User login
First guidelines for keto diets in adults with epilepsy released
Just as in children with epilepsy, ketogenic diet therapies can be safe and effective in adults with epilepsy but should only be undertaken with the support of medical professionals trained in their use, the group said.
“Motivation is the key to successful ketogenic diet therapy adherence,” first author Mackenzie Cervenka, MD, director of the Adult Epilepsy Diet Center and associate professor of neurology at Johns Hopkins University, Baltimore, said in an interview.
“Patients who are autonomous require self-motivation and having a strong support structure is important as well. For those patients who are dependents, their caregivers need to be motivated to manage their diet,” said Dr. Cervenka.
The guidelines were published online Oct. 30 in Neurology Clinical Practice.
Novel in adult neurology
Ketogenic diet therapies are high-fat, low-carbohydrate, and adequate-protein diets that induce fat metabolism and ketone production. Despite its use as an effective antiseizure therapy since the 1920s, ketogenic diet therapies remain novel in adult neurology.
Furthermore, while there are established guidelines for ketogenic diet therapies to reduce seizures in children, there were no formal recommendations for adults, until now.
Drawing on the experience of experts at 20 centers using ketogenic diet therapies in more than 2,100 adults with epilepsy in 10 countries, Dr. Cervenka and an international team developed recommendations on use of ketogenic diet therapies in adults.
The panel noted, “with a relatively mild side effect profile and the potential to reduce seizures in nearly 60% of adults with drug-resistant epilepsy, ketogenic diet therapies should be part of the repertoire of available options.”
Ketogenic diet therapies are appropriate to offer to adults with seizure types and epilepsy syndromes for which these treatments are known to be effective in children, they said. These include tuberous sclerosis complex, Rett syndrome, Lennox-Gastaut syndrome, glucose transporter type 1 deficiency syndrome, genetic generalized epilepsies, and focal epilepsies caused by underlying migrational disorders and resistant to antiseizure medication.
However, adults with drug-resistant focal epilepsy should be offered surgical evaluation first, given the higher anticipated rate of seizure freedom via this route, the panel said.
A focus on compliance
Experts at nearly all of the centers report using two or more ketogenic diet therapies. Ninety percent use the modified Atkins diet, 84% use the classic ketogenic diet, and 63% use the modified ketogenic diet and/or low glycemic index treatment. More than half of the centers (58%) use medium-chain triglyceride oil in combination with another ketogenic diet therapy to boost ketone body production.
The most important factors influencing the choice of ketogenic diet therapy are ease of diet application for the patient (100%) and patient and/or caregiver preference, home setting, and mode of feeding (90% each).
The panel recommended that ketogenic diet therapies be tailored to fit the needs of the individual, taking into account his or her physical and mental characteristics, underlying medical conditions, food preferences, type and amount of support from family and others, level of self-sufficiency, feeding habits, and ease of following the diet.
“Most of the differences between the child and adult recommendations have to do with compliance. Often, it’s more of a challenge for adults than for children,” said Dr. Cervenka.
The panel recommended providing adult patients with recipe ideas, individualized training on the ketogenic diet lifestyle from a dietitian or nutritionist, and guidance for meal planning and preparation before starting the diet. This will provide the greatest likelihood of success, as patients often report difficulties coping with carbohydrate restriction.
“In pediatric practice, positive responders typically remain on a ketogenic diet therapy for 2 years before considering weaning. Ketogenic diet therapy in adults is not time-limited. However, a minimum of 3 months of ketogenic diet therapy is recommended before any judgment of response is made,” the panel advised.
The panel pointed out the absolute metabolic contraindications and cautions related to feeding difficulties, gastrointestinal dysfunction, and digestion remain the same for both children and adults. However, they added that a range of common adult conditions such as hyperlipidemia, heart disease, diabetes, low bone density, and pregnancy “bring additional consideration, caution, and monitoring to ketogenic diet therapy use.”
Beyond epilepsy
The guidelines also call for pre–ketogenic diet therapy biochemical studies to screen adults for preexisting abnormalities and establish a reference for comparing follow-up results after 3, 6, and 12 months, and then annually or as needed.
They also noted that metabolic studies such as urine organic acid and serum amino acid levels are generally not needed in adults unless there is a strong clinical suspicion for an underlying metabolic disorder.
Updated genetic evaluation may also be considered in adults with intellectual disability and epilepsy of unknown etiology. Serial bone mineral density scans may be obtained every 5 years.
The guidelines also call for ketone monitoring (blood beta-hydroxybutyrate or urine amino acids) during the early months of ketogenic diet therapy as an objective indication of compliance and biochemical response.
Dietary adjustments should focus on optimizing the treatment response, minimizing side effects, and maximizing sustainability.
Adults on a ketogenic diet therapy should also be advised to take multivitamin and mineral supplements and drink plenty of fluids.
The panel said emerging evidence also supports the use of ketogenic diet therapies in other adult neurologic disorders such as migraine, Parkinson’s disease, dementia, and multiple sclerosis.
However, the panel said further evidence is needed to guide recommendations on use of ketogenic diet therapies in other neurologic conditions.
The research had no targeted funding. Dr. Cervenka has reported receiving grants from Nutricia, Vitaflo, BrightFocus Foundation, and Army Research Laboratory; honoraria from the American Epilepsy Society, the Neurology Center, Epigenix, LivaNova, and Nutricia; royalties from Demos; and consulting for Nutricia, Glut1 Deficiency Foundation, and Sage Therapeutics. Disclosures for the other authors are listed in the article.
A version of this article originally appeared on Medscape.com.
Just as in children with epilepsy, ketogenic diet therapies can be safe and effective in adults with epilepsy but should only be undertaken with the support of medical professionals trained in their use, the group said.
“Motivation is the key to successful ketogenic diet therapy adherence,” first author Mackenzie Cervenka, MD, director of the Adult Epilepsy Diet Center and associate professor of neurology at Johns Hopkins University, Baltimore, said in an interview.
“Patients who are autonomous require self-motivation and having a strong support structure is important as well. For those patients who are dependents, their caregivers need to be motivated to manage their diet,” said Dr. Cervenka.
The guidelines were published online Oct. 30 in Neurology Clinical Practice.
Novel in adult neurology
Ketogenic diet therapies are high-fat, low-carbohydrate, and adequate-protein diets that induce fat metabolism and ketone production. Despite its use as an effective antiseizure therapy since the 1920s, ketogenic diet therapies remain novel in adult neurology.
