
This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.
FROM JAMA DERMATOLOGY
As common respiratory viruses resurface, children are at serious risk
Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.
The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.
“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”
The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.
In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.
Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.
“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”
Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.
“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.
Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.
“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”
A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.
Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.
“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”
Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.
However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.
He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.
“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”
To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.
Dr. Harrison and Dr. Webby reported no conflicts of interest.
Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.
The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.
“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”
The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.
In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.
Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.
“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”
Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.
“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.
Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.
“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”
A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.
Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.
“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”
Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.
However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.
He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.
“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”
To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.
Dr. Harrison and Dr. Webby reported no conflicts of interest.
Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.
The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.
“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”
The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.
In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.
Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.
“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”
Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.
“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.
Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.
“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”
A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.
Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.
“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”
Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.
However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.
He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.
“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”
To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.
Dr. Harrison and Dr. Webby reported no conflicts of interest.
FDA approves first interchangeable biosimilar insulin
The
The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.
It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
Originally approved in June 2020 as a biosimilar to glargine, Semglee is now an “interchangeable biosimilar,” meaning that it has no clinically meaningful difference from the reference product and also may be substituted for that product – in this case, glargine (Lantus) – without prescriber intervention, just as generic drugs typically are, subject to state pharmacy laws.
For approval as an interchangeable biosimilar, manufacturers are required to provide additional data reflecting how the interchangeable biosimilar may be used in the marketplace with patients.
“Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” the FDA said in a statement.
Semglee comes in 10-mL and 3-mL prefilled pens, and is administered subcutaneously once daily, with individualized doses. The most common side effects are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions.
The FDA released new materials for health care providers regarding biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.
A version of this article first appeared on Medscape.com.
The
The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.
It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
Originally approved in June 2020 as a biosimilar to glargine, Semglee is now an “interchangeable biosimilar,” meaning that it has no clinically meaningful difference from the reference product and also may be substituted for that product – in this case, glargine (Lantus) – without prescriber intervention, just as generic drugs typically are, subject to state pharmacy laws.
For approval as an interchangeable biosimilar, manufacturers are required to provide additional data reflecting how the interchangeable biosimilar may be used in the marketplace with patients.
“Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” the FDA said in a statement.
Semglee comes in 10-mL and 3-mL prefilled pens, and is administered subcutaneously once daily, with individualized doses. The most common side effects are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions.
The FDA released new materials for health care providers regarding biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.
A version of this article first appeared on Medscape.com.
The
The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.
It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
Originally approved in June 2020 as a biosimilar to glargine, Semglee is now an “interchangeable biosimilar,” meaning that it has no clinically meaningful difference from the reference product and also may be substituted for that product – in this case, glargine (Lantus) – without prescriber intervention, just as generic drugs typically are, subject to state pharmacy laws.
For approval as an interchangeable biosimilar, manufacturers are required to provide additional data reflecting how the interchangeable biosimilar may be used in the marketplace with patients.
“Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” the FDA said in a statement.
Semglee comes in 10-mL and 3-mL prefilled pens, and is administered subcutaneously once daily, with individualized doses. The most common side effects are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions.
The FDA released new materials for health care providers regarding biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.
A version of this article first appeared on Medscape.com.
PCPs lag on albuminuria tests in patients with type 2 diabetes
U.S. primary care physicians are not properly checking patients with type 2 diabetes for chronic kidney disease (CKD) nearly as often as they should, meaning many of these patients miss getting a timely diagnosis.
Inadequate measurement of urinary albumin-to-creatinine ratio (uACR) is the issue.
Review of data from more than half a million U.S. primary care patients with type 2 diabetes seen at any of 1,164 practice sites run by any of 24 health care organizations during 2016-2019 showed that barely more than half, 52%, had both their uACR and estimated glomerular filtration rate (eGFR) checked annually as recommended by several U.S. medical societies, and just 73% had both values checked during a 3-year period, Nikita Stempniewicz, MSc, and associates reported in Diabetes Care.
More detailed data showed that measurement of eGFR was reasonably robust, measured at a 90% rate annually and in 97% of patients at least once every 3 years. But recording uACR values lagged, with a 53% annual rate and a 74% rate of measurement at least once every 3 years, reported Mr. Stempniewicz, director of research and analytics for the American Medical Group Association, a trade association based in Alexandria, Va. The 24 health care organizations that supplied the study’s data are all members of this association.
Prevailing recommendations from various medical societies call for annual monitoring of urinary albumin in patients with type 2 diabetes and specify the uACR, such as in the Standards of Medical Care in Diabetes from the American Diabetes Association, as well as in recommendations promoted by the National Kidney Foundation.
Missing half the CKD patients with eGFR only
“Half the patients with type 2 diabetes and chronic kidney disease have elevated albuminuria without decreased eGFR and would not be detected with eGFR testing alone,” Mr. Stempniewicz noted in an interview.
