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Patients with mental illness a priority for COVID vaccine, experts say
With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.
Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.
Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.
In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.
Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.
Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.
Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
High-risk population
Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.
For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.
Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.
Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.
In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.
“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.
The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
An argument for fairness
Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.
“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.
“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.
“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.
Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.
Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.
Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.
In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.
Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.
Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.
Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
High-risk population
Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.
For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.
Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.
Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.
In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.
“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.
The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
An argument for fairness
Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.
“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.
“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.
“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.
Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.
Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.
Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.
In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.
Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.
Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.
Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
High-risk population
Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.
For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.
Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.
Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.
In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.
“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.
The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
An argument for fairness
Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.
“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.
“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.
“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.
Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
FDA clears smartphone app to interrupt PTSD-related nightmares
The Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with posttraumatic stress disorder (PTSD).
The NightWare app, from Minneapolis-based NightWare Inc., runs on the Apple Watch and Apple iPhone.
During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.
When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company notes.
NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.
“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” Carlos Peña, PhD, director, Office of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health at the FDA, said in a news release.
This authorization “offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares,” said Dr. Peña.
NightWare was tested in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibrations were provided.
Both the sham and active groups showed improvement in sleep on standard sleep scales, with the active group showing greater improvement than sham. “The evidence demonstrated the probable benefits outweighed the probable risks,” the FDA said in a statement.
and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the agency said.
NightWare was granted breakthrough device designation for the treatment of nightmares in patients with PTSD. The device reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.
Along with this marketing authorization, the FDA is establishing “special controls” designed to provide a “reasonable assurance of safety and effectiveness for tests of this type,” the agency said.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with posttraumatic stress disorder (PTSD).
The NightWare app, from Minneapolis-based NightWare Inc., runs on the Apple Watch and Apple iPhone.
During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.
When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company notes.
NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.
“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” Carlos Peña, PhD, director, Office of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health at the FDA, said in a news release.
This authorization “offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares,” said Dr. Peña.
NightWare was tested in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibrations were provided.
Both the sham and active groups showed improvement in sleep on standard sleep scales, with the active group showing greater improvement than sham. “The evidence demonstrated the probable benefits outweighed the probable risks,” the FDA said in a statement.
and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the agency said.
NightWare was granted breakthrough device designation for the treatment of nightmares in patients with PTSD. The device reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.
Along with this marketing authorization, the FDA is establishing “special controls” designed to provide a “reasonable assurance of safety and effectiveness for tests of this type,” the agency said.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with posttraumatic stress disorder (PTSD).
The NightWare app, from Minneapolis-based NightWare Inc., runs on the Apple Watch and Apple iPhone.
During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.
When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company notes.
NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.
“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” Carlos Peña, PhD, director, Office of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health at the FDA, said in a news release.
This authorization “offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares,” said Dr. Peña.
NightWare was tested in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibrations were provided.
Both the sham and active groups showed improvement in sleep on standard sleep scales, with the active group showing greater improvement than sham. “The evidence demonstrated the probable benefits outweighed the probable risks,” the FDA said in a statement.
and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the agency said.
NightWare was granted breakthrough device designation for the treatment of nightmares in patients with PTSD. The device reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.
Along with this marketing authorization, the FDA is establishing “special controls” designed to provide a “reasonable assurance of safety and effectiveness for tests of this type,” the agency said.
A version of this article originally appeared on Medscape.com.
Add-on atypicals for depression carry ‘substantial’ death risk
Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.
“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.
The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”
The study was published online September 30 in PLOS ONE.
A last resort
Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.
To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.
After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.
The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.
A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.
(adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).
This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.
“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.
“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.
“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.
The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
Another red flag
Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”
“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.
Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”
Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”
The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.
“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.
The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”
The study was published online September 30 in PLOS ONE.
A last resort
Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.
To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.
After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.
The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.
A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.
(adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).
This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.
“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.
“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.
“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.
The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
Another red flag
Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”
“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.
Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”
Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”
The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.
“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.
The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”
The study was published online September 30 in PLOS ONE.
A last resort
Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.
To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.
After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.
The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.
A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.
(adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).
This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.
“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.
“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.
“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.
The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
Another red flag
Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”
“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.
Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”
Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”
The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Brain imaging reveals a neural basis for partisan politics
The differences between politically left- and right-leaning individuals may have neural underpinnings, results from a new brain imaging study suggest.
Investigators found that despite watching the same videos related to immigration policy, neural responses differed between liberals and conservatives.
“This divergence was strongest when the videos used language that highlighted threat, morality, and emotions, suggesting that certain words are more likely to drive polarized response,” lead researcher Yuan Chang Leong, PhD, a postdoctoral scholar in cognitive neuroscience at the University of California, Berkeley, told Medscape Medical News.
“The results suggest a neural basis for partisan biases in interpreting political messages, the effects these biases have on attitude change, and the type of language most likely to drive biased interpretations,” Leong added.
The study was published online Oct. 20 in Proceedings of the National Academy of Sciences.
Hardwired to disagree?
The researchers combined fMRI with semantic content analysis to investigate neural mechanisms that underlie the biased processing of political content.
They scanned 38 middle-aged men and women with liberal- or conservative-leaning immigration attitudes while the participants watched short news clips, campaign ads, and public speeches related to various immigration policies.
These policies included those that led to the United States–Mexico border wall, Deferred Action for Childhood Arrivals (DACA) protections for undocumented immigrants, the ban on refugees from majority-Muslim countries coming to the United States, and the cutting of federal funding to sanctuary cities.
