Mediterranean diet slows progression of atherosclerosis in CHD

Article Type
Changed
Tue, 05/03/2022 - 15:04

For patients with coronary heart disease (CHD), following a Mediterranean diet is more effective in reducing progression of atherosclerosis than following a low-fat diet, according to new data from the CORDIOPREV randomized, controlled trial.

Mediterranean style food: Fish, vegetables, herbs, chickpeas, olives, and cheese
OksanaKiian/Getty Images

“The current study is, to our knowledge, the first to establish an effective dietary strategy for secondary cardiovascular prevention, reinforcing the fact that the Mediterranean diet rich in extra virgin olive oil (EVOO) could prevent the progression of atherosclerosis,” the study team said.

The data also show that patients with a higher atherosclerotic burden might benefit the most from the Mediterranean diet.

The study was published online Aug. 10, 2021, in Stroke.
 

Mediterranean or low fat?

“It is well established that lifestyle and dietary habits powerfully affect cardiovascular risk,” study investigator Elena M. Yubero-Serrano, PhD, with Reina Sofia University Hospital/University of Cordoba (Spain), told this news organization.

“The effectiveness of the Mediterranean diet in reducing cardiovascular risk has been seen in primary prevention. However, currently there is no consensus about a recommended dietary model for the secondary prevention of cardiovascular disease,” she said.

The Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention (CORDIOPREV) study is an ongoing prospective study comparing the effects of two healthy diets for secondary prevention of cardiovascular disease (CVD) in 1002 patients.

The comparative effect of the diets in reducing CVD risk, assessed by quantification of intima-media thickness of the common carotid arteries (IMT-CC), is a key secondary endpoint of the study.

During the study, half of the patients follow a Mediterranean diet rich in EVOO, fruit and vegetables, whole grains, fish, and nuts. The other half follow a diet low in fat and rich in complex carbohydrates.

A total of 939 participants (459 in the low-fat diet group and 480 in the Mediterranean diet group) completed IMT-CC evaluation at baseline, and 809 (377 and 432, respectively) completed the IMT-CC evaluation at 5 years; 731 (335 and 396, respectively) did so at 7 years.

The Mediterranean diet significantly decreased IMT-CC both after 5 years (–0.027; P < .001) and after 7 years (–0.031 mm; P < .001), relative to baseline. In contrast, the low-fat diet did not exert any change on IMT-CC after 5 or 7 years, the researchers report.

The higher the IMT-CC at baseline, the greater the reduction in this parameter.

The Mediterranean diet also produced a greater decrease in IMT-CC and carotid plaque maximum height, compared with the low-fat diet throughout follow-up.

There were no between-group differences in carotid plaque numbers during follow-up.

“Our findings, in addition to reinforcing the clinical benefits of the Mediterranean diet, provide a beneficial dietary strategy as a clinical and therapeutic tool that could reduce the high cardiovascular recurrence in the context of secondary prevention,” Dr. Yubero-Serrano said in an interview.

Earlier data from CORDIOPREV showed that, after 1 year of eating a Mediterranean diet, compared with the low-fat diet, endothelial function was improved among patients with CHD, even those with type 2 diabetes, which was associated with a better balance of vascular homeostasis.

The Mediterranean diet may also modulate the lipid profile, particularly by increasing HDL cholesterol levels. The anti-inflammatory capacity of the Mediterranean diet could be another factor that contributes to reducing the progression of atherosclerosis, the researchers say.
 

Important study

Reached for comment, Alan Rozanski, MD, professor of medicine, Icahn School of Medicine at Mount Sinai and cardiologist at Mount Sinai Morningside, New York, said: “We know very well that lifestyle factors, diet, and exercise in particular are extremely important in promoting health, vitality, and decreasing risk for chronic diseases, including heart attack and stroke.

“But a lot of the studies depend on epidemiological work. Until now, we haven’t had important prospective studies evaluating different kinds of dietary approaches and how they affect carotid intimal thickening assessments that we can do by ultrasound. So having this kind of imaging study which shows that diet can halt progression of atherosclerosis is important,” said Dr. Rozanski.

“Changing one’s diet is extremely important and potentially beneficial in many ways, and being able to say to a patient with atherosclerosis that we have data that shows you can halt the progression of the disease can be extraordinarily encouraging to many patients,” he noted.

“When people have disease, they very often gravitate toward drugs, but continuing to emphasize lifestyle changes in these people is extremely important,” he added.

The CORDIOPREV study was supported by the Fundación Patrimonio Comunal Olivarero. Dr. Yubero-Serrano and Dr. Rozanski disclosed no relevant financial relationships.

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

Publications
Topics
Sections

For patients with coronary heart disease (CHD), following a Mediterranean diet is more effective in reducing progression of atherosclerosis than following a low-fat diet, according to new data from the CORDIOPREV randomized, controlled trial.

Mediterranean style food: Fish, vegetables, herbs, chickpeas, olives, and cheese
OksanaKiian/Getty Images

“The current study is, to our knowledge, the first to establish an effective dietary strategy for secondary cardiovascular prevention, reinforcing the fact that the Mediterranean diet rich in extra virgin olive oil (EVOO) could prevent the progression of atherosclerosis,” the study team said.

The data also show that patients with a higher atherosclerotic burden might benefit the most from the Mediterranean diet.

The study was published online Aug. 10, 2021, in Stroke.
 

Mediterranean or low fat?

“It is well established that lifestyle and dietary habits powerfully affect cardiovascular risk,” study investigator Elena M. Yubero-Serrano, PhD, with Reina Sofia University Hospital/University of Cordoba (Spain), told this news organization.

“The effectiveness of the Mediterranean diet in reducing cardiovascular risk has been seen in primary prevention. However, currently there is no consensus about a recommended dietary model for the secondary prevention of cardiovascular disease,” she said.

The Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention (CORDIOPREV) study is an ongoing prospective study comparing the effects of two healthy diets for secondary prevention of cardiovascular disease (CVD) in 1002 patients.

The comparative effect of the diets in reducing CVD risk, assessed by quantification of intima-media thickness of the common carotid arteries (IMT-CC), is a key secondary endpoint of the study.

During the study, half of the patients follow a Mediterranean diet rich in EVOO, fruit and vegetables, whole grains, fish, and nuts. The other half follow a diet low in fat and rich in complex carbohydrates.

A total of 939 participants (459 in the low-fat diet group and 480 in the Mediterranean diet group) completed IMT-CC evaluation at baseline, and 809 (377 and 432, respectively) completed the IMT-CC evaluation at 5 years; 731 (335 and 396, respectively) did so at 7 years.

The Mediterranean diet significantly decreased IMT-CC both after 5 years (–0.027; P < .001) and after 7 years (–0.031 mm; P < .001), relative to baseline. In contrast, the low-fat diet did not exert any change on IMT-CC after 5 or 7 years, the researchers report.

The higher the IMT-CC at baseline, the greater the reduction in this parameter.

The Mediterranean diet also produced a greater decrease in IMT-CC and carotid plaque maximum height, compared with the low-fat diet throughout follow-up.

There were no between-group differences in carotid plaque numbers during follow-up.

“Our findings, in addition to reinforcing the clinical benefits of the Mediterranean diet, provide a beneficial dietary strategy as a clinical and therapeutic tool that could reduce the high cardiovascular recurrence in the context of secondary prevention,” Dr. Yubero-Serrano said in an interview.

Earlier data from CORDIOPREV showed that, after 1 year of eating a Mediterranean diet, compared with the low-fat diet, endothelial function was improved among patients with CHD, even those with type 2 diabetes, which was associated with a better balance of vascular homeostasis.

The Mediterranean diet may also modulate the lipid profile, particularly by increasing HDL cholesterol levels. The anti-inflammatory capacity of the Mediterranean diet could be another factor that contributes to reducing the progression of atherosclerosis, the researchers say.
 

Important study

Reached for comment, Alan Rozanski, MD, professor of medicine, Icahn School of Medicine at Mount Sinai and cardiologist at Mount Sinai Morningside, New York, said: “We know very well that lifestyle factors, diet, and exercise in particular are extremely important in promoting health, vitality, and decreasing risk for chronic diseases, including heart attack and stroke.

“But a lot of the studies depend on epidemiological work. Until now, we haven’t had important prospective studies evaluating different kinds of dietary approaches and how they affect carotid intimal thickening assessments that we can do by ultrasound. So having this kind of imaging study which shows that diet can halt progression of atherosclerosis is important,” said Dr. Rozanski.

“Changing one’s diet is extremely important and potentially beneficial in many ways, and being able to say to a patient with atherosclerosis that we have data that shows you can halt the progression of the disease can be extraordinarily encouraging to many patients,” he noted.

“When people have disease, they very often gravitate toward drugs, but continuing to emphasize lifestyle changes in these people is extremely important,” he added.

The CORDIOPREV study was supported by the Fundación Patrimonio Comunal Olivarero. Dr. Yubero-Serrano and Dr. Rozanski disclosed no relevant financial relationships.

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

For patients with coronary heart disease (CHD), following a Mediterranean diet is more effective in reducing progression of atherosclerosis than following a low-fat diet, according to new data from the CORDIOPREV randomized, controlled trial.

Mediterranean style food: Fish, vegetables, herbs, chickpeas, olives, and cheese
OksanaKiian/Getty Images

“The current study is, to our knowledge, the first to establish an effective dietary strategy for secondary cardiovascular prevention, reinforcing the fact that the Mediterranean diet rich in extra virgin olive oil (EVOO) could prevent the progression of atherosclerosis,” the study team said.

The data also show that patients with a higher atherosclerotic burden might benefit the most from the Mediterranean diet.

The study was published online Aug. 10, 2021, in Stroke.
 

Mediterranean or low fat?

“It is well established that lifestyle and dietary habits powerfully affect cardiovascular risk,” study investigator Elena M. Yubero-Serrano, PhD, with Reina Sofia University Hospital/University of Cordoba (Spain), told this news organization.