“Many patients who present for nephrology care are incompletely assessed with only low eGFR but no urine testing. Missing albuminuria testing and uACR values means patients with high levels of albuminuria but normal kidney function go undetected and thus are not able to benefit from evidenced-based interventions, including nephrology services,” said Joseph A. Vassalotti, MD, a nephrologist, chief medical officer for the National Kidney Foundation, and a coauthor of the report.
Not testing patients with type 2 diabetes regularly for their uACR “is a missed opportunity to identify the highest-risk patients and treat them,” added Josef Coresh, MD, PhD, a professor of clinical epidemiology at Johns Hopkins University, Baltimore, and senior author on the study. Measurement of albuminuria is especially important for these patients because medications from the sodium-glucose cotransporter 2 inhibitor class have been proven to slow progression of CKD in patients with type 2 diabetes, but these drugs are expensive, and in some cases have labeling that specifies the presence of albuminuria.
“I have no doubt that improving albuminuria testing is a critical step to identify patients with diabetes at highest risk who should get the best treatment possible, including SGLT2 inhibitors,” Dr. Coresh said in an interview.
The new report is not the first to document inadequate assessment of albuminuria and uACR among primary care physicians (PCPs), but it came from the largest reported U.S. study to date. “eGFR is commonly collected in a routine laboratory blood panel, but collecting urine requires additional work flow,” noted Cara B. Litvin, MD, a general internal medicine researcher at the Medical University of South Carolina, Charleston, who has tested interventions aimed at boosting CKD assessment by PCPs and was not involved in the new study.
“There have also been conflicting guidelines,” such as a “now-inactive guideline from the American College of Physicians that recommended against routine urine albumin screening in patients with diabetes and already on treatment with an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker,” she said.
New renal drugs change the stakes
The availability of newer drugs for slowing CKD progression such as the SGLT2 inhibitors will help trigger greater support for routine albuminuria testing, Dr. Litvin predicted in an interview. “Now that we have more medications that can reduce albuminuria and improve outcomes, I see screening for albuminuria increasing.” Finerenone (Kerendia) is another new agent from a new class that recently received Food and Drug Administration approval for treating CKD in patients with type 2 diabetes.
Other drivers of increased uACR testing she expects include revised clinical practice guidelines, and new quality measures of clinical care.
“Undertesting of albuminuria means that [nephrologists] have incomplete data to detect and completely risk stratify the CKD population. That in turn results in a reduced ability to match population health interventions to the severity of the condition or the risk stratification based on eGFR and uACR,” Dr. Vassalotti said in an interview.
“We are missing opportunities to prevent or delay kidney failure and reduce the risk of cardiovascular events and cardiovascular death in these patients, particularly now that we have a number of medications that offer kidney and cardiovascular protection such as SGLT2 inhibitors,” he added. “Leaders in nephrology are beginning to understand the consequences of undertesting, and are working to innovate to improve risk stratification, CKD detection, and apply interventions to give Americans living with CKD better outcomes.”
Strategies proven to boost albuminuria testing
Mr. Stempniewicz and coauthors cited in their report potential strategies for improving albuminuria testing, including benchmarking to identify best-performing sites for albumin testing within a health system and encouraging replication of identified best practices at lower-performing sites, and implementation of clinical-decision support tools in the EHR such as pop-up test reminders.
These were among the tools tested in two studies led by Dr. Litvin. One study, with results reported in 2016, involved 12 small U.S. primary care practices with a total of more than 30,000 patients and compared performance in a series of clinical quality measures at baseline with performance after 2 years of receiving various interventions designed to boost awareness for albuminuria testing.
The second study, with findings reported in 2019, involved 21 U.S. primary care practices that collectively cared for more than 100,000 patients and randomized the practices to either undergo interventions aimed at boosting testing awareness or to serve as controls.
Results from both studies showed significant and substantial increases in serial testing for albuminuria in patients with diabetes or hypertension when practices received the interventions.
“We showed that [using a] clinical-decision support tool, along with standing orders to automatically collect urine specimens, dramatically increased screening for urinary albumin in primary care practices,” Dr. Litvin said. “However, perhaps because of conflicting guidelines and clinical inertia there hasn’t been a major impetus for primary care practices in general to improve screening.” She hopes that will quickly change.
“As we have shown, adoption of EHR-based reminders along with standing orders can very quickly improve screening for albuminuria in primary care.”
Variation in testing rates among sites ‘tremendous’
One finding of the new study gives Mr. Stempniewicz hope for greater future testing: The large variance that the researchers saw in albuminuria testing rates within individual health systems.
“The paper shows that higher rates of testing are completely achievable within each system. Some clinics do very well, and the other units can learn from these local successes,” he said. At least half the organizations in the study had individual sites that fell into the top 10% for testing rates across all the greater than 1,000 sites included, and those same organizations also had at least one site that fell into the bottom 10% for testing.