After each video, participants rated on a scale of 1 to 5 how much they agreed with the general message of the video, the credibility of the information presented, and the extent to which the video made them likely to change their position and to support the policy in question.
The study revealed evidence of “neural polarization” – activity in the brain that diverges between people who hold liberal vs. conservative political views, the researchers reported.
Neural polarization was observed in the dorsomedial prefrontal cortex (DMPFC), a brain region associated with the interpretation of narrative content.
Neural polarization in this region intensified during moments in the videos that included risk-related and moral-emotional language, highlighting content features most likely to drive divergent interpretations between conservatives and liberals, they noted.
For a given individual, the closer that brain activity resembled that of the “average conservative” or “average liberal,” the more likely the person was to adopt that group’s position after watching the videos.
“We know that partisans respond differently to the same information. So in that sense, it’s not surprising to find that their brains respond differently as well,” Leong told Medscape Medical News.
“What we weren’t sure about was where in the brain we would find these differences, how neural differences were related to attitude change, and what type of content would be most likely to be associated with these differences,” he said.
Importantly, said Leong, these differences do not imply that people are hardwired to disagree. Rather, individual experiences and the media that is consumed likely contribute to neural polarization.
“ – for example, by framing messages to appeal to the core values of the respective voter,” he said.
Brain stimulation to alter political perception?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist in Newton, Mass., and executive director, Global Neuroscience Initiative Foundation, said the research “puts us one step closer to identifying how our brains interpret political information.”
The study, Lakhan noted, implicates a specific brain structure, the DMPFC, which is the “lens” in which information that gets into our brain is “viewed and acted on.”
“I trust that there will be plenty more work using a similar fMRI approach to tease out scenarios outside of immigration policy, as used in this study. Down the line, brain signatures through fMRI may be able to tell an individual’s political bent, and perhaps technologies like transcranial magnetic stimulation may be able to modulate our perceptions of political content, Shaheen said.
The research was supported by a grant from the Army Research Office. Leong and Lakhan have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The differences between politically left- and right-leaning individuals may have neural underpinnings, results from a new brain imaging study suggest.
Investigators found that despite watching the same videos related to immigration policy, neural responses differed between liberals and conservatives.
“This divergence was strongest when the videos used language that highlighted threat, morality, and emotions, suggesting that certain words are more likely to drive polarized response,” lead researcher Yuan Chang Leong, PhD, a postdoctoral scholar in cognitive neuroscience at the University of California, Berkeley, told Medscape Medical News.
“The results suggest a neural basis for partisan biases in interpreting political messages, the effects these biases have on attitude change, and the type of language most likely to drive biased interpretations,” Leong added.
The study was published online Oct. 20 in Proceedings of the National Academy of Sciences.
Hardwired to disagree?
The researchers combined fMRI with semantic content analysis to investigate neural mechanisms that underlie the biased processing of political content.
They scanned 38 middle-aged men and women with liberal- or conservative-leaning immigration attitudes while the participants watched short news clips, campaign ads, and public speeches related to various immigration policies.
These policies included those that led to the United States–Mexico border wall, Deferred Action for Childhood Arrivals (DACA) protections for undocumented immigrants, the ban on refugees from majority-Muslim countries coming to the United States, and the cutting of federal funding to sanctuary cities.
After each video, participants rated on a scale of 1 to 5 how much they agreed with the general message of the video, the credibility of the information presented, and the extent to which the video made them likely to change their position and to support the policy in question.
The study revealed evidence of “neural polarization” – activity in the brain that diverges between people who hold liberal vs. conservative political views, the researchers reported.
Neural polarization was observed in the dorsomedial prefrontal cortex (DMPFC), a brain region associated with the interpretation of narrative content.
Neural polarization in this region intensified during moments in the videos that included risk-related and moral-emotional language, highlighting content features most likely to drive divergent interpretations between conservatives and liberals, they noted.
For a given individual, the closer that brain activity resembled that of the “average conservative” or “average liberal,” the more likely the person was to adopt that group’s position after watching the videos.
“We know that partisans respond differently to the same information. So in that sense, it’s not surprising to find that their brains respond differently as well,” Leong told Medscape Medical News.
“What we weren’t sure about was where in the brain we would find these differences, how neural differences were related to attitude change, and what type of content would be most likely to be associated with these differences,” he said.
Importantly, said Leong, these differences do not imply that people are hardwired to disagree. Rather, individual experiences and the media that is consumed likely contribute to neural polarization.
“ – for example, by framing messages to appeal to the core values of the respective voter,” he said.
Brain stimulation to alter political perception?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist in Newton, Mass., and executive director, Global Neuroscience Initiative Foundation, said the research “puts us one step closer to identifying how our brains interpret political information.”
The study, Lakhan noted, implicates a specific brain structure, the DMPFC, which is the “lens” in which information that gets into our brain is “viewed and acted on.”
“I trust that there will be plenty more work using a similar fMRI approach to tease out scenarios outside of immigration policy, as used in this study. Down the line, brain signatures through fMRI may be able to tell an individual’s political bent, and perhaps technologies like transcranial magnetic stimulation may be able to modulate our perceptions of political content, Shaheen said.
The research was supported by a grant from the Army Research Office. Leong and Lakhan have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The differences between politically left- and right-leaning individuals may have neural underpinnings, results from a new brain imaging study suggest.