“The effectiveness of the Mediterranean diet in reducing cardiovascular risk has been seen in primary prevention. However, currently there is no consensus about a recommended dietary model for the secondary prevention of cardiovascular disease,” she said.

The Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention (CORDIOPREV) study is an ongoing prospective study comparing the effects of two healthy diets for secondary prevention of cardiovascular disease (CVD) in 1002 patients.

The comparative effect of the diets in reducing CVD risk, assessed by quantification of intima-media thickness of the common carotid arteries (IMT-CC), is a key secondary endpoint of the study.

During the study, half of the patients follow a Mediterranean diet rich in EVOO, fruit and vegetables, whole grains, fish, and nuts. The other half follow a diet low in fat and rich in complex carbohydrates.

A total of 939 participants (459 in the low-fat diet group and 480 in the Mediterranean diet group) completed IMT-CC evaluation at baseline, and 809 (377 and 432, respectively) completed the IMT-CC evaluation at 5 years; 731 (335 and 396, respectively) did so at 7 years.

The Mediterranean diet significantly decreased IMT-CC both after 5 years (–0.027; P < .001) and after 7 years (–0.031 mm; P < .001), relative to baseline. In contrast, the low-fat diet did not exert any change on IMT-CC after 5 or 7 years, the researchers report.

The higher the IMT-CC at baseline, the greater the reduction in this parameter.

The Mediterranean diet also produced a greater decrease in IMT-CC and carotid plaque maximum height, compared with the low-fat diet throughout follow-up.

There were no between-group differences in carotid plaque numbers during follow-up.

“Our findings, in addition to reinforcing the clinical benefits of the Mediterranean diet, provide a beneficial dietary strategy as a clinical and therapeutic tool that could reduce the high cardiovascular recurrence in the context of secondary prevention,” Dr. Yubero-Serrano said in an interview.

Earlier data from CORDIOPREV showed that, after 1 year of eating a Mediterranean diet, compared with the low-fat diet, endothelial function was improved among patients with CHD, even those with type 2 diabetes, which was associated with a better balance of vascular homeostasis.

The Mediterranean diet may also modulate the lipid profile, particularly by increasing HDL cholesterol levels. The anti-inflammatory capacity of the Mediterranean diet could be another factor that contributes to reducing the progression of atherosclerosis, the researchers say.
 

Important study

Reached for comment, Alan Rozanski, MD, professor of medicine, Icahn School of Medicine at Mount Sinai and cardiologist at Mount Sinai Morningside, New York, said: “We know very well that lifestyle factors, diet, and exercise in particular are extremely important in promoting health, vitality, and decreasing risk for chronic diseases, including heart attack and stroke.

“But a lot of the studies depend on epidemiological work. Until now, we haven’t had important prospective studies evaluating different kinds of dietary approaches and how they affect carotid intimal thickening assessments that we can do by ultrasound. So having this kind of imaging study which shows that diet can halt progression of atherosclerosis is important,” said Dr. Rozanski.

“Changing one’s diet is extremely important and potentially beneficial in many ways, and being able to say to a patient with atherosclerosis that we have data that shows you can halt the progression of the disease can be extraordinarily encouraging to many patients,” he noted.

“When people have disease, they very often gravitate toward drugs, but continuing to emphasize lifestyle changes in these people is extremely important,” he added.

The CORDIOPREV study was supported by the Fundación Patrimonio Comunal Olivarero. Dr. Yubero-Serrano and Dr. Rozanski disclosed no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Psychiatrists’ income, wealth gain ground despite COVID-19 challenges

Article Type
Changed
Thu, 08/26/2021 - 15:43

Although many physicians endured pandemic-related income struggles in 2020, psychiatrists are doing fairly well with building their nest egg and paying down debt, according to the Medscape Psychiatrist Wealth and Debt Report 2021.

A plant grows out of a jar of coins
RomoloTavani/ThinkStock

Surprisingly, despite COVID-19, psychiatrists’ income improved somewhat this year – from $268,000 in 2020 to $275,000 in 2021.

However, that still puts psychiatrists among the lower-paid specialists.

The highest-paying specialty is plastic surgery ($526,000), followed by orthopedics and orthopedic surgery ($511,000) and cardiology ($459,000), according to the overall Medscape Physician Wealth and Debt Report 2021. The report is based on responses from nearly 18,000 physicians in 29 specialties. All were surveyed between Oct. 6, 2020, and Feb. 11, 2021.

Psychiatrists’ overall wealth gained some ground over the past year, with 40% reporting a net worth of $1 million to $5 million this year – up from 38% last year. Just 6% of psychiatrists have a net worth north of $5 million, up slightly from 5% last year.
 

Keeping up with bills

“The rise in home prices is certainly a factor,” said Joel Greenwald, MD, CFP, a wealth management advisor for physicians based in St. Louis Park, Minn. He noted that the rise in the stock market also played a role, with the S&P 500 finishing the year up over 18%.

Dr. Joel Greenwald

“I’ve seen clients accumulate cash, which has added to their net worth. They cut back on spending because they were worried about big declines in income and also because there was simply less to spend money on,” Dr. Greenwald said.

The percentage of psychiatrists with a net worth under $500,000 decreased from 37% last year to 32% this year. Psychiatry is still among the specialties reporting a high percentage of members with net worth below $500,000.

But gender matters. Earnings overall are higher for male than female psychiatrists, and that is reflected in net worth. Fewer female than male psychiatrists are worth more than $5 million (4% vs. 7%), and more female psychiatrists have a net worth of less than $500,000 (41% vs. 26%).

As in prior years, most psychiatrists are paying down a home mortgage on their primary residence (66%). Psychiatrists’ mortgage payments span a wide range, from less than $100,000 (23%) to more than $500,000 (15%). However, 27% report having no mortgage.

Mortgage aside, other top expenses or debts for psychiatrists are car loan payments (36%), paying off college and medical school debt (26%), credit card debt (25%), and medical expenses for self or loved ones (19%).

Other expenses include college tuition for children (16%), car lease payments (14%), mortgage on a second home (13%), private-school tuition for a child (12%), and child care (12%).

Despite some financially challenging months, the vast majority of psychiatrists (94%) kept up with paying their bills.

That’s better than what much of America experienced. According to a U.S. Census Bureau survey conducted last July, roughly 25% of adults missed a mortgage or rent payment because of COVID-related difficulties.

About half of psychiatrists pool their income to pay for bills. One-quarter do not have joint accounts with a spouse or partner.
 

 

 

Spender or saver?

About three-quarters of psychiatrists continued to spend as usual in 2020. About one-quarter took significant steps to lower their expenses, such as refinancing their home or moving to a less costly home.

In line with prior Medscape surveys, about half of psychiatrists have a general idea of how much they spend and on what, but they do not track or formalize it.

According to a recent survey by Intuit, only 35% of Americans say they know how much they spent last month. Viewed by age, 27% of millennials, 34% of Gen Xers, and 46% of baby boomers knew how much they spent.

Many psychiatrists have a higher-than-average number of credit cards; 42% have at least five. By comparison, the average American has four.

Savings was mixed for psychiatrists this past year; 61% put in the same amount or more each month into their 401(k) plans, but 33% put in less money, compared with last year.

For taxable savings accounts, half of psychiatrists put the same amount or more into after-tax accounts – but 22% put in less money, compared with last year. Another one-quarter did not use these savings accounts at all.

The percentage of psychiatrists who experienced losses because of practice problems rose from 6% to 9% in the past year. Much of that was likely because of COVID. However, about the same percentage reported no financial losses this year (76%), compared with last year (75%).

The vast majority of psychiatrists report living within or below their means; only 5% live above their means.

“There are certainly folks who believe that, as long as they pay off their credit card each month and contribute to their 401(k) enough to get their employer match, they’re doing okay,” Dr. Greenwald said.

However, “living within one’s means is having a 3-6 months’ emergency fund; saving at least 20% of gross income toward retirement; adequately funding 529 college accounts; and, for younger docs, paying down high-interest-rate debt at a good clip,” he added.

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

Publications
Topics
Sections

Although many physicians endured pandemic-related income struggles in 2020, psychiatrists are doing fairly well with building their nest egg and paying down debt, according to the Medscape Psychiatrist Wealth and Debt Report 2021.

A plant grows out of a jar of coins
RomoloTavani/ThinkStock

Surprisingly, despite COVID-19, psychiatrists’ income improved somewhat this year – from $268,000 in 2020 to $275,000 in 2021.

However, that still puts psychiatrists among the lower-paid specialists.

The highest-paying specialty is plastic surgery ($526,000), followed by orthopedics and orthopedic surgery ($511,000) and cardiology ($459,000), according to the overall Medscape Physician Wealth and Debt Report 2021. The report is based on responses from nearly 18,000 physicians in 29 specialties. All were surveyed between Oct. 6, 2020, and Feb. 11, 2021.

Psychiatrists’ overall wealth gained some ground over the past year, with 40% reporting a net worth of $1 million to $5 million this year – up from 38% last year. Just 6% of psychiatrists have a net worth north of $5 million, up slightly from 5% last year.
 

Keeping up with bills

“The rise in home prices is certainly a factor,” said Joel Greenwald, MD, CFP, a wealth management advisor for physicians based in St. Louis Park, Minn. He noted that the rise in the stock market also played a role, with the S&P 500 finishing the year up over 18%.

Dr. Joel Greenwald

“I’ve seen clients accumulate cash, which has added to their net worth. They cut back on spending because they were worried about big declines in income and also because there was simply less to spend money on,” Dr. Greenwald said.

The percentage of psychiatrists with a net worth under $500,000 decreased from 37% last year to 32% this year. Psychiatry is still among the specialties reporting a high percentage of members with net worth below $500,000.

But gender matters. Earnings overall are higher for male than female psychiatrists, and that is reflected in net worth. Fewer female than male psychiatrists are worth more than $5 million (4% vs. 7%), and more female psychiatrists have a net worth of less than $500,000 (41% vs. 26%).

