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OTC ‘brain boosters’ may pose serious risks, experts say
, new research shows.
“Americans spend more than $600 million on over-the-counter smart pills every year, but we know very little about what is actually in these products,” said Pieter A. Cohen, MD, of the department of medicine at Harvard Medical School, Boston.
“Finding new combinations of drugs [that have] never been tested in humans in over-the-counter brain-boosting supplements is alarming,” said Dr. Cohen.
The study was published online Sept. 23 in Neurology Clinical Practice, a journal of the American Academy of Neurology.
Buyer beware
In a search of the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database, Dr. Cohen and colleagues identified 10 supplements labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam – four analogues of piracetam that are not approved for human use in the United States. Piracetam is also not approved in the United States.
In these 10 products, five unapproved drugs were discovered – omberacetam and aniracetam along with three others (phenibut, vinpocetine and picamilon).
By consuming the recommended serving size of these products, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 mg omberacetam (typical pharmacologic dose 10 mg), 502 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 mg of phenibut (typical dose 250-500 mg), 4.3 mg of vinpocetine (typical dose 5-40 mg), and 90.1 mg of picamilon (typical dose 50-200 mg), the study team reported.
Several drugs detected in these “smart” pills were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, three-quarters of declared quantities were inaccurate.
Consumers who use these cognitive enhancers could be exposed to amounts of these unapproved drugs that are fourfold greater than pharmaceutical dosages and combinations never tested in humans, the study team says. One product combined three different unapproved drugs and another product contained four different drugs.
“We have previously shown that these products may contain individual foreign drugs, but in our new study we found complex combinations of foreign drugs, up to four different drugs in a single product,” Dr. Cohen said.
The presence of these unapproved drugs in supplements, including at supratherapeutic dosages, suggests “serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the U.S.,” Dr. Cohen and colleagues wrote.
“We should counsel our patients to avoid over-the-counter ‘smart pills’ until we can be assured as to the safety and efficacy of these products,” said Dr. Cohen.
Concerning findings
Glen R. Finney, MD, director of the Geisinger Memory and Cognition Program at the Neuroscience Institute, Geisinger Health System, Wilkes-Barre, Penn., said in an interview that two findings are very concerning: the lack of listed ingredients and especially the presence of unlisted drugs at active levels. “What if a person has a sensitivity or allergy to one of the unlisted drugs? This is a safety issue and a consumer issue,” Dr. Finney said.
Despite being widely promoted on television, “over-the-counter supplements are not regulated, so there is no guarantee that they contain what they claim, and there is very little evidence that they help memory and thinking even when they do have the ingredients they claim in the supplement,” said Dr. Finney,
“The best way to stay safe and help memory and thinking is to speak with your health providers about proven treatments that have good safety regulation, so you know what you’re getting, and what you’re getting from it,” Dr. Finney advised.
The study had no targeted funding. Dr. Cohen has collaborated in research with NSF International, received compensation from UptoDate, and received research support from Consumers Union and PEW Charitable Trusts. Dr. Finney has no relevant disclosures.
A version of this article originally appeared on Medscape.com.
, new research shows.
“Americans spend more than $600 million on over-the-counter smart pills every year, but we know very little about what is actually in these products,” said Pieter A. Cohen, MD, of the department of medicine at Harvard Medical School, Boston.
“Finding new combinations of drugs [that have] never been tested in humans in over-the-counter brain-boosting supplements is alarming,” said Dr. Cohen.
The study was published online Sept. 23 in Neurology Clinical Practice, a journal of the American Academy of Neurology.
Buyer beware
In a search of the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database, Dr. Cohen and colleagues identified 10 supplements labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam – four analogues of piracetam that are not approved for human use in the United States. Piracetam is also not approved in the United States.
In these 10 products, five unapproved drugs were discovered – omberacetam and aniracetam along with three others (phenibut, vinpocetine and picamilon).
By consuming the recommended serving size of these products, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 mg omberacetam (typical pharmacologic dose 10 mg), 502 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 mg of phenibut (typical dose 250-500 mg), 4.3 mg of vinpocetine (typical dose 5-40 mg), and 90.1 mg of picamilon (typical dose 50-200 mg), the study team reported.
Several drugs detected in these “smart” pills were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, three-quarters of declared quantities were inaccurate.
Consumers who use these cognitive enhancers could be exposed to amounts of these unapproved drugs that are fourfold greater than pharmaceutical dosages and combinations never tested in humans, the study team says. One product combined three different unapproved drugs and another product contained four different drugs.
“We have previously shown that these products may contain individual foreign drugs, but in our new study we found complex combinations of foreign drugs, up to four different drugs in a single product,” Dr. Cohen said.
The presence of these unapproved drugs in supplements, including at supratherapeutic dosages, suggests “serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the U.S.,” Dr. Cohen and colleagues wrote.
“We should counsel our patients to avoid over-the-counter ‘smart pills’ until we can be assured as to the safety and efficacy of these products,” said Dr. Cohen.