Investigators found that despite watching the same videos related to immigration policy, neural responses differed between liberals and conservatives.
“This divergence was strongest when the videos used language that highlighted threat, morality, and emotions, suggesting that certain words are more likely to drive polarized response,” lead researcher Yuan Chang Leong, PhD, a postdoctoral scholar in cognitive neuroscience at the University of California, Berkeley, told Medscape Medical News.
“The results suggest a neural basis for partisan biases in interpreting political messages, the effects these biases have on attitude change, and the type of language most likely to drive biased interpretations,” Leong added.
The study was published online Oct. 20 in Proceedings of the National Academy of Sciences.
Hardwired to disagree?
The researchers combined fMRI with semantic content analysis to investigate neural mechanisms that underlie the biased processing of political content.
They scanned 38 middle-aged men and women with liberal- or conservative-leaning immigration attitudes while the participants watched short news clips, campaign ads, and public speeches related to various immigration policies.
These policies included those that led to the United States–Mexico border wall, Deferred Action for Childhood Arrivals (DACA) protections for undocumented immigrants, the ban on refugees from majority-Muslim countries coming to the United States, and the cutting of federal funding to sanctuary cities.
After each video, participants rated on a scale of 1 to 5 how much they agreed with the general message of the video, the credibility of the information presented, and the extent to which the video made them likely to change their position and to support the policy in question.
The study revealed evidence of “neural polarization” – activity in the brain that diverges between people who hold liberal vs. conservative political views, the researchers reported.
Neural polarization was observed in the dorsomedial prefrontal cortex (DMPFC), a brain region associated with the interpretation of narrative content.
Neural polarization in this region intensified during moments in the videos that included risk-related and moral-emotional language, highlighting content features most likely to drive divergent interpretations between conservatives and liberals, they noted.
For a given individual, the closer that brain activity resembled that of the “average conservative” or “average liberal,” the more likely the person was to adopt that group’s position after watching the videos.
“We know that partisans respond differently to the same information. So in that sense, it’s not surprising to find that their brains respond differently as well,” Leong told Medscape Medical News.
“What we weren’t sure about was where in the brain we would find these differences, how neural differences were related to attitude change, and what type of content would be most likely to be associated with these differences,” he said.
Importantly, said Leong, these differences do not imply that people are hardwired to disagree. Rather, individual experiences and the media that is consumed likely contribute to neural polarization.
“ – for example, by framing messages to appeal to the core values of the respective voter,” he said.
Brain stimulation to alter political perception?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist in Newton, Mass., and executive director, Global Neuroscience Initiative Foundation, said the research “puts us one step closer to identifying how our brains interpret political information.”
The study, Lakhan noted, implicates a specific brain structure, the DMPFC, which is the “lens” in which information that gets into our brain is “viewed and acted on.”
“I trust that there will be plenty more work using a similar fMRI approach to tease out scenarios outside of immigration policy, as used in this study. Down the line, brain signatures through fMRI may be able to tell an individual’s political bent, and perhaps technologies like transcranial magnetic stimulation may be able to modulate our perceptions of political content, Shaheen said.
The research was supported by a grant from the Army Research Office. Leong and Lakhan have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
COVID-19 a new opportunity for suicide prevention
The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.
“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.
“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.
Mitigating suicide risk
Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.
Still, a number of pandemic-related risk factors could increase individual and population suicide risk.
They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.
There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.
“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.
The political will
Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.
A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.
COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.
“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.
One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.
As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.
Moutier reports no relevant financial relationships.
This article first appeared on Medscape.com.
The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.
“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.
“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.
Mitigating suicide risk
Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.
Still, a number of pandemic-related risk factors could increase individual and population suicide risk.
They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.
There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.
“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.
The political will
Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.
A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.
COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.
“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.
One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.
As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.
Moutier reports no relevant financial relationships.
This article first appeared on Medscape.com.
The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.
“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.
“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.
Mitigating suicide risk
Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.
Still, a number of pandemic-related risk factors could increase individual and population suicide risk.
They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.
There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.
“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.
The political will
Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.
A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.
COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.
“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.
One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.
As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.
Moutier reports no relevant financial relationships.
This article first appeared on Medscape.com.
Add-on psychotherapy a win in bipolar disorder
Adding psychotherapy to pharmacotherapy benefits patients with bipolar disorder (BD), particularly when delivered in family or group settings, results of a new meta-analysis confirms.
Outpatients with BD receiving drug therapy “should also be offered psychosocial treatments that emphasize illness management strategies and enhance coping skills; delivering these components in family or group format may be especially advantageous,” wrote the investigators, led by David Miklowitz, PhD, University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior.
The study was published online Oct. 14 in JAMA Psychiatry.
Drugs alone not enough
It’s increasingly recognized that drug therapy alone can’t prevent recurrences of BD or fully alleviate postepisode symptoms or functional impairment, the researchers noted in their article. Several psychotherapy protocols have been shown to benefit patients with BD when used in conjunction with drug therapy, but little is known about their comparative effectiveness.
To investigate, the researchers conducted a systematic review and component network meta-analysis of 39 randomized clinical trials (36 involving adults and three involving adolescents).
The trials involved 3,863 patients with BD and compared pharmacotherapy used in conjunction with manualized psychotherapy (cognitive-behavioral therapy [CBT], family or conjoint therapy, interpersonal therapy, and/or psychoeducational therapy) with pharmacotherapy delivered in conjunction with a control intervention (supportive therapy or treatment as usual).