As in prior years, most psychiatrists are paying down a home mortgage on their primary residence (66%). Psychiatrists’ mortgage payments span a wide range, from less than $100,000 (23%) to more than $500,000 (15%). However, 27% report having no mortgage.

Mortgage aside, other top expenses or debts for psychiatrists are car loan payments (36%), paying off college and medical school debt (26%), credit card debt (25%), and medical expenses for self or loved ones (19%).

Other expenses include college tuition for children (16%), car lease payments (14%), mortgage on a second home (13%), private-school tuition for a child (12%), and child care (12%).

Despite some financially challenging months, the vast majority of psychiatrists (94%) kept up with paying their bills.

That’s better than what much of America experienced. According to a U.S. Census Bureau survey conducted last July, roughly 25% of adults missed a mortgage or rent payment because of COVID-related difficulties.

About half of psychiatrists pool their income to pay for bills. One-quarter do not have joint accounts with a spouse or partner.
 

 

 

Spender or saver?

About three-quarters of psychiatrists continued to spend as usual in 2020. About one-quarter took significant steps to lower their expenses, such as refinancing their home or moving to a less costly home.

In line with prior Medscape surveys, about half of psychiatrists have a general idea of how much they spend and on what, but they do not track or formalize it.

According to a recent survey by Intuit, only 35% of Americans say they know how much they spent last month. Viewed by age, 27% of millennials, 34% of Gen Xers, and 46% of baby boomers knew how much they spent.

Many psychiatrists have a higher-than-average number of credit cards; 42% have at least five. By comparison, the average American has four.

Savings was mixed for psychiatrists this past year; 61% put in the same amount or more each month into their 401(k) plans, but 33% put in less money, compared with last year.

For taxable savings accounts, half of psychiatrists put the same amount or more into after-tax accounts – but 22% put in less money, compared with last year. Another one-quarter did not use these savings accounts at all.

The percentage of psychiatrists who experienced losses because of practice problems rose from 6% to 9% in the past year. Much of that was likely because of COVID. However, about the same percentage reported no financial losses this year (76%), compared with last year (75%).

The vast majority of psychiatrists report living within or below their means; only 5% live above their means.

“There are certainly folks who believe that, as long as they pay off their credit card each month and contribute to their 401(k) enough to get their employer match, they’re doing okay,” Dr. Greenwald said.

However, “living within one’s means is having a 3-6 months’ emergency fund; saving at least 20% of gross income toward retirement; adequately funding 529 college accounts; and, for younger docs, paying down high-interest-rate debt at a good clip,” he added.

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

Although many physicians endured pandemic-related income struggles in 2020, psychiatrists are doing fairly well with building their nest egg and paying down debt, according to the Medscape Psychiatrist Wealth and Debt Report 2021.

A plant grows out of a jar of coins
RomoloTavani/ThinkStock

Surprisingly, despite COVID-19, psychiatrists’ income improved somewhat this year – from $268,000 in 2020 to $275,000 in 2021.

However, that still puts psychiatrists among the lower-paid specialists.

The highest-paying specialty is plastic surgery ($526,000), followed by orthopedics and orthopedic surgery ($511,000) and cardiology ($459,000), according to the overall Medscape Physician Wealth and Debt Report 2021. The report is based on responses from nearly 18,000 physicians in 29 specialties. All were surveyed between Oct. 6, 2020, and Feb. 11, 2021.

Psychiatrists’ overall wealth gained some ground over the past year, with 40% reporting a net worth of $1 million to $5 million this year – up from 38% last year. Just 6% of psychiatrists have a net worth north of $5 million, up slightly from 5% last year.
 

Keeping up with bills

“The rise in home prices is certainly a factor,” said Joel Greenwald, MD, CFP, a wealth management advisor for physicians based in St. Louis Park, Minn. He noted that the rise in the stock market also played a role, with the S&P 500 finishing the year up over 18%.

Dr. Joel Greenwald

“I’ve seen clients accumulate cash, which has added to their net worth. They cut back on spending because they were worried about big declines in income and also because there was simply less to spend money on,” Dr. Greenwald said.

The percentage of psychiatrists with a net worth under $500,000 decreased from 37% last year to 32% this year. Psychiatry is still among the specialties reporting a high percentage of members with net worth below $500,000.

But gender matters. Earnings overall are higher for male than female psychiatrists, and that is reflected in net worth. Fewer female than male psychiatrists are worth more than $5 million (4% vs. 7%), and more female psychiatrists have a net worth of less than $500,000 (41% vs. 26%).

As in prior years, most psychiatrists are paying down a home mortgage on their primary residence (66%). Psychiatrists’ mortgage payments span a wide range, from less than $100,000 (23%) to more than $500,000 (15%). However, 27% report having no mortgage.

Mortgage aside, other top expenses or debts for psychiatrists are car loan payments (36%), paying off college and medical school debt (26%), credit card debt (25%), and medical expenses for self or loved ones (19%).

Other expenses include college tuition for children (16%), car lease payments (14%), mortgage on a second home (13%), private-school tuition for a child (12%), and child care (12%).

Despite some financially challenging months, the vast majority of psychiatrists (94%) kept up with paying their bills.

That’s better than what much of America experienced. According to a U.S. Census Bureau survey conducted last July, roughly 25% of adults missed a mortgage or rent payment because of COVID-related difficulties.

About half of psychiatrists pool their income to pay for bills. One-quarter do not have joint accounts with a spouse or partner.
 

 

 

Spender or saver?

About three-quarters of psychiatrists continued to spend as usual in 2020. About one-quarter took significant steps to lower their expenses, such as refinancing their home or moving to a less costly home.

In line with prior Medscape surveys, about half of psychiatrists have a general idea of how much they spend and on what, but they do not track or formalize it.

According to a recent survey by Intuit, only 35% of Americans say they know how much they spent last month. Viewed by age, 27% of millennials, 34% of Gen Xers, and 46% of baby boomers knew how much they spent.

Many psychiatrists have a higher-than-average number of credit cards; 42% have at least five. By comparison, the average American has four.

Savings was mixed for psychiatrists this past year; 61% put in the same amount or more each month into their 401(k) plans, but 33% put in less money, compared with last year.

For taxable savings accounts, half of psychiatrists put the same amount or more into after-tax accounts – but 22% put in less money, compared with last year. Another one-quarter did not use these savings accounts at all.

The percentage of psychiatrists who experienced losses because of practice problems rose from 6% to 9% in the past year. Much of that was likely because of COVID. However, about the same percentage reported no financial losses this year (76%), compared with last year (75%).

The vast majority of psychiatrists report living within or below their means; only 5% live above their means.

“There are certainly folks who believe that, as long as they pay off their credit card each month and contribute to their 401(k) enough to get their employer match, they’re doing okay,” Dr. Greenwald said.

However, “living within one’s means is having a 3-6 months’ emergency fund; saving at least 20% of gross income toward retirement; adequately funding 529 college accounts; and, for younger docs, paying down high-interest-rate debt at a good clip,” he added.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

‘No justification’ for suicide warning on all antiseizure meds

Article Type
Changed
Thu, 12/15/2022 - 15:40

There is currently no evidence that newer antiseizure medications increase the risk for suicide among patients with epilepsy, new research shows. “There appears to be no justification for the FDA to label every new antiseizure medication with a warning that it may increase risk of suicidality,” said study investigator Michael R. Sperling, MD, professor of neurology, Thomas Jefferson University, Philadelphia.

“How many patients are afraid of their medication and do not take it because of the warning – and are consequently at risk because of that? We do not know, but have anecdotal experience that this is certainly an issue,” Dr. Sperling, who is director of the Jefferson Comprehensive Epilepsy Center, added.

The study was published online August 2 in JAMA Neurology.
 

Blanket warning

In 2008, the FDA issued an alert stating that antiseizure medications increase suicidality. The alert was based on pooled data from placebo-controlled clinical trials that included 11 antiseizure medications – carbamazepinefelbamategabapentinlamotriginelevetiracetamoxcarbazepinepregabalintiagabinetopiramate, valproate, and zonisamide.

The meta-analytic review showed that, compared with placebo, antiseizure medications nearly doubled suicide risk among patients treated for epilepsy, psychiatric disorders, and other diseases. As a result of the FDA study, all antiseizure medications that have been approved since 2008 carry a warning for suicidality.

However, subsequent analyses did not show the same results, Dr. Sperling and colleagues noted.

“Pivotal” antiseizure medication epilepsy trials since 2008 have evaluated suicidality prospectively. Since 2011, trials have included the validated Columbia Suicidality Severity Rating Scale, they noted.
 

Meta analysis showed no increased risk

Dr. Sperling and colleagues conducted a meta-analysis of 17 randomized placebo-controlled epilepsy trials of five antiseizure medications approved since 2008. These antiseizure medications were eslicarbazepine, perampanelbrivaracetamcannabidiol, and cenobamate. The trials involved 5,996 patients, including 4,000 who were treated with antiseizure medications and 1,996 who were treated with placebo.

Confining the analysis to epilepsy trials avoids potential confounders, such as possible differences in suicidality risks between different diseases, the researchers noted.

They found no evidence of increased risk for suicidal ideation (overall risk ratio, antiseizure medications vs. placebo: 0.75; 95% confidence interval: 0.35-1.60) or suicide attempt (risk ratio, 0.75; 95% CI: 0.30-1.87) overall or for any individual antiseizure medication.

Suicidal ideation occurred in 12 of 4,000 patients treated with antiseizure medications (0.30%), versus 7 of 1,996 patients treated with placebo (0.35%) (P = .74). Three patients who were treated with antiseizure medications attempted suicide; no patients who were treated with placebo attempted suicide (P = .22). There were no completed suicides.

“There is no current evidence that the five antiseizure medications evaluated in this study increase suicidality in epilepsy and merit a suicidality class warning,” the investigators wrote. When prescribed for epilepsy, “evidence does not support the FDA’s labeling practice of a blanket assumption of increased suicidality,” said Dr. Sperling.

