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Antipsychotics protective against COVID-19?
Antipsychotics may protect against SARS-CoV-2 infection or lead to a milder course of illness, new research suggests.
“Counterintuitively,” the investigators noted, vulnerable people with severe mental illness “on antipsychotic treatment showed a lower risk of SARS-CoV-2 infection and a likely better COVID-19 prognosis.”
“These are very interesting findings that reflect a clinical reality where we see few patients with severe COVID-19, despite the presence of various risk factors,” study investigator Manuel Canal-Rivero, PhD, clinical psychologist, Virgen del Rocio University Hospital, Sevilla, Spain, said in a news release.
“The number of COVID-19 patients is lower than expected among this group of people and in cases where a proven infection does occur, the evolution is benign and does not reach a life-threatening clinical situation. These data as a whole seem to point to the protective effect of the medication,” Dr. Canal-Rivero added.
The study was published online as a letter to the editor February 19, 2021, in Schizophrenia Research.
A ‘striking’ finding
The researchers assessed the prevalence and prognosis of COVID-19 in 698 patients with serious mental disorders (SMDs) receiving treatment with long-acting injectable antipsychotic medication. The non-SMD population included the catchment area population of 557,576 individuals.
From February to November 2020, 4.1% of the non-SMD population were infected with SARS-CoV-2 versus just 1.3% of the SMD population (9 of 698 patients). All but one patient with SMD had asymptomatic illness (8 of 9, 89%). Accurate information on asymptomatic illness in the non-SMD population was not available.
There were also fewer hospital admissions in the SMD population (0% vs. 8.5%), ICU admissions (0% vs. 0.9%) and deaths because of COVID-19 (0% vs. 1.1%), although the differences were not statistically significant.
In related research, the same investigators found that many of the genes whose expression is altered by SARS-CoV-2 infection are significantly down-regulated by antipsychotic drugs.
“In a striking way, we have shown how antipsychotics reduce the activation of genes involved in many of the inflammatory and immunological pathways associated with the severity of COVID-19 infection,” Benedicto Crespo-Facorro, MD, PhD, University of Sevilla, who led the study, said in the news release.
“Although this finding requires replication, the discovery could be very significant because the treatment of COVID-19 with drugs originally indicated for unrelated clinical situations, that is to say drug repositioning, has been shown to be an interesting source of effective treatments for COVID-19 patients,” he added.
Antiviral properties?
In a comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said the findings are “fascinating” and should be explored further.
While the findings on long-acting injectable antipsychotic treatment “seem counterintuitive at first, they are in line with other studies,” said Dr. Ahmad, who heads the inpatient psychiatry unit at Bellevue Hospital Center and is founder of the Integrative Center for Wellness in New York.
“ and antidepressant medications appear to activate key cellular proteins that the SARS-CoV-2 virus uses for replication,” explained Dr. Ahmad, who was not associated with the study.
For example, as reported by this news organization, a preliminary study published in 2020 showed that early treatment with the antidepressant fluvoxamine prevented clinical deterioration in adult outpatients with confirmed COVID-19.
The antipsychotic aripiprazole has also shown potential to treat severe COVID-19 infection.
“Consequently, there appears to be a possible explanation as to why these drugs afford patients with severe mental disorders increased protection against the SARS-CoV-2 virus,” Dr. Ahmad said in an interview.
However, he cautioned, there are several factors at play that could influence the results. Therefore, more research is needed before drawing any firm conclusions.
“Still, the possibility that psychiatric medications may have antiviral properties is a tremendous development and I really hope that additional studies confirm the preliminary findings,” Dr. Ahmad said.
The study had no specific funding. The authors and Dr. Ahmad disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antipsychotics may protect against SARS-CoV-2 infection or lead to a milder course of illness, new research suggests.
“Counterintuitively,” the investigators noted, vulnerable people with severe mental illness “on antipsychotic treatment showed a lower risk of SARS-CoV-2 infection and a likely better COVID-19 prognosis.”
“These are very interesting findings that reflect a clinical reality where we see few patients with severe COVID-19, despite the presence of various risk factors,” study investigator Manuel Canal-Rivero, PhD, clinical psychologist, Virgen del Rocio University Hospital, Sevilla, Spain, said in a news release.
“The number of COVID-19 patients is lower than expected among this group of people and in cases where a proven infection does occur, the evolution is benign and does not reach a life-threatening clinical situation. These data as a whole seem to point to the protective effect of the medication,” Dr. Canal-Rivero added.
The study was published online as a letter to the editor February 19, 2021, in Schizophrenia Research.
A ‘striking’ finding
The researchers assessed the prevalence and prognosis of COVID-19 in 698 patients with serious mental disorders (SMDs) receiving treatment with long-acting injectable antipsychotic medication. The non-SMD population included the catchment area population of 557,576 individuals.
From February to November 2020, 4.1% of the non-SMD population were infected with SARS-CoV-2 versus just 1.3% of the SMD population (9 of 698 patients). All but one patient with SMD had asymptomatic illness (8 of 9, 89%). Accurate information on asymptomatic illness in the non-SMD population was not available.
There were also fewer hospital admissions in the SMD population (0% vs. 8.5%), ICU admissions (0% vs. 0.9%) and deaths because of COVID-19 (0% vs. 1.1%), although the differences were not statistically significant.
In related research, the same investigators found that many of the genes whose expression is altered by SARS-CoV-2 infection are significantly down-regulated by antipsychotic drugs.
“In a striking way, we have shown how antipsychotics reduce the activation of genes involved in many of the inflammatory and immunological pathways associated with the severity of COVID-19 infection,” Benedicto Crespo-Facorro, MD, PhD, University of Sevilla, who led the study, said in the news release.
“Although this finding requires replication, the discovery could be very significant because the treatment of COVID-19 with drugs originally indicated for unrelated clinical situations, that is to say drug repositioning, has been shown to be an interesting source of effective treatments for COVID-19 patients,” he added.
Antiviral properties?
In a comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said the findings are “fascinating” and should be explored further.
While the findings on long-acting injectable antipsychotic treatment “seem counterintuitive at first, they are in line with other studies,” said Dr. Ahmad, who heads the inpatient psychiatry unit at Bellevue Hospital Center and is founder of the Integrative Center for Wellness in New York.
“ and antidepressant medications appear to activate key cellular proteins that the SARS-CoV-2 virus uses for replication,” explained Dr. Ahmad, who was not associated with the study.
For example, as reported by this news organization, a preliminary study published in 2020 showed that early treatment with the antidepressant fluvoxamine prevented clinical deterioration in adult outpatients with confirmed COVID-19.
The antipsychotic aripiprazole has also shown potential to treat severe COVID-19 infection.
“Consequently, there appears to be a possible explanation as to why these drugs afford patients with severe mental disorders increased protection against the SARS-CoV-2 virus,” Dr. Ahmad said in an interview.
However, he cautioned, there are several factors at play that could influence the results. Therefore, more research is needed before drawing any firm conclusions.
“Still, the possibility that psychiatric medications may have antiviral properties is a tremendous development and I really hope that additional studies confirm the preliminary findings,” Dr. Ahmad said.
The study had no specific funding. The authors and Dr. Ahmad disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antipsychotics may protect against SARS-CoV-2 infection or lead to a milder course of illness, new research suggests.
“Counterintuitively,” the investigators noted, vulnerable people with severe mental illness “on antipsychotic treatment showed a lower risk of SARS-CoV-2 infection and a likely better COVID-19 prognosis.”
“These are very interesting findings that reflect a clinical reality where we see few patients with severe COVID-19, despite the presence of various risk factors,” study investigator Manuel Canal-Rivero, PhD, clinical psychologist, Virgen del Rocio University Hospital, Sevilla, Spain, said in a news release.
“The number of COVID-19 patients is lower than expected among this group of people and in cases where a proven infection does occur, the evolution is benign and does not reach a life-threatening clinical situation. These data as a whole seem to point to the protective effect of the medication,” Dr. Canal-Rivero added.
The study was published online as a letter to the editor February 19, 2021, in Schizophrenia Research.
A ‘striking’ finding
The researchers assessed the prevalence and prognosis of COVID-19 in 698 patients with serious mental disorders (SMDs) receiving treatment with long-acting injectable antipsychotic medication. The non-SMD population included the catchment area population of 557,576 individuals.
From February to November 2020, 4.1% of the non-SMD population were infected with SARS-CoV-2 versus just 1.3% of the SMD population (9 of 698 patients). All but one patient with SMD had asymptomatic illness (8 of 9, 89%). Accurate information on asymptomatic illness in the non-SMD population was not available.
There were also fewer hospital admissions in the SMD population (0% vs. 8.5%), ICU admissions (0% vs. 0.9%) and deaths because of COVID-19 (0% vs. 1.1%), although the differences were not statistically significant.
In related research, the same investigators found that many of the genes whose expression is altered by SARS-CoV-2 infection are significantly down-regulated by antipsychotic drugs.
“In a striking way, we have shown how antipsychotics reduce the activation of genes involved in many of the inflammatory and immunological pathways associated with the severity of COVID-19 infection,” Benedicto Crespo-Facorro, MD, PhD, University of Sevilla, who led the study, said in the news release.
“Although this finding requires replication, the discovery could be very significant because the treatment of COVID-19 with drugs originally indicated for unrelated clinical situations, that is to say drug repositioning, has been shown to be an interesting source of effective treatments for COVID-19 patients,” he added.
Antiviral properties?
In a comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said the findings are “fascinating” and should be explored further.
While the findings on long-acting injectable antipsychotic treatment “seem counterintuitive at first, they are in line with other studies,” said Dr. Ahmad, who heads the inpatient psychiatry unit at Bellevue Hospital Center and is founder of the Integrative Center for Wellness in New York.
“ and antidepressant medications appear to activate key cellular proteins that the SARS-CoV-2 virus uses for replication,” explained Dr. Ahmad, who was not associated with the study.
For example, as reported by this news organization, a preliminary study published in 2020 showed that early treatment with the antidepressant fluvoxamine prevented clinical deterioration in adult outpatients with confirmed COVID-19.
The antipsychotic aripiprazole has also shown potential to treat severe COVID-19 infection.
“Consequently, there appears to be a possible explanation as to why these drugs afford patients with severe mental disorders increased protection against the SARS-CoV-2 virus,” Dr. Ahmad said in an interview.
However, he cautioned, there are several factors at play that could influence the results. Therefore, more research is needed before drawing any firm conclusions.
“Still, the possibility that psychiatric medications may have antiviral properties is a tremendous development and I really hope that additional studies confirm the preliminary findings,” Dr. Ahmad said.
The study had no specific funding. The authors and Dr. Ahmad disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA clears nonstimulant for ADHD in children aged 6 years and up
The Food and Drug Administration has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6-17 years, the company has announced.
Viloxazine (formerly SPN-812) is a selective norepinephrine reuptake inhibitor. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce, as needed.
The approval of viloxazine is supported by data from four phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years, the company said.
In one randomized, placebo-controlled phase 3 study that included more than 400 children, viloxazine reduced symptoms of ADHD as soon as 1 week after dosing and was well tolerated.
As reported by this news organization, the study was published last July in Clinical Therapeutics.
In addition to its fast onset of action, the fact that it was effective for both inattentive and hyperactive/impulsive clusters of symptoms is “impressive,” study investigator Andrew Cutler, MD, clinical associate professor of psychiatry, SUNY Upstate Medical University, Syracuse, N.Y., said in an interview.
Also noteworthy was the improvement in measures of quality of life and function, “especially function in the areas of school, home life, family relations, and peer relationships, which can be really disrupted with ADHD,” Dr. Cutler said.
The prescribing label for viloxazine includes a boxed warning regarding the potential for suicidal thoughts and behaviors in some children with ADHD treated with the drug, especially within the first few months of treatment or when the dose is changed.
In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with viloxazine than in patients treated with placebo. Patients taking viloxazine should be closely monitored for any new or sudden changes in mood, behavior, thoughts, and feelings.
Viloxazine has shown promise in a phase 3 trial involving adults with ADHD.
The company plans to submit a supplemental new drug application to the FDA for viloxazine in adults later this year.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6-17 years, the company has announced.
Viloxazine (formerly SPN-812) is a selective norepinephrine reuptake inhibitor. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce, as needed.
The approval of viloxazine is supported by data from four phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years, the company said.
In one randomized, placebo-controlled phase 3 study that included more than 400 children, viloxazine reduced symptoms of ADHD as soon as 1 week after dosing and was well tolerated.
As reported by this news organization, the study was published last July in Clinical Therapeutics.
In addition to its fast onset of action, the fact that it was effective for both inattentive and hyperactive/impulsive clusters of symptoms is “impressive,” study investigator Andrew Cutler, MD, clinical associate professor of psychiatry, SUNY Upstate Medical University, Syracuse, N.Y., said in an interview.