Across 20 two-group trials that provided usable information, manualized psychotherapies were associated with a lower probability of illness recurrence (the primary outcome), compared with control interventions (odds ratio, 0.56; 95% CI, 0.43-0.74).
Psychoeducation with guided practice of illness management skills in a family or group format was superior to these strategies delivered in an individual format (OR, 0.12; 95% CI, 0.02-0.94).
Family or conjoint therapy and brief psychoeducation were associated with lower attrition rates than standard psychoeducation.
For the secondary outcome of stabilization of depressive or manic symptoms over 12 months, CBT and, with less certainty, family or conjoint therapy and interpersonal therapy were more effective than treatment as usual.
The investigators note that the findings are in line with a network meta-analysis published earlier this year that found that combining psychotherapy with pharmacotherapy is the best option for stabilizing episodes and preventing recurrences of major depression.
“[T]here is enough evidence from this analysis and others to conclude that health care systems should offer combinations of evidence-based pharmacotherapy and psychotherapy” to outpatients with BD, the researchers note.
and active tasks to enhance coping skills (e.g., monitoring and managing prodromal symptoms) rather than being passive recipients of didactic education,” they wrote.
“When the immediate goal is recovery from moderately severe depressive or manic symptoms, cognitive restructuring, regulating daily rhythms, and communication training may be associated with stabilization,” they added.
A call to action
The coauthors of an editorial in JAMA Psychiatry noted that the findings “further reinforce extant treatment guidelines recommending medication management and adjunctive evidence-based psychosocial treatments for individuals with BD.”
The findings also “identify specific treatment components and formats most strongly associated with preventing relapse and addressing mood symptoms,” write Tina Goldstein, PhD, and Danella Hafeman, MD, PhD, from Western Psychiatric Hospital, University of Pittsburgh.
The study “may further serve as a call to action to enhance availability and uptake of these treatments in the community. Unfortunately, data suggest substantially lower rates of psychotherapy receipt (26%-50%), compared with medication management (46%-90%) among adults with BD,” they wrote.
Dr. Goldstein and Dr. Hafeman noted future steps for the field include “demonstrating effectiveness of evidence-based treatment approaches for BD in the community, maximizing accessibility, and furthering knowledge that informs individualized treatment selection with substantial promise to optimize outcomes for individuals with BD.”
The study was supported in part by a grant from the National Institute for Health Research Oxford Health Biomedical Research Centre. Dr. Miklowitz has received research support from the NIHR, the Danny Alberts Foundation, the Attias Family Foundation, the Carl and Roberta Deutsch Foundation, the Kayne Family Foundation, AIM for Mental Health, and the Max Gray Fund; book royalties from Guilford Press and John Wiley and Sons; and served as principal investigator on four of the trials included in this meta-analysis. Dr. Goldstein has received grants from the National Institute of Mental Health, the American Foundation for Suicide Prevention, the University of Pittsburgh Clinical and Translational Science Institute, and the Brain and Behavior Research Foundation and royalties from Guilford Press outside the submitted work. Dr. Hafeman has received grants from the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the Klingenstein Third Generation Foundation.
This article first appeared on Medscape.com.
Adding psychotherapy to pharmacotherapy benefits patients with bipolar disorder (BD), particularly when delivered in family or group settings, results of a new meta-analysis confirms.
Outpatients with BD receiving drug therapy “should also be offered psychosocial treatments that emphasize illness management strategies and enhance coping skills; delivering these components in family or group format may be especially advantageous,” wrote the investigators, led by David Miklowitz, PhD, University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior.
The study was published online Oct. 14 in JAMA Psychiatry.
Drugs alone not enough
It’s increasingly recognized that drug therapy alone can’t prevent recurrences of BD or fully alleviate postepisode symptoms or functional impairment, the researchers noted in their article. Several psychotherapy protocols have been shown to benefit patients with BD when used in conjunction with drug therapy, but little is known about their comparative effectiveness.
To investigate, the researchers conducted a systematic review and component network meta-analysis of 39 randomized clinical trials (36 involving adults and three involving adolescents).
The trials involved 3,863 patients with BD and compared pharmacotherapy used in conjunction with manualized psychotherapy (cognitive-behavioral therapy [CBT], family or conjoint therapy, interpersonal therapy, and/or psychoeducational therapy) with pharmacotherapy delivered in conjunction with a control intervention (supportive therapy or treatment as usual).
Across 20 two-group trials that provided usable information, manualized psychotherapies were associated with a lower probability of illness recurrence (the primary outcome), compared with control interventions (odds ratio, 0.56; 95% CI, 0.43-0.74).
Psychoeducation with guided practice of illness management skills in a family or group format was superior to these strategies delivered in an individual format (OR, 0.12; 95% CI, 0.02-0.94).
Family or conjoint therapy and brief psychoeducation were associated with lower attrition rates than standard psychoeducation.
For the secondary outcome of stabilization of depressive or manic symptoms over 12 months, CBT and, with less certainty, family or conjoint therapy and interpersonal therapy were more effective than treatment as usual.
The investigators note that the findings are in line with a network meta-analysis published earlier this year that found that combining psychotherapy with pharmacotherapy is the best option for stabilizing episodes and preventing recurrences of major depression.
