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FDA approves first drug for idiopathic hypersomnia
, 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 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 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.
Obesity leads to depression via social and metabolic factors
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.
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.
“ 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.”
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.
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.
“ 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.”
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.
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.
“ 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.”
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.
Novel antidepressant shines in phase 2 trial, but FDA has issues with its NDA
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,
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,
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,
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.
Pandemic demand for NPs soars, softens for primary care: Report
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.
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.
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.
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.
Opioid prescribing laws having an impact
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.
, 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.
, 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.
, 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.
Myocarditis in adolescents after COVID-19 vaccine typically mild
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.
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.
Flavonoids dietary ‘powerhouses’ for cognitive decline prevention
, new research shows.
Among the different types of flavonoids, flavones (found in some spices and yellow or orange fruits and vegetables) and anthocyanins (found in blueberries, blackberries, and cherries) seem to have most protective effect, the researchers report.
“There is mounting evidence suggesting flavonoids are powerhouses when it comes to preventing your thinking skills from declining as you get older,” study investigator Walter Willett, MD, DrPH, Harvard University, Boston, said in a statement.
“Our results are exciting because they show that making simple changes to your diet could help prevent cognitive decline,” said Dr. Willett.
The study was published online July 28 in the journal Neurology.
Antioxidant punch
Flavonoids, naturally occurring phytochemicals found in plants, are strong antioxidants. Considering the likely role of oxidative stress in age-related cognitive decline, flavonoids have been proposed as a potentially important preventive.
For the study, Dr. Willett and colleagues prospectively examined associations between long-term dietary flavonoids (flavonols, flavones, flavanones, flavan-3-ols, anthocyanins, polymeric flavonoids, and proanthocyanidins) and subjective cognitive decline in 49,493 women from the Nurses’ Health Study (1984-2006) and 27,842 men from the Health Professionals Follow-up Study (1986-2002).
Those in the highest quintile of flavonoid consumption consumed about 600 mg daily on average while those in the lowest quintile got only about 150 mg daily.
After adjusting for age, total energy intake, major nondietary factors, and specific dietary factors, a higher intake of total flavonoids was associated with lower likelihood of self-reported subjective cognitive decline during follow up.
Individuals in the highest quintile of daily consumption had about a 20% lower risk of subjective cognitive decline relative to peers in the lowest quintile (pooled multivariable-adjusted odds ratio: 0.81; 95% confidence interval, 0.76-0.89).
The strongest protective associations were found for flavones (OR, 0.62; 95% confidence interval, 0.57-0.68), flavanones (OR, 0.64; 95% CI, 0.58-0.68), and anthocyanins (OR, 0.76; 95% CI, 0.72-0.84) (P trend < .0001 for all groups).
“The people in our study who did the best over time ate an average of at least half a serving per day of foods like orange juice, oranges, peppers, celery, grapefruits, grapefruit juice, apples, and pears,” Dr. Willett said.
“While it is possible other phytochemicals are at work here, a colorful diet rich in flavonoids – and specifically flavones and anthocyanins – seems to be a good bet for promoting long-term brain health,” he added.
A limitation of the study is that participants reported on their diets and may not recall perfectly what they ate or how much.
Healthy diet best bet for brain health
Reached for comment, Christopher Weber, PhD, director of global science initiatives for the Alzheimer’s Association, said this study “adds to our understanding of which elements of a healthy diet may be important in reducing dementia risk; flavonols may be one of those elements.”
“However, at this point, people should not put too much stock in specific nutrients – including subsets of flavonols – for reducing dementia risk until more research is done. Rather, they should focus on eating an overall healthy diet,” he said.
“It would be wonderful if a particular food or supplement could delay or prevent Alzheimer’s disease, but we do not have scientific evidence to support such claims. Randomized controlled clinical trials are necessary to evaluate whether any food or supplement has a scientifically proven beneficial effect,” Dr. Weber added.
For now, the Alzheimer’s Association “encourages everyone to eat a healthy and balanced diet as a way to help reduce the risk of cognitive decline,” Dr. Weber said.