Furthermore, while there are established guidelines for ketogenic diet therapies to reduce seizures in children, there were no formal recommendations for adults, until now.
Drawing on the experience of experts at 20 centers using ketogenic diet therapies in more than 2,100 adults with epilepsy in 10 countries, Dr. Cervenka and an international team developed recommendations on use of ketogenic diet therapies in adults.
The panel noted, “with a relatively mild side effect profile and the potential to reduce seizures in nearly 60% of adults with drug-resistant epilepsy, ketogenic diet therapies should be part of the repertoire of available options.”
Ketogenic diet therapies are appropriate to offer to adults with seizure types and epilepsy syndromes for which these treatments are known to be effective in children, they said. These include tuberous sclerosis complex, Rett syndrome, Lennox-Gastaut syndrome, glucose transporter type 1 deficiency syndrome, genetic generalized epilepsies, and focal epilepsies caused by underlying migrational disorders and resistant to antiseizure medication.
However, adults with drug-resistant focal epilepsy should be offered surgical evaluation first, given the higher anticipated rate of seizure freedom via this route, the panel said.
A focus on compliance
Experts at nearly all of the centers report using two or more ketogenic diet therapies. Ninety percent use the modified Atkins diet, 84% use the classic ketogenic diet, and 63% use the modified ketogenic diet and/or low glycemic index treatment. More than half of the centers (58%) use medium-chain triglyceride oil in combination with another ketogenic diet therapy to boost ketone body production.
The most important factors influencing the choice of ketogenic diet therapy are ease of diet application for the patient (100%) and patient and/or caregiver preference, home setting, and mode of feeding (90% each).
The panel recommended that ketogenic diet therapies be tailored to fit the needs of the individual, taking into account his or her physical and mental characteristics, underlying medical conditions, food preferences, type and amount of support from family and others, level of self-sufficiency, feeding habits, and ease of following the diet.
“Most of the differences between the child and adult recommendations have to do with compliance. Often, it’s more of a challenge for adults than for children,” said Dr. Cervenka.
The panel recommended providing adult patients with recipe ideas, individualized training on the ketogenic diet lifestyle from a dietitian or nutritionist, and guidance for meal planning and preparation before starting the diet. This will provide the greatest likelihood of success, as patients often report difficulties coping with carbohydrate restriction.
“In pediatric practice, positive responders typically remain on a ketogenic diet therapy for 2 years before considering weaning. Ketogenic diet therapy in adults is not time-limited. However, a minimum of 3 months of ketogenic diet therapy is recommended before any judgment of response is made,” the panel advised.
The panel pointed out the absolute metabolic contraindications and cautions related to feeding difficulties, gastrointestinal dysfunction, and digestion remain the same for both children and adults. However, they added that a range of common adult conditions such as hyperlipidemia, heart disease, diabetes, low bone density, and pregnancy “bring additional consideration, caution, and monitoring to ketogenic diet therapy use.”
Beyond epilepsy
The guidelines also call for pre–ketogenic diet therapy biochemical studies to screen adults for preexisting abnormalities and establish a reference for comparing follow-up results after 3, 6, and 12 months, and then annually or as needed.
They also noted that metabolic studies such as urine organic acid and serum amino acid levels are generally not needed in adults unless there is a strong clinical suspicion for an underlying metabolic disorder.
Updated genetic evaluation may also be considered in adults with intellectual disability and epilepsy of unknown etiology. Serial bone mineral density scans may be obtained every 5 years.
The guidelines also call for ketone monitoring (blood beta-hydroxybutyrate or urine amino acids) during the early months of ketogenic diet therapy as an objective indication of compliance and biochemical response.
Dietary adjustments should focus on optimizing the treatment response, minimizing side effects, and maximizing sustainability.
Adults on a ketogenic diet therapy should also be advised to take multivitamin and mineral supplements and drink plenty of fluids.
The panel said emerging evidence also supports the use of ketogenic diet therapies in other adult neurologic disorders such as migraine, Parkinson’s disease, dementia, and multiple sclerosis.
However, the panel said further evidence is needed to guide recommendations on use of ketogenic diet therapies in other neurologic conditions.
The research had no targeted funding. Dr. Cervenka has reported receiving grants from Nutricia, Vitaflo, BrightFocus Foundation, and Army Research Laboratory; honoraria from the American Epilepsy Society, the Neurology Center, Epigenix, LivaNova, and Nutricia; royalties from Demos; and consulting for Nutricia, Glut1 Deficiency Foundation, and Sage Therapeutics. Disclosures for the other authors are listed in the article.
A version of this article originally appeared on Medscape.com.
Just as in children with epilepsy, ketogenic diet therapies can be safe and effective in adults with epilepsy but should only be undertaken with the support of medical professionals trained in their use, the group said.
“Motivation is the key to successful ketogenic diet therapy adherence,” first author Mackenzie Cervenka, MD, director of the Adult Epilepsy Diet Center and associate professor of neurology at Johns Hopkins University, Baltimore, said in an interview.
“Patients who are autonomous require self-motivation and having a strong support structure is important as well. For those patients who are dependents, their caregivers need to be motivated to manage their diet,” said Dr. Cervenka.
The guidelines were published online Oct. 30 in Neurology Clinical Practice.
Novel in adult neurology
Ketogenic diet therapies are high-fat, low-carbohydrate, and adequate-protein diets that induce fat metabolism and ketone production. Despite its use as an effective antiseizure therapy since the 1920s, ketogenic diet therapies remain novel in adult neurology.
Furthermore, while there are established guidelines for ketogenic diet therapies to reduce seizures in children, there were no formal recommendations for adults, until now.
Drawing on the experience of experts at 20 centers using ketogenic diet therapies in more than 2,100 adults with epilepsy in 10 countries, Dr. Cervenka and an international team developed recommendations on use of ketogenic diet therapies in adults.
The panel noted, “with a relatively mild side effect profile and the potential to reduce seizures in nearly 60% of adults with drug-resistant epilepsy, ketogenic diet therapies should be part of the repertoire of available options.”
Ketogenic diet therapies are appropriate to offer to adults with seizure types and epilepsy syndromes for which these treatments are known to be effective in children, they said. These include tuberous sclerosis complex, Rett syndrome, Lennox-Gastaut syndrome, glucose transporter type 1 deficiency syndrome, genetic generalized epilepsies, and focal epilepsies caused by underlying migrational disorders and resistant to antiseizure medication.
However, adults with drug-resistant focal epilepsy should be offered surgical evaluation first, given the higher anticipated rate of seizure freedom via this route, the panel said.