“[T]here is enough evidence from this analysis and others to conclude that health care systems should offer combinations of evidence-based pharmacotherapy and psychotherapy” to outpatients with BD, the researchers note.
and active tasks to enhance coping skills (e.g., monitoring and managing prodromal symptoms) rather than being passive recipients of didactic education,” they wrote.
“When the immediate goal is recovery from moderately severe depressive or manic symptoms, cognitive restructuring, regulating daily rhythms, and communication training may be associated with stabilization,” they added.
A call to action
The coauthors of an editorial in JAMA Psychiatry noted that the findings “further reinforce extant treatment guidelines recommending medication management and adjunctive evidence-based psychosocial treatments for individuals with BD.”
The findings also “identify specific treatment components and formats most strongly associated with preventing relapse and addressing mood symptoms,” write Tina Goldstein, PhD, and Danella Hafeman, MD, PhD, from Western Psychiatric Hospital, University of Pittsburgh.
The study “may further serve as a call to action to enhance availability and uptake of these treatments in the community. Unfortunately, data suggest substantially lower rates of psychotherapy receipt (26%-50%), compared with medication management (46%-90%) among adults with BD,” they wrote.
Dr. Goldstein and Dr. Hafeman noted future steps for the field include “demonstrating effectiveness of evidence-based treatment approaches for BD in the community, maximizing accessibility, and furthering knowledge that informs individualized treatment selection with substantial promise to optimize outcomes for individuals with BD.”
The study was supported in part by a grant from the National Institute for Health Research Oxford Health Biomedical Research Centre. Dr. Miklowitz has received research support from the NIHR, the Danny Alberts Foundation, the Attias Family Foundation, the Carl and Roberta Deutsch Foundation, the Kayne Family Foundation, AIM for Mental Health, and the Max Gray Fund; book royalties from Guilford Press and John Wiley and Sons; and served as principal investigator on four of the trials included in this meta-analysis. Dr. Goldstein has received grants from the National Institute of Mental Health, the American Foundation for Suicide Prevention, the University of Pittsburgh Clinical and Translational Science Institute, and the Brain and Behavior Research Foundation and royalties from Guilford Press outside the submitted work. Dr. Hafeman has received grants from the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the Klingenstein Third Generation Foundation.
This article first appeared on Medscape.com.
Adding psychotherapy to pharmacotherapy benefits patients with bipolar disorder (BD), particularly when delivered in family or group settings, results of a new meta-analysis confirms.
Outpatients with BD receiving drug therapy “should also be offered psychosocial treatments that emphasize illness management strategies and enhance coping skills; delivering these components in family or group format may be especially advantageous,” wrote the investigators, led by David Miklowitz, PhD, University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior.
The study was published online Oct. 14 in JAMA Psychiatry.
Drugs alone not enough
It’s increasingly recognized that drug therapy alone can’t prevent recurrences of BD or fully alleviate postepisode symptoms or functional impairment, the researchers noted in their article. Several psychotherapy protocols have been shown to benefit patients with BD when used in conjunction with drug therapy, but little is known about their comparative effectiveness.
To investigate, the researchers conducted a systematic review and component network meta-analysis of 39 randomized clinical trials (36 involving adults and three involving adolescents).
The trials involved 3,863 patients with BD and compared pharmacotherapy used in conjunction with manualized psychotherapy (cognitive-behavioral therapy [CBT], family or conjoint therapy, interpersonal therapy, and/or psychoeducational therapy) with pharmacotherapy delivered in conjunction with a control intervention (supportive therapy or treatment as usual).
Across 20 two-group trials that provided usable information, manualized psychotherapies were associated with a lower probability of illness recurrence (the primary outcome), compared with control interventions (odds ratio, 0.56; 95% CI, 0.43-0.74).
Psychoeducation with guided practice of illness management skills in a family or group format was superior to these strategies delivered in an individual format (OR, 0.12; 95% CI, 0.02-0.94).
Family or conjoint therapy and brief psychoeducation were associated with lower attrition rates than standard psychoeducation.
For the secondary outcome of stabilization of depressive or manic symptoms over 12 months, CBT and, with less certainty, family or conjoint therapy and interpersonal therapy were more effective than treatment as usual.
The investigators note that the findings are in line with a network meta-analysis published earlier this year that found that combining psychotherapy with pharmacotherapy is the best option for stabilizing episodes and preventing recurrences of major depression.
“[T]here is enough evidence from this analysis and others to conclude that health care systems should offer combinations of evidence-based pharmacotherapy and psychotherapy” to outpatients with BD, the researchers note.
and active tasks to enhance coping skills (e.g., monitoring and managing prodromal symptoms) rather than being passive recipients of didactic education,” they wrote.
“When the immediate goal is recovery from moderately severe depressive or manic symptoms, cognitive restructuring, regulating daily rhythms, and communication training may be associated with stabilization,” they added.
A call to action
The coauthors of an editorial in JAMA Psychiatry noted that the findings “further reinforce extant treatment guidelines recommending medication management and adjunctive evidence-based psychosocial treatments for individuals with BD.”
The findings also “identify specific treatment components and formats most strongly associated with preventing relapse and addressing mood symptoms,” write Tina Goldstein, PhD, and Danella Hafeman, MD, PhD, from Western Psychiatric Hospital, University of Pittsburgh.