Concerning findings
Glen R. Finney, MD, director of the Geisinger Memory and Cognition Program at the Neuroscience Institute, Geisinger Health System, Wilkes-Barre, Penn., said in an interview that two findings are very concerning: the lack of listed ingredients and especially the presence of unlisted drugs at active levels. “What if a person has a sensitivity or allergy to one of the unlisted drugs? This is a safety issue and a consumer issue,” Dr. Finney said.
Despite being widely promoted on television, “over-the-counter supplements are not regulated, so there is no guarantee that they contain what they claim, and there is very little evidence that they help memory and thinking even when they do have the ingredients they claim in the supplement,” said Dr. Finney,
“The best way to stay safe and help memory and thinking is to speak with your health providers about proven treatments that have good safety regulation, so you know what you’re getting, and what you’re getting from it,” Dr. Finney advised.
The study had no targeted funding. Dr. Cohen has collaborated in research with NSF International, received compensation from UptoDate, and received research support from Consumers Union and PEW Charitable Trusts. Dr. Finney has no relevant disclosures.
A version of this article originally appeared on Medscape.com.
, new research shows.
“Americans spend more than $600 million on over-the-counter smart pills every year, but we know very little about what is actually in these products,” said Pieter A. Cohen, MD, of the department of medicine at Harvard Medical School, Boston.
“Finding new combinations of drugs [that have] never been tested in humans in over-the-counter brain-boosting supplements is alarming,” said Dr. Cohen.
The study was published online Sept. 23 in Neurology Clinical Practice, a journal of the American Academy of Neurology.
Buyer beware
In a search of the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database, Dr. Cohen and colleagues identified 10 supplements labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam – four analogues of piracetam that are not approved for human use in the United States. Piracetam is also not approved in the United States.
In these 10 products, five unapproved drugs were discovered – omberacetam and aniracetam along with three others (phenibut, vinpocetine and picamilon).
By consuming the recommended serving size of these products, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 mg omberacetam (typical pharmacologic dose 10 mg), 502 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 mg of phenibut (typical dose 250-500 mg), 4.3 mg of vinpocetine (typical dose 5-40 mg), and 90.1 mg of picamilon (typical dose 50-200 mg), the study team reported.
Several drugs detected in these “smart” pills were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, three-quarters of declared quantities were inaccurate.
Consumers who use these cognitive enhancers could be exposed to amounts of these unapproved drugs that are fourfold greater than pharmaceutical dosages and combinations never tested in humans, the study team says. One product combined three different unapproved drugs and another product contained four different drugs.
“We have previously shown that these products may contain individual foreign drugs, but in our new study we found complex combinations of foreign drugs, up to four different drugs in a single product,” Dr. Cohen said.
The presence of these unapproved drugs in supplements, including at supratherapeutic dosages, suggests “serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the U.S.,” Dr. Cohen and colleagues wrote.
“We should counsel our patients to avoid over-the-counter ‘smart pills’ until we can be assured as to the safety and efficacy of these products,” said Dr. Cohen.
Concerning findings
Glen R. Finney, MD, director of the Geisinger Memory and Cognition Program at the Neuroscience Institute, Geisinger Health System, Wilkes-Barre, Penn., said in an interview that two findings are very concerning: the lack of listed ingredients and especially the presence of unlisted drugs at active levels. “What if a person has a sensitivity or allergy to one of the unlisted drugs? This is a safety issue and a consumer issue,” Dr. Finney said.
Despite being widely promoted on television, “over-the-counter supplements are not regulated, so there is no guarantee that they contain what they claim, and there is very little evidence that they help memory and thinking even when they do have the ingredients they claim in the supplement,” said Dr. Finney,
“The best way to stay safe and help memory and thinking is to speak with your health providers about proven treatments that have good safety regulation, so you know what you’re getting, and what you’re getting from it,” Dr. Finney advised.
The study had no targeted funding. Dr. Cohen has collaborated in research with NSF International, received compensation from UptoDate, and received research support from Consumers Union and PEW Charitable Trusts. Dr. Finney has no relevant disclosures.
A version of this article originally appeared on Medscape.com.
FROM NEUROLOGY CLINICAL PRACTICE
COVID-19 shutdown fuels sharp rise in alcohol use
Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.
The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.
The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.
“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.
The results were published online as a research letter Sept. 29 in JAMA Network Open.
Booming business
After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.
“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.
The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.
Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.
Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.
Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic.
In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.
Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.
For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period.
“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.
The authors note , and whether psychological and physical well-being are subsequently affected.
The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.
The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.
The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.
“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.
The results were published online as a research letter Sept. 29 in JAMA Network Open.
Booming business
After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.
“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.
The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.
Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.
Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.
Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic.
In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.
Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.
For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period.
“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.
The authors note , and whether psychological and physical well-being are subsequently affected.
The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.
The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.
The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.
“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.
The results were published online as a research letter Sept. 29 in JAMA Network Open.
Booming business
After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.
“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.
The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.
Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.
Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.
Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic.
In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.
Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.
For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period.
“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.
The authors note , and whether psychological and physical well-being are subsequently affected.
The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FDA orders stronger warnings on benzodiazepines
The Food and Drug Administration wants updated boxed warnings on benzodiazepines to reflect the “serious” risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with these medications.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said in a safety communication.