A focus on compliance
Experts at nearly all of the centers report using two or more ketogenic diet therapies. Ninety percent use the modified Atkins diet, 84% use the classic ketogenic diet, and 63% use the modified ketogenic diet and/or low glycemic index treatment. More than half of the centers (58%) use medium-chain triglyceride oil in combination with another ketogenic diet therapy to boost ketone body production.
The most important factors influencing the choice of ketogenic diet therapy are ease of diet application for the patient (100%) and patient and/or caregiver preference, home setting, and mode of feeding (90% each).
The panel recommended that ketogenic diet therapies be tailored to fit the needs of the individual, taking into account his or her physical and mental characteristics, underlying medical conditions, food preferences, type and amount of support from family and others, level of self-sufficiency, feeding habits, and ease of following the diet.
“Most of the differences between the child and adult recommendations have to do with compliance. Often, it’s more of a challenge for adults than for children,” said Dr. Cervenka.
The panel recommended providing adult patients with recipe ideas, individualized training on the ketogenic diet lifestyle from a dietitian or nutritionist, and guidance for meal planning and preparation before starting the diet. This will provide the greatest likelihood of success, as patients often report difficulties coping with carbohydrate restriction.
“In pediatric practice, positive responders typically remain on a ketogenic diet therapy for 2 years before considering weaning. Ketogenic diet therapy in adults is not time-limited. However, a minimum of 3 months of ketogenic diet therapy is recommended before any judgment of response is made,” the panel advised.
The panel pointed out the absolute metabolic contraindications and cautions related to feeding difficulties, gastrointestinal dysfunction, and digestion remain the same for both children and adults. However, they added that a range of common adult conditions such as hyperlipidemia, heart disease, diabetes, low bone density, and pregnancy “bring additional consideration, caution, and monitoring to ketogenic diet therapy use.”
Beyond epilepsy
The guidelines also call for pre–ketogenic diet therapy biochemical studies to screen adults for preexisting abnormalities and establish a reference for comparing follow-up results after 3, 6, and 12 months, and then annually or as needed.
They also noted that metabolic studies such as urine organic acid and serum amino acid levels are generally not needed in adults unless there is a strong clinical suspicion for an underlying metabolic disorder.
Updated genetic evaluation may also be considered in adults with intellectual disability and epilepsy of unknown etiology. Serial bone mineral density scans may be obtained every 5 years.
The guidelines also call for ketone monitoring (blood beta-hydroxybutyrate or urine amino acids) during the early months of ketogenic diet therapy as an objective indication of compliance and biochemical response.
Dietary adjustments should focus on optimizing the treatment response, minimizing side effects, and maximizing sustainability.
Adults on a ketogenic diet therapy should also be advised to take multivitamin and mineral supplements and drink plenty of fluids.
The panel said emerging evidence also supports the use of ketogenic diet therapies in other adult neurologic disorders such as migraine, Parkinson’s disease, dementia, and multiple sclerosis.
However, the panel said further evidence is needed to guide recommendations on use of ketogenic diet therapies in other neurologic conditions.
The research had no targeted funding. Dr. Cervenka has reported receiving grants from Nutricia, Vitaflo, BrightFocus Foundation, and Army Research Laboratory; honoraria from the American Epilepsy Society, the Neurology Center, Epigenix, LivaNova, and Nutricia; royalties from Demos; and consulting for Nutricia, Glut1 Deficiency Foundation, and Sage Therapeutics. Disclosures for the other authors are listed in the article.
A version of this article originally appeared on Medscape.com.
Renowned interventional cardiologist dies of COVID-19
The interventional cardiology community is mourning the loss of Anthony “Tony” Gershlick, MBBS, who died Nov. 20 of COVID-19. He was 69 years old.
Dr. Gershlick was a “talented, dedicated and much loved colleague,” reads a statement issued by the University of Leicester (England), where he was affiliated for more than 3 decades.
Dr. Gershlick, a consultant cardiologist at Glenfield Hospital and professor of interventional cardiology, University of Leicester, passed away in the intensive care unit of the hospital where he worked.
Nishan Canagarajah, PhD, president and vice-chancellor, University of Leicester, said Dr. Gershlick “left an indelible mark on the life of the University. He will be remembered with great affection by all and will be sorely missed.”
In 2017, Dr. Gershlick was honored with the inaugural British Cardiovascular Intervention Society (BCIS) Lifetime Achievement Career Award for his “outstanding contribution to the specialty of coronary intervention.”
Gershlick was a pioneer in the field of percutaneous coronary intervention. He was the first UK cardiologist to implant a drug-eluting stent and a bioabsorbable stent, according to an article in the European Heart Journal.
Throughout his career, Dr. Gershlick had been involved in “practice-changing” research that changed the way patients are treated and led to national and international guidelines. He was the UK lead for more than 10 international trials, the university said.
“Tony was determined to push the boundaries of clinical care, to make a difference for his patients, and indeed, patients around the world,” said Philip Baker, DM, FMedSci, head of the College of Life Science, University of Leicester.
Andrew Furlong, medical director at the University Hospitals of Leicester, noted that Dr. Gershlick was “deeply committed to the training and development of junior doctors and registrars and known for his dedication to his field and his patients. He made a difference to many, many lives.”
According to the university, Dr. Gershlick had been working in non-COVID environments since April and was doing much of his work via virtual consultations. He took on cases from other consultants to help during the pandemic and had been working “tirelessly” to provide continuing care to cardiology patients.
The news of Dr. Gershlick’s passing prompted an outpouring of sadness and remembrances of him on Twitter.
A version of this article originally appeared on Medscape.com.
The interventional cardiology community is mourning the loss of Anthony “Tony” Gershlick, MBBS, who died Nov. 20 of COVID-19. He was 69 years old.
Dr. Gershlick was a “talented, dedicated and much loved colleague,” reads a statement issued by the University of Leicester (England), where he was affiliated for more than 3 decades.
Dr. Gershlick, a consultant cardiologist at Glenfield Hospital and professor of interventional cardiology, University of Leicester, passed away in the intensive care unit of the hospital where he worked.
Nishan Canagarajah, PhD, president and vice-chancellor, University of Leicester, said Dr. Gershlick “left an indelible mark on the life of the University. He will be remembered with great affection by all and will be sorely missed.”
In 2017, Dr. Gershlick was honored with the inaugural British Cardiovascular Intervention Society (BCIS) Lifetime Achievement Career Award for his “outstanding contribution to the specialty of coronary intervention.”