“With more than 6 million Americans living with Alzheimer’s disease and other dementia today, there is a pressing need to test the effectiveness of a healthy lifestyle regimen to reduce risk of cognitive decline in a large and diverse population,” he added.
The Alzheimer’s Association has launched a 2-year clinical trial, called the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), to do just that.
“While we research that definitive lifestyle ‘recipe,’ there are things we can do today that may decrease our risk of cognitive decline as we age. Eating a heart-healthy diet, exercising regularly, and staying cognitively engaged are just a few,” Dr. Weber added.
Also weighing in, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said the study results are not surprising.
“Scientific data on the ability of flavonoids to prevent age-related chronic diseases, including cognitive decline, has accumulated immensely over the last decade. This epidemiological study reinforces findings from smaller shorter-duration clinical trials and mechanistic studies,” said Dr. Wallace, who was not involved in the study.
“Flavonoids show great potential in reducing inflammation and oxidative stress in the body. They are also vasodilators that help improve blood flow, which is important for the cardiovascular and cerebrovascular systems,” he noted.
“Typically, foods rich in flavonoids are also nutrient-dense in vitamins, minerals, and dietary fiber (eg, fruits and vegetables). Anthocyanins in blueberries have long been known to prevent cognitive decline with age,” Dr. Wallace said.
Dr. Wallace was part of a 14-member panel of nutrition scientists who recently reviewed available evidence around fruit and vegetable intake and health.
“Our findings are consistent with this study in regard to cognitive decline and other disease states. Cruciferous vegetables, dark-green leafy vegetables, citrus fruits, and dark-colored berries seem to have superior effects on health promotion and disease prevention in general,” said Dr. Wallace.
This work was supported by grants from the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Weber has no relevant disclosures. Dr. Wallace is principal and chief executive officer of the Think Healthy Group; editor of the Journal of Dietary Supplements; and deputy editor-in-chief of the Journal of the American College of Nutrition.
A version of this article first appeared on Medscape.com.
, new research shows.
Among the different types of flavonoids, flavones (found in some spices and yellow or orange fruits and vegetables) and anthocyanins (found in blueberries, blackberries, and cherries) seem to have most protective effect, the researchers report.
“There is mounting evidence suggesting flavonoids are powerhouses when it comes to preventing your thinking skills from declining as you get older,” study investigator Walter Willett, MD, DrPH, Harvard University, Boston, said in a statement.
“Our results are exciting because they show that making simple changes to your diet could help prevent cognitive decline,” said Dr. Willett.
The study was published online July 28 in the journal Neurology.
Antioxidant punch
Flavonoids, naturally occurring phytochemicals found in plants, are strong antioxidants. Considering the likely role of oxidative stress in age-related cognitive decline, flavonoids have been proposed as a potentially important preventive.
For the study, Dr. Willett and colleagues prospectively examined associations between long-term dietary flavonoids (flavonols, flavones, flavanones, flavan-3-ols, anthocyanins, polymeric flavonoids, and proanthocyanidins) and subjective cognitive decline in 49,493 women from the Nurses’ Health Study (1984-2006) and 27,842 men from the Health Professionals Follow-up Study (1986-2002).
Those in the highest quintile of flavonoid consumption consumed about 600 mg daily on average while those in the lowest quintile got only about 150 mg daily.
After adjusting for age, total energy intake, major nondietary factors, and specific dietary factors, a higher intake of total flavonoids was associated with lower likelihood of self-reported subjective cognitive decline during follow up.
Individuals in the highest quintile of daily consumption had about a 20% lower risk of subjective cognitive decline relative to peers in the lowest quintile (pooled multivariable-adjusted odds ratio: 0.81; 95% confidence interval, 0.76-0.89).
The strongest protective associations were found for flavones (OR, 0.62; 95% confidence interval, 0.57-0.68), flavanones (OR, 0.64; 95% CI, 0.58-0.68), and anthocyanins (OR, 0.76; 95% CI, 0.72-0.84) (P trend < .0001 for all groups).