Also noteworthy was the improvement in measures of quality of life and function, “especially function in the areas of school, home life, family relations, and peer relationships, which can be really disrupted with ADHD,” Dr. Cutler said.
The prescribing label for viloxazine includes a boxed warning regarding the potential for suicidal thoughts and behaviors in some children with ADHD treated with the drug, especially within the first few months of treatment or when the dose is changed.
In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with viloxazine than in patients treated with placebo. Patients taking viloxazine should be closely monitored for any new or sudden changes in mood, behavior, thoughts, and feelings.
Viloxazine has shown promise in a phase 3 trial involving adults with ADHD.
The company plans to submit a supplemental new drug application to the FDA for viloxazine in adults later this year.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6-17 years, the company has announced.
Viloxazine (formerly SPN-812) is a selective norepinephrine reuptake inhibitor. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce, as needed.
The approval of viloxazine is supported by data from four phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years, the company said.
In one randomized, placebo-controlled phase 3 study that included more than 400 children, viloxazine reduced symptoms of ADHD as soon as 1 week after dosing and was well tolerated.
As reported by this news organization, the study was published last July in Clinical Therapeutics.
In addition to its fast onset of action, the fact that it was effective for both inattentive and hyperactive/impulsive clusters of symptoms is “impressive,” study investigator Andrew Cutler, MD, clinical associate professor of psychiatry, SUNY Upstate Medical University, Syracuse, N.Y., said in an interview.
Also noteworthy was the improvement in measures of quality of life and function, “especially function in the areas of school, home life, family relations, and peer relationships, which can be really disrupted with ADHD,” Dr. Cutler said.
The prescribing label for viloxazine includes a boxed warning regarding the potential for suicidal thoughts and behaviors in some children with ADHD treated with the drug, especially within the first few months of treatment or when the dose is changed.
In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with viloxazine than in patients treated with placebo. Patients taking viloxazine should be closely monitored for any new or sudden changes in mood, behavior, thoughts, and feelings.
Viloxazine has shown promise in a phase 3 trial involving adults with ADHD.
The company plans to submit a supplemental new drug application to the FDA for viloxazine in adults later this year.
A version of this article first appeared on Medscape.com.
Six pregnancy complications flag later heart disease risk
Six pregnancy-related complications increase a woman’s risk of developing risk factors for cardiovascular disease (CVD) and subsequently developing CVD, the American Heart Association says in a new scientific statement.
They are hypertensive disorders of pregnancy, preterm delivery, gestational diabetes, small-for-gestational-age (SGA) delivery, placental abruption (abruptio placentae), and pregnancy loss.
A history of any of these adverse pregnancy outcomes should prompt “more vigorous primordial prevention of CVD risk factors and primary prevention of CVD,” the writing group says.
“Adverse pregnancy outcomes are linked to women having hypertension, diabetes, abnormal cholesterol, and cardiovascular disease events, including heart attack and stroke, long after their pregnancies,” Nisha I. Parikh, MD, MPH, chair of the writing group, said in a news release.
Adverse pregnancy outcomes can be a “powerful window” into CVD prevention “if women and their health care professionals harness the knowledge and use it for health improvement,” said Dr. Parikh, associate professor of medicine in the cardiovascular division at the University of California, San Francisco.
The statement was published online March 29 in Circulation.
For the scientific statement, the writing group reviewed the latest scientific literature on adverse pregnancy outcomes and CVD risk.
The evidence in the literature linking adverse pregnancy outcomes to later CVD is “consistent over many years and confirmed in nearly every study we examined,” Dr. Parikh said. Among their key findings:
- Gestational hypertension is associated with an increased risk of CVD later in life by 67% and the odds of stroke by 83%. Moderate and severe is associated with a more than twofold increase in the risk for CVD.
- Gestational diabetes is associated with an increase in the risk for CVD by 68% and the risk of developing after pregnancy by 10-fold.
- Preterm delivery (before 37 weeks) is associated with double the risk of developing CVD and is strongly associated with later heart disease, stroke, and CVD.
- Placental abruption is associated with an 82% increased risk for CVD.
- Stillbirth is associated with about double the risk for CVD.
“This statement should inform future prevention guidelines in terms of the important factors to consider for determining women’s risk for heart diseases and stroke,” Dr. Parikh added.
The statement emphasizes the importance of recognizing these adverse pregnancy outcomes when evaluating CVD risk in women but notes that their value in reclassifying CVD risk may not be established.
It highlights the importance of adopting a heart-healthy diet and increasing physical activity among women with any of these pregnancy-related complications, starting right after childbirth and continuing across the life span to decrease CVD risk.
Lactation and breastfeeding may lower a woman’s later cardiometabolic risk, the writing group notes.
‘Golden year of opportunity’
The statement highlights several opportunities to improve transition of care for women with adverse pregnancy outcomes and to implement strategies to reduce their long-term CVD risk.
One strategy is longer postpartum follow-up care, sometimes referred to as the “fourth trimester,” to screen for CVD risk factors and provide CVD prevention counseling.
Another strategy involves improving the transfer of health information between ob/gyns and primary care physicians to eliminate inconsistencies in electronic health record documentation, which should improve patient care.
A third strategy is obtaining a short and targeted health history for each woman to confirm if she has any of the six pregnancy-related complications.
“If a woman has had any of these adverse pregnancy outcomes, consider close blood pressure monitoring, type 2 diabetes and lipid screening, and more aggressive risk factor modification and CVD prevention recommendations,” Dr. Parikh advised.
“Our data [lend] support to the prior AHA recommendation that these important adverse pregnancy outcomes should be ‘risk enhancers’ to guide consideration for statin therapy aimed at CVD prevention in women,” Dr. Parikh added.
In a commentary in Circulation, Eliza C. Miller, MD, assistant professor of neurology at Columbia University, New York, notes that pregnancy and the postpartum period are a critical time window in a woman’s life to identify CVD risk and improve a woman’s health trajectory.
“The so-called ‘Golden Hour’ for conditions such as sepsis and acute stroke refers to a critical time window for early recognition and treatment, when we can change a patient’s clinical trajectory and prevent severe morbidity and mortality,” writes Dr. Miller.
“Pregnancy and the postpartum period can be considered a ‘Golden Year’ in a woman’s life, offering a rare opportunity for clinicians to identify young women at risk and work with them to improve their cardiovascular health trajectories,” she notes.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular and Stroke Nursing; and the Stroke Council.
The authors of the scientific statement have disclosed no relevant financial relationships. Dr. Miller received personal compensation from Finch McCranie and Argionis & Associates for expert testimony regarding maternal stroke; and personal compensation from Elsevier for editorial work on Handbook of Clinical Neurology, Vol. 171 and 172 (Neurology of Pregnancy).
A version of this article first appeared on Medscape.com.
Six pregnancy-related complications increase a woman’s risk of developing risk factors for cardiovascular disease (CVD) and subsequently developing CVD, the American Heart Association says in a new scientific statement.
They are hypertensive disorders of pregnancy, preterm delivery, gestational diabetes, small-for-gestational-age (SGA) delivery, placental abruption (abruptio placentae), and pregnancy loss.
A history of any of these adverse pregnancy outcomes should prompt “more vigorous primordial prevention of CVD risk factors and primary prevention of CVD,” the writing group says.
“Adverse pregnancy outcomes are linked to women having hypertension, diabetes, abnormal cholesterol, and cardiovascular disease events, including heart attack and stroke, long after their pregnancies,” Nisha I. Parikh, MD, MPH, chair of the writing group, said in a news release.
Adverse pregnancy outcomes can be a “powerful window” into CVD prevention “if women and their health care professionals harness the knowledge and use it for health improvement,” said Dr. Parikh, associate professor of medicine in the cardiovascular division at the University of California, San Francisco.
The statement was published online March 29 in Circulation.
For the scientific statement, the writing group reviewed the latest scientific literature on adverse pregnancy outcomes and CVD risk.
The evidence in the literature linking adverse pregnancy outcomes to later CVD is “consistent over many years and confirmed in nearly every study we examined,” Dr. Parikh said. Among their key findings:
- Gestational hypertension is associated with an increased risk of CVD later in life by 67% and the odds of stroke by 83%. Moderate and severe is associated with a more than twofold increase in the risk for CVD.
- Gestational diabetes is associated with an increase in the risk for CVD by 68% and the risk of developing after pregnancy by 10-fold.
- Preterm delivery (before 37 weeks) is associated with double the risk of developing CVD and is strongly associated with later heart disease, stroke, and CVD.
- Placental abruption is associated with an 82% increased risk for CVD.
- Stillbirth is associated with about double the risk for CVD.
“This statement should inform future prevention guidelines in terms of the important factors to consider for determining women’s risk for heart diseases and stroke,” Dr. Parikh added.
The statement emphasizes the importance of recognizing these adverse pregnancy outcomes when evaluating CVD risk in women but notes that their value in reclassifying CVD risk may not be established.
It highlights the importance of adopting a heart-healthy diet and increasing physical activity among women with any of these pregnancy-related complications, starting right after childbirth and continuing across the life span to decrease CVD risk.
Lactation and breastfeeding may lower a woman’s later cardiometabolic risk, the writing group notes.
‘Golden year of opportunity’
The statement highlights several opportunities to improve transition of care for women with adverse pregnancy outcomes and to implement strategies to reduce their long-term CVD risk.
One strategy is longer postpartum follow-up care, sometimes referred to as the “fourth trimester,” to screen for CVD risk factors and provide CVD prevention counseling.
Another strategy involves improving the transfer of health information between ob/gyns and primary care physicians to eliminate inconsistencies in electronic health record documentation, which should improve patient care.
A third strategy is obtaining a short and targeted health history for each woman to confirm if she has any of the six pregnancy-related complications.
“If a woman has had any of these adverse pregnancy outcomes, consider close blood pressure monitoring, type 2 diabetes and lipid screening, and more aggressive risk factor modification and CVD prevention recommendations,” Dr. Parikh advised.
“Our data [lend] support to the prior AHA recommendation that these important adverse pregnancy outcomes should be ‘risk enhancers’ to guide consideration for statin therapy aimed at CVD prevention in women,” Dr. Parikh added.
In a commentary in Circulation, Eliza C. Miller, MD, assistant professor of neurology at Columbia University, New York, notes that pregnancy and the postpartum period are a critical time window in a woman’s life to identify CVD risk and improve a woman’s health trajectory.
“The so-called ‘Golden Hour’ for conditions such as sepsis and acute stroke refers to a critical time window for early recognition and treatment, when we can change a patient’s clinical trajectory and prevent severe morbidity and mortality,” writes Dr. Miller.
“Pregnancy and the postpartum period can be considered a ‘Golden Year’ in a woman’s life, offering a rare opportunity for clinicians to identify young women at risk and work with them to improve their cardiovascular health trajectories,” she notes.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular and Stroke Nursing; and the Stroke Council.
The authors of the scientific statement have disclosed no relevant financial relationships. Dr. Miller received personal compensation from Finch McCranie and Argionis & Associates for expert testimony regarding maternal stroke; and personal compensation from Elsevier for editorial work on Handbook of Clinical Neurology, Vol. 171 and 172 (Neurology of Pregnancy).
A version of this article first appeared on Medscape.com.
Six pregnancy-related complications increase a woman’s risk of developing risk factors for cardiovascular disease (CVD) and subsequently developing CVD, the American Heart Association says in a new scientific statement.
They are hypertensive disorders of pregnancy, preterm delivery, gestational diabetes, small-for-gestational-age (SGA) delivery, placental abruption (abruptio placentae), and pregnancy loss.
A history of any of these adverse pregnancy outcomes should prompt “more vigorous primordial prevention of CVD risk factors and primary prevention of CVD,” the writing group says.
“Adverse pregnancy outcomes are linked to women having hypertension, diabetes, abnormal cholesterol, and cardiovascular disease events, including heart attack and stroke, long after their pregnancies,” Nisha I. Parikh, MD, MPH, chair of the writing group, said in a news release.
Adverse pregnancy outcomes can be a “powerful window” into CVD prevention “if women and their health care professionals harness the knowledge and use it for health improvement,” said Dr. Parikh, associate professor of medicine in the cardiovascular division at the University of California, San Francisco.
The statement was published online March 29 in Circulation.
For the scientific statement, the writing group reviewed the latest scientific literature on adverse pregnancy outcomes and CVD risk.
The evidence in the literature linking adverse pregnancy outcomes to later CVD is “consistent over many years and confirmed in nearly every study we examined,” Dr. Parikh said. Among their key findings:
- Gestational hypertension is associated with an increased risk of CVD later in life by 67% and the odds of stroke by 83%. Moderate and severe is associated with a more than twofold increase in the risk for CVD.