“The variation is tremendous, and highlights an opportunity for improvement,” declared Mr. Stempniewicz.
“For routine testing, you need systems that help people. Clinicians shouldn’t have to think about doing routine testing. It should just happen,” said Dr. Coresh.
The study was funded in part by Janssen. Mr. Stempniewicz and Dr. Litvin had no disclosures. Dr. Coresh is an adviser to Healthy.io, a company that markets a home albuminuria testing kit to patients. Dr. Vassalotti has received personal fees from Renalytix.
U.S. primary care physicians are not properly checking patients with type 2 diabetes for chronic kidney disease (CKD) nearly as often as they should, meaning many of these patients miss getting a timely diagnosis.
Inadequate measurement of urinary albumin-to-creatinine ratio (uACR) is the issue.
Review of data from more than half a million U.S. primary care patients with type 2 diabetes seen at any of 1,164 practice sites run by any of 24 health care organizations during 2016-2019 showed that barely more than half, 52%, had both their uACR and estimated glomerular filtration rate (eGFR) checked annually as recommended by several U.S. medical societies, and just 73% had both values checked during a 3-year period, Nikita Stempniewicz, MSc, and associates reported in Diabetes Care.
More detailed data showed that measurement of eGFR was reasonably robust, measured at a 90% rate annually and in 97% of patients at least once every 3 years. But recording uACR values lagged, with a 53% annual rate and a 74% rate of measurement at least once every 3 years, reported Mr. Stempniewicz, director of research and analytics for the American Medical Group Association, a trade association based in Alexandria, Va. The 24 health care organizations that supplied the study’s data are all members of this association.
Prevailing recommendations from various medical societies call for annual monitoring of urinary albumin in patients with type 2 diabetes and specify the uACR, such as in the Standards of Medical Care in Diabetes from the American Diabetes Association, as well as in recommendations promoted by the National Kidney Foundation.
Missing half the CKD patients with eGFR only
“Half the patients with type 2 diabetes and chronic kidney disease have elevated albuminuria without decreased eGFR and would not be detected with eGFR testing alone,” Mr. Stempniewicz noted in an interview.
“Many patients who present for nephrology care are incompletely assessed with only low eGFR but no urine testing. Missing albuminuria testing and uACR values means patients with high levels of albuminuria but normal kidney function go undetected and thus are not able to benefit from evidenced-based interventions, including nephrology services,” said Joseph A. Vassalotti, MD, a nephrologist, chief medical officer for the National Kidney Foundation, and a coauthor of the report.
Not testing patients with type 2 diabetes regularly for their uACR “is a missed opportunity to identify the highest-risk patients and treat them,” added Josef Coresh, MD, PhD, a professor of clinical epidemiology at Johns Hopkins University, Baltimore, and senior author on the study. Measurement of albuminuria is especially important for these patients because medications from the sodium-glucose cotransporter 2 inhibitor class have been proven to slow progression of CKD in patients with type 2 diabetes, but these drugs are expensive, and in some cases have labeling that specifies the presence of albuminuria.
“I have no doubt that improving albuminuria testing is a critical step to identify patients with diabetes at highest risk who should get the best treatment possible, including SGLT2 inhibitors,” Dr. Coresh said in an interview.
The new report is not the first to document inadequate assessment of albuminuria and uACR among primary care physicians (PCPs), but it came from the largest reported U.S. study to date. “eGFR is commonly collected in a routine laboratory blood panel, but collecting urine requires additional work flow,” noted Cara B. Litvin, MD, a general internal medicine researcher at the Medical University of South Carolina, Charleston, who has tested interventions aimed at boosting CKD assessment by PCPs and was not involved in the new study.
“There have also been conflicting guidelines,” such as a “now-inactive guideline from the American College of Physicians that recommended against routine urine albumin screening in patients with diabetes and already on treatment with an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker,” she said.
New renal drugs change the stakes
The availability of newer drugs for slowing CKD progression such as the SGLT2 inhibitors will help trigger greater support for routine albuminuria testing, Dr. Litvin predicted in an interview. “Now that we have more medications that can reduce albuminuria and improve outcomes, I see screening for albuminuria increasing.” Finerenone (Kerendia) is another new agent from a new class that recently received Food and Drug Administration approval for treating CKD in patients with type 2 diabetes.
Other drivers of increased uACR testing she expects include revised clinical practice guidelines, and new quality measures of clinical care.
“Undertesting of albuminuria means that [nephrologists] have incomplete data to detect and completely risk stratify the CKD population. That in turn results in a reduced ability to match population health interventions to the severity of the condition or the risk stratification based on eGFR and uACR,” Dr. Vassalotti said in an interview.