“The people in our study who did the best over time ate an average of at least half a serving per day of foods like orange juice, oranges, peppers, celery, grapefruits, grapefruit juice, apples, and pears,” Dr. Willett said.
“While it is possible other phytochemicals are at work here, a colorful diet rich in flavonoids – and specifically flavones and anthocyanins – seems to be a good bet for promoting long-term brain health,” he added.
A limitation of the study is that participants reported on their diets and may not recall perfectly what they ate or how much.
Healthy diet best bet for brain health
Reached for comment, Christopher Weber, PhD, director of global science initiatives for the Alzheimer’s Association, said this study “adds to our understanding of which elements of a healthy diet may be important in reducing dementia risk; flavonols may be one of those elements.”
“However, at this point, people should not put too much stock in specific nutrients – including subsets of flavonols – for reducing dementia risk until more research is done. Rather, they should focus on eating an overall healthy diet,” he said.
“It would be wonderful if a particular food or supplement could delay or prevent Alzheimer’s disease, but we do not have scientific evidence to support such claims. Randomized controlled clinical trials are necessary to evaluate whether any food or supplement has a scientifically proven beneficial effect,” Dr. Weber added.
For now, the Alzheimer’s Association “encourages everyone to eat a healthy and balanced diet as a way to help reduce the risk of cognitive decline,” Dr. Weber said.
“With more than 6 million Americans living with Alzheimer’s disease and other dementia today, there is a pressing need to test the effectiveness of a healthy lifestyle regimen to reduce risk of cognitive decline in a large and diverse population,” he added.
The Alzheimer’s Association has launched a 2-year clinical trial, called the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), to do just that.
“While we research that definitive lifestyle ‘recipe,’ there are things we can do today that may decrease our risk of cognitive decline as we age. Eating a heart-healthy diet, exercising regularly, and staying cognitively engaged are just a few,” Dr. Weber added.
Also weighing in, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said the study results are not surprising.
“Scientific data on the ability of flavonoids to prevent age-related chronic diseases, including cognitive decline, has accumulated immensely over the last decade. This epidemiological study reinforces findings from smaller shorter-duration clinical trials and mechanistic studies,” said Dr. Wallace, who was not involved in the study.
“Flavonoids show great potential in reducing inflammation and oxidative stress in the body. They are also vasodilators that help improve blood flow, which is important for the cardiovascular and cerebrovascular systems,” he noted.
“Typically, foods rich in flavonoids are also nutrient-dense in vitamins, minerals, and dietary fiber (eg, fruits and vegetables). Anthocyanins in blueberries have long been known to prevent cognitive decline with age,” Dr. Wallace said.
Dr. Wallace was part of a 14-member panel of nutrition scientists who recently reviewed available evidence around fruit and vegetable intake and health.
“Our findings are consistent with this study in regard to cognitive decline and other disease states. Cruciferous vegetables, dark-green leafy vegetables, citrus fruits, and dark-colored berries seem to have superior effects on health promotion and disease prevention in general,” said Dr. Wallace.
This work was supported by grants from the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Weber has no relevant disclosures. Dr. Wallace is principal and chief executive officer of the Think Healthy Group; editor of the Journal of Dietary Supplements; and deputy editor-in-chief of the Journal of the American College of Nutrition.
A version of this article first appeared on Medscape.com.
, new research shows.
Among the different types of flavonoids, flavones (found in some spices and yellow or orange fruits and vegetables) and anthocyanins (found in blueberries, blackberries, and cherries) seem to have most protective effect, the researchers report.
“There is mounting evidence suggesting flavonoids are powerhouses when it comes to preventing your thinking skills from declining as you get older,” study investigator Walter Willett, MD, DrPH, Harvard University, Boston, said in a statement.
“Our results are exciting because they show that making simple changes to your diet could help prevent cognitive decline,” said Dr. Willett.
The study was published online July 28 in the journal Neurology.
Antioxidant punch
Flavonoids, naturally occurring phytochemicals found in plants, are strong antioxidants. Considering the likely role of oxidative stress in age-related cognitive decline, flavonoids have been proposed as a potentially important preventive.