- Gestational diabetes is associated with an increase in the risk for CVD by 68% and the risk of developing after pregnancy by 10-fold.
- Preterm delivery (before 37 weeks) is associated with double the risk of developing CVD and is strongly associated with later heart disease, stroke, and CVD.
- Placental abruption is associated with an 82% increased risk for CVD.
- Stillbirth is associated with about double the risk for CVD.
“This statement should inform future prevention guidelines in terms of the important factors to consider for determining women’s risk for heart diseases and stroke,” Dr. Parikh added.
The statement emphasizes the importance of recognizing these adverse pregnancy outcomes when evaluating CVD risk in women but notes that their value in reclassifying CVD risk may not be established.
It highlights the importance of adopting a heart-healthy diet and increasing physical activity among women with any of these pregnancy-related complications, starting right after childbirth and continuing across the life span to decrease CVD risk.
Lactation and breastfeeding may lower a woman’s later cardiometabolic risk, the writing group notes.
‘Golden year of opportunity’
The statement highlights several opportunities to improve transition of care for women with adverse pregnancy outcomes and to implement strategies to reduce their long-term CVD risk.
One strategy is longer postpartum follow-up care, sometimes referred to as the “fourth trimester,” to screen for CVD risk factors and provide CVD prevention counseling.
Another strategy involves improving the transfer of health information between ob/gyns and primary care physicians to eliminate inconsistencies in electronic health record documentation, which should improve patient care.
A third strategy is obtaining a short and targeted health history for each woman to confirm if she has any of the six pregnancy-related complications.
“If a woman has had any of these adverse pregnancy outcomes, consider close blood pressure monitoring, type 2 diabetes and lipid screening, and more aggressive risk factor modification and CVD prevention recommendations,” Dr. Parikh advised.
“Our data [lend] support to the prior AHA recommendation that these important adverse pregnancy outcomes should be ‘risk enhancers’ to guide consideration for statin therapy aimed at CVD prevention in women,” Dr. Parikh added.
In a commentary in Circulation, Eliza C. Miller, MD, assistant professor of neurology at Columbia University, New York, notes that pregnancy and the postpartum period are a critical time window in a woman’s life to identify CVD risk and improve a woman’s health trajectory.
“The so-called ‘Golden Hour’ for conditions such as sepsis and acute stroke refers to a critical time window for early recognition and treatment, when we can change a patient’s clinical trajectory and prevent severe morbidity and mortality,” writes Dr. Miller.
“Pregnancy and the postpartum period can be considered a ‘Golden Year’ in a woman’s life, offering a rare opportunity for clinicians to identify young women at risk and work with them to improve their cardiovascular health trajectories,” she notes.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular and Stroke Nursing; and the Stroke Council.
The authors of the scientific statement have disclosed no relevant financial relationships. Dr. Miller received personal compensation from Finch McCranie and Argionis & Associates for expert testimony regarding maternal stroke; and personal compensation from Elsevier for editorial work on Handbook of Clinical Neurology, Vol. 171 and 172 (Neurology of Pregnancy).
A version of this article first appeared on Medscape.com.
New expert guidance on ketamine for resistant depression
An international panel of mood disorder experts has published guidance on how to safely and effectively use ketamine and esketamine to treat adults with treatment-resistant depression (TRD).
“Ketamine and esketamine are the first rapid-onset treatments for adults with TRD, and there was an international need for best-practice guidance on the deft and safe implementation of ketamine and esketamine at the point of care, as none previously existed,” first author Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said in an interview.
“This need has only been amplified by the significant increase in the number of clinics and centers providing this treatment,” added Dr. McIntyre, head of the mood disorders psychopharmacology unit.
Their article was published online March 17 in the American Journal of Psychiatry.
Insufficient evidence of long-term efficacy
As reported by this news organization, the U.S. Food and Drug Administration (FDA) approved esketamine nasal spray (Spravato) for TRD in March 2019.
In August 2020, the FDA updated the approval to include adults with major depression and suicidal thoughts or actions.
To provide clinical guidance, Dr. McIntyre and colleagues synthesized the available literature on the efficacy, safety, and tolerability of ketamine and esketamine for TRD.
The evidence, they note, supports the rapid-onset (within 1-2 days) efficacy of esketamine and ketamine in TRD.
The strongest evidence of efficacy is for intranasal esketamine and intravenous ketamine. There is insufficient evidence for oral, subcutaneous, or intramuscular ketamine for TRD, they report.
Intranasal esketamine demonstrates efficacy, safety, and tolerability for up to 1 year in adults with TRD. Evidence for long-term efficacy, safety, and tolerability of intravenous ketamine for patients with TRD is insufficient, the group notes.
They also note that esketamine is approved in the United States for major depression in association with suicidal ideation or behavior and that it has been proven to reduce suicide completion.
Safety concerns with ketamine and esketamine identified in the literature include, but are not limited to, psychiatric, neurologic/cognitive, genitourinary, and hemodynamic effects.
Implementation checklist
The group has developed an “implementation checklist” for use of ketamine/esketamine in clinical practice.
Starting with patient selection, they note that appropriate patients are those with a confirmed diagnosis of TRD for whom psychosis and other conditions that would significantly affect the risk-benefit ratio have been ruled out.
They suggest that a physical examination and monitoring of vital signs be undertaken during treatment and during posttreatment surveillance. A urine drug screen should be considered if appropriate.
The group advises that esketamine and ketamine be administered only in settings with multidisciplinary personnel, including, but not limited to, those with expertise in the assessment of mood disorders.
Clinics should be equipped with appropriate cardiorespiratory monitoring and be capable of psychiatric assessment of dissociation and psychotomimetic effects.
Depressive symptoms should be measured, and the authors suggest assessing for anxiety, cognitive function, well-being, and psychosocial function.
Patients should be monitored immediately after treatment to ensure cardiorespiratory stability, clear sensorium, and attenuation of dissociative and psychotomimetic effects.
The United States and some other countries require a risk evaluation and mitigation strategy (REMS) when administering esketamine. Regarding the REMS, it is advised that all patients be monitored for a minimum of 2 hours before discharge.
Patients should arrange for reliable transportation for each appointment, and they should be advised not to operate motor vehicles or hazardous machinery without at least one night of sleep.
, only worsened by COVID-19,” said Dr. McIntyre.
“Clinicians of different professional backgrounds have been interested in ketamine/esketamine, and we are extraordinarily pleased to see our international guidelines published,” he added.
‘Extremely useful’
Reached for comment, Alan Schatzberg, MD, professor of psychiatry and behavioral sciences at Stanford (Calif.) University, said this document “puts a lot of information in one place as far as what we know and what we don’t know right now, and that’s helpful. I think it’s an attempt to have a kind of a somewhat objective review of the literature, and it’s in a good journal.”
The article, Dr. Schatzberg added, “could be extremely useful for someone who is considering whether ketamine is useful for a patient or what they can tell a patient about ketamine, that is, about how long they might need, is it going to work, will it continue to work, and the level of data we have either on benefits or side effects.”
The research had no specific funding. The original article contains a complete list of author disclosures. Dr. Schatzberg has received grant support from Janssen; has served as a consultant for Alkermes, Avanir, Brain Resource, Bracket, Compass, Delpor, Epiodyne, GLG, Jazz, Janssen Pharmaceuticals, Lundbeck/Takeda, McKinsey and Company, Merck, Myriad Genetics, Neuronetics, Owl Analytics, Pfizer, Sage, Sunovion, and Xhale; holds equity in Corcept (cofounder), Delpor, Dermira, Epiodyne, Gilead, Incyte Genetics, Intersect ENT, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale; and is listed as an inventor on patents for pharmacogenetics and antiglucocorticoid use in the prediction of antidepressant response.
A version of this article first appeared on Medscape.com.
An international panel of mood disorder experts has published guidance on how to safely and effectively use ketamine and esketamine to treat adults with treatment-resistant depression (TRD).
“Ketamine and esketamine are the first rapid-onset treatments for adults with TRD, and there was an international need for best-practice guidance on the deft and safe implementation of ketamine and esketamine at the point of care, as none previously existed,” first author Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said in an interview.
“This need has only been amplified by the significant increase in the number of clinics and centers providing this treatment,” added Dr. McIntyre, head of the mood disorders psychopharmacology unit.
Their article was published online March 17 in the American Journal of Psychiatry.
Insufficient evidence of long-term efficacy
As reported by this news organization, the U.S. Food and Drug Administration (FDA) approved esketamine nasal spray (Spravato) for TRD in March 2019.
In August 2020, the FDA updated the approval to include adults with major depression and suicidal thoughts or actions.
To provide clinical guidance, Dr. McIntyre and colleagues synthesized the available literature on the efficacy, safety, and tolerability of ketamine and esketamine for TRD.
The evidence, they note, supports the rapid-onset (within 1-2 days) efficacy of esketamine and ketamine in TRD.
The strongest evidence of efficacy is for intranasal esketamine and intravenous ketamine. There is insufficient evidence for oral, subcutaneous, or intramuscular ketamine for TRD, they report.
Intranasal esketamine demonstrates efficacy, safety, and tolerability for up to 1 year in adults with TRD. Evidence for long-term efficacy, safety, and tolerability of intravenous ketamine for patients with TRD is insufficient, the group notes.
They also note that esketamine is approved in the United States for major depression in association with suicidal ideation or behavior and that it has been proven to reduce suicide completion.
Safety concerns with ketamine and esketamine identified in the literature include, but are not limited to, psychiatric, neurologic/cognitive, genitourinary, and hemodynamic effects.
Implementation checklist
The group has developed an “implementation checklist” for use of ketamine/esketamine in clinical practice.
Starting with patient selection, they note that appropriate patients are those with a confirmed diagnosis of TRD for whom psychosis and other conditions that would significantly affect the risk-benefit ratio have been ruled out.
They suggest that a physical examination and monitoring of vital signs be undertaken during treatment and during posttreatment surveillance. A urine drug screen should be considered if appropriate.
The group advises that esketamine and ketamine be administered only in settings with multidisciplinary personnel, including, but not limited to, those with expertise in the assessment of mood disorders.
Clinics should be equipped with appropriate cardiorespiratory monitoring and be capable of psychiatric assessment of dissociation and psychotomimetic effects.
Depressive symptoms should be measured, and the authors suggest assessing for anxiety, cognitive function, well-being, and psychosocial function.
Patients should be monitored immediately after treatment to ensure cardiorespiratory stability, clear sensorium, and attenuation of dissociative and psychotomimetic effects.
The United States and some other countries require a risk evaluation and mitigation strategy (REMS) when administering esketamine. Regarding the REMS, it is advised that all patients be monitored for a minimum of 2 hours before discharge.
Patients should arrange for reliable transportation for each appointment, and they should be advised not to operate motor vehicles or hazardous machinery without at least one night of sleep.
, only worsened by COVID-19,” said Dr. McIntyre.
“Clinicians of different professional backgrounds have been interested in ketamine/esketamine, and we are extraordinarily pleased to see our international guidelines published,” he added.
‘Extremely useful’
Reached for comment, Alan Schatzberg, MD, professor of psychiatry and behavioral sciences at Stanford (Calif.) University, said this document “puts a lot of information in one place as far as what we know and what we don’t know right now, and that’s helpful. I think it’s an attempt to have a kind of a somewhat objective review of the literature, and it’s in a good journal.”
The article, Dr. Schatzberg added, “could be extremely useful for someone who is considering whether ketamine is useful for a patient or what they can tell a patient about ketamine, that is, about how long they might need, is it going to work, will it continue to work, and the level of data we have either on benefits or side effects.”
The research had no specific funding. The original article contains a complete list of author disclosures. Dr. Schatzberg has received grant support from Janssen; has served as a consultant for Alkermes, Avanir, Brain Resource, Bracket, Compass, Delpor, Epiodyne, GLG, Jazz, Janssen Pharmaceuticals, Lundbeck/Takeda, McKinsey and Company, Merck, Myriad Genetics, Neuronetics, Owl Analytics, Pfizer, Sage, Sunovion, and Xhale; holds equity in Corcept (cofounder), Delpor, Dermira, Epiodyne, Gilead, Incyte Genetics, Intersect ENT, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale; and is listed as an inventor on patents for pharmacogenetics and antiglucocorticoid use in the prediction of antidepressant response.
A version of this article first appeared on Medscape.com.
An international panel of mood disorder experts has published guidance on how to safely and effectively use ketamine and esketamine to treat adults with treatment-resistant depression (TRD).
“Ketamine and esketamine are the first rapid-onset treatments for adults with TRD, and there was an international need for best-practice guidance on the deft and safe implementation of ketamine and esketamine at the point of care, as none previously existed,” first author Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said in an interview.