“We are missing opportunities to prevent or delay kidney failure and reduce the risk of cardiovascular events and cardiovascular death in these patients, particularly now that we have a number of medications that offer kidney and cardiovascular protection such as SGLT2 inhibitors,” he added. “Leaders in nephrology are beginning to understand the consequences of undertesting, and are working to innovate to improve risk stratification, CKD detection, and apply interventions to give Americans living with CKD better outcomes.”
Strategies proven to boost albuminuria testing
Mr. Stempniewicz and coauthors cited in their report potential strategies for improving albuminuria testing, including benchmarking to identify best-performing sites for albumin testing within a health system and encouraging replication of identified best practices at lower-performing sites, and implementation of clinical-decision support tools in the EHR such as pop-up test reminders.
These were among the tools tested in two studies led by Dr. Litvin. One study, with results reported in 2016, involved 12 small U.S. primary care practices with a total of more than 30,000 patients and compared performance in a series of clinical quality measures at baseline with performance after 2 years of receiving various interventions designed to boost awareness for albuminuria testing.
The second study, with findings reported in 2019, involved 21 U.S. primary care practices that collectively cared for more than 100,000 patients and randomized the practices to either undergo interventions aimed at boosting testing awareness or to serve as controls.
Results from both studies showed significant and substantial increases in serial testing for albuminuria in patients with diabetes or hypertension when practices received the interventions.
“We showed that [using a] clinical-decision support tool, along with standing orders to automatically collect urine specimens, dramatically increased screening for urinary albumin in primary care practices,” Dr. Litvin said. “However, perhaps because of conflicting guidelines and clinical inertia there hasn’t been a major impetus for primary care practices in general to improve screening.” She hopes that will quickly change.
“As we have shown, adoption of EHR-based reminders along with standing orders can very quickly improve screening for albuminuria in primary care.”
Variation in testing rates among sites ‘tremendous’
One finding of the new study gives Mr. Stempniewicz hope for greater future testing: The large variance that the researchers saw in albuminuria testing rates within individual health systems.
“The paper shows that higher rates of testing are completely achievable within each system. Some clinics do very well, and the other units can learn from these local successes,” he said. At least half the organizations in the study had individual sites that fell into the top 10% for testing rates across all the greater than 1,000 sites included, and those same organizations also had at least one site that fell into the bottom 10% for testing.
“The variation is tremendous, and highlights an opportunity for improvement,” declared Mr. Stempniewicz.
“For routine testing, you need systems that help people. Clinicians shouldn’t have to think about doing routine testing. It should just happen,” said Dr. Coresh.
The study was funded in part by Janssen. Mr. Stempniewicz and Dr. Litvin had no disclosures. Dr. Coresh is an adviser to Healthy.io, a company that markets a home albuminuria testing kit to patients. Dr. Vassalotti has received personal fees from Renalytix.
U.S. primary care physicians are not properly checking patients with type 2 diabetes for chronic kidney disease (CKD) nearly as often as they should, meaning many of these patients miss getting a timely diagnosis.
Inadequate measurement of urinary albumin-to-creatinine ratio (uACR) is the issue.
Review of data from more than half a million U.S. primary care patients with type 2 diabetes seen at any of 1,164 practice sites run by any of 24 health care organizations during 2016-2019 showed that barely more than half, 52%, had both their uACR and estimated glomerular filtration rate (eGFR) checked annually as recommended by several U.S. medical societies, and just 73% had both values checked during a 3-year period, Nikita Stempniewicz, MSc, and associates reported in Diabetes Care.
More detailed data showed that measurement of eGFR was reasonably robust, measured at a 90% rate annually and in 97% of patients at least once every 3 years. But recording uACR values lagged, with a 53% annual rate and a 74% rate of measurement at least once every 3 years, reported Mr. Stempniewicz, director of research and analytics for the American Medical Group Association, a trade association based in Alexandria, Va. The 24 health care organizations that supplied the study’s data are all members of this association.
Prevailing recommendations from various medical societies call for annual monitoring of urinary albumin in patients with type 2 diabetes and specify the uACR, such as in the Standards of Medical Care in Diabetes from the American Diabetes Association, as well as in recommendations promoted by the National Kidney Foundation.
Missing half the CKD patients with eGFR only
“Half the patients with type 2 diabetes and chronic kidney disease have elevated albuminuria without decreased eGFR and would not be detected with eGFR testing alone,” Mr. Stempniewicz noted in an interview.
“Many patients who present for nephrology care are incompletely assessed with only low eGFR but no urine testing. Missing albuminuria testing and uACR values means patients with high levels of albuminuria but normal kidney function go undetected and thus are not able to benefit from evidenced-based interventions, including nephrology services,” said Joseph A. Vassalotti, MD, a nephrologist, chief medical officer for the National Kidney Foundation, and a coauthor of the report.