For the study, Dr. Willett and colleagues prospectively examined associations between long-term dietary flavonoids (flavonols, flavones, flavanones, flavan-3-ols, anthocyanins, polymeric flavonoids, and proanthocyanidins) and subjective cognitive decline in 49,493 women from the Nurses’ Health Study (1984-2006) and 27,842 men from the Health Professionals Follow-up Study (1986-2002).
Those in the highest quintile of flavonoid consumption consumed about 600 mg daily on average while those in the lowest quintile got only about 150 mg daily.
After adjusting for age, total energy intake, major nondietary factors, and specific dietary factors, a higher intake of total flavonoids was associated with lower likelihood of self-reported subjective cognitive decline during follow up.
Individuals in the highest quintile of daily consumption had about a 20% lower risk of subjective cognitive decline relative to peers in the lowest quintile (pooled multivariable-adjusted odds ratio: 0.81; 95% confidence interval, 0.76-0.89).
The strongest protective associations were found for flavones (OR, 0.62; 95% confidence interval, 0.57-0.68), flavanones (OR, 0.64; 95% CI, 0.58-0.68), and anthocyanins (OR, 0.76; 95% CI, 0.72-0.84) (P trend < .0001 for all groups).
“The people in our study who did the best over time ate an average of at least half a serving per day of foods like orange juice, oranges, peppers, celery, grapefruits, grapefruit juice, apples, and pears,” Dr. Willett said.
“While it is possible other phytochemicals are at work here, a colorful diet rich in flavonoids – and specifically flavones and anthocyanins – seems to be a good bet for promoting long-term brain health,” he added.
A limitation of the study is that participants reported on their diets and may not recall perfectly what they ate or how much.
Healthy diet best bet for brain health
Reached for comment, Christopher Weber, PhD, director of global science initiatives for the Alzheimer’s Association, said this study “adds to our understanding of which elements of a healthy diet may be important in reducing dementia risk; flavonols may be one of those elements.”
“However, at this point, people should not put too much stock in specific nutrients – including subsets of flavonols – for reducing dementia risk until more research is done. Rather, they should focus on eating an overall healthy diet,” he said.
“It would be wonderful if a particular food or supplement could delay or prevent Alzheimer’s disease, but we do not have scientific evidence to support such claims. Randomized controlled clinical trials are necessary to evaluate whether any food or supplement has a scientifically proven beneficial effect,” Dr. Weber added.
For now, the Alzheimer’s Association “encourages everyone to eat a healthy and balanced diet as a way to help reduce the risk of cognitive decline,” Dr. Weber said.
“With more than 6 million Americans living with Alzheimer’s disease and other dementia today, there is a pressing need to test the effectiveness of a healthy lifestyle regimen to reduce risk of cognitive decline in a large and diverse population,” he added.
The Alzheimer’s Association has launched a 2-year clinical trial, called the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), to do just that.
“While we research that definitive lifestyle ‘recipe,’ there are things we can do today that may decrease our risk of cognitive decline as we age. Eating a heart-healthy diet, exercising regularly, and staying cognitively engaged are just a few,” Dr. Weber added.
Also weighing in, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said the study results are not surprising.
“Scientific data on the ability of flavonoids to prevent age-related chronic diseases, including cognitive decline, has accumulated immensely over the last decade. This epidemiological study reinforces findings from smaller shorter-duration clinical trials and mechanistic studies,” said Dr. Wallace, who was not involved in the study.
“Flavonoids show great potential in reducing inflammation and oxidative stress in the body. They are also vasodilators that help improve blood flow, which is important for the cardiovascular and cerebrovascular systems,” he noted.
“Typically, foods rich in flavonoids are also nutrient-dense in vitamins, minerals, and dietary fiber (eg, fruits and vegetables). Anthocyanins in blueberries have long been known to prevent cognitive decline with age,” Dr. Wallace said.
Dr. Wallace was part of a 14-member panel of nutrition scientists who recently reviewed available evidence around fruit and vegetable intake and health.