“This need has only been amplified by the significant increase in the number of clinics and centers providing this treatment,” added Dr. McIntyre, head of the mood disorders psychopharmacology unit.
Their article was published online March 17 in the American Journal of Psychiatry.
Insufficient evidence of long-term efficacy
As reported by this news organization, the U.S. Food and Drug Administration (FDA) approved esketamine nasal spray (Spravato) for TRD in March 2019.
In August 2020, the FDA updated the approval to include adults with major depression and suicidal thoughts or actions.
To provide clinical guidance, Dr. McIntyre and colleagues synthesized the available literature on the efficacy, safety, and tolerability of ketamine and esketamine for TRD.
The evidence, they note, supports the rapid-onset (within 1-2 days) efficacy of esketamine and ketamine in TRD.
The strongest evidence of efficacy is for intranasal esketamine and intravenous ketamine. There is insufficient evidence for oral, subcutaneous, or intramuscular ketamine for TRD, they report.
Intranasal esketamine demonstrates efficacy, safety, and tolerability for up to 1 year in adults with TRD. Evidence for long-term efficacy, safety, and tolerability of intravenous ketamine for patients with TRD is insufficient, the group notes.
They also note that esketamine is approved in the United States for major depression in association with suicidal ideation or behavior and that it has been proven to reduce suicide completion.
Safety concerns with ketamine and esketamine identified in the literature include, but are not limited to, psychiatric, neurologic/cognitive, genitourinary, and hemodynamic effects.
Implementation checklist
The group has developed an “implementation checklist” for use of ketamine/esketamine in clinical practice.
Starting with patient selection, they note that appropriate patients are those with a confirmed diagnosis of TRD for whom psychosis and other conditions that would significantly affect the risk-benefit ratio have been ruled out.
They suggest that a physical examination and monitoring of vital signs be undertaken during treatment and during posttreatment surveillance. A urine drug screen should be considered if appropriate.
The group advises that esketamine and ketamine be administered only in settings with multidisciplinary personnel, including, but not limited to, those with expertise in the assessment of mood disorders.
Clinics should be equipped with appropriate cardiorespiratory monitoring and be capable of psychiatric assessment of dissociation and psychotomimetic effects.
Depressive symptoms should be measured, and the authors suggest assessing for anxiety, cognitive function, well-being, and psychosocial function.
Patients should be monitored immediately after treatment to ensure cardiorespiratory stability, clear sensorium, and attenuation of dissociative and psychotomimetic effects.
The United States and some other countries require a risk evaluation and mitigation strategy (REMS) when administering esketamine. Regarding the REMS, it is advised that all patients be monitored for a minimum of 2 hours before discharge.
Patients should arrange for reliable transportation for each appointment, and they should be advised not to operate motor vehicles or hazardous machinery without at least one night of sleep.
, only worsened by COVID-19,” said Dr. McIntyre.
“Clinicians of different professional backgrounds have been interested in ketamine/esketamine, and we are extraordinarily pleased to see our international guidelines published,” he added.
‘Extremely useful’
Reached for comment, Alan Schatzberg, MD, professor of psychiatry and behavioral sciences at Stanford (Calif.) University, said this document “puts a lot of information in one place as far as what we know and what we don’t know right now, and that’s helpful. I think it’s an attempt to have a kind of a somewhat objective review of the literature, and it’s in a good journal.”
The article, Dr. Schatzberg added, “could be extremely useful for someone who is considering whether ketamine is useful for a patient or what they can tell a patient about ketamine, that is, about how long they might need, is it going to work, will it continue to work, and the level of data we have either on benefits or side effects.”
The research had no specific funding. The original article contains a complete list of author disclosures. Dr. Schatzberg has received grant support from Janssen; has served as a consultant for Alkermes, Avanir, Brain Resource, Bracket, Compass, Delpor, Epiodyne, GLG, Jazz, Janssen Pharmaceuticals, Lundbeck/Takeda, McKinsey and Company, Merck, Myriad Genetics, Neuronetics, Owl Analytics, Pfizer, Sage, Sunovion, and Xhale; holds equity in Corcept (cofounder), Delpor, Dermira, Epiodyne, Gilead, Incyte Genetics, Intersect ENT, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale; and is listed as an inventor on patents for pharmacogenetics and antiglucocorticoid use in the prediction of antidepressant response.
A version of this article first appeared on Medscape.com.
Prenatal dietary folate not enough to offset AEDs’ effect on kids’ cognition
New research underscores the importance of folic acid supplementation for pregnant women with epilepsy who are taking antiepileptic drugs (AEDs).
Dietary folate alone, even in the United States, where food is fortified with folic acid, is “not sufficient” to improve cognitive outcomes for children of women who take AEDs during pregnancy, the researchers report.
“We found that dietary folate was not related to outcomes,” study investigator Kimford Meador, MD, professor of neurology and neurologic sciences, Stanford (Calif.) University, told this news organization.
“Only when the mother was taking extra folate did we see an improvement in child outcomes,” he added.
The findings were published online Feb. 23 in Epilepsy and Behavior.
Cognitive boost
“Daily folate is recommended to women in the general populations to reduce congenital malformations,” Dr. Meador said. In addition, periconceptional use of folate has been shown in previous research to improve neurodevelopmental outcomes for children of mothers with epilepsy who are taking AEDs.
Whether folate-fortified food alone, without supplements, has any effect on cognitive outcomes in this population of children has not been examined previously.
To investigate, the researchers assessed 117 children from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, a prospective, observational study of women with epilepsy who were taking one of four AEDs: carbamazepine, lamotrigine, phenytoin, or valproate.
Results showed that dietary folate from fortified food alone, without supplements, had no significant impact on IQ at age 6 years among children with prenatal exposure to AEDs.
In contrast, use of periconceptual folate supplements was significantly associated with a 10-point higher IQ at age 6 in the adjusted analyses (95% confidence interval, 5.2-15.0; P < .001).
These six other nutrients from food and supplements had no significant association with IQ at age 6 years: vitamins C, D, and E, omega-3, gamma tocopherol, and vitamin B12.
Optimal dose unclear
The findings indicate that folates, including natural folate and folic acid, in food do not have positive cognitive effects for children of women with epilepsy who take AEDs, the researchers write.
Dr. Meador noted that the optimal dose of folic acid supplementation to provide a cognitive benefit remains unclear.
The U.S. Centers for Disease Control recommends 0.4 mg/d for the general population of women of childbearing age. In Europe, the recommendation is 1 mg/d.
“Higher doses are recommended if there is a personal or family history of spina bifida in prior pregnancies, but there is some concern that very high doses of folate may be detrimental,” Dr. Meador said.
For women with epilepsy, he would recommend “at least 1 mg/d and not more than 4 mg/d.”
Proves a point?
Commenting on the study for this news organization, Derek Chong, MD, vice chair of neurology and director of epilepsy at Lenox Hill Hospital, New York, said the finding that folate fortification of food alone is not adequate for women with epilepsy is “not groundbreaking” but does prove something previously thought.
“Folic acid is important for all women, but it does seem like folic acid may be even more important in the epilepsy population,” said Dr. Chong, who was not involved with the research.
He cautioned that the current analysis included only four medications, three of which are not used very often anymore.
“Lamotrigine is probably the most commonly used one now. It’s unfortunate that this study did not include Keppra [levetiracetam], which probably is the number one medication that we use now,” Dr. Chong said.
The research was supported by the National Institutes of Health. Dr. Meador and Dr. Chong have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New research underscores the importance of folic acid supplementation for pregnant women with epilepsy who are taking antiepileptic drugs (AEDs).
Dietary folate alone, even in the United States, where food is fortified with folic acid, is “not sufficient” to improve cognitive outcomes for children of women who take AEDs during pregnancy, the researchers report.
“We found that dietary folate was not related to outcomes,” study investigator Kimford Meador, MD, professor of neurology and neurologic sciences, Stanford (Calif.) University, told this news organization.
“Only when the mother was taking extra folate did we see an improvement in child outcomes,” he added.
The findings were published online Feb. 23 in Epilepsy and Behavior.
Cognitive boost
“Daily folate is recommended to women in the general populations to reduce congenital malformations,” Dr. Meador said. In addition, periconceptional use of folate has been shown in previous research to improve neurodevelopmental outcomes for children of mothers with epilepsy who are taking AEDs.
Whether folate-fortified food alone, without supplements, has any effect on cognitive outcomes in this population of children has not been examined previously.
To investigate, the researchers assessed 117 children from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, a prospective, observational study of women with epilepsy who were taking one of four AEDs: carbamazepine, lamotrigine, phenytoin, or valproate.
Results showed that dietary folate from fortified food alone, without supplements, had no significant impact on IQ at age 6 years among children with prenatal exposure to AEDs.
In contrast, use of periconceptual folate supplements was significantly associated with a 10-point higher IQ at age 6 in the adjusted analyses (95% confidence interval, 5.2-15.0; P < .001).
These six other nutrients from food and supplements had no significant association with IQ at age 6 years: vitamins C, D, and E, omega-3, gamma tocopherol, and vitamin B12.
Optimal dose unclear
The findings indicate that folates, including natural folate and folic acid, in food do not have positive cognitive effects for children of women with epilepsy who take AEDs, the researchers write.
Dr. Meador noted that the optimal dose of folic acid supplementation to provide a cognitive benefit remains unclear.
The U.S. Centers for Disease Control recommends 0.4 mg/d for the general population of women of childbearing age. In Europe, the recommendation is 1 mg/d.
“Higher doses are recommended if there is a personal or family history of spina bifida in prior pregnancies, but there is some concern that very high doses of folate may be detrimental,” Dr. Meador said.
For women with epilepsy, he would recommend “at least 1 mg/d and not more than 4 mg/d.”
Proves a point?
Commenting on the study for this news organization, Derek Chong, MD, vice chair of neurology and director of epilepsy at Lenox Hill Hospital, New York, said the finding that folate fortification of food alone is not adequate for women with epilepsy is “not groundbreaking” but does prove something previously thought.
“Folic acid is important for all women, but it does seem like folic acid may be even more important in the epilepsy population,” said Dr. Chong, who was not involved with the research.
He cautioned that the current analysis included only four medications, three of which are not used very often anymore.
“Lamotrigine is probably the most commonly used one now. It’s unfortunate that this study did not include Keppra [levetiracetam], which probably is the number one medication that we use now,” Dr. Chong said.
The research was supported by the National Institutes of Health. Dr. Meador and Dr. Chong have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New research underscores the importance of folic acid supplementation for pregnant women with epilepsy who are taking antiepileptic drugs (AEDs).
Dietary folate alone, even in the United States, where food is fortified with folic acid, is “not sufficient” to improve cognitive outcomes for children of women who take AEDs during pregnancy, the researchers report.
“We found that dietary folate was not related to outcomes,” study investigator Kimford Meador, MD, professor of neurology and neurologic sciences, Stanford (Calif.) University, told this news organization.
“Only when the mother was taking extra folate did we see an improvement in child outcomes,” he added.
The findings were published online Feb. 23 in Epilepsy and Behavior.
Cognitive boost
“Daily folate is recommended to women in the general populations to reduce congenital malformations,” Dr. Meador said. In addition, periconceptional use of folate has been shown in previous research to improve neurodevelopmental outcomes for children of mothers with epilepsy who are taking AEDs.
Whether folate-fortified food alone, without supplements, has any effect on cognitive outcomes in this population of children has not been examined previously.
To investigate, the researchers assessed 117 children from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, a prospective, observational study of women with epilepsy who were taking one of four AEDs: carbamazepine, lamotrigine, phenytoin, or valproate.
Results showed that dietary folate from fortified food alone, without supplements, had no significant impact on IQ at age 6 years among children with prenatal exposure to AEDs.
In contrast, use of periconceptual folate supplements was significantly associated with a 10-point higher IQ at age 6 in the adjusted analyses (95% confidence interval, 5.2-15.0; P < .001).
These six other nutrients from food and supplements had no significant association with IQ at age 6 years: vitamins C, D, and E, omega-3, gamma tocopherol, and vitamin B12.
Optimal dose unclear
The findings indicate that folates, including natural folate and folic acid, in food do not have positive cognitive effects for children of women with epilepsy who take AEDs, the researchers write.
Dr. Meador noted that the optimal dose of folic acid supplementation to provide a cognitive benefit remains unclear.
The U.S. Centers for Disease Control recommends 0.4 mg/d for the general population of women of childbearing age. In Europe, the recommendation is 1 mg/d.
“Higher doses are recommended if there is a personal or family history of spina bifida in prior pregnancies, but there is some concern that very high doses of folate may be detrimental,” Dr. Meador said.