Gershlick was a pioneer in the field of percutaneous coronary intervention. He was the first UK cardiologist to implant a drug-eluting stent and a bioabsorbable stent, according to an article in the European Heart Journal.
Throughout his career, Dr. Gershlick had been involved in “practice-changing” research that changed the way patients are treated and led to national and international guidelines. He was the UK lead for more than 10 international trials, the university said.
“Tony was determined to push the boundaries of clinical care, to make a difference for his patients, and indeed, patients around the world,” said Philip Baker, DM, FMedSci, head of the College of Life Science, University of Leicester.
Andrew Furlong, medical director at the University Hospitals of Leicester, noted that Dr. Gershlick was “deeply committed to the training and development of junior doctors and registrars and known for his dedication to his field and his patients. He made a difference to many, many lives.”
According to the university, Dr. Gershlick had been working in non-COVID environments since April and was doing much of his work via virtual consultations. He took on cases from other consultants to help during the pandemic and had been working “tirelessly” to provide continuing care to cardiology patients.
The news of Dr. Gershlick’s passing prompted an outpouring of sadness and remembrances of him on Twitter.
A version of this article originally appeared on Medscape.com.
The interventional cardiology community is mourning the loss of Anthony “Tony” Gershlick, MBBS, who died Nov. 20 of COVID-19. He was 69 years old.
Dr. Gershlick was a “talented, dedicated and much loved colleague,” reads a statement issued by the University of Leicester (England), where he was affiliated for more than 3 decades.
Dr. Gershlick, a consultant cardiologist at Glenfield Hospital and professor of interventional cardiology, University of Leicester, passed away in the intensive care unit of the hospital where he worked.
Nishan Canagarajah, PhD, president and vice-chancellor, University of Leicester, said Dr. Gershlick “left an indelible mark on the life of the University. He will be remembered with great affection by all and will be sorely missed.”
In 2017, Dr. Gershlick was honored with the inaugural British Cardiovascular Intervention Society (BCIS) Lifetime Achievement Career Award for his “outstanding contribution to the specialty of coronary intervention.”
Gershlick was a pioneer in the field of percutaneous coronary intervention. He was the first UK cardiologist to implant a drug-eluting stent and a bioabsorbable stent, according to an article in the European Heart Journal.
Throughout his career, Dr. Gershlick had been involved in “practice-changing” research that changed the way patients are treated and led to national and international guidelines. He was the UK lead for more than 10 international trials, the university said.
“Tony was determined to push the boundaries of clinical care, to make a difference for his patients, and indeed, patients around the world,” said Philip Baker, DM, FMedSci, head of the College of Life Science, University of Leicester.
Andrew Furlong, medical director at the University Hospitals of Leicester, noted that Dr. Gershlick was “deeply committed to the training and development of junior doctors and registrars and known for his dedication to his field and his patients. He made a difference to many, many lives.”
According to the university, Dr. Gershlick had been working in non-COVID environments since April and was doing much of his work via virtual consultations. He took on cases from other consultants to help during the pandemic and had been working “tirelessly” to provide continuing care to cardiology patients.
The news of Dr. Gershlick’s passing prompted an outpouring of sadness and remembrances of him on Twitter.
A version of this article originally appeared on Medscape.com.
FDA expands Xofluza indication to include postexposure flu prophylaxis
The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.
“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.
In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.
The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.
A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.
The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.
The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.
Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.
The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.
Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.
Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.
Full prescribing information is available online.
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.
“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.
In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.
The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.
A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.
The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.
The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.
Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.
The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.
Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.
Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.
Full prescribing information is available online.
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.
“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.
In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.
The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.
A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.
The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.
The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.
Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.
The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.
Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.
Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.
Full prescribing information is available online.
This article first appeared on Medscape.com.
Antidepressant shows early promise for mild COVID-19
Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.
In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.
“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital,” study investigator Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University, St. Louis, said in a statement.
“Our study suggests fluvoxamine may help fill that niche,” Lenze added.
The study was published online Nov. 12 in the JAMA.
Antiviral effects?
The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.
Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.
The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).
Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
Hypothesis generating
The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”
However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.
Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.
“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.
“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.
She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”
The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”
However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.
This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.
Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.
In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.
“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital,” study investigator Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University, St. Louis, said in a statement.
“Our study suggests fluvoxamine may help fill that niche,” Lenze added.
The study was published online Nov. 12 in the JAMA.
Antiviral effects?
The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.
Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.
The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).
Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
Hypothesis generating
The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”
However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.
Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.
“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.
“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.
She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”
The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”
However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.
This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.
Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.
In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.
“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital,” study investigator Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University, St. Louis, said in a statement.
“Our study suggests fluvoxamine may help fill that niche,” Lenze added.
The study was published online Nov. 12 in the JAMA.
Antiviral effects?
The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.
Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.
The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).
Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
Hypothesis generating
The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”
However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.
Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.
“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.
“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.
She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”
The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”
However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.
This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.
Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
‘Impressive’ outcomes sans chemo in poor-prognosis ALL
The days of using chemotherapy to treat Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) may be numbered.
In a phase 2 trial, upfront chemotherapy-free induction/consolidation with the tyrosine kinase inhibitor dasatinib (Sprycel) and the bispecific T-cell engager antibody blinatumomab (Blincyto) yielded high rates of molecular response, “impressive” survival at 18 months, and few toxic effects of grade 3 or higher, say researchers.
With this approach, “60% of adult Ph+ ALL patients, of all ages, can obtain a molecular response, and this percent can increase further with more cycles of blinatumomab,” lead researcher Robin Foà, MD, from Sapienza University of Rome, said in an interview.
“The rates of disease-free survival and overall survival at 18 months are highly favorable, and the protocol is associated with limited toxicity,” Dr. Foà added.
“I see this chemo-free approach becoming a realistic approach for a substantial proportion of adult Ph+ ALL patients, particularly for the older patients, keeping in mind that the incidence of Ph+ ALL increases with age,” Dr. Foà said.
The results of the study were published Oct. 22 in the New England Journal of Medicine.
‘Innovative’ and ‘highly successful’
This “innovative” chemotherapy-free approach proved “highly successful” with “surprisingly” few toxic effects, Dieter Hoelzer, MD, PhD, University of Frankfurt (Germany), wrote in a linked editorial.
The Italian GIMEMA LAL2116 D-ALBA trial enrolled 63 adults (median age, 54 years; range, 24-82 years) with newly diagnosed Ph+ ALL. All patients received a glucocorticoid for 31 days beginning 7 days before starting treatment with dasatinib.