“Our findings indicate the nonspecific suicide warning for all epilepsy drugs is simply not justifiable,” he said. “The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to expect that every drug would increase suicide risk for every patient,” Dr. Sperling said in a statement.

“It’s important to recognize that epilepsy has many causes – perinatal injury, stroke, tumor, head trauma, developmental malformations, genetic causes, and others – and these underlying etiologies may well contribute to the presence of depression and suicidality in this population,” he said in an interview. “Psychodynamic influences also may occur as a consequence of having seizures. This is a complicated area, and drugs are simply one piece of the puzzle,” he added.

Dr. Sperling said the FDA has accomplished “one useful thing with its warning – it highlighted that physicians and other health care providers must pay attention to their patients’ psychological state, ask questions, and treat accordingly.”

The study had no specific funding. Dr. Sperling has received grants from Eisai, Medtronic, Neurelis, SK Life Science, Sunovion, Takeda, Xenon, Cerevel Therapeutics, UCB Pharma, and Engage Pharma; personal fees from Neurelis, Medscape, Neurology Live, International Medical Press, UCB Pharma, Eisai, Oxford University Press, and Projects in Knowledge. He has also consulted for Medtronic outside the submitted work; payments went to Thomas Jefferson University. A complete list of authors’ disclosures is available with the original article.

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

Issue
Neurology Reviews- 29(9)
Publications
Topics
Sections

There is currently no evidence that newer antiseizure medications increase the risk for suicide among patients with epilepsy, new research shows. “There appears to be no justification for the FDA to label every new antiseizure medication with a warning that it may increase risk of suicidality,” said study investigator Michael R. Sperling, MD, professor of neurology, Thomas Jefferson University, Philadelphia.

“How many patients are afraid of their medication and do not take it because of the warning – and are consequently at risk because of that? We do not know, but have anecdotal experience that this is certainly an issue,” Dr. Sperling, who is director of the Jefferson Comprehensive Epilepsy Center, added.

The study was published online August 2 in JAMA Neurology.
 

Blanket warning

In 2008, the FDA issued an alert stating that antiseizure medications increase suicidality. The alert was based on pooled data from placebo-controlled clinical trials that included 11 antiseizure medications – carbamazepinefelbamategabapentinlamotriginelevetiracetamoxcarbazepinepregabalintiagabinetopiramate, valproate, and zonisamide.

The meta-analytic review showed that, compared with placebo, antiseizure medications nearly doubled suicide risk among patients treated for epilepsy, psychiatric disorders, and other diseases. As a result of the FDA study, all antiseizure medications that have been approved since 2008 carry a warning for suicidality.

However, subsequent analyses did not show the same results, Dr. Sperling and colleagues noted.

“Pivotal” antiseizure medication epilepsy trials since 2008 have evaluated suicidality prospectively. Since 2011, trials have included the validated Columbia Suicidality Severity Rating Scale, they noted.
 

Meta analysis showed no increased risk

Dr. Sperling and colleagues conducted a meta-analysis of 17 randomized placebo-controlled epilepsy trials of five antiseizure medications approved since 2008. These antiseizure medications were eslicarbazepine, perampanelbrivaracetamcannabidiol, and cenobamate. The trials involved 5,996 patients, including 4,000 who were treated with antiseizure medications and 1,996 who were treated with placebo.

Confining the analysis to epilepsy trials avoids potential confounders, such as possible differences in suicidality risks between different diseases, the researchers noted.

They found no evidence of increased risk for suicidal ideation (overall risk ratio, antiseizure medications vs. placebo: 0.75; 95% confidence interval: 0.35-1.60) or suicide attempt (risk ratio, 0.75; 95% CI: 0.30-1.87) overall or for any individual antiseizure medication.

Suicidal ideation occurred in 12 of 4,000 patients treated with antiseizure medications (0.30%), versus 7 of 1,996 patients treated with placebo (0.35%) (P = .74). Three patients who were treated with antiseizure medications attempted suicide; no patients who were treated with placebo attempted suicide (P = .22). There were no completed suicides.

“There is no current evidence that the five antiseizure medications evaluated in this study increase suicidality in epilepsy and merit a suicidality class warning,” the investigators wrote. When prescribed for epilepsy, “evidence does not support the FDA’s labeling practice of a blanket assumption of increased suicidality,” said Dr. Sperling.

“Our findings indicate the nonspecific suicide warning for all epilepsy drugs is simply not justifiable,” he said. “The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to expect that every drug would increase suicide risk for every patient,” Dr. Sperling said in a statement.

“It’s important to recognize that epilepsy has many causes – perinatal injury, stroke, tumor, head trauma, developmental malformations, genetic causes, and others – and these underlying etiologies may well contribute to the presence of depression and suicidality in this population,” he said in an interview. “Psychodynamic influences also may occur as a consequence of having seizures. This is a complicated area, and drugs are simply one piece of the puzzle,” he added.

Dr. Sperling said the FDA has accomplished “one useful thing with its warning – it highlighted that physicians and other health care providers must pay attention to their patients’ psychological state, ask questions, and treat accordingly.”

The study had no specific funding. Dr. Sperling has received grants from Eisai, Medtronic, Neurelis, SK Life Science, Sunovion, Takeda, Xenon, Cerevel Therapeutics, UCB Pharma, and Engage Pharma; personal fees from Neurelis, Medscape, Neurology Live, International Medical Press, UCB Pharma, Eisai, Oxford University Press, and Projects in Knowledge. He has also consulted for Medtronic outside the submitted work; payments went to Thomas Jefferson University. A complete list of authors’ disclosures is available with the original article.

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

There is currently no evidence that newer antiseizure medications increase the risk for suicide among patients with epilepsy, new research shows. “There appears to be no justification for the FDA to label every new antiseizure medication with a warning that it may increase risk of suicidality,” said study investigator Michael R. Sperling, MD, professor of neurology, Thomas Jefferson University, Philadelphia.

“How many patients are afraid of their medication and do not take it because of the warning – and are consequently at risk because of that? We do not know, but have anecdotal experience that this is certainly an issue,” Dr. Sperling, who is director of the Jefferson Comprehensive Epilepsy Center, added.

The study was published online August 2 in JAMA Neurology.
 

Blanket warning

In 2008, the FDA issued an alert stating that antiseizure medications increase suicidality. The alert was based on pooled data from placebo-controlled clinical trials that included 11 antiseizure medications – carbamazepinefelbamategabapentinlamotriginelevetiracetamoxcarbazepinepregabalintiagabinetopiramate, valproate, and zonisamide.

The meta-analytic review showed that, compared with placebo, antiseizure medications nearly doubled suicide risk among patients treated for epilepsy, psychiatric disorders, and other diseases. As a result of the FDA study, all antiseizure medications that have been approved since 2008 carry a warning for suicidality.

However, subsequent analyses did not show the same results, Dr. Sperling and colleagues noted.

“Pivotal” antiseizure medication epilepsy trials since 2008 have evaluated suicidality prospectively. Since 2011, trials have included the validated Columbia Suicidality Severity Rating Scale, they noted.
 

Meta analysis showed no increased risk

Dr. Sperling and colleagues conducted a meta-analysis of 17 randomized placebo-controlled epilepsy trials of five antiseizure medications approved since 2008. These antiseizure medications were eslicarbazepine, perampanelbrivaracetamcannabidiol, and cenobamate. The trials involved 5,996 patients, including 4,000 who were treated with antiseizure medications and 1,996 who were treated with placebo.

Confining the analysis to epilepsy trials avoids potential confounders, such as possible differences in suicidality risks between different diseases, the researchers noted.

They found no evidence of increased risk for suicidal ideation (overall risk ratio, antiseizure medications vs. placebo: 0.75; 95% confidence interval: 0.35-1.60) or suicide attempt (risk ratio, 0.75; 95% CI: 0.30-1.87) overall or for any individual antiseizure medication.

Suicidal ideation occurred in 12 of 4,000 patients treated with antiseizure medications (0.30%), versus 7 of 1,996 patients treated with placebo (0.35%) (P = .74). Three patients who were treated with antiseizure medications attempted suicide; no patients who were treated with placebo attempted suicide (P = .22). There were no completed suicides.

“There is no current evidence that the five antiseizure medications evaluated in this study increase suicidality in epilepsy and merit a suicidality class warning,” the investigators wrote. When prescribed for epilepsy, “evidence does not support the FDA’s labeling practice of a blanket assumption of increased suicidality,” said Dr. Sperling.

“Our findings indicate the nonspecific suicide warning for all epilepsy drugs is simply not justifiable,” he said. “The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to expect that every drug would increase suicide risk for every patient,” Dr. Sperling said in a statement.

“It’s important to recognize that epilepsy has many causes – perinatal injury, stroke, tumor, head trauma, developmental malformations, genetic causes, and others – and these underlying etiologies may well contribute to the presence of depression and suicidality in this population,” he said in an interview. “Psychodynamic influences also may occur as a consequence of having seizures. This is a complicated area, and drugs are simply one piece of the puzzle,” he added.

Dr. Sperling said the FDA has accomplished “one useful thing with its warning – it highlighted that physicians and other health care providers must pay attention to their patients’ psychological state, ask questions, and treat accordingly.”

The study had no specific funding. Dr. Sperling has received grants from Eisai, Medtronic, Neurelis, SK Life Science, Sunovion, Takeda, Xenon, Cerevel Therapeutics, UCB Pharma, and Engage Pharma; personal fees from Neurelis, Medscape, Neurology Live, International Medical Press, UCB Pharma, Eisai, Oxford University Press, and Projects in Knowledge. He has also consulted for Medtronic outside the submitted work; payments went to Thomas Jefferson University. A complete list of authors’ disclosures is available with the original article.