Not testing patients with type 2 diabetes regularly for their uACR “is a missed opportunity to identify the highest-risk patients and treat them,” added Josef Coresh, MD, PhD, a professor of clinical epidemiology at Johns Hopkins University, Baltimore, and senior author on the study. Measurement of albuminuria is especially important for these patients because medications from the sodium-glucose cotransporter 2 inhibitor class have been proven to slow progression of CKD in patients with type 2 diabetes, but these drugs are expensive, and in some cases have labeling that specifies the presence of albuminuria.
“I have no doubt that improving albuminuria testing is a critical step to identify patients with diabetes at highest risk who should get the best treatment possible, including SGLT2 inhibitors,” Dr. Coresh said in an interview.
The new report is not the first to document inadequate assessment of albuminuria and uACR among primary care physicians (PCPs), but it came from the largest reported U.S. study to date. “eGFR is commonly collected in a routine laboratory blood panel, but collecting urine requires additional work flow,” noted Cara B. Litvin, MD, a general internal medicine researcher at the Medical University of South Carolina, Charleston, who has tested interventions aimed at boosting CKD assessment by PCPs and was not involved in the new study.
“There have also been conflicting guidelines,” such as a “now-inactive guideline from the American College of Physicians that recommended against routine urine albumin screening in patients with diabetes and already on treatment with an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker,” she said.
New renal drugs change the stakes
The availability of newer drugs for slowing CKD progression such as the SGLT2 inhibitors will help trigger greater support for routine albuminuria testing, Dr. Litvin predicted in an interview. “Now that we have more medications that can reduce albuminuria and improve outcomes, I see screening for albuminuria increasing.” Finerenone (Kerendia) is another new agent from a new class that recently received Food and Drug Administration approval for treating CKD in patients with type 2 diabetes.
Other drivers of increased uACR testing she expects include revised clinical practice guidelines, and new quality measures of clinical care.
“Undertesting of albuminuria means that [nephrologists] have incomplete data to detect and completely risk stratify the CKD population. That in turn results in a reduced ability to match population health interventions to the severity of the condition or the risk stratification based on eGFR and uACR,” Dr. Vassalotti said in an interview.
“We are missing opportunities to prevent or delay kidney failure and reduce the risk of cardiovascular events and cardiovascular death in these patients, particularly now that we have a number of medications that offer kidney and cardiovascular protection such as SGLT2 inhibitors,” he added. “Leaders in nephrology are beginning to understand the consequences of undertesting, and are working to innovate to improve risk stratification, CKD detection, and apply interventions to give Americans living with CKD better outcomes.”
Strategies proven to boost albuminuria testing
Mr. Stempniewicz and coauthors cited in their report potential strategies for improving albuminuria testing, including benchmarking to identify best-performing sites for albumin testing within a health system and encouraging replication of identified best practices at lower-performing sites, and implementation of clinical-decision support tools in the EHR such as pop-up test reminders.
These were among the tools tested in two studies led by Dr. Litvin. One study, with results reported in 2016, involved 12 small U.S. primary care practices with a total of more than 30,000 patients and compared performance in a series of clinical quality measures at baseline with performance after 2 years of receiving various interventions designed to boost awareness for albuminuria testing.
The second study, with findings reported in 2019, involved 21 U.S. primary care practices that collectively cared for more than 100,000 patients and randomized the practices to either undergo interventions aimed at boosting testing awareness or to serve as controls.
Results from both studies showed significant and substantial increases in serial testing for albuminuria in patients with diabetes or hypertension when practices received the interventions.
“We showed that [using a] clinical-decision support tool, along with standing orders to automatically collect urine specimens, dramatically increased screening for urinary albumin in primary care practices,” Dr. Litvin said. “However, perhaps because of conflicting guidelines and clinical inertia there hasn’t been a major impetus for primary care practices in general to improve screening.” She hopes that will quickly change.
“As we have shown, adoption of EHR-based reminders along with standing orders can very quickly improve screening for albuminuria in primary care.”
Variation in testing rates among sites ‘tremendous’
One finding of the new study gives Mr. Stempniewicz hope for greater future testing: The large variance that the researchers saw in albuminuria testing rates within individual health systems.
“The paper shows that higher rates of testing are completely achievable within each system. Some clinics do very well, and the other units can learn from these local successes,” he said. At least half the organizations in the study had individual sites that fell into the top 10% for testing rates across all the greater than 1,000 sites included, and those same organizations also had at least one site that fell into the bottom 10% for testing.
“The variation is tremendous, and highlights an opportunity for improvement,” declared Mr. Stempniewicz.
“For routine testing, you need systems that help people. Clinicians shouldn’t have to think about doing routine testing. It should just happen,” said Dr. Coresh.
The study was funded in part by Janssen. Mr. Stempniewicz and Dr. Litvin had no disclosures. Dr. Coresh is an adviser to Healthy.io, a company that markets a home albuminuria testing kit to patients. Dr. Vassalotti has received personal fees from Renalytix.