Dasatinib (140 mg once daily) induction therapy lasted 85 days. All patients who completed the induction phase received blinatumomab (28 mcg/d) consolidation therapy. Dexamethasone (20 mg) was administered before each blinatumomab cycle. To prevent central nervous system adverse events, levetiracetam (500 mg twice daily) was administered.
All but two patients completed dasatinib induction. One was a 73-year-old woman who withdrew from the trial because of toxic effects after 10 days of dasatinib treatment. She later died of pneumonia. The other was an 82-year-old woman who had a complete hematologic response but left the trial because of pneumonia and pneumonitis.
At the end of the induction phase, 98% of the patients (62 of 63) had a complete hematologic response, including the patient with a complete hematologic response who withdrew; 29% (17 of 59 patients) had a molecular response.
Of the 61 patients who completed the induction phase, 58 received one cycle of blinatumomab, 56 received two cycles, 45 received three cycles, 37 received four cycles, and 29 received five cycles. At the end of the second blinatumomab cycle, 60% of the patients (33 of 55 patients) had a molecular response.
The percentage of patients with a molecular response increased further after receiving additional cycles of blinatumomab – to 70% (28 of 40 patients) after the third cycle, 81% (29 of 36 patients) after the fourth cycle, and 72% (21 of 29 patients) after the fifth cycle.
At a median follow-up of 18 months, overall survival was 95%, and disease-free survival was 88%.
There were no significant differences in DFS between patients with p190-kd fusion protein (85%) and those with p210-kd fusion protein (95%). However, DFS was lower in patients with IKZF1 deletion plus additional genetic aberrations (CDKN2A or CDKN2B, PAX5, or both).
ABL1 mutations were present in six patients who had increased minimal residual disease during induction therapy. All these mutations were cleared by blinatumomab.
There were six relapses, of which three were hematologic. One occurred in a patient with a major protocol violation (a delay of more than 2 months in receiving blinatumomab), one occurred after 12 months in the patient who discontinued the trial after receiving dasatinib for 12 days, and one occurred in a patient after the second cycle of blinatumomab.
A total of 21 adverse events of grade 3 or higher were noted. They included cytomegalovirus reactivation or infection in six patients; neutropenia in four patients; persistent fever in two patients; and pleural effusion, pulmonary hypertension, and a neurologic disorder in one patient each.
Of the 24 patients who received a stem-cell allograft, two died, but only one death was related to transplant (4%).
The very low nonrelapse mortality among patients who underwent transplant during remission is “remarkable,” Dr. Hoelzer wrote. It suggests that toxicity from induction chemotherapy puts the patient at risk for toxic effects and death from subsequent stem-cell transplant – “a consequence that is avoided with targeted therapy.”
Unanswered questions
“Will the excellent outcomes be preserved with longer follow-up? The answer is probably yes, given that the majority of relapses in ALL occur within the first 1.5 to 2.0 years after the initiation of treatment,” Dr. Hoelzer wrote.
He said other outstanding questions include whether long-term outcomes will differ between patients who undergo transplant and those who do not; whether ABL1 mutations emerge; whether minimal residual disease recurs with longer follow-up; and whether this treatment approach can be used for patients with other subtypes of ALL, such as Ph-negative, B-lineage ALL, or even T-cell ALL.
“If these promising trial results hold, chemotherapy-free induction without the immediate and long-term toxic effects of intensive chemotherapy regimens could also be used in adolescents and, finally, in children. These questions will need to be addressed with longer follow-up and large, prospective trials,” Dr. Hoelzer concluded.
The study was supported by grants from the Italian Association for Cancer Research and Sapienza University of Rome.
A version of this article originally appeared on Medscape.com
The days of using chemotherapy to treat Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) may be numbered.
In a phase 2 trial, upfront chemotherapy-free induction/consolidation with the tyrosine kinase inhibitor dasatinib (Sprycel) and the bispecific T-cell engager antibody blinatumomab (Blincyto) yielded high rates of molecular response, “impressive” survival at 18 months, and few toxic effects of grade 3 or higher, say researchers.
With this approach, “60% of adult Ph+ ALL patients, of all ages, can obtain a molecular response, and this percent can increase further with more cycles of blinatumomab,” lead researcher Robin Foà, MD, from Sapienza University of Rome, said in an interview.
“The rates of disease-free survival and overall survival at 18 months are highly favorable, and the protocol is associated with limited toxicity,” Dr. Foà added.
“I see this chemo-free approach becoming a realistic approach for a substantial proportion of adult Ph+ ALL patients, particularly for the older patients, keeping in mind that the incidence of Ph+ ALL increases with age,” Dr. Foà said.
The results of the study were published Oct. 22 in the New England Journal of Medicine.
‘Innovative’ and ‘highly successful’
This “innovative” chemotherapy-free approach proved “highly successful” with “surprisingly” few toxic effects, Dieter Hoelzer, MD, PhD, University of Frankfurt (Germany), wrote in a linked editorial.
The Italian GIMEMA LAL2116 D-ALBA trial enrolled 63 adults (median age, 54 years; range, 24-82 years) with newly diagnosed Ph+ ALL. All patients received a glucocorticoid for 31 days beginning 7 days before starting treatment with dasatinib.
Dasatinib (140 mg once daily) induction therapy lasted 85 days. All patients who completed the induction phase received blinatumomab (28 mcg/d) consolidation therapy. Dexamethasone (20 mg) was administered before each blinatumomab cycle. To prevent central nervous system adverse events, levetiracetam (500 mg twice daily) was administered.
All but two patients completed dasatinib induction. One was a 73-year-old woman who withdrew from the trial because of toxic effects after 10 days of dasatinib treatment. She later died of pneumonia. The other was an 82-year-old woman who had a complete hematologic response but left the trial because of pneumonia and pneumonitis.
At the end of the induction phase, 98% of the patients (62 of 63) had a complete hematologic response, including the patient with a complete hematologic response who withdrew; 29% (17 of 59 patients) had a molecular response.
Of the 61 patients who completed the induction phase, 58 received one cycle of blinatumomab, 56 received two cycles, 45 received three cycles, 37 received four cycles, and 29 received five cycles. At the end of the second blinatumomab cycle, 60% of the patients (33 of 55 patients) had a molecular response.