The study “may further serve as a call to action to enhance availability and uptake of these treatments in the community. Unfortunately, data suggest substantially lower rates of psychotherapy receipt (26%-50%), compared with medication management (46%-90%) among adults with BD,” they wrote.
Dr. Goldstein and Dr. Hafeman noted future steps for the field include “demonstrating effectiveness of evidence-based treatment approaches for BD in the community, maximizing accessibility, and furthering knowledge that informs individualized treatment selection with substantial promise to optimize outcomes for individuals with BD.”
The study was supported in part by a grant from the National Institute for Health Research Oxford Health Biomedical Research Centre. Dr. Miklowitz has received research support from the NIHR, the Danny Alberts Foundation, the Attias Family Foundation, the Carl and Roberta Deutsch Foundation, the Kayne Family Foundation, AIM for Mental Health, and the Max Gray Fund; book royalties from Guilford Press and John Wiley and Sons; and served as principal investigator on four of the trials included in this meta-analysis. Dr. Goldstein has received grants from the National Institute of Mental Health, the American Foundation for Suicide Prevention, the University of Pittsburgh Clinical and Translational Science Institute, and the Brain and Behavior Research Foundation and royalties from Guilford Press outside the submitted work. Dr. Hafeman has received grants from the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the Klingenstein Third Generation Foundation.
This article first appeared on Medscape.com.
COVID-19: A second wave of mental illness 'imminent'
The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.
“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.
In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.
Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.
The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.
It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.
The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.
“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.
“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.
As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.
The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.
How will the United States manage this impending wave of mental health problems?
“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.
“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.
Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
A version of this article originally appeared on Medscape.com.
The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.
“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.
In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.
Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.
The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.
It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.
The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.
“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.
“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.
As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.
The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.
How will the United States manage this impending wave of mental health problems?
“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.
“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.
Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
A version of this article originally appeared on Medscape.com.
The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.
“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.
In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.
Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.
The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.
It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.
The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.
“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.
“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.
As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.
The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.
How will the United States manage this impending wave of mental health problems?
“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.
“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.
Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
A version of this article originally appeared on Medscape.com.
Migraine nerve stimulation device now available over the counter
The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.
Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.
The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.
At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.
“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.
The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.
An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.
Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.
Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.
The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.
At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.
“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.
The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.
An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.
Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.
Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.
The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.
At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.
“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.
The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.
An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.
Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.
A version of this article originally appeared on Medscape.com.
AHA issues new scientific statement on heart health for LGBTQ adults
Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.
“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.
“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.
The statement was published online Oct. 8 in Circulation.
‘Invisible’ population
There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.
There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.
While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:
- LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
- Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
- Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
- Transgender women and nonbinary persons are more likely to binge drink.
- Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.
“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.
He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.
“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
Discrimination in health care
Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.
The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.
“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.
“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.
The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”
Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.
But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.
The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.
A version of this article originally appeared on Medscape.com.
Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.
“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.
“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.
The statement was published online Oct. 8 in Circulation.
‘Invisible’ population
There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.
There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.
While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:
- LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
- Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
- Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
- Transgender women and nonbinary persons are more likely to binge drink.
- Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.
“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.
He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.
“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
Discrimination in health care
Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.
The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.
“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.
“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.
The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”
Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.
But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.
The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.
A version of this article originally appeared on Medscape.com.
Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.
“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.
“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.
The statement was published online Oct. 8 in Circulation.
‘Invisible’ population
There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.
There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.
While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:
- LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
- Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
- Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
- Transgender women and nonbinary persons are more likely to binge drink.
- Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.
“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.
He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.
“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
Discrimination in health care
Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.
The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.
“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.
“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.
The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”
Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.
But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.
The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.
A version of this article originally appeared on Medscape.com.
AHA scientific statement highlights cardiorenal benefit of new diabetes drugs
To protect the heart and kidneys, sodium-glucose transporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) receptor agonists should be considered for people with type 2 diabetes and chronic kidney disease (CKD), the American Heart Association advised in a new scientific statement.
Taken together, the results of relevant clinical trials indicate that SGLT2 inhibitors and GLP-1 receptor agonists safely and significantly reduce the risk for cardiovascular (CV) events, death, and the slow progression of CKD to end-stage kidney disease, including the risks for dialysis, transplantation, and death, the writing group says.
The scientific statement was published online Sept. 28 in Circulation.
“There has been rapid reporting of high-quality data in the cardio-renal-metabolic space with significant heart and kidney benefits, particularly with these two newer classes of antihyperglycemic agents,” Janani Rangaswami, MD, who chaired the writing group, said in an interview.
“More recent data show benefits in chronic kidney disease and heart failure even in patients without diabetes,” said Dr. Rangaswami, Einstein Medical Center and Sidney Kimmel Medical College, both in Philadelphia.
“These data are practice-changing in both cardiology and nephrology, and usher in a new era of disease-modifying therapies in heart and kidney disease,” Dr. Rangaswami added.
Recommendations at a glance
- Provide early and ongoing assessment of risks for CVD and CKD to patients who may benefit from SGLT2 inhibitors of GLP-1 receptor agonists.
- Tailor medication choices that meet the needs of individual patients. Realize that, given “consistent class-wide effects,” the choice of a specific SGLT2 inhibitor or GLP-1 receptor agonist may be dictated by affordability, coverage, and formulary considerations.
- Adjust all medications in tandem with these medicines and consider the burden of polypharmacy, which is common among people with type 2 diabetes. Adjust concomitant therapies and deprescribe where possible.