“Our findings are consistent with this study in regard to cognitive decline and other disease states. Cruciferous vegetables, dark-green leafy vegetables, citrus fruits, and dark-colored berries seem to have superior effects on health promotion and disease prevention in general,” said Dr. Wallace.
This work was supported by grants from the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Weber has no relevant disclosures. Dr. Wallace is principal and chief executive officer of the Think Healthy Group; editor of the Journal of Dietary Supplements; and deputy editor-in-chief of the Journal of the American College of Nutrition.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
FDA approves new enzyme replacement therapy for Pompe disease
Pompe disease is a rare genetic disease that occurs in an estimated 1 in 40,000 births. It is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA), which leads to a buildup of glycogen in skeletal and cardiac muscle cells, causing muscle weakness and premature death from respiratory failure or heart failure.
Nexviazyme, administered by intravenous infusion every 2 weeks, supplements GAA and helps reduce glycogen accumulation.
The approval of this product “brings patients with Pompe disease another enzyme replacement therapy option for this rare disease,” said Janet Maynard, MD, deputy director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research, in a news release.
In 2010, the FDA approved alglucosidase alfa (Lumizyme) for the treatment of late-onset Pompe disease.
“The FDA will continue to work with stakeholders to advance the development of additional new, effective, and safe therapies for rare diseases, including Pompe disease,” said Dr. Maynard.
The approval is based on positive phase 3 data that demonstrated improvements in key disease burden measures, including respiratory function and walking disease, and that established the drug’s safety profile, Genzyme said in a news release.
The most common side effects were headache, fatigue, diarrhea, nausea, joint pain, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
Serious reactions included hypersensitivity reactions, such as anaphylaxis, and infusion-associated reactions, including respiratory distress, chills, and pyrexia.
Patients susceptible to fluid volume overload or those with compromised cardiac or respiratory function may be at risk for serious acute cardiorespiratory failure.
The FDA granted Nexviazyme orphan drug designation, priority review, and breakthrough status.
Genzyme expects the new therapy to be available in the United States in the coming weeks and said it will be priced on par with Lumizyme.
A version of this article first appeared on Medscape.com.
Pompe disease is a rare genetic disease that occurs in an estimated 1 in 40,000 births. It is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA), which leads to a buildup of glycogen in skeletal and cardiac muscle cells, causing muscle weakness and premature death from respiratory failure or heart failure.
Nexviazyme, administered by intravenous infusion every 2 weeks, supplements GAA and helps reduce glycogen accumulation.
The approval of this product “brings patients with Pompe disease another enzyme replacement therapy option for this rare disease,” said Janet Maynard, MD, deputy director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research, in a news release.
In 2010, the FDA approved alglucosidase alfa (Lumizyme) for the treatment of late-onset Pompe disease.
“The FDA will continue to work with stakeholders to advance the development of additional new, effective, and safe therapies for rare diseases, including Pompe disease,” said Dr. Maynard.
The approval is based on positive phase 3 data that demonstrated improvements in key disease burden measures, including respiratory function and walking disease, and that established the drug’s safety profile, Genzyme said in a news release.
The most common side effects were headache, fatigue, diarrhea, nausea, joint pain, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
Serious reactions included hypersensitivity reactions, such as anaphylaxis, and infusion-associated reactions, including respiratory distress, chills, and pyrexia.
Patients susceptible to fluid volume overload or those with compromised cardiac or respiratory function may be at risk for serious acute cardiorespiratory failure.
The FDA granted Nexviazyme orphan drug designation, priority review, and breakthrough status.
Genzyme expects the new therapy to be available in the United States in the coming weeks and said it will be priced on par with Lumizyme.
A version of this article first appeared on Medscape.com.
Pompe disease is a rare genetic disease that occurs in an estimated 1 in 40,000 births. It is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA), which leads to a buildup of glycogen in skeletal and cardiac muscle cells, causing muscle weakness and premature death from respiratory failure or heart failure.
Nexviazyme, administered by intravenous infusion every 2 weeks, supplements GAA and helps reduce glycogen accumulation.