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

Issue
Neurology Reviews- 29(9)
Issue
Neurology Reviews- 29(9)
Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA NEUROLOGY

Citation Override
Publish date: August 16, 2021
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Brain memory signals appear to regulate metabolism

Article Type
Changed
Tue, 05/03/2022 - 15:04

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

Dr. György Buzsáki

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

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

Issue
Neurology Reviews- 29(9)
Publications
Topics
Sections

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

Dr. György Buzsáki

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

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

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

Dr. György Buzsáki

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

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

Issue
Neurology Reviews- 29(9)
Issue
Neurology Reviews- 29(9)
Publications
Publications
Topics
Article Type
Sections
Citation Override
Publish date: August 13, 2021
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

FDA approves first drug for idiopathic hypersomnia

Article Type
Changed
Tue, 08/31/2021 - 10:09

The Food and Drug Administration has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav) for the treatment of idiopathic hypersomnia in adults, the company announced in a news release.

It marks the second approval for Xywav. The FDA approved it last year for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy as young as 7 years of age.

This recent approval is the first for a treatment for idiopathic hypersomnia.

“Idiopathic hypersomnia can have a significant impact on the social, educational, and occupational functioning of people living with the condition,” Diane Powell, board chair and CEO of the Hypersomnia Foundation, noted in the release.

This FDA approval “is a major milestone for the entire idiopathic hypersomnia community as Xywav becomes the first medicine approved to manage this chronic sleep disorder,” said Ms. Powell.

Low sodium oxybate product

Xywav is a novel oxybate product with a unique composition of cations. It contains 92% less sodium than sodium oxybate (Xyrem) at the recommended adult dosage range of 6 to 9 g, the company noted in a news release.

An estimated 37,000 people in the United States have been diagnosed with idiopathic hypersomnia, a neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

Other symptoms of the disorder may include severe sleep inertia or sleep drunkenness (prolonged difficulty waking with frequent re-entries into sleep, confusion, and irritability), as well as prolonged, nonrestorative night-time sleep, cognitive impairment, and long and unrefreshing naps.

The approval was based on findings from a phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal study.

Results showed “statistically significant and clinically meaningful” differences compared with placebo in change in the primary endpoint of Epworth Sleepiness Scale score (P < .0001) and the secondary endpoints of Patient Global Impression of Change (P < .0001) and the Idiopathic Hypersomnia Severity Scale (P < .0001), the company reported.

The most common adverse reactions were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.

The novel agent can be administered once or twice nightly for the treatment of idiopathic hypersomnia in adults.

“To optimize response, a patient’s health care provider may consider prescribing a twice-nightly regimen in equally or unequally divided doses at bedtime and 2.5 to 4 hours later and gradually titrate Xywav so that a patient may receive an individualized dose and regimen based on efficacy and tolerability,” the company said.

Xywav carries a boxed warning because it is a central nervous system depressant and because there is potential for abuse and misuse. The drug is only available through a risk evaluation and mitigation strategy (REMS) program.

The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following implementation of the REMS program.

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

Issue
Neurology Reviews- 29(9)
Publications
Topics
Sections

The Food and Drug Administration has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav) for the treatment of idiopathic hypersomnia in adults, the company announced in a news release.

It marks the second approval for Xywav. The FDA approved it last year for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy as young as 7 years of age.

This recent approval is the first for a treatment for idiopathic hypersomnia.

“Idiopathic hypersomnia can have a significant impact on the social, educational, and occupational functioning of people living with the condition,” Diane Powell, board chair and CEO of the Hypersomnia Foundation, noted in the release.

This FDA approval “is a major milestone for the entire idiopathic hypersomnia community as Xywav becomes the first medicine approved to manage this chronic sleep disorder,” said Ms. Powell.

Low sodium oxybate product

Xywav is a novel oxybate product with a unique composition of cations. It contains 92% less sodium than sodium oxybate (Xyrem) at the recommended adult dosage range of 6 to 9 g, the company noted in a news release.

An estimated 37,000 people in the United States have been diagnosed with idiopathic hypersomnia, a neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

Other symptoms of the disorder may include severe sleep inertia or sleep drunkenness (prolonged difficulty waking with frequent re-entries into sleep, confusion, and irritability), as well as prolonged, nonrestorative night-time sleep, cognitive impairment, and long and unrefreshing naps.

The approval was based on findings from a phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal study.

Results showed “statistically significant and clinically meaningful” differences compared with placebo in change in the primary endpoint of Epworth Sleepiness Scale score (P < .0001) and the secondary endpoints of Patient Global Impression of Change (P < .0001) and the Idiopathic Hypersomnia Severity Scale (P < .0001), the company reported.

The most common adverse reactions were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.

The novel agent can be administered once or twice nightly for the treatment of idiopathic hypersomnia in adults.

“To optimize response, a patient’s health care provider may consider prescribing a twice-nightly regimen in equally or unequally divided doses at bedtime and 2.5 to 4 hours later and gradually titrate Xywav so that a patient may receive an individualized dose and regimen based on efficacy and tolerability,” the company said.

Xywav carries a boxed warning because it is a central nervous system depressant and because there is potential for abuse and misuse. The drug is only available through a risk evaluation and mitigation strategy (REMS) program.

The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following implementation of the REMS program.

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

The Food and Drug Administration has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav) for the treatment of idiopathic hypersomnia in adults, the company announced in a news release.

It marks the second approval for Xywav. The FDA approved it last year for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy as young as 7 years of age.

This recent approval is the first for a treatment for idiopathic hypersomnia.

“Idiopathic hypersomnia can have a significant impact on the social, educational, and occupational functioning of people living with the condition,” Diane Powell, board chair and CEO of the Hypersomnia Foundation, noted in the release.

This FDA approval “is a major milestone for the entire idiopathic hypersomnia community as Xywav becomes the first medicine approved to manage this chronic sleep disorder,” said Ms. Powell.

Low sodium oxybate product

Xywav is a novel oxybate product with a unique composition of cations. It contains 92% less sodium than sodium oxybate (Xyrem) at the recommended adult dosage range of 6 to 9 g, the company noted in a news release.

An estimated 37,000 people in the United States have been diagnosed with idiopathic hypersomnia, a neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

Other symptoms of the disorder may include severe sleep inertia or sleep drunkenness (prolonged difficulty waking with frequent re-entries into sleep, confusion, and irritability), as well as prolonged, nonrestorative night-time sleep, cognitive impairment, and long and unrefreshing naps.

The approval was based on findings from a phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal study.

Results showed “statistically significant and clinically meaningful” differences compared with placebo in change in the primary endpoint of Epworth Sleepiness Scale score (P < .0001) and the secondary endpoints of Patient Global Impression of Change (P < .0001) and the Idiopathic Hypersomnia Severity Scale (P < .0001), the company reported.

The most common adverse reactions were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.

The novel agent can be administered once or twice nightly for the treatment of idiopathic hypersomnia in adults.

“To optimize response, a patient’s health care provider may consider prescribing a twice-nightly regimen in equally or unequally divided doses at bedtime and 2.5 to 4 hours later and gradually titrate Xywav so that a patient may receive an individualized dose and regimen based on efficacy and tolerability,” the company said.

Xywav carries a boxed warning because it is a central nervous system depressant and because there is potential for abuse and misuse. The drug is only available through a risk evaluation and mitigation strategy (REMS) program.

The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following implementation of the REMS program.

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

Issue
Neurology Reviews- 29(9)
Issue
Neurology Reviews- 29(9)
Publications
Publications
Topics
Article Type
Sections
Citation Override
Publish date: August 13, 2021
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Obesity leads to depression via social and metabolic factors

Article Type
Changed
Tue, 05/03/2022 - 15:04

New research provides further evidence that a high body mass index (BMI) leads to depressed mood and poor well-being via social and physical factors.

Dr. Jessica O'Loughlin

Obesity and depression are “major global health challenges; our findings suggest that reducing obesity will lower depression and improve well-being,” co–lead author Jessica O’Loughlin, PhD student, University of Exeter Medical School, United Kingdom, told this news organization.

“Doctors should consider both the biological consequences of having a higher BMI as well as the social implications when treating patients with obesity in order to help reduce the odds of them developing depression,” Ms. O’Loughlin added.

The study was published online July 16 in Human Molecular Genetics.
 

Large body of evidence

A large body of evidence indicates that higher BMI leads to depression.

Ms. O’Loughlin and colleagues leveraged genetic data from more than 145,000 individuals in the UK Biobank and Mendelian randomization to determine whether the causal link between high BMI and depression is the result of psychosocial pathways, physical pathways, or both.

The analysis showed that a genetically determined 1 standard deviation higher BMI (4.6 kg/m2) was associated with higher likelihood of depression (odds ratio, 1.50; 95% confidence interval, 1.15-1.95) and lower well-being (beta, -0.15; 95% CI, -0.26 to -0.04).

Using genetics to distinguish metabolic and psychosocial effects, the results also indicate that, even in the absence of adverse metabolic effects, “higher adiposity remains causal to depression and lowers wellbeing,” the researchers report.

We showed similar findings when looking at genetically predicted BMI and when using genetic variants that make you fatter but metabolically healthier (favorable adiposity genetic variants),” said Ms. O’Loughlin.

“Although we can’t tell which factor plays a bigger role in the adiposity-depression relationship, our analysis suggests that both physical and social factors (e.g., social stigma) play a role in the relationship between higher BMI and higher odds of depression,” she added.

In contrast, there was little evidence that higher BMI in the presence or absence of adverse metabolic consequences causes generalized anxiety disorder.

“Finding ways to support people to lose weight could benefit their mental health as well as their physical health,” co–lead author Francesco Casanova, PhD, with the University of Exeter, said in a statement.
 

Unexpected finding

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said that “multiple studies have shown a correlation between stress, obesity, inflammation, overall well-being, and psychiatric disorders, particularly depressive and anxiety disorders.”

Dr. Samoon Ahmad
Dr. Samoon Ahmad

He said this new study is important for three reasons.

“The first is the cohort size. There were over 145,000 participants involved in the study, which is significant and serves to make its conclusions stronger,” Dr. Ahmad noted.