- Identify risks for hypoglycemia and educate patients on the signs so they can seek treatment quickly.
- Monitor and control high blood pressure.
- Counsel patients about the risks for and symptoms of euglycemic diabetic ketoacidosis when taking SGLT2 inhibitors, as well as classic DKA, which can be fatal.
- Regularly screen and counsel patients about foot care to prevent foot ulcers or blisters that can quickly become infected and lead to amputation.
The writing group identified two additional patient subgroups that may benefit from SGLT2 inhibitors and GLP-1 receptor agonists: those with heart failure with reduced ejection fraction with or without diabetes; and those with CKD who do not have diabetes. They say more data are anticipated to validate the use of SGLT2 inhibitors and GLP-1 receptor agonists in these “at-risk” patients.
Collaborative care model
The writing group proposed a collaborative care model, bridging cardiologists, nephrologists, endocrinologists, and primary care physicians, to help facilitate the “prompt and appropriate” integration of these new classes of medications in the management of patients with type 2 diabetes and CKD.
There is “an unmet need for a cardio-renal-metabolic care model that incorporates best practices in the real world to help align these therapies, especially with vulnerable high-risk patients with cardiorenal disease, and to overcome barriers toward uptake of these agents. Hopefully this statement provides some guidance to the cardiology and nephrology communities in that area,” Dr. Rangaswami said in an interview.
But old habits die hard, as research continues to show the slow adoption of these newer medications in the real world.
For example, a large observational study published last year showed a “striking” discordance between evidence-based, guideline-recommended use of SGLT2 inhibitors for the treatment of type 2 diabetes and their actual uptake in clinical practice.
Paradoxically, patients with CVD, heart failure, hypertension, CKD, and those at risk for hypoglycemia were less apt to receive an SGLT2 inhibitor than other patients.
“The relatively slow uptake of these agents is multifactorial,” Dr. Rangaswami said. “Cardiologists and nephrologists may suffer from some level of ‘therapeutic inertia’ when using new agents they are unfamiliar with and originally branded as ‘antidiabetic’ agents, with the perception of these agents being outside the scope of their practice.”
Two other factors are also at play. “The current health care system is based on ‘specialty silos,’ where specialists tend to stick to the traditional scope of their specialty and are reluctant to view these agents as part of their therapeutic armamentarium. Finally, insurance coverage barriers and affordability also limit the use on a widespread basis,” Dr. Rangaswami said.
A version of this article originally appeared on Medscape.com .
To protect the heart and kidneys, sodium-glucose transporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) receptor agonists should be considered for people with type 2 diabetes and chronic kidney disease (CKD), the American Heart Association advised in a new scientific statement.
Taken together, the results of relevant clinical trials indicate that SGLT2 inhibitors and GLP-1 receptor agonists safely and significantly reduce the risk for cardiovascular (CV) events, death, and the slow progression of CKD to end-stage kidney disease, including the risks for dialysis, transplantation, and death, the writing group says.
The scientific statement was published online Sept. 28 in Circulation.
“There has been rapid reporting of high-quality data in the cardio-renal-metabolic space with significant heart and kidney benefits, particularly with these two newer classes of antihyperglycemic agents,” Janani Rangaswami, MD, who chaired the writing group, said in an interview.
“More recent data show benefits in chronic kidney disease and heart failure even in patients without diabetes,” said Dr. Rangaswami, Einstein Medical Center and Sidney Kimmel Medical College, both in Philadelphia.
“These data are practice-changing in both cardiology and nephrology, and usher in a new era of disease-modifying therapies in heart and kidney disease,” Dr. Rangaswami added.
Recommendations at a glance
- Provide early and ongoing assessment of risks for CVD and CKD to patients who may benefit from SGLT2 inhibitors of GLP-1 receptor agonists.
- Tailor medication choices that meet the needs of individual patients. Realize that, given “consistent class-wide effects,” the choice of a specific SGLT2 inhibitor or GLP-1 receptor agonist may be dictated by affordability, coverage, and formulary considerations.
- Adjust all medications in tandem with these medicines and consider the burden of polypharmacy, which is common among people with type 2 diabetes. Adjust concomitant therapies and deprescribe where possible.
- Identify risks for hypoglycemia and educate patients on the signs so they can seek treatment quickly.
- Monitor and control high blood pressure.
- Counsel patients about the risks for and symptoms of euglycemic diabetic ketoacidosis when taking SGLT2 inhibitors, as well as classic DKA, which can be fatal.
- Regularly screen and counsel patients about foot care to prevent foot ulcers or blisters that can quickly become infected and lead to amputation.
The writing group identified two additional patient subgroups that may benefit from SGLT2 inhibitors and GLP-1 receptor agonists: those with heart failure with reduced ejection fraction with or without diabetes; and those with CKD who do not have diabetes. They say more data are anticipated to validate the use of SGLT2 inhibitors and GLP-1 receptor agonists in these “at-risk” patients.
Collaborative care model
The writing group proposed a collaborative care model, bridging cardiologists, nephrologists, endocrinologists, and primary care physicians, to help facilitate the “prompt and appropriate” integration of these new classes of medications in the management of patients with type 2 diabetes and CKD.
There is “an unmet need for a cardio-renal-metabolic care model that incorporates best practices in the real world to help align these therapies, especially with vulnerable high-risk patients with cardiorenal disease, and to overcome barriers toward uptake of these agents. Hopefully this statement provides some guidance to the cardiology and nephrology communities in that area,” Dr. Rangaswami said in an interview.