FROM DIABETES CARE
Pfizer vaccine protection wanes after 6 months, study finds
, according to a new study.
The July 28 preprint report of the study, which has not been peer reviewed, suggests a gradual “declining trend in vaccine efficacy” over 6 months after two doses of the Pfizer vaccine in more than 45,000 people worldwide.
The study finds overall effectiveness falls from 96% to 84%.
At the same time, a third booster dose of the Pfizer vaccine increases neutralizing antibody levels against the Delta variant by more than five times, compared to levels after just a second dose in people aged 18-55 years, new data from Pfizer shows.
The third-dose immune response appears even more robust – more than 11 times higher than the second shot – among people aged 65-85 years.
The company noted this could mean an estimated 100-fold increase in Delta variant protection after a third dose. These new findings are outlined in a Pfizer second-quarter 2021 earnings report, which notes that the data are submitted for publication in a medical journal.
The data come from a relatively small number of people studied. There were 11 people in the 18- to 55-year-old group and 12 people in the 65- to 85-year-old group.
“These preliminary data are very encouraging as Delta continues to spread,” Mikael Dolsten, MD, chief scientific officer and president of the Worldwide Research, Development, and Medical organization at Pfizer, said during prepared remarks on a company earnings call July 28, CNN reported.
Availability of a third dose of any of the current COVID-19 vaccines would require amendment of the Food and Drug Administration’s emergency use authorization, or full FDA approval for the vaccine.
The possibility of a third dose authorization or approval has not been without controversy. For example, when Pfizer announced intentions to file for FDA authorization of a booster dose on July 8, the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health were quick to issue a joint statement saying they would decide when the timing is right for Americans to have a third immunization. The agencies stated, in part, “We are prepared for booster doses if and when the science demonstrates that they are needed.”
In addition, the World Health Organization said at a media briefing on July 12 that rich countries should prioritize sharing of COVID-19 vaccine supplies to other countries in need worldwide before allocating doses for a booster shot for its own residents.
A version of this article first appeared on WebMD.com.
, according to a new study.
The July 28 preprint report of the study, which has not been peer reviewed, suggests a gradual “declining trend in vaccine efficacy” over 6 months after two doses of the Pfizer vaccine in more than 45,000 people worldwide.
The study finds overall effectiveness falls from 96% to 84%.
At the same time, a third booster dose of the Pfizer vaccine increases neutralizing antibody levels against the Delta variant by more than five times, compared to levels after just a second dose in people aged 18-55 years, new data from Pfizer shows.
The third-dose immune response appears even more robust – more than 11 times higher than the second shot – among people aged 65-85 years.
The company noted this could mean an estimated 100-fold increase in Delta variant protection after a third dose. These new findings are outlined in a Pfizer second-quarter 2021 earnings report, which notes that the data are submitted for publication in a medical journal.
The data come from a relatively small number of people studied. There were 11 people in the 18- to 55-year-old group and 12 people in the 65- to 85-year-old group.
“These preliminary data are very encouraging as Delta continues to spread,” Mikael Dolsten, MD, chief scientific officer and president of the Worldwide Research, Development, and Medical organization at Pfizer, said during prepared remarks on a company earnings call July 28, CNN reported.
Availability of a third dose of any of the current COVID-19 vaccines would require amendment of the Food and Drug Administration’s emergency use authorization, or full FDA approval for the vaccine.
The possibility of a third dose authorization or approval has not been without controversy. For example, when Pfizer announced intentions to file for FDA authorization of a booster dose on July 8, the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health were quick to issue a joint statement saying they would decide when the timing is right for Americans to have a third immunization. The agencies stated, in part, “We are prepared for booster doses if and when the science demonstrates that they are needed.”
In addition, the World Health Organization said at a media briefing on July 12 that rich countries should prioritize sharing of COVID-19 vaccine supplies to other countries in need worldwide before allocating doses for a booster shot for its own residents.
A version of this article first appeared on WebMD.com.
, according to a new study.
The July 28 preprint report of the study, which has not been peer reviewed, suggests a gradual “declining trend in vaccine efficacy” over 6 months after two doses of the Pfizer vaccine in more than 45,000 people worldwide.
The study finds overall effectiveness falls from 96% to 84%.
At the same time, a third booster dose of the Pfizer vaccine increases neutralizing antibody levels against the Delta variant by more than five times, compared to levels after just a second dose in people aged 18-55 years, new data from Pfizer shows.
The third-dose immune response appears even more robust – more than 11 times higher than the second shot – among people aged 65-85 years.
The company noted this could mean an estimated 100-fold increase in Delta variant protection after a third dose. These new findings are outlined in a Pfizer second-quarter 2021 earnings report, which notes that the data are submitted for publication in a medical journal.
The data come from a relatively small number of people studied. There were 11 people in the 18- to 55-year-old group and 12 people in the 65- to 85-year-old group.