For women with epilepsy, he would recommend “at least 1 mg/d and not more than 4 mg/d.”
Proves a point?
Commenting on the study for this news organization, Derek Chong, MD, vice chair of neurology and director of epilepsy at Lenox Hill Hospital, New York, said the finding that folate fortification of food alone is not adequate for women with epilepsy is “not groundbreaking” but does prove something previously thought.
“Folic acid is important for all women, but it does seem like folic acid may be even more important in the epilepsy population,” said Dr. Chong, who was not involved with the research.
He cautioned that the current analysis included only four medications, three of which are not used very often anymore.
“Lamotrigine is probably the most commonly used one now. It’s unfortunate that this study did not include Keppra [levetiracetam], which probably is the number one medication that we use now,” Dr. Chong said.
The research was supported by the National Institutes of Health. Dr. Meador and Dr. Chong have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Blood pressure meds tied to increased schizophrenia risk
ACE inhibitors may be associated with an increased risk for schizophrenia and may affect psychiatric symptoms, new research suggests.
Investigators found individuals who carry a genetic variant associated with lower levels of the ACE gene and protein have increased liability to schizophrenia, suggesting that drugs that lower ACE levels or activity may do the same.
“Our findings warrant further investigation into the role of ACE in schizophrenia and closer monitoring by clinicians of individuals, especially those with schizophrenia, who may be on medication that lower ACE activity, such as ACE inhibitors,” Sonia Shah, PhD, Institute for Biomedical Sciences, University of Queensland, Brisbane, Australia, said in an interview.
The study was published online March 10, 2021, in JAMA Psychiatry.
Antihypertensives and mental illness
Hypertension is common in patients with psychiatric disorders and observational studies have reported associations between antihypertensive medication and these disorders, although the findings have been mixed.
Dr. Shah and colleagues estimated the potential of different antihypertensive drug classes on schizophrenia, bipolar disorder, and major depressive disorder.
In a two-sample Mendelian randomization study, they evaluated ties between a single-nucleotide variant and drug-target gene expression derived from expression quantitative trait loci data in blood (sample 1) and the SNV disease association from published case-control, genomewide association studies (sample 2).
The analyses included 40,675 patients with schizophrenia and 64,643 controls; 20,352 with bipolar disorder and 31,358 controls; and 135,458 with major depressive disorder and 344,901 controls.
The major finding was that a one standard deviation–lower expression of the ACE gene in blood was associated with lower systolic blood pressure of 4.0 mm Hg (95% confidence interval, 2.7-5.3), but also an increased risk of schizophrenia (odds ratio, 1.75; 95% CI, 1.28-2.38).
Could ACE inhibitors worsen symptoms or trigger episodes?
In their article, the researchers noted that, in most patients, onset of schizophrenia occurs in late adolescence or early adult life, ruling out ACE inhibitor treatment as a potential causal factor for most cases.
“However, if lower ACE levels play a causal role for schizophrenia risk, it would be reasonable to hypothesize that further lowering of ACE activity in existing patients could worsen symptoms or trigger a new episode,” they wrote.
Dr. Shah emphasized that evidence from genetic analyses alone is “not sufficient to justify changes in prescription guidelines.”
“Patients should not stop taking these medications if they are effective at controlling their blood pressure and they don’t suffer any adverse effects. But it would be reasonable to encourage greater pharmacovigilance,” she said in an interview.
“One way in which we are hoping to follow up these findings,” said Dr. Shah, “is to access electronic health record data for millions of individuals to investigate if there is evidence of increased rates of psychotic episodes in individuals who use ACE inhibitors, compared to other classes of blood pressure–lowering medication.”
Caution warranted
Reached for comment, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Staten Island University Hospital in New York, noted that this is an “extremely complicated” study and urged caution in interpreting the results.
“Since most people develop schizophrenia earlier in life, before they usually develop problems with blood pressure, it’s not so much that these drugs might cause schizophrenia,” Dr. Sullivan said.
“But because of their effects on this particular gene, there’s a possibility that they might worsen symptoms or in somebody with borderline risk might cause them to develop symptoms later in life. This may apply to a relatively small number of people who develop symptoms of schizophrenia in their 40s and beyond,” he added.
That’s where “pharmacovigilance” comes into play, Dr. Sullivan said. “In other words, that they otherwise wouldn’t experience?”
Support for the study was provided by the National Health and Medical Research Council (Australia) and U.S. National Institute for Mental Health. Dr. Shah and Dr. Sullivan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ACE inhibitors may be associated with an increased risk for schizophrenia and may affect psychiatric symptoms, new research suggests.
Investigators found individuals who carry a genetic variant associated with lower levels of the ACE gene and protein have increased liability to schizophrenia, suggesting that drugs that lower ACE levels or activity may do the same.
“Our findings warrant further investigation into the role of ACE in schizophrenia and closer monitoring by clinicians of individuals, especially those with schizophrenia, who may be on medication that lower ACE activity, such as ACE inhibitors,” Sonia Shah, PhD, Institute for Biomedical Sciences, University of Queensland, Brisbane, Australia, said in an interview.
The study was published online March 10, 2021, in JAMA Psychiatry.
Antihypertensives and mental illness
Hypertension is common in patients with psychiatric disorders and observational studies have reported associations between antihypertensive medication and these disorders, although the findings have been mixed.
Dr. Shah and colleagues estimated the potential of different antihypertensive drug classes on schizophrenia, bipolar disorder, and major depressive disorder.
In a two-sample Mendelian randomization study, they evaluated ties between a single-nucleotide variant and drug-target gene expression derived from expression quantitative trait loci data in blood (sample 1) and the SNV disease association from published case-control, genomewide association studies (sample 2).
The analyses included 40,675 patients with schizophrenia and 64,643 controls; 20,352 with bipolar disorder and 31,358 controls; and 135,458 with major depressive disorder and 344,901 controls.
The major finding was that a one standard deviation–lower expression of the ACE gene in blood was associated with lower systolic blood pressure of 4.0 mm Hg (95% confidence interval, 2.7-5.3), but also an increased risk of schizophrenia (odds ratio, 1.75; 95% CI, 1.28-2.38).
Could ACE inhibitors worsen symptoms or trigger episodes?
In their article, the researchers noted that, in most patients, onset of schizophrenia occurs in late adolescence or early adult life, ruling out ACE inhibitor treatment as a potential causal factor for most cases.
“However, if lower ACE levels play a causal role for schizophrenia risk, it would be reasonable to hypothesize that further lowering of ACE activity in existing patients could worsen symptoms or trigger a new episode,” they wrote.
Dr. Shah emphasized that evidence from genetic analyses alone is “not sufficient to justify changes in prescription guidelines.”
“Patients should not stop taking these medications if they are effective at controlling their blood pressure and they don’t suffer any adverse effects. But it would be reasonable to encourage greater pharmacovigilance,” she said in an interview.
“One way in which we are hoping to follow up these findings,” said Dr. Shah, “is to access electronic health record data for millions of individuals to investigate if there is evidence of increased rates of psychotic episodes in individuals who use ACE inhibitors, compared to other classes of blood pressure–lowering medication.”
Caution warranted
Reached for comment, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Staten Island University Hospital in New York, noted that this is an “extremely complicated” study and urged caution in interpreting the results.
“Since most people develop schizophrenia earlier in life, before they usually develop problems with blood pressure, it’s not so much that these drugs might cause schizophrenia,” Dr. Sullivan said.
“But because of their effects on this particular gene, there’s a possibility that they might worsen symptoms or in somebody with borderline risk might cause them to develop symptoms later in life. This may apply to a relatively small number of people who develop symptoms of schizophrenia in their 40s and beyond,” he added.
That’s where “pharmacovigilance” comes into play, Dr. Sullivan said. “In other words, that they otherwise wouldn’t experience?”
Support for the study was provided by the National Health and Medical Research Council (Australia) and U.S. National Institute for Mental Health. Dr. Shah and Dr. Sullivan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ACE inhibitors may be associated with an increased risk for schizophrenia and may affect psychiatric symptoms, new research suggests.
Investigators found individuals who carry a genetic variant associated with lower levels of the ACE gene and protein have increased liability to schizophrenia, suggesting that drugs that lower ACE levels or activity may do the same.
“Our findings warrant further investigation into the role of ACE in schizophrenia and closer monitoring by clinicians of individuals, especially those with schizophrenia, who may be on medication that lower ACE activity, such as ACE inhibitors,” Sonia Shah, PhD, Institute for Biomedical Sciences, University of Queensland, Brisbane, Australia, said in an interview.
The study was published online March 10, 2021, in JAMA Psychiatry.
Antihypertensives and mental illness
Hypertension is common in patients with psychiatric disorders and observational studies have reported associations between antihypertensive medication and these disorders, although the findings have been mixed.
Dr. Shah and colleagues estimated the potential of different antihypertensive drug classes on schizophrenia, bipolar disorder, and major depressive disorder.
In a two-sample Mendelian randomization study, they evaluated ties between a single-nucleotide variant and drug-target gene expression derived from expression quantitative trait loci data in blood (sample 1) and the SNV disease association from published case-control, genomewide association studies (sample 2).
The analyses included 40,675 patients with schizophrenia and 64,643 controls; 20,352 with bipolar disorder and 31,358 controls; and 135,458 with major depressive disorder and 344,901 controls.
The major finding was that a one standard deviation–lower expression of the ACE gene in blood was associated with lower systolic blood pressure of 4.0 mm Hg (95% confidence interval, 2.7-5.3), but also an increased risk of schizophrenia (odds ratio, 1.75; 95% CI, 1.28-2.38).
Could ACE inhibitors worsen symptoms or trigger episodes?
In their article, the researchers noted that, in most patients, onset of schizophrenia occurs in late adolescence or early adult life, ruling out ACE inhibitor treatment as a potential causal factor for most cases.
“However, if lower ACE levels play a causal role for schizophrenia risk, it would be reasonable to hypothesize that further lowering of ACE activity in existing patients could worsen symptoms or trigger a new episode,” they wrote.
Dr. Shah emphasized that evidence from genetic analyses alone is “not sufficient to justify changes in prescription guidelines.”
“Patients should not stop taking these medications if they are effective at controlling their blood pressure and they don’t suffer any adverse effects. But it would be reasonable to encourage greater pharmacovigilance,” she said in an interview.
“One way in which we are hoping to follow up these findings,” said Dr. Shah, “is to access electronic health record data for millions of individuals to investigate if there is evidence of increased rates of psychotic episodes in individuals who use ACE inhibitors, compared to other classes of blood pressure–lowering medication.”
Caution warranted
Reached for comment, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Staten Island University Hospital in New York, noted that this is an “extremely complicated” study and urged caution in interpreting the results.
“Since most people develop schizophrenia earlier in life, before they usually develop problems with blood pressure, it’s not so much that these drugs might cause schizophrenia,” Dr. Sullivan said.
“But because of their effects on this particular gene, there’s a possibility that they might worsen symptoms or in somebody with borderline risk might cause them to develop symptoms later in life. This may apply to a relatively small number of people who develop symptoms of schizophrenia in their 40s and beyond,” he added.
That’s where “pharmacovigilance” comes into play, Dr. Sullivan said. “In other words, that they otherwise wouldn’t experience?”
Support for the study was provided by the National Health and Medical Research Council (Australia) and U.S. National Institute for Mental Health. Dr. Shah and Dr. Sullivan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Despite risks and warnings, CNS polypharmacy is prevalent among patients with dementia
, new research suggests.
Investigators found that 14% of these individuals were receiving CNS-active polypharmacy, defined as combinations of multiple psychotropic and opioid medications taken for more than 30 days.
“For most patients, the risks of these medications, particularly in combination, are almost certainly greater than the potential benefits,” said Donovan Maust, MD, associate director of the geriatric psychiatry program, University of Michigan, Ann Arbor.
The study was published online March 9 in JAMA.
Serious risks
Memory impairment is the cardinal feature of dementia, but behavioral and psychological symptoms, which can include apathy, delusions, and agitation, are common during all stages of illness and cause significant caregiver distress, the researchers noted.
They noted that there is a dearth of high-quality evidence to support prescribing these medications in this patient population, yet “clinicians regularly prescribe psychotropic medications to community-dwelling persons with dementia in rates that far exceed use in the general older adult population.”
The Beers Criteria, from the American Geriatrics Society, advise against the practice of CNS polypharmacy because of the significant increase in risk for falls as well as impaired cognition, cardiac conduction abnormalities, respiratory suppression, and death when polypharmacy involves opioids.
They note that previous studies from Europe of polypharmacy for patients with dementia have not included antiepileptic medications or opioids, so the true extent of CNS-active polypharmacy may be “significantly” underestimated.