“The second point is that the authors found that the correlation between higher adiposity and depression and lower well-being scores occurred even in patients without adverse metabolic effects,” he said in an interview.

“Of note, obesity significantly increases the risk of developing type 2 diabetes, hypertension, and a host of other illnesses as well as inflammatory conditions, which can all have a negative impact on quality of life. Consequently, these can contribute to depression as well as anxiety,” Dr. Ahmad added.

“Interestingly, what this study suggests is that even people without these additional stressors are reporting higher rates of depression and lower scores of well-being, while higher adiposity is the common denominator,” he noted.

“Third, the paper found little to no correlation between higher adiposity and generalized anxiety disorder. This comes as a complete surprise because anxiety and depression are very common comorbidities,” Dr. Ahmad said.

“Moreover, numerous studies as well as clinical data suggest that obesity leads to chronic inflammation, which in turn is associated with less favorable metabolic profiles, and that anxiety and depressive disorders may in some way be psychiatric manifestations of inflammation. To see one but not the other was quite an unexpected finding,” Dr. Ahmad said.

The study was funded by the Academy of Medical Sciences. Ms. O’Loughlin, Dr. Casanova, and Dr. Ahmad have disclosed no relevant conflicts of interest.

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

Publications
Topics
Sections

New research provides further evidence that a high body mass index (BMI) leads to depressed mood and poor well-being via social and physical factors.

Dr. Jessica O'Loughlin

Obesity and depression are “major global health challenges; our findings suggest that reducing obesity will lower depression and improve well-being,” co–lead author Jessica O’Loughlin, PhD student, University of Exeter Medical School, United Kingdom, told this news organization.

“Doctors should consider both the biological consequences of having a higher BMI as well as the social implications when treating patients with obesity in order to help reduce the odds of them developing depression,” Ms. O’Loughlin added.

The study was published online July 16 in Human Molecular Genetics.
 

Large body of evidence

A large body of evidence indicates that higher BMI leads to depression.

Ms. O’Loughlin and colleagues leveraged genetic data from more than 145,000 individuals in the UK Biobank and Mendelian randomization to determine whether the causal link between high BMI and depression is the result of psychosocial pathways, physical pathways, or both.

The analysis showed that a genetically determined 1 standard deviation higher BMI (4.6 kg/m2) was associated with higher likelihood of depression (odds ratio, 1.50; 95% confidence interval, 1.15-1.95) and lower well-being (beta, -0.15; 95% CI, -0.26 to -0.04).

Using genetics to distinguish metabolic and psychosocial effects, the results also indicate that, even in the absence of adverse metabolic effects, “higher adiposity remains causal to depression and lowers wellbeing,” the researchers report.

We showed similar findings when looking at genetically predicted BMI and when using genetic variants that make you fatter but metabolically healthier (favorable adiposity genetic variants),” said Ms. O’Loughlin.

“Although we can’t tell which factor plays a bigger role in the adiposity-depression relationship, our analysis suggests that both physical and social factors (e.g., social stigma) play a role in the relationship between higher BMI and higher odds of depression,” she added.

In contrast, there was little evidence that higher BMI in the presence or absence of adverse metabolic consequences causes generalized anxiety disorder.

“Finding ways to support people to lose weight could benefit their mental health as well as their physical health,” co–lead author Francesco Casanova, PhD, with the University of Exeter, said in a statement.
 

Unexpected finding

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said that “multiple studies have shown a correlation between stress, obesity, inflammation, overall well-being, and psychiatric disorders, particularly depressive and anxiety disorders.”

Dr. Samoon Ahmad
Dr. Samoon Ahmad

He said this new study is important for three reasons.

“The first is the cohort size. There were over 145,000 participants involved in the study, which is significant and serves to make its conclusions stronger,” Dr. Ahmad noted.

“The second point is that the authors found that the correlation between higher adiposity and depression and lower well-being scores occurred even in patients without adverse metabolic effects,” he said in an interview.

“Of note, obesity significantly increases the risk of developing type 2 diabetes, hypertension, and a host of other illnesses as well as inflammatory conditions, which can all have a negative impact on quality of life. Consequently, these can contribute to depression as well as anxiety,” Dr. Ahmad added.

“Interestingly, what this study suggests is that even people without these additional stressors are reporting higher rates of depression and lower scores of well-being, while higher adiposity is the common denominator,” he noted.

“Third, the paper found little to no correlation between higher adiposity and generalized anxiety disorder. This comes as a complete surprise because anxiety and depression are very common comorbidities,” Dr. Ahmad said.

“Moreover, numerous studies as well as clinical data suggest that obesity leads to chronic inflammation, which in turn is associated with less favorable metabolic profiles, and that anxiety and depressive disorders may in some way be psychiatric manifestations of inflammation. To see one but not the other was quite an unexpected finding,” Dr. Ahmad said.

The study was funded by the Academy of Medical Sciences. Ms. O’Loughlin, Dr. Casanova, and Dr. Ahmad have disclosed no relevant conflicts of interest.

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

New research provides further evidence that a high body mass index (BMI) leads to depressed mood and poor well-being via social and physical factors.

Dr. Jessica O'Loughlin

Obesity and depression are “major global health challenges; our findings suggest that reducing obesity will lower depression and improve well-being,” co–lead author Jessica O’Loughlin, PhD student, University of Exeter Medical School, United Kingdom, told this news organization.

“Doctors should consider both the biological consequences of having a higher BMI as well as the social implications when treating patients with obesity in order to help reduce the odds of them developing depression,” Ms. O’Loughlin added.

The study was published online July 16 in Human Molecular Genetics.
 

Large body of evidence

A large body of evidence indicates that higher BMI leads to depression.

Ms. O’Loughlin and colleagues leveraged genetic data from more than 145,000 individuals in the UK Biobank and Mendelian randomization to determine whether the causal link between high BMI and depression is the result of psychosocial pathways, physical pathways, or both.

The analysis showed that a genetically determined 1 standard deviation higher BMI (4.6 kg/m2) was associated with higher likelihood of depression (odds ratio, 1.50; 95% confidence interval, 1.15-1.95) and lower well-being (beta, -0.15; 95% CI, -0.26 to -0.04).

Using genetics to distinguish metabolic and psychosocial effects, the results also indicate that, even in the absence of adverse metabolic effects, “higher adiposity remains causal to depression and lowers wellbeing,” the researchers report.

We showed similar findings when looking at genetically predicted BMI and when using genetic variants that make you fatter but metabolically healthier (favorable adiposity genetic variants),” said Ms. O’Loughlin.

“Although we can’t tell which factor plays a bigger role in the adiposity-depression relationship, our analysis suggests that both physical and social factors (e.g., social stigma) play a role in the relationship between higher BMI and higher odds of depression,” she added.

In contrast, there was little evidence that higher BMI in the presence or absence of adverse metabolic consequences causes generalized anxiety disorder.

“Finding ways to support people to lose weight could benefit their mental health as well as their physical health,” co–lead author Francesco Casanova, PhD, with the University of Exeter, said in a statement.
 

Unexpected finding

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said that “multiple studies have shown a correlation between stress, obesity, inflammation, overall well-being, and psychiatric disorders, particularly depressive and anxiety disorders.”

Dr. Samoon Ahmad
Dr. Samoon Ahmad

He said this new study is important for three reasons.

“The first is the cohort size. There were over 145,000 participants involved in the study, which is significant and serves to make its conclusions stronger,” Dr. Ahmad noted.

“The second point is that the authors found that the correlation between higher adiposity and depression and lower well-being scores occurred even in patients without adverse metabolic effects,” he said in an interview.

“Of note, obesity significantly increases the risk of developing type 2 diabetes, hypertension, and a host of other illnesses as well as inflammatory conditions, which can all have a negative impact on quality of life. Consequently, these can contribute to depression as well as anxiety,” Dr. Ahmad added.

“Interestingly, what this study suggests is that even people without these additional stressors are reporting higher rates of depression and lower scores of well-being, while higher adiposity is the common denominator,” he noted.

“Third, the paper found little to no correlation between higher adiposity and generalized anxiety disorder. This comes as a complete surprise because anxiety and depression are very common comorbidities,” Dr. Ahmad said.

“Moreover, numerous studies as well as clinical data suggest that obesity leads to chronic inflammation, which in turn is associated with less favorable metabolic profiles, and that anxiety and depressive disorders may in some way be psychiatric manifestations of inflammation. To see one but not the other was quite an unexpected finding,” Dr. Ahmad said.

The study was funded by the Academy of Medical Sciences. Ms. O’Loughlin, Dr. Casanova, and Dr. Ahmad have disclosed no relevant conflicts of interest.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Novel antidepressant shines in phase 2 trial, but FDA has issues with its NDA

Article Type
Changed
Tue, 08/17/2021 - 09:06

Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.

In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.

The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.

In addition, the agency is currently reviewing a new drug application (NDA) for AXS-05 for the treatment of MDD, with a target action date of August 22.

However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”

The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
 

‘Well tolerated’

A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.

All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.

Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).

The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.

One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.

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

Publications
Topics
Sections

Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.

In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.

The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.

In addition, the agency is currently reviewing a new drug application (NDA) for AXS-05 for the treatment of MDD, with a target action date of August 22.

However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”

The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
 

‘Well tolerated’

A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.

All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.

Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).

The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.

One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.

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

Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.

In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.

The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.

In addition, the agency is currently reviewing a new drug application (NDA) for AXS-05 for the treatment of MDD, with a target action date of August 22.

However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”

The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
 

‘Well tolerated’

A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.

All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.

Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).

The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.

One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Pandemic demand for NPs soars, softens for primary care: Report

Article Type
Changed
Thu, 08/12/2021 - 14:00

The COVID-19 pandemic has fueled a growing demand for nurse practitioners (NPs), while demand for primary care physicians has cooled, according to Merritt Hawkins’ annual review of physician and advanced practitioner recruiting trends.

This marks the first time in the review’s 28-year history that NPs have topped the list of the most recruited practitioners, according to the medical search firm. In the 27 prior years, physicians held the top spot. For the previous 14 years, the No. 1 position was held by family physicians.