“These preliminary data are very encouraging as Delta continues to spread,” Mikael Dolsten, MD, chief scientific officer and president of the Worldwide Research, Development, and Medical organization at Pfizer, said during prepared remarks on a company earnings call July 28, CNN reported.
Availability of a third dose of any of the current COVID-19 vaccines would require amendment of the Food and Drug Administration’s emergency use authorization, or full FDA approval for the vaccine.
The possibility of a third dose authorization or approval has not been without controversy. For example, when Pfizer announced intentions to file for FDA authorization of a booster dose on July 8, the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health were quick to issue a joint statement saying they would decide when the timing is right for Americans to have a third immunization. The agencies stated, in part, “We are prepared for booster doses if and when the science demonstrates that they are needed.”
In addition, the World Health Organization said at a media briefing on July 12 that rich countries should prioritize sharing of COVID-19 vaccine supplies to other countries in need worldwide before allocating doses for a booster shot for its own residents.
A version of this article first appeared on WebMD.com.
Leg rash
The appearance and location of this rash are classic signs for necrobiosis lipoidica, a chronic granulomatous skin disease commonly associated with diabetes. The patient’s initial hemoglobin A1c was 12.4%, confirming a diagnosis of type 2 diabetes, and a punch biopsy of the lesion demonstrated a broad zone of necrobiosis in the mid to lower dermis and a chronic inflammatory infiltrate, including plasma cells.
Necrobiosis lipoidica is rare, typically affects middle-aged adults, and is more common in women than in men.1 Although commonly associated with diabetes (hence the historical name necrobiosis lipoidica diabeticorum), a significant number of cases occur in patients without diabetes.2 The pathogenesis is not fully understood. The condition first appears as asymptomatic yellow to red-brown papules and plaques, most commonly on the anterior legs. The lesions then flatten over time, forming broad, yellow-pink patches and plaques.1,2
Generally, the diagnosis can be made clinically but, if uncertain, a punch biopsy is the preferred technique for confirmation. The differential diagnosis includes chronic cutaneous lupus erythematosus (LE), sarcoidosis, and dermatophytosis. Although the appearance of lesions associated with LE or sarcoidosis can vary, neither one manifests with the yellow coloring seen here. Dermatophytosis typically demonstrates scale and pruritus with an active border; viewing a potassium hydroxide preparation of a skin scraping is usually sufficient to make a diagnosis.
Treatment for necrobiosis lipoidica includes counseling patients to avoid trauma to the affected areas, high-potency topical corticosteroids, and photodynamic therapy.3 Often, lesions are permanent.
For this patient’s diabetes treatment, she was prescribed metformin and insulin glargine and counseled extensively on weight loss, regular exercise, and appropriate diet adjustments. The rash was treated topically with triamcinolone 0.1% cream bid. At her 4-month follow-up, the patient’s hemoglobin A1c value had dropped to 5.4%, and the rash had become less prominent and widespread. The patient was pleased with the cosmetic outcome and declined referral to a dermatologist for further treatment.
Photo and text courtesy of Samuel Dickmann, MD, and James Medley, MD, University of Florida College of Medicine, Gainesville.
1. Hashemi DA, Brown-Joel ZO, Tkachenko E, et al. Clinical features and comorbidities of patients with necrobiosis lipoidica with or without diabetes. JAMA Dermatol. 2019;155:455-459. doi: 10.1001/jamadermatol.2018.5635
2. O’Toole EA, Kennedy U, Nolan JJ, et al. Necrobiosis lipoidica: only a minority of patients have diabetes mellitus. Br J Dermatol. 1999;140:283-286. doi: 10.1046/j.1365-2133.1999.02663.x
3. Heidenheim M, Jemec GBE. Successful treatment of necrobiosis lipoidica diabeticorum with photodynamic therapy. Arch Dermatol. 2006;142:1548-1550. doi: 10.1001/archderm.142.12.1548
The appearance and location of this rash are classic signs for necrobiosis lipoidica, a chronic granulomatous skin disease commonly associated with diabetes. The patient’s initial hemoglobin A1c was 12.4%, confirming a diagnosis of type 2 diabetes, and a punch biopsy of the lesion demonstrated a broad zone of necrobiosis in the mid to lower dermis and a chronic inflammatory infiltrate, including plasma cells.
Necrobiosis lipoidica is rare, typically affects middle-aged adults, and is more common in women than in men.1 Although commonly associated with diabetes (hence the historical name necrobiosis lipoidica diabeticorum), a significant number of cases occur in patients without diabetes.2 The pathogenesis is not fully understood. The condition first appears as asymptomatic yellow to red-brown papules and plaques, most commonly on the anterior legs. The lesions then flatten over time, forming broad, yellow-pink patches and plaques.1,2
Generally, the diagnosis can be made clinically but, if uncertain, a punch biopsy is the preferred technique for confirmation. The differential diagnosis includes chronic cutaneous lupus erythematosus (LE), sarcoidosis, and dermatophytosis. Although the appearance of lesions associated with LE or sarcoidosis can vary, neither one manifests with the yellow coloring seen here. Dermatophytosis typically demonstrates scale and pruritus with an active border; viewing a potassium hydroxide preparation of a skin scraping is usually sufficient to make a diagnosis.