To determine the prevalence of polypharmacy with CNS-active medications among community-dwelling older adults with dementia, the researchers analyzed data on prescription fills for nearly 1.2 million community-dwelling Medicare patients with dementia.
The primary outcome was the prevalence of CNS-active polypharmacy in 2018. They defined CNS-active polypharmacy as exposure to three or more medications for more than 30 consecutive days from the following drug classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, nonbenzodiazepines, benzodiazepine receptor agonist hypnotics, and opioids.
They found that roughly one in seven (13.9%) patients met criteria for CNS-active polypharmacy. Of those receiving a CNS-active polypharmacy regimen, 57.8% had been doing so for longer than 180 days, and 6.8% had been doing so for a year. Nearly 30% of patients were exposed to five or more medications, and 5.2% were exposed to five or more medication classes.
Conservative approach warranted
Nearly all (92%) patients taking three or more CNS-active medications were taking an antidepressant, “consistent with their place as the psychotropic class most commonly prescribed both to older adults overall and those with dementia,” the investigators noted.
There is minimal high-quality evidence to support the efficacy of antidepressants for the treatment of depression for patients with dementia, they pointed out.
Nearly half (47%) of patients who were taking three or more CNS-active medications received at least one antipsychotic, most often quetiapine. Antipsychotics are not approved for people with dementia but are often prescribed off label for agitation, anxiety, and sleep problems, the researchers noted.
Nearly two thirds (62%) of patients with dementia who were taking three or more CNS drugs were taking an antiepileptic (most commonly, gabapentin); 41%, benzodiazepines; 32%, opioids; and 6%, Z-drugs.
The most common polypharmacy class combination included at least one antidepressant, one antiepileptic, and one antipsychotic. These accounted for 12.9% of polypharmacy days.
Despite limited high-quality evidence of efficacy, the prescribing of psychotropic medications and opioids is “pervasive” for adults with dementia in the United States, the investigators noted.
“Especially given that older adults with dementia might not be able to convey side effects they are experiencing, I think clinicians should be more conservative in how they are prescribing these medications and skeptical about the potential for benefit,” said Dr. Maust.
Regarding study limitations, the researchers noted that prescription medication claims may have led to an overestimation of the exposure to polypharmacy, insofar as the prescriptions may have been filled but not taken or were taken only on an as-needed basis.
In addition, the investigators were unable to determine the appropriateness of the particular combinations used or to examine the specific harms associated with CNS-active polypharmacy.
A major clinical challenge
Weighing in on the results, Howard Fillit, MD, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study is important because polypharmacy is one of the “geriatric giants, and the question is, what do you do about it?”
Dr. Fillit said it is important to conduct a careful medication review for all older patients, “making sure that the use of each drug is appropriate. The most important thing is to define what is the appropriate utilization of these kinds of drugs. That goes for both overutilization or misuse of these drugs and underutilization, where people are undertreated for symptoms that can’t be managed by behavioral management, for example,” Dr. Fillit said.
Dr. Fillit also said the finding that about 14% of dementia patients were receiving three or more of these drugs “may not be an outrageous number, because these patients, especially as they get into moderate and severe stages of disease, can be incredibly difficult to manage.
“Very often, dementia patients have depression, and up to 90% will have agitation and even psychosis during the course of dementia. And many of these patients need these types of drugs,” said Dr. Fillit.
Echoing the authors, Dr. Fillit said a key limitation of the study is not knowing whether the prescribing was appropriate or not.
The study was supported by a grant from the National Institute on Aging. Dr. Maust and Dr. Fillit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Investigators found that 14% of these individuals were receiving CNS-active polypharmacy, defined as combinations of multiple psychotropic and opioid medications taken for more than 30 days.
“For most patients, the risks of these medications, particularly in combination, are almost certainly greater than the potential benefits,” said Donovan Maust, MD, associate director of the geriatric psychiatry program, University of Michigan, Ann Arbor.
The study was published online March 9 in JAMA.
Serious risks
Memory impairment is the cardinal feature of dementia, but behavioral and psychological symptoms, which can include apathy, delusions, and agitation, are common during all stages of illness and cause significant caregiver distress, the researchers noted.
They noted that there is a dearth of high-quality evidence to support prescribing these medications in this patient population, yet “clinicians regularly prescribe psychotropic medications to community-dwelling persons with dementia in rates that far exceed use in the general older adult population.”
The Beers Criteria, from the American Geriatrics Society, advise against the practice of CNS polypharmacy because of the significant increase in risk for falls as well as impaired cognition, cardiac conduction abnormalities, respiratory suppression, and death when polypharmacy involves opioids.
They note that previous studies from Europe of polypharmacy for patients with dementia have not included antiepileptic medications or opioids, so the true extent of CNS-active polypharmacy may be “significantly” underestimated.
To determine the prevalence of polypharmacy with CNS-active medications among community-dwelling older adults with dementia, the researchers analyzed data on prescription fills for nearly 1.2 million community-dwelling Medicare patients with dementia.
The primary outcome was the prevalence of CNS-active polypharmacy in 2018. They defined CNS-active polypharmacy as exposure to three or more medications for more than 30 consecutive days from the following drug classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, nonbenzodiazepines, benzodiazepine receptor agonist hypnotics, and opioids.
They found that roughly one in seven (13.9%) patients met criteria for CNS-active polypharmacy. Of those receiving a CNS-active polypharmacy regimen, 57.8% had been doing so for longer than 180 days, and 6.8% had been doing so for a year. Nearly 30% of patients were exposed to five or more medications, and 5.2% were exposed to five or more medication classes.
Conservative approach warranted
Nearly all (92%) patients taking three or more CNS-active medications were taking an antidepressant, “consistent with their place as the psychotropic class most commonly prescribed both to older adults overall and those with dementia,” the investigators noted.
There is minimal high-quality evidence to support the efficacy of antidepressants for the treatment of depression for patients with dementia, they pointed out.
Nearly half (47%) of patients who were taking three or more CNS-active medications received at least one antipsychotic, most often quetiapine. Antipsychotics are not approved for people with dementia but are often prescribed off label for agitation, anxiety, and sleep problems, the researchers noted.
Nearly two thirds (62%) of patients with dementia who were taking three or more CNS drugs were taking an antiepileptic (most commonly, gabapentin); 41%, benzodiazepines; 32%, opioids; and 6%, Z-drugs.
The most common polypharmacy class combination included at least one antidepressant, one antiepileptic, and one antipsychotic. These accounted for 12.9% of polypharmacy days.
Despite limited high-quality evidence of efficacy, the prescribing of psychotropic medications and opioids is “pervasive” for adults with dementia in the United States, the investigators noted.
“Especially given that older adults with dementia might not be able to convey side effects they are experiencing, I think clinicians should be more conservative in how they are prescribing these medications and skeptical about the potential for benefit,” said Dr. Maust.
Regarding study limitations, the researchers noted that prescription medication claims may have led to an overestimation of the exposure to polypharmacy, insofar as the prescriptions may have been filled but not taken or were taken only on an as-needed basis.
In addition, the investigators were unable to determine the appropriateness of the particular combinations used or to examine the specific harms associated with CNS-active polypharmacy.
A major clinical challenge
Weighing in on the results, Howard Fillit, MD, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study is important because polypharmacy is one of the “geriatric giants, and the question is, what do you do about it?”
Dr. Fillit said it is important to conduct a careful medication review for all older patients, “making sure that the use of each drug is appropriate. The most important thing is to define what is the appropriate utilization of these kinds of drugs. That goes for both overutilization or misuse of these drugs and underutilization, where people are undertreated for symptoms that can’t be managed by behavioral management, for example,” Dr. Fillit said.
Dr. Fillit also said the finding that about 14% of dementia patients were receiving three or more of these drugs “may not be an outrageous number, because these patients, especially as they get into moderate and severe stages of disease, can be incredibly difficult to manage.
“Very often, dementia patients have depression, and up to 90% will have agitation and even psychosis during the course of dementia. And many of these patients need these types of drugs,” said Dr. Fillit.
Echoing the authors, Dr. Fillit said a key limitation of the study is not knowing whether the prescribing was appropriate or not.
The study was supported by a grant from the National Institute on Aging. Dr. Maust and Dr. Fillit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Investigators found that 14% of these individuals were receiving CNS-active polypharmacy, defined as combinations of multiple psychotropic and opioid medications taken for more than 30 days.
“For most patients, the risks of these medications, particularly in combination, are almost certainly greater than the potential benefits,” said Donovan Maust, MD, associate director of the geriatric psychiatry program, University of Michigan, Ann Arbor.
The study was published online March 9 in JAMA.
Serious risks
Memory impairment is the cardinal feature of dementia, but behavioral and psychological symptoms, which can include apathy, delusions, and agitation, are common during all stages of illness and cause significant caregiver distress, the researchers noted.
They noted that there is a dearth of high-quality evidence to support prescribing these medications in this patient population, yet “clinicians regularly prescribe psychotropic medications to community-dwelling persons with dementia in rates that far exceed use in the general older adult population.”
The Beers Criteria, from the American Geriatrics Society, advise against the practice of CNS polypharmacy because of the significant increase in risk for falls as well as impaired cognition, cardiac conduction abnormalities, respiratory suppression, and death when polypharmacy involves opioids.
They note that previous studies from Europe of polypharmacy for patients with dementia have not included antiepileptic medications or opioids, so the true extent of CNS-active polypharmacy may be “significantly” underestimated.
To determine the prevalence of polypharmacy with CNS-active medications among community-dwelling older adults with dementia, the researchers analyzed data on prescription fills for nearly 1.2 million community-dwelling Medicare patients with dementia.
The primary outcome was the prevalence of CNS-active polypharmacy in 2018. They defined CNS-active polypharmacy as exposure to three or more medications for more than 30 consecutive days from the following drug classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, nonbenzodiazepines, benzodiazepine receptor agonist hypnotics, and opioids.
They found that roughly one in seven (13.9%) patients met criteria for CNS-active polypharmacy. Of those receiving a CNS-active polypharmacy regimen, 57.8% had been doing so for longer than 180 days, and 6.8% had been doing so for a year. Nearly 30% of patients were exposed to five or more medications, and 5.2% were exposed to five or more medication classes.
Conservative approach warranted
Nearly all (92%) patients taking three or more CNS-active medications were taking an antidepressant, “consistent with their place as the psychotropic class most commonly prescribed both to older adults overall and those with dementia,” the investigators noted.
There is minimal high-quality evidence to support the efficacy of antidepressants for the treatment of depression for patients with dementia, they pointed out.
Nearly half (47%) of patients who were taking three or more CNS-active medications received at least one antipsychotic, most often quetiapine. Antipsychotics are not approved for people with dementia but are often prescribed off label for agitation, anxiety, and sleep problems, the researchers noted.
Nearly two thirds (62%) of patients with dementia who were taking three or more CNS drugs were taking an antiepileptic (most commonly, gabapentin); 41%, benzodiazepines; 32%, opioids; and 6%, Z-drugs.
The most common polypharmacy class combination included at least one antidepressant, one antiepileptic, and one antipsychotic. These accounted for 12.9% of polypharmacy days.
Despite limited high-quality evidence of efficacy, the prescribing of psychotropic medications and opioids is “pervasive” for adults with dementia in the United States, the investigators noted.
“Especially given that older adults with dementia might not be able to convey side effects they are experiencing, I think clinicians should be more conservative in how they are prescribing these medications and skeptical about the potential for benefit,” said Dr. Maust.
Regarding study limitations, the researchers noted that prescription medication claims may have led to an overestimation of the exposure to polypharmacy, insofar as the prescriptions may have been filled but not taken or were taken only on an as-needed basis.
In addition, the investigators were unable to determine the appropriateness of the particular combinations used or to examine the specific harms associated with CNS-active polypharmacy.
A major clinical challenge
Weighing in on the results, Howard Fillit, MD, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the study is important because polypharmacy is one of the “geriatric giants, and the question is, what do you do about it?”
Dr. Fillit said it is important to conduct a careful medication review for all older patients, “making sure that the use of each drug is appropriate. The most important thing is to define what is the appropriate utilization of these kinds of drugs. That goes for both overutilization or misuse of these drugs and underutilization, where people are undertreated for symptoms that can’t be managed by behavioral management, for example,” Dr. Fillit said.
Dr. Fillit also said the finding that about 14% of dementia patients were receiving three or more of these drugs “may not be an outrageous number, because these patients, especially as they get into moderate and severe stages of disease, can be incredibly difficult to manage.
“Very often, dementia patients have depression, and up to 90% will have agitation and even psychosis during the course of dementia. And many of these patients need these types of drugs,” said Dr. Fillit.
Echoing the authors, Dr. Fillit said a key limitation of the study is not knowing whether the prescribing was appropriate or not.