“COVID-19 and other market forces are changing the dynamics of physician and advanced practitioner recruiting. NPs are coming into their own in a market that puts a premium on easy access to care and cost containment,” Tom Florence, president of Merritt Hawkins, said in a statement.
 

Primary care ‘recruiting frenzy’ over

Mr. Florence said primary care physicians remain a “vital part of team-based care and will be increasingly responsible for coordinating the care of older patients with multiple chronic conditions. But the recruiting frenzy in primary care is over.”

Merritt Hawkins says that overall COVID-19 has had a “severely inhibiting” effect on demand for physicians. The number of searches the company conducted dropped 25%, compared with 2020, and many hospitals and medical groups shut down or lost money during the pandemic.

But the drop-off in demand for physicians is likely to be temporary because the underlying dynamics driving physician supply and demand remain in place, according to the report. These include a growing and aging population, a limited supply of newly trained physicians, and an aging physician workforce.

COVID-19 will not permanently change these market conditions, and demand for physicians already is rebounding, the company said.

The 2021 review of physician and advanced practitioner recruiting is based on a representative sample of 2,458 permanent search engagements that Merritt Hawkins/AMN Healthcare’s physician staffing companies conducted or were in the process of conducting during the 12-month period from April 1, 2020, to March 31, 2021.

Among the key findings:

  • 18% of Merritt Hawkins’ recruiting searches were for advanced practitioners, including NPs, physician assistants (PAs), and certified registered nurse anesthetists, up from 13% in the 2020 review. This represents the highest percentage in the 28 years the review has been conducted.
  • About two-thirds (64%) of Merritt Hawkins’ search engagements were for physician specialists, including radiologists, psychiatrists, gastroenterologists, and others, “highlighting the robust demand for specialty physicians.”
  • In 2021, 18% of Merritt Hawkins’ search engagements were for primary care physicians, down from 20% in 2020 and 22% in 2019, “signaling a relative decline in demand for primary care doctors.”
  • Psychiatrists placed fourth on the list of most requested search engagements, a sign of continued strong demand for mental health professionals that is likely to accelerate because of COVID-19.

Starting salaries take a pandemic hit

Owing to the reduced demand for practitioners, starting salaries decreased for many types of health care professions, with the exception of NPs and PAs.

Average starting salaries for NPs showed strong growth, increasing 12% year over year, from $125,000 to $140,000. The average starting salaries for PAs also showed strong growth, increasing by 14% year over year, from $112,000 to $128,000.

Among physicians, interventional cardiologists were offered the highest average starting salaries, at $611,000, followed by orthopedic surgeons, at $546,000. Pediatricians were offered the lowest average starting salaries, at $236,000.

Merritt Hawkins said only 3% of their search engagements were for solo practice or partnership settings, “underscoring the decline of physician private practice.”

Roughly two-thirds (67%) of Merritt Hawkins’ search engagements were in communities of 100,000 people or more, indicating that demand for physicians and advanced practitioners is not limited to small or rural communities.

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

Publications
Topics
Sections

The COVID-19 pandemic has fueled a growing demand for nurse practitioners (NPs), while demand for primary care physicians has cooled, according to Merritt Hawkins’ annual review of physician and advanced practitioner recruiting trends.

This marks the first time in the review’s 28-year history that NPs have topped the list of the most recruited practitioners, according to the medical search firm. In the 27 prior years, physicians held the top spot. For the previous 14 years, the No. 1 position was held by family physicians.

“COVID-19 and other market forces are changing the dynamics of physician and advanced practitioner recruiting. NPs are coming into their own in a market that puts a premium on easy access to care and cost containment,” Tom Florence, president of Merritt Hawkins, said in a statement.
 

Primary care ‘recruiting frenzy’ over

Mr. Florence said primary care physicians remain a “vital part of team-based care and will be increasingly responsible for coordinating the care of older patients with multiple chronic conditions. But the recruiting frenzy in primary care is over.”

Merritt Hawkins says that overall COVID-19 has had a “severely inhibiting” effect on demand for physicians. The number of searches the company conducted dropped 25%, compared with 2020, and many hospitals and medical groups shut down or lost money during the pandemic.

But the drop-off in demand for physicians is likely to be temporary because the underlying dynamics driving physician supply and demand remain in place, according to the report. These include a growing and aging population, a limited supply of newly trained physicians, and an aging physician workforce.

COVID-19 will not permanently change these market conditions, and demand for physicians already is rebounding, the company said.

The 2021 review of physician and advanced practitioner recruiting is based on a representative sample of 2,458 permanent search engagements that Merritt Hawkins/AMN Healthcare’s physician staffing companies conducted or were in the process of conducting during the 12-month period from April 1, 2020, to March 31, 2021.

Among the key findings:

  • 18% of Merritt Hawkins’ recruiting searches were for advanced practitioners, including NPs, physician assistants (PAs), and certified registered nurse anesthetists, up from 13% in the 2020 review. This represents the highest percentage in the 28 years the review has been conducted.
  • About two-thirds (64%) of Merritt Hawkins’ search engagements were for physician specialists, including radiologists, psychiatrists, gastroenterologists, and others, “highlighting the robust demand for specialty physicians.”
  • In 2021, 18% of Merritt Hawkins’ search engagements were for primary care physicians, down from 20% in 2020 and 22% in 2019, “signaling a relative decline in demand for primary care doctors.”
  • Psychiatrists placed fourth on the list of most requested search engagements, a sign of continued strong demand for mental health professionals that is likely to accelerate because of COVID-19.

Starting salaries take a pandemic hit

Owing to the reduced demand for practitioners, starting salaries decreased for many types of health care professions, with the exception of NPs and PAs.

Average starting salaries for NPs showed strong growth, increasing 12% year over year, from $125,000 to $140,000. The average starting salaries for PAs also showed strong growth, increasing by 14% year over year, from $112,000 to $128,000.

Among physicians, interventional cardiologists were offered the highest average starting salaries, at $611,000, followed by orthopedic surgeons, at $546,000. Pediatricians were offered the lowest average starting salaries, at $236,000.

Merritt Hawkins said only 3% of their search engagements were for solo practice or partnership settings, “underscoring the decline of physician private practice.”

Roughly two-thirds (67%) of Merritt Hawkins’ search engagements were in communities of 100,000 people or more, indicating that demand for physicians and advanced practitioners is not limited to small or rural communities.

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

The COVID-19 pandemic has fueled a growing demand for nurse practitioners (NPs), while demand for primary care physicians has cooled, according to Merritt Hawkins’ annual review of physician and advanced practitioner recruiting trends.

This marks the first time in the review’s 28-year history that NPs have topped the list of the most recruited practitioners, according to the medical search firm. In the 27 prior years, physicians held the top spot. For the previous 14 years, the No. 1 position was held by family physicians.

“COVID-19 and other market forces are changing the dynamics of physician and advanced practitioner recruiting. NPs are coming into their own in a market that puts a premium on easy access to care and cost containment,” Tom Florence, president of Merritt Hawkins, said in a statement.
 

Primary care ‘recruiting frenzy’ over

Mr. Florence said primary care physicians remain a “vital part of team-based care and will be increasingly responsible for coordinating the care of older patients with multiple chronic conditions. But the recruiting frenzy in primary care is over.”

Merritt Hawkins says that overall COVID-19 has had a “severely inhibiting” effect on demand for physicians. The number of searches the company conducted dropped 25%, compared with 2020, and many hospitals and medical groups shut down or lost money during the pandemic.

But the drop-off in demand for physicians is likely to be temporary because the underlying dynamics driving physician supply and demand remain in place, according to the report. These include a growing and aging population, a limited supply of newly trained physicians, and an aging physician workforce.

COVID-19 will not permanently change these market conditions, and demand for physicians already is rebounding, the company said.

The 2021 review of physician and advanced practitioner recruiting is based on a representative sample of 2,458 permanent search engagements that Merritt Hawkins/AMN Healthcare’s physician staffing companies conducted or were in the process of conducting during the 12-month period from April 1, 2020, to March 31, 2021.

Among the key findings:

  • 18% of Merritt Hawkins’ recruiting searches were for advanced practitioners, including NPs, physician assistants (PAs), and certified registered nurse anesthetists, up from 13% in the 2020 review. This represents the highest percentage in the 28 years the review has been conducted.
  • About two-thirds (64%) of Merritt Hawkins’ search engagements were for physician specialists, including radiologists, psychiatrists, gastroenterologists, and others, “highlighting the robust demand for specialty physicians.”
  • In 2021, 18% of Merritt Hawkins’ search engagements were for primary care physicians, down from 20% in 2020 and 22% in 2019, “signaling a relative decline in demand for primary care doctors.”
  • Psychiatrists placed fourth on the list of most requested search engagements, a sign of continued strong demand for mental health professionals that is likely to accelerate because of COVID-19.

Starting salaries take a pandemic hit

Owing to the reduced demand for practitioners, starting salaries decreased for many types of health care professions, with the exception of NPs and PAs.

Average starting salaries for NPs showed strong growth, increasing 12% year over year, from $125,000 to $140,000. The average starting salaries for PAs also showed strong growth, increasing by 14% year over year, from $112,000 to $128,000.

Among physicians, interventional cardiologists were offered the highest average starting salaries, at $611,000, followed by orthopedic surgeons, at $546,000. Pediatricians were offered the lowest average starting salaries, at $236,000.

Merritt Hawkins said only 3% of their search engagements were for solo practice or partnership settings, “underscoring the decline of physician private practice.”

Roughly two-thirds (67%) of Merritt Hawkins’ search engagements were in communities of 100,000 people or more, indicating that demand for physicians and advanced practitioners is not limited to small or rural communities.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Opioid prescribing laws having an impact

Article Type
Changed
Thu, 08/12/2021 - 12:55

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

Publications
Topics
Sections

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Myocarditis in adolescents after COVID-19 vaccine typically mild

Article Type
Changed
Thu, 08/26/2021 - 15:43

Adolescents can develop mild myocarditis as a rare complication after COVID-19 vaccination, as has been reported in adults, an early case series from Boston confirms.