But old habits die hard, as research continues to show the slow adoption of these newer medications in the real world.
For example, a large observational study published last year showed a “striking” discordance between evidence-based, guideline-recommended use of SGLT2 inhibitors for the treatment of type 2 diabetes and their actual uptake in clinical practice.
Paradoxically, patients with CVD, heart failure, hypertension, CKD, and those at risk for hypoglycemia were less apt to receive an SGLT2 inhibitor than other patients.
“The relatively slow uptake of these agents is multifactorial,” Dr. Rangaswami said. “Cardiologists and nephrologists may suffer from some level of ‘therapeutic inertia’ when using new agents they are unfamiliar with and originally branded as ‘antidiabetic’ agents, with the perception of these agents being outside the scope of their practice.”
Two other factors are also at play. “The current health care system is based on ‘specialty silos,’ where specialists tend to stick to the traditional scope of their specialty and are reluctant to view these agents as part of their therapeutic armamentarium. Finally, insurance coverage barriers and affordability also limit the use on a widespread basis,” Dr. Rangaswami said.
A version of this article originally appeared on Medscape.com .
To protect the heart and kidneys, sodium-glucose transporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) receptor agonists should be considered for people with type 2 diabetes and chronic kidney disease (CKD), the American Heart Association advised in a new scientific statement.
Taken together, the results of relevant clinical trials indicate that SGLT2 inhibitors and GLP-1 receptor agonists safely and significantly reduce the risk for cardiovascular (CV) events, death, and the slow progression of CKD to end-stage kidney disease, including the risks for dialysis, transplantation, and death, the writing group says.
The scientific statement was published online Sept. 28 in Circulation.
“There has been rapid reporting of high-quality data in the cardio-renal-metabolic space with significant heart and kidney benefits, particularly with these two newer classes of antihyperglycemic agents,” Janani Rangaswami, MD, who chaired the writing group, said in an interview.
“More recent data show benefits in chronic kidney disease and heart failure even in patients without diabetes,” said Dr. Rangaswami, Einstein Medical Center and Sidney Kimmel Medical College, both in Philadelphia.
“These data are practice-changing in both cardiology and nephrology, and usher in a new era of disease-modifying therapies in heart and kidney disease,” Dr. Rangaswami added.
Recommendations at a glance
- Provide early and ongoing assessment of risks for CVD and CKD to patients who may benefit from SGLT2 inhibitors of GLP-1 receptor agonists.
- Tailor medication choices that meet the needs of individual patients. Realize that, given “consistent class-wide effects,” the choice of a specific SGLT2 inhibitor or GLP-1 receptor agonist may be dictated by affordability, coverage, and formulary considerations.
- Adjust all medications in tandem with these medicines and consider the burden of polypharmacy, which is common among people with type 2 diabetes. Adjust concomitant therapies and deprescribe where possible.
- Identify risks for hypoglycemia and educate patients on the signs so they can seek treatment quickly.
- Monitor and control high blood pressure.
- Counsel patients about the risks for and symptoms of euglycemic diabetic ketoacidosis when taking SGLT2 inhibitors, as well as classic DKA, which can be fatal.
- Regularly screen and counsel patients about foot care to prevent foot ulcers or blisters that can quickly become infected and lead to amputation.
The writing group identified two additional patient subgroups that may benefit from SGLT2 inhibitors and GLP-1 receptor agonists: those with heart failure with reduced ejection fraction with or without diabetes; and those with CKD who do not have diabetes. They say more data are anticipated to validate the use of SGLT2 inhibitors and GLP-1 receptor agonists in these “at-risk” patients.
Collaborative care model
The writing group proposed a collaborative care model, bridging cardiologists, nephrologists, endocrinologists, and primary care physicians, to help facilitate the “prompt and appropriate” integration of these new classes of medications in the management of patients with type 2 diabetes and CKD.
There is “an unmet need for a cardio-renal-metabolic care model that incorporates best practices in the real world to help align these therapies, especially with vulnerable high-risk patients with cardiorenal disease, and to overcome barriers toward uptake of these agents. Hopefully this statement provides some guidance to the cardiology and nephrology communities in that area,” Dr. Rangaswami said in an interview.
But old habits die hard, as research continues to show the slow adoption of these newer medications in the real world.
For example, a large observational study published last year showed a “striking” discordance between evidence-based, guideline-recommended use of SGLT2 inhibitors for the treatment of type 2 diabetes and their actual uptake in clinical practice.
Paradoxically, patients with CVD, heart failure, hypertension, CKD, and those at risk for hypoglycemia were less apt to receive an SGLT2 inhibitor than other patients.
“The relatively slow uptake of these agents is multifactorial,” Dr. Rangaswami said. “Cardiologists and nephrologists may suffer from some level of ‘therapeutic inertia’ when using new agents they are unfamiliar with and originally branded as ‘antidiabetic’ agents, with the perception of these agents being outside the scope of their practice.”
Two other factors are also at play. “The current health care system is based on ‘specialty silos,’ where specialists tend to stick to the traditional scope of their specialty and are reluctant to view these agents as part of their therapeutic armamentarium. Finally, insurance coverage barriers and affordability also limit the use on a widespread basis,” Dr. Rangaswami said.
A version of this article originally appeared on Medscape.com .