The study was supported by a grant from the National Institute on Aging. Dr. Maust and Dr. Fillit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA
Smartphone ‘addiction’ tied to poor sleep in young adults
Smartphone “addiction” may explain poor sleep quality in a significant proportion of young adults, new research suggests.
Investigators found that almost 40% of adults aged 18-30 years who self-reported excessive smartphone use also reported poor sleep.
“Our study provides further support to the growing body of evidence that smartphone addiction has a deleterious impact on sleep,” wrote the researchers.
The study was published online March 2 in Frontiers of Psychiatry.
Not a clinical diagnosis
Smartphone addiction is not formally recognized as a clinical diagnosis, but it’s an “active” area of research, lead investigator Ben Carter, PhD, King’s College London, noted in the report.
In a cross-sectional survey, 1,043 college students (aged 18-30 years, 73% women) completed the 10-question validated Smartphone Addiction Scale Short Version (SAS-SV) and the adapted Pittsburgh Sleep Quality Score Index.
On the SAS-SV, 406 students (38.9%) reported “addiction” to their smartphones. This estimated prevalence is consistent with other reported studies in young adult populations globally, which is in the range of 30%-45%, the researchers noted.
Overall, 61.6% of participants surveyed reported poor sleep; among those who reported smartphone addiction, 68.7% had poor sleep quality, vs. 57.1% of those who did not report smartphone addiction.
In multivariable analysis that adjusted for a variety of relevant factors, among those for whom there was evidence of smartphone addiction, the odds of poor sleep were increased by 41% (adjusted odds ratio [aOR] = 1.41; 95% confidence interval, 1.06-1.87, P = .018).
The findings also suggest that a greater amount of time spent using the phone and greater use late at night can raise the risk for smartphone addiction.
“Should smartphone addiction become firmly established as a focus of clinical concern, those using their phones after midnight or using their phones for four or more hours per day are likely to be at high risk, and should guide administration of the SAS-SV,” the researchers wrote.
Caveats, cautions, and concerns
Reached for comment, Paul Weigle, MD, psychiatrist with Hartford HealthCare and Hartford (Conn.) Hospital, and member of the American Academy of Child and Adolescent Psychiatry, said the finding of a relationship between addictive smartphone usage and poor sleep quality is not surprising.
“Great increases in adolescent screen media habits in recent decades have seen a concurrent increase in rates of insomnia among this population,” he said in an interview.
Dr. Weigle also noted that young people who use the phone excessively often do so in bed, “which decreases sleep onset by disrupting conditioning (the tendency for our bodies to relate bed with sleep) and by increasing physiological arousal, which makes it more difficult to fall asleep. The blue light from smartphones used at night disrupts our body’s natural circadian rhythms, confusing our brains regarding whether it is night or day, and further worsens sleep.”
Dr. Weigle said in an interview that some of his patients come to him seeking sleep medications, although the best treatment is to perform a “smartphone-ectomy” every evening.
Teenage patients will “beg, borrow, or steal” to be allowed to keep their phones by the bed with the promise not to use them overnight. Three-quarters of the time, when the parents are able to charge the phone in another room, “the sleep problem resolves,” Dr. Weigle said.
One caveat, he said, is that it’s “somewhat unclear whether this is best classified as an addiction or simply a seriously problematic habit. Either way, this type of habit causes a great deal of distress and dysfunction in the lives of those it affects, so it is important to understand,” he said.
In a statement, Bob Patton, PhD, lecturer in clinical psychology, University of Surrey, Guildford, England, noted that this is a cross-sectional study “and as such cannot lead to any firm conclusions about phone usage as the cause of reduced sleep quality.
“It does, however, provide some compelling evidence,” Dr. Patton said, “that the nature of smartphone usage and its related consequences are important considerations in addressing the emerging phenomenon of ‘smartphone addiction.’ ”
Also weighing in, Andrew Przybylski, PhD, director of research, Oxford (England) Internet Institute, University of Oxford, said by any global health body and is not a psychiatric disorder.
“The study is a correlational analysis of a sample of participants recruited on university campuses and therefore only reflects the experiences of those who had the purpose of the study explained to them. It can say nothing about behaviors in the general population,” Dr. Przybylski said in a statement.
“Readers should be cautious of making any firm conclusions about the impact of smartphone use in the general population, or the idea that they’re addictive in any objective sense, on the basis of this work,” he added. The study had no specific funding. Dr. Carter, Dr. Weigle, Dr. Patton, and Dr. Przybylski have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Smartphone “addiction” may explain poor sleep quality in a significant proportion of young adults, new research suggests.
Investigators found that almost 40% of adults aged 18-30 years who self-reported excessive smartphone use also reported poor sleep.
“Our study provides further support to the growing body of evidence that smartphone addiction has a deleterious impact on sleep,” wrote the researchers.
The study was published online March 2 in Frontiers of Psychiatry.
Not a clinical diagnosis
Smartphone addiction is not formally recognized as a clinical diagnosis, but it’s an “active” area of research, lead investigator Ben Carter, PhD, King’s College London, noted in the report.
In a cross-sectional survey, 1,043 college students (aged 18-30 years, 73% women) completed the 10-question validated Smartphone Addiction Scale Short Version (SAS-SV) and the adapted Pittsburgh Sleep Quality Score Index.
On the SAS-SV, 406 students (38.9%) reported “addiction” to their smartphones. This estimated prevalence is consistent with other reported studies in young adult populations globally, which is in the range of 30%-45%, the researchers noted.
Overall, 61.6% of participants surveyed reported poor sleep; among those who reported smartphone addiction, 68.7% had poor sleep quality, vs. 57.1% of those who did not report smartphone addiction.
In multivariable analysis that adjusted for a variety of relevant factors, among those for whom there was evidence of smartphone addiction, the odds of poor sleep were increased by 41% (adjusted odds ratio [aOR] = 1.41; 95% confidence interval, 1.06-1.87, P = .018).
The findings also suggest that a greater amount of time spent using the phone and greater use late at night can raise the risk for smartphone addiction.
“Should smartphone addiction become firmly established as a focus of clinical concern, those using their phones after midnight or using their phones for four or more hours per day are likely to be at high risk, and should guide administration of the SAS-SV,” the researchers wrote.
Caveats, cautions, and concerns
Reached for comment, Paul Weigle, MD, psychiatrist with Hartford HealthCare and Hartford (Conn.) Hospital, and member of the American Academy of Child and Adolescent Psychiatry, said the finding of a relationship between addictive smartphone usage and poor sleep quality is not surprising.
“Great increases in adolescent screen media habits in recent decades have seen a concurrent increase in rates of insomnia among this population,” he said in an interview.
Dr. Weigle also noted that young people who use the phone excessively often do so in bed, “which decreases sleep onset by disrupting conditioning (the tendency for our bodies to relate bed with sleep) and by increasing physiological arousal, which makes it more difficult to fall asleep. The blue light from smartphones used at night disrupts our body’s natural circadian rhythms, confusing our brains regarding whether it is night or day, and further worsens sleep.”
Dr. Weigle said in an interview that some of his patients come to him seeking sleep medications, although the best treatment is to perform a “smartphone-ectomy” every evening.
Teenage patients will “beg, borrow, or steal” to be allowed to keep their phones by the bed with the promise not to use them overnight. Three-quarters of the time, when the parents are able to charge the phone in another room, “the sleep problem resolves,” Dr. Weigle said.
One caveat, he said, is that it’s “somewhat unclear whether this is best classified as an addiction or simply a seriously problematic habit. Either way, this type of habit causes a great deal of distress and dysfunction in the lives of those it affects, so it is important to understand,” he said.
In a statement, Bob Patton, PhD, lecturer in clinical psychology, University of Surrey, Guildford, England, noted that this is a cross-sectional study “and as such cannot lead to any firm conclusions about phone usage as the cause of reduced sleep quality.
“It does, however, provide some compelling evidence,” Dr. Patton said, “that the nature of smartphone usage and its related consequences are important considerations in addressing the emerging phenomenon of ‘smartphone addiction.’ ”
Also weighing in, Andrew Przybylski, PhD, director of research, Oxford (England) Internet Institute, University of Oxford, said by any global health body and is not a psychiatric disorder.
“The study is a correlational analysis of a sample of participants recruited on university campuses and therefore only reflects the experiences of those who had the purpose of the study explained to them. It can say nothing about behaviors in the general population,” Dr. Przybylski said in a statement.
“Readers should be cautious of making any firm conclusions about the impact of smartphone use in the general population, or the idea that they’re addictive in any objective sense, on the basis of this work,” he added. The study had no specific funding. Dr. Carter, Dr. Weigle, Dr. Patton, and Dr. Przybylski have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Smartphone “addiction” may explain poor sleep quality in a significant proportion of young adults, new research suggests.
Investigators found that almost 40% of adults aged 18-30 years who self-reported excessive smartphone use also reported poor sleep.
“Our study provides further support to the growing body of evidence that smartphone addiction has a deleterious impact on sleep,” wrote the researchers.
The study was published online March 2 in Frontiers of Psychiatry.
Not a clinical diagnosis
Smartphone addiction is not formally recognized as a clinical diagnosis, but it’s an “active” area of research, lead investigator Ben Carter, PhD, King’s College London, noted in the report.
In a cross-sectional survey, 1,043 college students (aged 18-30 years, 73% women) completed the 10-question validated Smartphone Addiction Scale Short Version (SAS-SV) and the adapted Pittsburgh Sleep Quality Score Index.
On the SAS-SV, 406 students (38.9%) reported “addiction” to their smartphones. This estimated prevalence is consistent with other reported studies in young adult populations globally, which is in the range of 30%-45%, the researchers noted.
Overall, 61.6% of participants surveyed reported poor sleep; among those who reported smartphone addiction, 68.7% had poor sleep quality, vs. 57.1% of those who did not report smartphone addiction.
In multivariable analysis that adjusted for a variety of relevant factors, among those for whom there was evidence of smartphone addiction, the odds of poor sleep were increased by 41% (adjusted odds ratio [aOR] = 1.41; 95% confidence interval, 1.06-1.87, P = .018).
The findings also suggest that a greater amount of time spent using the phone and greater use late at night can raise the risk for smartphone addiction.
“Should smartphone addiction become firmly established as a focus of clinical concern, those using their phones after midnight or using their phones for four or more hours per day are likely to be at high risk, and should guide administration of the SAS-SV,” the researchers wrote.
Caveats, cautions, and concerns
Reached for comment, Paul Weigle, MD, psychiatrist with Hartford HealthCare and Hartford (Conn.) Hospital, and member of the American Academy of Child and Adolescent Psychiatry, said the finding of a relationship between addictive smartphone usage and poor sleep quality is not surprising.
“Great increases in adolescent screen media habits in recent decades have seen a concurrent increase in rates of insomnia among this population,” he said in an interview.
Dr. Weigle also noted that young people who use the phone excessively often do so in bed, “which decreases sleep onset by disrupting conditioning (the tendency for our bodies to relate bed with sleep) and by increasing physiological arousal, which makes it more difficult to fall asleep. The blue light from smartphones used at night disrupts our body’s natural circadian rhythms, confusing our brains regarding whether it is night or day, and further worsens sleep.”
Dr. Weigle said in an interview that some of his patients come to him seeking sleep medications, although the best treatment is to perform a “smartphone-ectomy” every evening.
Teenage patients will “beg, borrow, or steal” to be allowed to keep their phones by the bed with the promise not to use them overnight. Three-quarters of the time, when the parents are able to charge the phone in another room, “the sleep problem resolves,” Dr. Weigle said.
One caveat, he said, is that it’s “somewhat unclear whether this is best classified as an addiction or simply a seriously problematic habit. Either way, this type of habit causes a great deal of distress and dysfunction in the lives of those it affects, so it is important to understand,” he said.
In a statement, Bob Patton, PhD, lecturer in clinical psychology, University of Surrey, Guildford, England, noted that this is a cross-sectional study “and as such cannot lead to any firm conclusions about phone usage as the cause of reduced sleep quality.
“It does, however, provide some compelling evidence,” Dr. Patton said, “that the nature of smartphone usage and its related consequences are important considerations in addressing the emerging phenomenon of ‘smartphone addiction.’ ”
Also weighing in, Andrew Przybylski, PhD, director of research, Oxford (England) Internet Institute, University of Oxford, said by any global health body and is not a psychiatric disorder.
“The study is a correlational analysis of a sample of participants recruited on university campuses and therefore only reflects the experiences of those who had the purpose of the study explained to them. It can say nothing about behaviors in the general population,” Dr. Przybylski said in a statement.