Treatment for necrobiosis lipoidica includes counseling patients to avoid trauma to the affected areas, high-potency topical corticosteroids, and photodynamic therapy.3 Often, lesions are permanent.
For this patient’s diabetes treatment, she was prescribed metformin and insulin glargine and counseled extensively on weight loss, regular exercise, and appropriate diet adjustments. The rash was treated topically with triamcinolone 0.1% cream bid. At her 4-month follow-up, the patient’s hemoglobin A1c value had dropped to 5.4%, and the rash had become less prominent and widespread. The patient was pleased with the cosmetic outcome and declined referral to a dermatologist for further treatment.
Photo and text courtesy of Samuel Dickmann, MD, and James Medley, MD, University of Florida College of Medicine, Gainesville.
The appearance and location of this rash are classic signs for necrobiosis lipoidica, a chronic granulomatous skin disease commonly associated with diabetes. The patient’s initial hemoglobin A1c was 12.4%, confirming a diagnosis of type 2 diabetes, and a punch biopsy of the lesion demonstrated a broad zone of necrobiosis in the mid to lower dermis and a chronic inflammatory infiltrate, including plasma cells.
Necrobiosis lipoidica is rare, typically affects middle-aged adults, and is more common in women than in men.1 Although commonly associated with diabetes (hence the historical name necrobiosis lipoidica diabeticorum), a significant number of cases occur in patients without diabetes.2 The pathogenesis is not fully understood. The condition first appears as asymptomatic yellow to red-brown papules and plaques, most commonly on the anterior legs. The lesions then flatten over time, forming broad, yellow-pink patches and plaques.1,2
Generally, the diagnosis can be made clinically but, if uncertain, a punch biopsy is the preferred technique for confirmation. The differential diagnosis includes chronic cutaneous lupus erythematosus (LE), sarcoidosis, and dermatophytosis. Although the appearance of lesions associated with LE or sarcoidosis can vary, neither one manifests with the yellow coloring seen here. Dermatophytosis typically demonstrates scale and pruritus with an active border; viewing a potassium hydroxide preparation of a skin scraping is usually sufficient to make a diagnosis.
Treatment for necrobiosis lipoidica includes counseling patients to avoid trauma to the affected areas, high-potency topical corticosteroids, and photodynamic therapy.3 Often, lesions are permanent.
For this patient’s diabetes treatment, she was prescribed metformin and insulin glargine and counseled extensively on weight loss, regular exercise, and appropriate diet adjustments. The rash was treated topically with triamcinolone 0.1% cream bid. At her 4-month follow-up, the patient’s hemoglobin A1c value had dropped to 5.4%, and the rash had become less prominent and widespread. The patient was pleased with the cosmetic outcome and declined referral to a dermatologist for further treatment.
Photo and text courtesy of Samuel Dickmann, MD, and James Medley, MD, University of Florida College of Medicine, Gainesville.
1. Hashemi DA, Brown-Joel ZO, Tkachenko E, et al. Clinical features and comorbidities of patients with necrobiosis lipoidica with or without diabetes. JAMA Dermatol. 2019;155:455-459. doi: 10.1001/jamadermatol.2018.5635
2. O’Toole EA, Kennedy U, Nolan JJ, et al. Necrobiosis lipoidica: only a minority of patients have diabetes mellitus. Br J Dermatol. 1999;140:283-286. doi: 10.1046/j.1365-2133.1999.02663.x
3. Heidenheim M, Jemec GBE. Successful treatment of necrobiosis lipoidica diabeticorum with photodynamic therapy. Arch Dermatol. 2006;142:1548-1550. doi: 10.1001/archderm.142.12.1548
1. Hashemi DA, Brown-Joel ZO, Tkachenko E, et al. Clinical features and comorbidities of patients with necrobiosis lipoidica with or without diabetes. JAMA Dermatol. 2019;155:455-459. doi: 10.1001/jamadermatol.2018.5635
2. O’Toole EA, Kennedy U, Nolan JJ, et al. Necrobiosis lipoidica: only a minority of patients have diabetes mellitus. Br J Dermatol. 1999;140:283-286. doi: 10.1046/j.1365-2133.1999.02663.x
3. Heidenheim M, Jemec GBE. Successful treatment of necrobiosis lipoidica diabeticorum with photodynamic therapy. Arch Dermatol. 2006;142:1548-1550. doi: 10.1001/archderm.142.12.1548