The approval of this product “brings patients with Pompe disease another enzyme replacement therapy option for this rare disease,” said Janet Maynard, MD, deputy director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research, in a news release.
In 2010, the FDA approved alglucosidase alfa (Lumizyme) for the treatment of late-onset Pompe disease.
“The FDA will continue to work with stakeholders to advance the development of additional new, effective, and safe therapies for rare diseases, including Pompe disease,” said Dr. Maynard.
The approval is based on positive phase 3 data that demonstrated improvements in key disease burden measures, including respiratory function and walking disease, and that established the drug’s safety profile, Genzyme said in a news release.
The most common side effects were headache, fatigue, diarrhea, nausea, joint pain, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
Serious reactions included hypersensitivity reactions, such as anaphylaxis, and infusion-associated reactions, including respiratory distress, chills, and pyrexia.
Patients susceptible to fluid volume overload or those with compromised cardiac or respiratory function may be at risk for serious acute cardiorespiratory failure.
The FDA granted Nexviazyme orphan drug designation, priority review, and breakthrough status.
Genzyme expects the new therapy to be available in the United States in the coming weeks and said it will be priced on par with Lumizyme.
A version of this article first appeared on Medscape.com.
Myocarditis tied to COVID-19 shots more common than reported?
While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).
They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.
Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.
Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.
They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.
The median age of the cohort was 57 years and 59% were women.
A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.
The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).
A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.
The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.
“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.
Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
Myocarditis cases
The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.
Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.
None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
Pericarditis cases
The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.
Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.
Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.
At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.
The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).
The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).
The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.
“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.
In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.
Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.
“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.
The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.
A version of this article first appeared on Medscape.com.
While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).
They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.
Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.
Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.
They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.
The median age of the cohort was 57 years and 59% were women.
A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.
The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).
A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.
The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.
“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.
Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
Myocarditis cases
The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.
Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.
None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
Pericarditis cases
The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.
Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.
Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.
At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.
The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).
The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).
The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.
“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.
In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.
Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.
“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.
The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.
A version of this article first appeared on Medscape.com.
While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).
They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.
Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.
Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.
They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.
The median age of the cohort was 57 years and 59% were women.
A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.
The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).
A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.
The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.
“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.
Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
Myocarditis cases
The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.
Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.
None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
Pericarditis cases
The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.
Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.
Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.
At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.
The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).
The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).
The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.
“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.
In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.
Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.
“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.
The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.
A version of this article first appeared on Medscape.com.
‘Alarming’ data on early cognitive decline in transgender adults
, new research shows.
Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.
“Trans populations are disproportionately impacted by health disparities and also risk factors for dementia. Putting these pieces together, I wasn’t surprised by their greater risk of cognitive decline,” said study investigator Ethan Cicero, PhD, RN, an assistant professor at Emory University, Atlanta.
The findings were presented at the 2021 Alzheimer’s Association International Conference.
‘Alarming’ finding
SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.
The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019).
The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.
Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).
Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).
The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.
The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.
The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
Cause unclear
“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.
“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.
Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”
“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said.
“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.
“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.
The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.
“Trans populations are disproportionately impacted by health disparities and also risk factors for dementia. Putting these pieces together, I wasn’t surprised by their greater risk of cognitive decline,” said study investigator Ethan Cicero, PhD, RN, an assistant professor at Emory University, Atlanta.
The findings were presented at the 2021 Alzheimer’s Association International Conference.
‘Alarming’ finding
SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.
The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019).
The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.
Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).
Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).
The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.
The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.
The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
Cause unclear
“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.
“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.
Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”
“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said.
“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.
“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.
The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.
“Trans populations are disproportionately impacted by health disparities and also risk factors for dementia. Putting these pieces together, I wasn’t surprised by their greater risk of cognitive decline,” said study investigator Ethan Cicero, PhD, RN, an assistant professor at Emory University, Atlanta.
The findings were presented at the 2021 Alzheimer’s Association International Conference.
‘Alarming’ finding
SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.
The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019).
The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.
Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).
Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).
The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.
The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.
The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
Cause unclear
“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.
“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.
Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”
“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said.
“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.
“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.
The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From AAIC 2021