The percentage of patients with a molecular response increased further after receiving additional cycles of blinatumomab – to 70% (28 of 40 patients) after the third cycle, 81% (29 of 36 patients) after the fourth cycle, and 72% (21 of 29 patients) after the fifth cycle.
At a median follow-up of 18 months, overall survival was 95%, and disease-free survival was 88%.
There were no significant differences in DFS between patients with p190-kd fusion protein (85%) and those with p210-kd fusion protein (95%). However, DFS was lower in patients with IKZF1 deletion plus additional genetic aberrations (CDKN2A or CDKN2B, PAX5, or both).
ABL1 mutations were present in six patients who had increased minimal residual disease during induction therapy. All these mutations were cleared by blinatumomab.
There were six relapses, of which three were hematologic. One occurred in a patient with a major protocol violation (a delay of more than 2 months in receiving blinatumomab), one occurred after 12 months in the patient who discontinued the trial after receiving dasatinib for 12 days, and one occurred in a patient after the second cycle of blinatumomab.
A total of 21 adverse events of grade 3 or higher were noted. They included cytomegalovirus reactivation or infection in six patients; neutropenia in four patients; persistent fever in two patients; and pleural effusion, pulmonary hypertension, and a neurologic disorder in one patient each.
Of the 24 patients who received a stem-cell allograft, two died, but only one death was related to transplant (4%).
The very low nonrelapse mortality among patients who underwent transplant during remission is “remarkable,” Dr. Hoelzer wrote. It suggests that toxicity from induction chemotherapy puts the patient at risk for toxic effects and death from subsequent stem-cell transplant – “a consequence that is avoided with targeted therapy.”
Unanswered questions
“Will the excellent outcomes be preserved with longer follow-up? The answer is probably yes, given that the majority of relapses in ALL occur within the first 1.5 to 2.0 years after the initiation of treatment,” Dr. Hoelzer wrote.
He said other outstanding questions include whether long-term outcomes will differ between patients who undergo transplant and those who do not; whether ABL1 mutations emerge; whether minimal residual disease recurs with longer follow-up; and whether this treatment approach can be used for patients with other subtypes of ALL, such as Ph-negative, B-lineage ALL, or even T-cell ALL.
“If these promising trial results hold, chemotherapy-free induction without the immediate and long-term toxic effects of intensive chemotherapy regimens could also be used in adolescents and, finally, in children. These questions will need to be addressed with longer follow-up and large, prospective trials,” Dr. Hoelzer concluded.
The study was supported by grants from the Italian Association for Cancer Research and Sapienza University of Rome.
A version of this article originally appeared on Medscape.com
The days of using chemotherapy to treat Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) may be numbered.
In a phase 2 trial, upfront chemotherapy-free induction/consolidation with the tyrosine kinase inhibitor dasatinib (Sprycel) and the bispecific T-cell engager antibody blinatumomab (Blincyto) yielded high rates of molecular response, “impressive” survival at 18 months, and few toxic effects of grade 3 or higher, say researchers.
With this approach, “60% of adult Ph+ ALL patients, of all ages, can obtain a molecular response, and this percent can increase further with more cycles of blinatumomab,” lead researcher Robin Foà, MD, from Sapienza University of Rome, said in an interview.
“The rates of disease-free survival and overall survival at 18 months are highly favorable, and the protocol is associated with limited toxicity,” Dr. Foà added.
“I see this chemo-free approach becoming a realistic approach for a substantial proportion of adult Ph+ ALL patients, particularly for the older patients, keeping in mind that the incidence of Ph+ ALL increases with age,” Dr. Foà said.
The results of the study were published Oct. 22 in the New England Journal of Medicine.
‘Innovative’ and ‘highly successful’
This “innovative” chemotherapy-free approach proved “highly successful” with “surprisingly” few toxic effects, Dieter Hoelzer, MD, PhD, University of Frankfurt (Germany), wrote in a linked editorial.
The Italian GIMEMA LAL2116 D-ALBA trial enrolled 63 adults (median age, 54 years; range, 24-82 years) with newly diagnosed Ph+ ALL. All patients received a glucocorticoid for 31 days beginning 7 days before starting treatment with dasatinib.
Dasatinib (140 mg once daily) induction therapy lasted 85 days. All patients who completed the induction phase received blinatumomab (28 mcg/d) consolidation therapy. Dexamethasone (20 mg) was administered before each blinatumomab cycle. To prevent central nervous system adverse events, levetiracetam (500 mg twice daily) was administered.
All but two patients completed dasatinib induction. One was a 73-year-old woman who withdrew from the trial because of toxic effects after 10 days of dasatinib treatment. She later died of pneumonia. The other was an 82-year-old woman who had a complete hematologic response but left the trial because of pneumonia and pneumonitis.
At the end of the induction phase, 98% of the patients (62 of 63) had a complete hematologic response, including the patient with a complete hematologic response who withdrew; 29% (17 of 59 patients) had a molecular response.
Of the 61 patients who completed the induction phase, 58 received one cycle of blinatumomab, 56 received two cycles, 45 received three cycles, 37 received four cycles, and 29 received five cycles. At the end of the second blinatumomab cycle, 60% of the patients (33 of 55 patients) had a molecular response.
The percentage of patients with a molecular response increased further after receiving additional cycles of blinatumomab – to 70% (28 of 40 patients) after the third cycle, 81% (29 of 36 patients) after the fourth cycle, and 72% (21 of 29 patients) after the fifth cycle.
At a median follow-up of 18 months, overall survival was 95%, and disease-free survival was 88%.
There were no significant differences in DFS between patients with p190-kd fusion protein (85%) and those with p210-kd fusion protein (95%). However, DFS was lower in patients with IKZF1 deletion plus additional genetic aberrations (CDKN2A or CDKN2B, PAX5, or both).
ABL1 mutations were present in six patients who had increased minimal residual disease during induction therapy. All these mutations were cleared by blinatumomab.
There were six relapses, of which three were hematologic. One occurred in a patient with a major protocol violation (a delay of more than 2 months in receiving blinatumomab), one occurred after 12 months in the patient who discontinued the trial after receiving dasatinib for 12 days, and one occurred in a patient after the second cycle of blinatumomab.
A total of 21 adverse events of grade 3 or higher were noted. They included cytomegalovirus reactivation or infection in six patients; neutropenia in four patients; persistent fever in two patients; and pleural effusion, pulmonary hypertension, and a neurologic disorder in one patient each.
Of the 24 patients who received a stem-cell allograft, two died, but only one death was related to transplant (4%).