“Readers should be cautious of making any firm conclusions about the impact of smartphone use in the general population, or the idea that they’re addictive in any objective sense, on the basis of this work,” he added. The study had no specific funding. Dr. Carter, Dr. Weigle, Dr. Patton, and Dr. Przybylski have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Stunning’ report shows eating disorders are vastly underestimated
A “stunning” new analysis of global data on eating disorders show that they are far more prevalent and disabling than previously reported.
Investigators found the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 underestimated the prevalence of eating disorders by nearly 42 million cases, meaning these disorders are four times more common than previously reported.
“Our work highlights that eating disorders are far more prevalent and disabling than previously quantified,” lead author Damian F. Santomauro, PhD, University of Queensland and Center for Mental Health Research, Brisbane, Australia, said in an interview.
The study was published online March 3 in The Lancet Psychiatry.
Policy implications
The GBD Study 2019 reports the prevalence and burden of anorexia nervosa and bulimia nervosa under the umbrella of “eating disorders.”
However, binge-eating disorder (BED) and other specified feeding or eating disorder (OSFED) are more common, the investigators noted.
By excluding BED and OSFED, 41.9 million cases of eating disorders were not represented in the study.
The researchers calculate that the GBD 2019 overlooked 17.3 million people with BED and 24.6 million people with OSFED.
, bringing the total eating disorder DALYs to 6.6 million in 2019, they reported.
“When disorders are left out of the GBD, there is a risk that policymakers and service planners will interpret that these diseases are not prevalent or disabling and therefore not important to address,” said Dr. Santomauro.
“Our results show that the formal inclusion of binge-eating disorder and OSFED in GBD is both feasible and important and will lead to better representation of eating disorder burden globally.
“In turn, this will enhance recognition of the burden experienced by people living with these disorders and hopefully motivate increased investment in research, prevention, and treatment in future,” he added.
Landmark article, clarion call for action
In an accompanying commentary, Jennifer J. Thomas, PhD, and Kendra R. Becker, PhD, with the Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said that this “stunning” analysis highlights that eating disorders are four times more common than previously thought.
This “landmark” analysis also demonstrates that BED and OSFED are especially common with increasing age. It highlights the burden of eating disorders in men, “shattering the inaccurate but entrenched stereotype that eating disorders affect only thin, young, White women,” Dr. Thomas and Dr. Becker pointed out.
This article, they wrote, is a “clarion call” for BED and OSFED to be included in future versions of the GBD Study.
Going a step further, Dr. Thomas and Dr. Becker said the GBD Study should also include estimates of the prevalence of avoidant/restrictive food intake disorder, rumination disorder, and pica and that the investigators should obtain direct measures of the disability associated with all feeding and eating disorders included in the DSM-5.
“If they do, the reported global burden will be even greater, underscoring the clear need for increased funding to study, prevent, and treat these debilitating illnesses,” they concluded.
The study was funded by Queensland Health, the Australian National Health and Medical Research Council, and the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships. Disclosures for the editorialists are listed with the original article.
A version of this article first appeared on Medscape.com.
A “stunning” new analysis of global data on eating disorders show that they are far more prevalent and disabling than previously reported.
Investigators found the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 underestimated the prevalence of eating disorders by nearly 42 million cases, meaning these disorders are four times more common than previously reported.
“Our work highlights that eating disorders are far more prevalent and disabling than previously quantified,” lead author Damian F. Santomauro, PhD, University of Queensland and Center for Mental Health Research, Brisbane, Australia, said in an interview.
The study was published online March 3 in The Lancet Psychiatry.
Policy implications
The GBD Study 2019 reports the prevalence and burden of anorexia nervosa and bulimia nervosa under the umbrella of “eating disorders.”
However, binge-eating disorder (BED) and other specified feeding or eating disorder (OSFED) are more common, the investigators noted.
By excluding BED and OSFED, 41.9 million cases of eating disorders were not represented in the study.
The researchers calculate that the GBD 2019 overlooked 17.3 million people with BED and 24.6 million people with OSFED.
, bringing the total eating disorder DALYs to 6.6 million in 2019, they reported.
“When disorders are left out of the GBD, there is a risk that policymakers and service planners will interpret that these diseases are not prevalent or disabling and therefore not important to address,” said Dr. Santomauro.
“Our results show that the formal inclusion of binge-eating disorder and OSFED in GBD is both feasible and important and will lead to better representation of eating disorder burden globally.
“In turn, this will enhance recognition of the burden experienced by people living with these disorders and hopefully motivate increased investment in research, prevention, and treatment in future,” he added.
Landmark article, clarion call for action
In an accompanying commentary, Jennifer J. Thomas, PhD, and Kendra R. Becker, PhD, with the Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said that this “stunning” analysis highlights that eating disorders are four times more common than previously thought.
This “landmark” analysis also demonstrates that BED and OSFED are especially common with increasing age. It highlights the burden of eating disorders in men, “shattering the inaccurate but entrenched stereotype that eating disorders affect only thin, young, White women,” Dr. Thomas and Dr. Becker pointed out.
This article, they wrote, is a “clarion call” for BED and OSFED to be included in future versions of the GBD Study.
Going a step further, Dr. Thomas and Dr. Becker said the GBD Study should also include estimates of the prevalence of avoidant/restrictive food intake disorder, rumination disorder, and pica and that the investigators should obtain direct measures of the disability associated with all feeding and eating disorders included in the DSM-5.
“If they do, the reported global burden will be even greater, underscoring the clear need for increased funding to study, prevent, and treat these debilitating illnesses,” they concluded.
The study was funded by Queensland Health, the Australian National Health and Medical Research Council, and the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships. Disclosures for the editorialists are listed with the original article.
A version of this article first appeared on Medscape.com.
A “stunning” new analysis of global data on eating disorders show that they are far more prevalent and disabling than previously reported.
Investigators found the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 underestimated the prevalence of eating disorders by nearly 42 million cases, meaning these disorders are four times more common than previously reported.
“Our work highlights that eating disorders are far more prevalent and disabling than previously quantified,” lead author Damian F. Santomauro, PhD, University of Queensland and Center for Mental Health Research, Brisbane, Australia, said in an interview.
The study was published online March 3 in The Lancet Psychiatry.
Policy implications
The GBD Study 2019 reports the prevalence and burden of anorexia nervosa and bulimia nervosa under the umbrella of “eating disorders.”
However, binge-eating disorder (BED) and other specified feeding or eating disorder (OSFED) are more common, the investigators noted.
By excluding BED and OSFED, 41.9 million cases of eating disorders were not represented in the study.
The researchers calculate that the GBD 2019 overlooked 17.3 million people with BED and 24.6 million people with OSFED.
, bringing the total eating disorder DALYs to 6.6 million in 2019, they reported.
“When disorders are left out of the GBD, there is a risk that policymakers and service planners will interpret that these diseases are not prevalent or disabling and therefore not important to address,” said Dr. Santomauro.
“Our results show that the formal inclusion of binge-eating disorder and OSFED in GBD is both feasible and important and will lead to better representation of eating disorder burden globally.
“In turn, this will enhance recognition of the burden experienced by people living with these disorders and hopefully motivate increased investment in research, prevention, and treatment in future,” he added.
Landmark article, clarion call for action
In an accompanying commentary, Jennifer J. Thomas, PhD, and Kendra R. Becker, PhD, with the Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said that this “stunning” analysis highlights that eating disorders are four times more common than previously thought.
This “landmark” analysis also demonstrates that BED and OSFED are especially common with increasing age. It highlights the burden of eating disorders in men, “shattering the inaccurate but entrenched stereotype that eating disorders affect only thin, young, White women,” Dr. Thomas and Dr. Becker pointed out.
This article, they wrote, is a “clarion call” for BED and OSFED to be included in future versions of the GBD Study.
Going a step further, Dr. Thomas and Dr. Becker said the GBD Study should also include estimates of the prevalence of avoidant/restrictive food intake disorder, rumination disorder, and pica and that the investigators should obtain direct measures of the disability associated with all feeding and eating disorders included in the DSM-5.
“If they do, the reported global burden will be even greater, underscoring the clear need for increased funding to study, prevent, and treat these debilitating illnesses,” they concluded.
The study was funded by Queensland Health, the Australian National Health and Medical Research Council, and the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships. Disclosures for the editorialists are listed with the original article.
A version of this article first appeared on Medscape.com.
FDA authorizes first molecular at-home, OTC COVID-19 test
The U.S. Food and Drug Administration has granted emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter Use (Cue OTC Test, Cue Health).
The Cue OTC Test is the first molecular diagnostic test available to consumers without a prescription.
The test detects genetic material from SARS-CoV-2 present in the nostrils and delivers results in about 20 minutes to the user’s mobile smart device via the Cue Health app.
In testing, the Cue OTC Test correctly identified 96% of positive nasal swab samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms.
The test is intended for use in people aged 2 years and older with and without symptoms.
“With this authorization, consumers can purchase and self-administer one of the easiest, fastest, and most accurate tests without a prescription,” Clint Sever, cofounder and chief product officer of Cue Health, said in a news release.
“This FDA authorization will help us improve patient outcomes with a solution that provides the accuracy of central lab tests, with the speed and accessibility required to address emergent global health issues,” he said.
Cue Health expects to produce more than 100,000 single-use test kits per day by this summer. Dena Cook, the company’s chief communications officer, told this news organization that the company hasn’t announced pricing information yet, but the price will be “comparable” to other price points and other products on the market.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“Cue COVID-19 Test for Home and Over-the-Counter Use provides access to accurate and reliable testing at home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public,” he said.
In June, the FDA granted an EUA to Cue Health’s COVID-19 test for use in clinical and point-of-care settings.
The test is currently being used in hospitals, physicians’ offices, and dental clinics, as well as schools, essential businesses, nursing homes, and other congregate-care facilities. The test is also being distributed through a program led by the U.S. Department of Defense and the U.S. Department of Health & Human Services across several states.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter Use (Cue OTC Test, Cue Health).
The Cue OTC Test is the first molecular diagnostic test available to consumers without a prescription.
The test detects genetic material from SARS-CoV-2 present in the nostrils and delivers results in about 20 minutes to the user’s mobile smart device via the Cue Health app.
In testing, the Cue OTC Test correctly identified 96% of positive nasal swab samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms.
The test is intended for use in people aged 2 years and older with and without symptoms.
“With this authorization, consumers can purchase and self-administer one of the easiest, fastest, and most accurate tests without a prescription,” Clint Sever, cofounder and chief product officer of Cue Health, said in a news release.
“This FDA authorization will help us improve patient outcomes with a solution that provides the accuracy of central lab tests, with the speed and accessibility required to address emergent global health issues,” he said.
Cue Health expects to produce more than 100,000 single-use test kits per day by this summer. Dena Cook, the company’s chief communications officer, told this news organization that the company hasn’t announced pricing information yet, but the price will be “comparable” to other price points and other products on the market.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“Cue COVID-19 Test for Home and Over-the-Counter Use provides access to accurate and reliable testing at home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public,” he said.
In June, the FDA granted an EUA to Cue Health’s COVID-19 test for use in clinical and point-of-care settings.
The test is currently being used in hospitals, physicians’ offices, and dental clinics, as well as schools, essential businesses, nursing homes, and other congregate-care facilities. The test is also being distributed through a program led by the U.S. Department of Defense and the U.S. Department of Health & Human Services across several states.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter Use (Cue OTC Test, Cue Health).
The Cue OTC Test is the first molecular diagnostic test available to consumers without a prescription.
The test detects genetic material from SARS-CoV-2 present in the nostrils and delivers results in about 20 minutes to the user’s mobile smart device via the Cue Health app.
In testing, the Cue OTC Test correctly identified 96% of positive nasal swab samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms.
The test is intended for use in people aged 2 years and older with and without symptoms.
“With this authorization, consumers can purchase and self-administer one of the easiest, fastest, and most accurate tests without a prescription,” Clint Sever, cofounder and chief product officer of Cue Health, said in a news release.
“This FDA authorization will help us improve patient outcomes with a solution that provides the accuracy of central lab tests, with the speed and accessibility required to address emergent global health issues,” he said.
Cue Health expects to produce more than 100,000 single-use test kits per day by this summer. Dena Cook, the company’s chief communications officer, told this news organization that the company hasn’t announced pricing information yet, but the price will be “comparable” to other price points and other products on the market.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“Cue COVID-19 Test for Home and Over-the-Counter Use provides access to accurate and reliable testing at home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public,” he said.
In June, the FDA granted an EUA to Cue Health’s COVID-19 test for use in clinical and point-of-care settings.
The test is currently being used in hospitals, physicians’ offices, and dental clinics, as well as schools, essential businesses, nursing homes, and other congregate-care facilities. The test is also being distributed through a program led by the U.S. Department of Defense and the U.S. Department of Health & Human Services across several states.
A version of this article first appeared on Medscape.com.