The adolescents who developed heart inflammation after vaccination typically had a benign course, with symptoms resolving without treatment, although one patient had persistent borderline low left ventricular (LV) function, report Audrey Dionne, MD, and colleagues at Boston Children’s Hospital.

“Despite the risks of myocarditis associated with vaccination, the benefits of vaccination likely outweigh risks in children and adolescents,” they say.

They estimate that for males 12-29 years of age COVID-19 vaccination prevents 11,000 COVID-19 cases, 560 hospitalizations, 138 intensive care unit admissions, and six deaths, compared with 39-47 expected myocarditis cases.

The case series was published online Aug. 10 in JAMA Cardiology.

Long-term risks unknown 

Dr. Dionne and colleagues reviewed the results of comprehensive cardiac imaging in 14 boys and 1 girl, 12-18 years of age (median, 15 years), who were hospitalized with myocarditis after receiving the Pfizer-BioNTech messenger RNA COVID-19 vaccine.

Symptoms started 1-6 days after vaccine administration (most after the second dose) and included chest pain in all 15 patients, fever in 10 (67%), myalgia in eight (53%), and headache in six (40%).

On admission, all patients had elevated troponin levels (median, 0.25 ng/mL; range, 0.08-3.15 ng/mL). Troponin levels peaked 0.1-2.3 days after admission.

Echocardiography revealed decreased LV ejection fraction (EF) in three patients (20%) and abnormal global longitudinal or circumferential strain in five patients (33%). No patient had a pericardial effusion.

Cardiac MRI findings were consistent with myocarditis in 13 patients (87%), including late gadolinium enhancement in 12 (80%), regional hyperintensity on T2-weighted imaging in two (13%), elevated extracellular volume fraction in three (20%), and elevated LV global native T1 in two (20%).

The patients remained in the hospital for 1-5 days (median, 2 days) and were discharged. No patient required admission to the intensive care unit.

In follow-up assessments performed 1-13 days after hospital discharge, symptoms of myocarditis had resolved in 11 patients (73%).

One patient (7%) had persistent borderline low LV systolic function on echocardiogram (LVEF, 54%).

Troponin levels remained mildly elevated in three patients (20%). One patient (7%) had nonsustained ventricular tachycardia on ambulatory monitor.

The authors say longitudinal studies of patients with myocarditis after COVID-19 vaccine “will be important to better understand long-term risks.”

In a statement from the UK nonprofit Science Media Centre, Peter Openshaw, FMedSci, Imperial College London, says: “The problem with case series of this type is the lack of comparison groups. How many cases of myocarditis might be seen in normal children, or those given other vaccines (including those that are not for COVID), or in teenagers infected with SARS-CoV-2?”

“As the authors note, myocarditis does happen after other vaccines. The estimated rate (62.8 cases per million) makes this a rare event,” Dr. Openshaw says.

“My view that teenagers should be considered for vaccination is not changed by this new publication,” he adds.

This study was funded by the McCance Foundation. The authors have declared no relevant conflicts of interest. Dr. Openshaw has served on scientific advisory boards for Janssen/J&J, Oxford Immunotech, GSK, Nestle, and Pfizer in relation to immunity to viruses (fees paid to Imperial College London).

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

Publications
Topics
Sections

Adolescents can develop mild myocarditis as a rare complication after COVID-19 vaccination, as has been reported in adults, an early case series from Boston confirms.

The adolescents who developed heart inflammation after vaccination typically had a benign course, with symptoms resolving without treatment, although one patient had persistent borderline low left ventricular (LV) function, report Audrey Dionne, MD, and colleagues at Boston Children’s Hospital.

“Despite the risks of myocarditis associated with vaccination, the benefits of vaccination likely outweigh risks in children and adolescents,” they say.

They estimate that for males 12-29 years of age COVID-19 vaccination prevents 11,000 COVID-19 cases, 560 hospitalizations, 138 intensive care unit admissions, and six deaths, compared with 39-47 expected myocarditis cases.

The case series was published online Aug. 10 in JAMA Cardiology.

Long-term risks unknown 

Dr. Dionne and colleagues reviewed the results of comprehensive cardiac imaging in 14 boys and 1 girl, 12-18 years of age (median, 15 years), who were hospitalized with myocarditis after receiving the Pfizer-BioNTech messenger RNA COVID-19 vaccine.

Symptoms started 1-6 days after vaccine administration (most after the second dose) and included chest pain in all 15 patients, fever in 10 (67%), myalgia in eight (53%), and headache in six (40%).

On admission, all patients had elevated troponin levels (median, 0.25 ng/mL; range, 0.08-3.15 ng/mL). Troponin levels peaked 0.1-2.3 days after admission.

Echocardiography revealed decreased LV ejection fraction (EF) in three patients (20%) and abnormal global longitudinal or circumferential strain in five patients (33%). No patient had a pericardial effusion.

Cardiac MRI findings were consistent with myocarditis in 13 patients (87%), including late gadolinium enhancement in 12 (80%), regional hyperintensity on T2-weighted imaging in two (13%), elevated extracellular volume fraction in three (20%), and elevated LV global native T1 in two (20%).

The patients remained in the hospital for 1-5 days (median, 2 days) and were discharged. No patient required admission to the intensive care unit.

In follow-up assessments performed 1-13 days after hospital discharge, symptoms of myocarditis had resolved in 11 patients (73%).

One patient (7%) had persistent borderline low LV systolic function on echocardiogram (LVEF, 54%).

Troponin levels remained mildly elevated in three patients (20%). One patient (7%) had nonsustained ventricular tachycardia on ambulatory monitor.

The authors say longitudinal studies of patients with myocarditis after COVID-19 vaccine “will be important to better understand long-term risks.”

In a statement from the UK nonprofit Science Media Centre, Peter Openshaw, FMedSci, Imperial College London, says: “The problem with case series of this type is the lack of comparison groups. How many cases of myocarditis might be seen in normal children, or those given other vaccines (including those that are not for COVID), or in teenagers infected with SARS-CoV-2?”

“As the authors note, myocarditis does happen after other vaccines. The estimated rate (62.8 cases per million) makes this a rare event,” Dr. Openshaw says.

“My view that teenagers should be considered for vaccination is not changed by this new publication,” he adds.

This study was funded by the McCance Foundation. The authors have declared no relevant conflicts of interest. Dr. Openshaw has served on scientific advisory boards for Janssen/J&J, Oxford Immunotech, GSK, Nestle, and Pfizer in relation to immunity to viruses (fees paid to Imperial College London).

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

Adolescents can develop mild myocarditis as a rare complication after COVID-19 vaccination, as has been reported in adults, an early case series from Boston confirms.

The adolescents who developed heart inflammation after vaccination typically had a benign course, with symptoms resolving without treatment, although one patient had persistent borderline low left ventricular (LV) function, report Audrey Dionne, MD, and colleagues at Boston Children’s Hospital.

“Despite the risks of myocarditis associated with vaccination, the benefits of vaccination likely outweigh risks in children and adolescents,” they say.

They estimate that for males 12-29 years of age COVID-19 vaccination prevents 11,000 COVID-19 cases, 560 hospitalizations, 138 intensive care unit admissions, and six deaths, compared with 39-47 expected myocarditis cases.

The case series was published online Aug. 10 in JAMA Cardiology.

Long-term risks unknown 

Dr. Dionne and colleagues reviewed the results of comprehensive cardiac imaging in 14 boys and 1 girl, 12-18 years of age (median, 15 years), who were hospitalized with myocarditis after receiving the Pfizer-BioNTech messenger RNA COVID-19 vaccine.

Symptoms started 1-6 days after vaccine administration (most after the second dose) and included chest pain in all 15 patients, fever in 10 (67%), myalgia in eight (53%), and headache in six (40%).

On admission, all patients had elevated troponin levels (median, 0.25 ng/mL; range, 0.08-3.15 ng/mL). Troponin levels peaked 0.1-2.3 days after admission.

Echocardiography revealed decreased LV ejection fraction (EF) in three patients (20%) and abnormal global longitudinal or circumferential strain in five patients (33%). No patient had a pericardial effusion.

Cardiac MRI findings were consistent with myocarditis in 13 patients (87%), including late gadolinium enhancement in 12 (80%), regional hyperintensity on T2-weighted imaging in two (13%), elevated extracellular volume fraction in three (20%), and elevated LV global native T1 in two (20%).

The patients remained in the hospital for 1-5 days (median, 2 days) and were discharged. No patient required admission to the intensive care unit.

In follow-up assessments performed 1-13 days after hospital discharge, symptoms of myocarditis had resolved in 11 patients (73%).

One patient (7%) had persistent borderline low LV systolic function on echocardiogram (LVEF, 54%).

Troponin levels remained mildly elevated in three patients (20%). One patient (7%) had nonsustained ventricular tachycardia on ambulatory monitor.

The authors say longitudinal studies of patients with myocarditis after COVID-19 vaccine “will be important to better understand long-term risks.”

In a statement from the UK nonprofit Science Media Centre, Peter Openshaw, FMedSci, Imperial College London, says: “The problem with case series of this type is the lack of comparison groups. How many cases of myocarditis might be seen in normal children, or those given other vaccines (including those that are not for COVID), or in teenagers infected with SARS-CoV-2?”

“As the authors note, myocarditis does happen after other vaccines. The estimated rate (62.8 cases per million) makes this a rare event,” Dr. Openshaw says.

“My view that teenagers should be considered for vaccination is not changed by this new publication,” he adds.

This study was funded by the McCance Foundation. The authors have declared no relevant conflicts of interest. Dr. Openshaw has served on scientific advisory boards for Janssen/J&J, Oxford Immunotech, GSK, Nestle, and Pfizer in relation to immunity to viruses (fees paid to Imperial College London).

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article