The very low nonrelapse mortality among patients who underwent transplant during remission is “remarkable,” Dr. Hoelzer wrote. It suggests that toxicity from induction chemotherapy puts the patient at risk for toxic effects and death from subsequent stem-cell transplant – “a consequence that is avoided with targeted therapy.”
Unanswered questions
“Will the excellent outcomes be preserved with longer follow-up? The answer is probably yes, given that the majority of relapses in ALL occur within the first 1.5 to 2.0 years after the initiation of treatment,” Dr. Hoelzer wrote.
He said other outstanding questions include whether long-term outcomes will differ between patients who undergo transplant and those who do not; whether ABL1 mutations emerge; whether minimal residual disease recurs with longer follow-up; and whether this treatment approach can be used for patients with other subtypes of ALL, such as Ph-negative, B-lineage ALL, or even T-cell ALL.
“If these promising trial results hold, chemotherapy-free induction without the immediate and long-term toxic effects of intensive chemotherapy regimens could also be used in adolescents and, finally, in children. These questions will need to be addressed with longer follow-up and large, prospective trials,” Dr. Hoelzer concluded.
The study was supported by grants from the Italian Association for Cancer Research and Sapienza University of Rome.
A version of this article originally appeared on Medscape.com
Nearly one in five develop mental illness following COVID-19
One in five COVID-19 patients are diagnosed with a psychiatric disorder such as anxiety or depression within 3 months of testing positive for the virus, new research suggests.
“People have been worried that COVID-19 survivors will be at greater risk of psychiatric disorders, and our findings in a large and detailed study show this to be true,” principal investigator Paul Harrison, BM, DM, professor of psychiatry, University of Oxford, Oxford, United Kingdom, said in a statement.
Health services “need to be ready to provide care, especially since our results are likely to be underestimates of the actual number of cases,” said Harrison.
The study also showed that having a psychiatric disorder independently increases the risk of getting COVID-19 – a finding that’s in line with research published earlier this month.
“Having a psychiatric illness should be added to the list of risk factors for COVID-19,” study coauthor Maxime Taquet, PhD, University of Oxford, said in the release.
The study was published online Nov. 9 in The Lancet Psychiatry.
Double the risk
The investigators took advantage of the TriNetX analytics network, which captured deidentified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States.
Of those patients, 62,354 adults were diagnosed with COVID-19 between Jan. 20 and Aug. 1, 2020.
To assess the psychiatric sequelae of COVID-19, the investigators created propensity score–matched cohorts of patients who had received a diagnosis of other conditions that represented a range of common acute presentations.
In 14 to 90 days after being diagnosed with COVID-19, 5.8% of patients received a first recorded diagnosis of psychiatric illness. Among patients with health problems other than COVID, 2.5% to 3.4% of patients received a psychiatric diagnosis, the authors report. The risk was greatest for anxiety disorders, depression, and insomnia.
Older COVID-19 patients had a two- to threefold increased risk for a first dementia diagnosis, a finding that supports an earlier UK study.
Some of this excess risk could reflect misdiagnosed cases of delirium or transient cognitive impairment due to reversible cerebral events, the authors noted.
The study also revealed a bidirectional relationship between mental illness and COVID-19. Individuals with a psychiatric diagnosis were about 65% more likely to be diagnosed with COVID-19 in comparison with their counterparts who did not have mental illness, independently of known physical health risk factors for COVID-19.
“We did not anticipate that psychiatric history would be an independent risk factor for COVID-19. This finding appears robust, being observed in all age strata and in both sexes, and was substantial,” the authors write.
At present, “we don’t understand what the explanation is for the associations between COVID and mental illness. We are looking into this in more detail to try and understand better what subgroups are particularly vulnerable in this regard,” Harrison told Medscape Medical News.
“Ambitious” research
Commenting on the findings for Medscape Medical News, Roy H. Perlis, MD, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, said this is “an ambitious effort to understand the short-term consequences of COVID in terms of brain diseases.”
Perlis said he’s not particularly surprised by the increase in psychiatric diagnoses among COVID-19 patients.
“After COVID infection, people are more likely to get close medical follow-up than usual. They’re more likely to be accessing the healthcare system; after all, they’ve already had COVID, so they’re probably less fearful of seeing their doctor. But, that probably also means they’re more likely to get a new diagnosis of something like depression,” he said.
Dementia may be the clearest illustration of this, Perlis said. “It seems less likely that dementia develops a month after COVID; more likely, something that happens during the illness leads someone to be more likely to diagnose dementia later on,” he noted.
Perlis cautioned against being “unnecessarily alarmed” by the findings in this study.
“We know that rates of depression in the UK and the US, as in much of the world, are substantially elevated right now. Much of this is likely a consequence of the stress and disruption that accompanies the pandemic,” said Perlis.
The study was funded by the National Institute for Health Research. Harrison has disclosed no relevant financial relationships. One author is an employee of TriNetX. Perlis has received consulting fees for service on scientific advisory boards of Belle Artificial Intelligence, Burrage Capital, Genomind, Psy Therapeutics, Outermost Therapeutics, RID Ventures, and Takeda. He holds equity in Psy Therapeutics and Outermost Therapeutics.
This article first appeared on Medscape.com.
One in five COVID-19 patients are diagnosed with a psychiatric disorder such as anxiety or depression within 3 months of testing positive for the virus, new research suggests.
“People have been worried that COVID-19 survivors will be at greater risk of psychiatric disorders, and our findings in a large and detailed study show this to be true,” principal investigator Paul Harrison, BM, DM, professor of psychiatry, University of Oxford, Oxford, United Kingdom, said in a statement.
Health services “need to be ready to provide care, especially since our results are likely to be underestimates of the actual number of cases,” said Harrison.
The study also showed that having a psychiatric disorder independently increases the risk of getting COVID-19 – a finding that’s in line with research published earlier this month.
“Having a psychiatric illness should be added to the list of risk factors for COVID-19,” study coauthor Maxime Taquet, PhD, University of Oxford, said in the release.
The study was published online Nov. 9 in The Lancet Psychiatry.
Double the risk
The investigators took advantage of the TriNetX analytics network, which captured deidentified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States.
Of those patients, 62,354 adults were diagnosed with COVID-19 between Jan. 20 and Aug. 1, 2020.
To assess the psychiatric sequelae of COVID-19, the investigators created propensity score–matched cohorts of patients who had received a diagnosis of other conditions that represented a range of common acute presentations.
In 14 to 90 days after being diagnosed with COVID-19, 5.8% of patients received a first recorded diagnosis of psychiatric illness. Among patients with health problems other than COVID, 2.5% to 3.4% of patients received a psychiatric diagnosis, the authors report. The risk was greatest for anxiety disorders, depression, and insomnia.
Older COVID-19 patients had a two- to threefold increased risk for a first dementia diagnosis, a finding that supports an earlier UK study.
Some of this excess risk could reflect misdiagnosed cases of delirium or transient cognitive impairment due to reversible cerebral events, the authors noted.
The study also revealed a bidirectional relationship between mental illness and COVID-19. Individuals with a psychiatric diagnosis were about 65% more likely to be diagnosed with COVID-19 in comparison with their counterparts who did not have mental illness, independently of known physical health risk factors for COVID-19.
“We did not anticipate that psychiatric history would be an independent risk factor for COVID-19. This finding appears robust, being observed in all age strata and in both sexes, and was substantial,” the authors write.
At present, “we don’t understand what the explanation is for the associations between COVID and mental illness. We are looking into this in more detail to try and understand better what subgroups are particularly vulnerable in this regard,” Harrison told Medscape Medical News.
“Ambitious” research
Commenting on the findings for Medscape Medical News, Roy H. Perlis, MD, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, said this is “an ambitious effort to understand the short-term consequences of COVID in terms of brain diseases.”
Perlis said he’s not particularly surprised by the increase in psychiatric diagnoses among COVID-19 patients.
“After COVID infection, people are more likely to get close medical follow-up than usual. They’re more likely to be accessing the healthcare system; after all, they’ve already had COVID, so they’re probably less fearful of seeing their doctor. But, that probably also means they’re more likely to get a new diagnosis of something like depression,” he said.
Dementia may be the clearest illustration of this, Perlis said. “It seems less likely that dementia develops a month after COVID; more likely, something that happens during the illness leads someone to be more likely to diagnose dementia later on,” he noted.
Perlis cautioned against being “unnecessarily alarmed” by the findings in this study.
“We know that rates of depression in the UK and the US, as in much of the world, are substantially elevated right now. Much of this is likely a consequence of the stress and disruption that accompanies the pandemic,” said Perlis.
The study was funded by the National Institute for Health Research. Harrison has disclosed no relevant financial relationships. One author is an employee of TriNetX. Perlis has received consulting fees for service on scientific advisory boards of Belle Artificial Intelligence, Burrage Capital, Genomind, Psy Therapeutics, Outermost Therapeutics, RID Ventures, and Takeda. He holds equity in Psy Therapeutics and Outermost Therapeutics.
This article first appeared on Medscape.com.
One in five COVID-19 patients are diagnosed with a psychiatric disorder such as anxiety or depression within 3 months of testing positive for the virus, new research suggests.
“People have been worried that COVID-19 survivors will be at greater risk of psychiatric disorders, and our findings in a large and detailed study show this to be true,” principal investigator Paul Harrison, BM, DM, professor of psychiatry, University of Oxford, Oxford, United Kingdom, said in a statement.
Health services “need to be ready to provide care, especially since our results are likely to be underestimates of the actual number of cases,” said Harrison.
The study also showed that having a psychiatric disorder independently increases the risk of getting COVID-19 – a finding that’s in line with research published earlier this month.
“Having a psychiatric illness should be added to the list of risk factors for COVID-19,” study coauthor Maxime Taquet, PhD, University of Oxford, said in the release.
The study was published online Nov. 9 in The Lancet Psychiatry.
Double the risk
The investigators took advantage of the TriNetX analytics network, which captured deidentified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States.
Of those patients, 62,354 adults were diagnosed with COVID-19 between Jan. 20 and Aug. 1, 2020.
To assess the psychiatric sequelae of COVID-19, the investigators created propensity score–matched cohorts of patients who had received a diagnosis of other conditions that represented a range of common acute presentations.
In 14 to 90 days after being diagnosed with COVID-19, 5.8% of patients received a first recorded diagnosis of psychiatric illness. Among patients with health problems other than COVID, 2.5% to 3.4% of patients received a psychiatric diagnosis, the authors report. The risk was greatest for anxiety disorders, depression, and insomnia.
Older COVID-19 patients had a two- to threefold increased risk for a first dementia diagnosis, a finding that supports an earlier UK study.
Some of this excess risk could reflect misdiagnosed cases of delirium or transient cognitive impairment due to reversible cerebral events, the authors noted.
The study also revealed a bidirectional relationship between mental illness and COVID-19. Individuals with a psychiatric diagnosis were about 65% more likely to be diagnosed with COVID-19 in comparison with their counterparts who did not have mental illness, independently of known physical health risk factors for COVID-19.
“We did not anticipate that psychiatric history would be an independent risk factor for COVID-19. This finding appears robust, being observed in all age strata and in both sexes, and was substantial,” the authors write.
At present, “we don’t understand what the explanation is for the associations between COVID and mental illness. We are looking into this in more detail to try and understand better what subgroups are particularly vulnerable in this regard,” Harrison told Medscape Medical News.
“Ambitious” research
Commenting on the findings for Medscape Medical News, Roy H. Perlis, MD, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, said this is “an ambitious effort to understand the short-term consequences of COVID in terms of brain diseases.”
Perlis said he’s not particularly surprised by the increase in psychiatric diagnoses among COVID-19 patients.
“After COVID infection, people are more likely to get close medical follow-up than usual. They’re more likely to be accessing the healthcare system; after all, they’ve already had COVID, so they’re probably less fearful of seeing their doctor. But, that probably also means they’re more likely to get a new diagnosis of something like depression,” he said.
Dementia may be the clearest illustration of this, Perlis said. “It seems less likely that dementia develops a month after COVID; more likely, something that happens during the illness leads someone to be more likely to diagnose dementia later on,” he noted.
Perlis cautioned against being “unnecessarily alarmed” by the findings in this study.
“We know that rates of depression in the UK and the US, as in much of the world, are substantially elevated right now. Much of this is likely a consequence of the stress and disruption that accompanies the pandemic,” said Perlis.
The study was funded by the National Institute for Health Research. Harrison has disclosed no relevant financial relationships. One author is an employee of TriNetX. Perlis has received consulting fees for service on scientific advisory boards of Belle Artificial Intelligence, Burrage Capital, Genomind, Psy Therapeutics, Outermost Therapeutics, RID Ventures, and Takeda. He holds equity in Psy Therapeutics and Outermost Therapeutics.
This article first appeared on Medscape.com.
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.