The FDA also wants revisions to the patient medication guides for benzodiazepines to help educate patients and caregivers about these risks.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that, while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction, and dependence,” said Dr. Hahn.
Ninety-two million prescriptions in 2019
Benzodiazepines are widely used to treat anxiety, insomnia, seizures, and other conditions, often for extended periods of time.
According to the FDA, in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.
Data from 2018 show that roughly 5.4 million people in the United States 12 years and older abused or misused benzodiazepines in the previous year.
Although the precise risk of benzodiazepine addiction remains unclear, population data “clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said.
Data from the National Survey on Drug Use and Health from 2015-2016 suggest that half million community-dwelling U.S. adults were estimated to have a benzodiazepine use disorder.
Jump in overdose deaths
Overdose deaths involving benzodiazepines jumped from 1,298 in 2010 to 11,537 in 2017 – an increase of more 780%. Most of these deaths involved benzodiazepines taken with prescription opioids.
the FDA said.
The agency urged particular caution when prescribing benzodiazepines with opioids and other central nervous system depressants, which has resulted in serious adverse events including severe respiratory depression and death.
The FDA also says patients and caregivers should be warned about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Physicians are encouraged to report adverse events involving benzodiazepines or other medicines to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration wants updated boxed warnings on benzodiazepines to reflect the “serious” risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with these medications.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said in a safety communication.
The FDA also wants revisions to the patient medication guides for benzodiazepines to help educate patients and caregivers about these risks.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that, while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction, and dependence,” said Dr. Hahn.
Ninety-two million prescriptions in 2019
Benzodiazepines are widely used to treat anxiety, insomnia, seizures, and other conditions, often for extended periods of time.
According to the FDA, in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.
Data from 2018 show that roughly 5.4 million people in the United States 12 years and older abused or misused benzodiazepines in the previous year.
Although the precise risk of benzodiazepine addiction remains unclear, population data “clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said.
Data from the National Survey on Drug Use and Health from 2015-2016 suggest that half million community-dwelling U.S. adults were estimated to have a benzodiazepine use disorder.
Jump in overdose deaths
Overdose deaths involving benzodiazepines jumped from 1,298 in 2010 to 11,537 in 2017 – an increase of more 780%. Most of these deaths involved benzodiazepines taken with prescription opioids.
the FDA said.
The agency urged particular caution when prescribing benzodiazepines with opioids and other central nervous system depressants, which has resulted in serious adverse events including severe respiratory depression and death.
The FDA also says patients and caregivers should be warned about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Physicians are encouraged to report adverse events involving benzodiazepines or other medicines to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration wants updated boxed warnings on benzodiazepines to reflect the “serious” risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with these medications.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said in a safety communication.
The FDA also wants revisions to the patient medication guides for benzodiazepines to help educate patients and caregivers about these risks.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that, while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction, and dependence,” said Dr. Hahn.
Ninety-two million prescriptions in 2019
Benzodiazepines are widely used to treat anxiety, insomnia, seizures, and other conditions, often for extended periods of time.
According to the FDA, in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.
Data from 2018 show that roughly 5.4 million people in the United States 12 years and older abused or misused benzodiazepines in the previous year.
Although the precise risk of benzodiazepine addiction remains unclear, population data “clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said.
Data from the National Survey on Drug Use and Health from 2015-2016 suggest that half million community-dwelling U.S. adults were estimated to have a benzodiazepine use disorder.
Jump in overdose deaths
Overdose deaths involving benzodiazepines jumped from 1,298 in 2010 to 11,537 in 2017 – an increase of more 780%. Most of these deaths involved benzodiazepines taken with prescription opioids.
the FDA said.
The agency urged particular caution when prescribing benzodiazepines with opioids and other central nervous system depressants, which has resulted in serious adverse events including severe respiratory depression and death.
The FDA also says patients and caregivers should be warned about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Physicians are encouraged to report adverse events involving benzodiazepines or other medicines to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
EMA panel backs baricitinib for moderate to severe atopic dermatitis
The
Baricitinib (Olumiant) is already approved in the European Union and the United States to treat moderate to severe active rheumatoid arthritis.
If approved in Europe, it will be the first Janus kinase (JAK) inhibitor and first oral medication indicated to treat patients with AD.
The CHMP’s positive opinion on baricitinib for AD was based on three phase 3, randomized, double-blind, placebo-controlled studies where the JAK inhibitor was used alone or in combination with topical treatments in adults with moderate to severe AD for whom topical treatments were insufficient or not tolerated. In all three studies, baricitinib was shown to be more effective than placebo in achieving skin that is “clear” or “almost clear” at 16 weeks.
“Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option,” Thomas Bieber, MD, PhD, professor of dermatology and allergy, University of Bonn (Germany), said in a company news release.
The most common side effects with baricitinib in clinical trials include increased LDL cholesterol, upper respiratory tract infections, and headache.
Patients receiving baricitinib, particularly in combination with immunosuppressants, are at risk of developing serious infections that may lead to hospitalization or death. If a serious infection develops, baricitinib should be stopped until the infection is controlled.
The CHMP’s positive opinion will be sent to the European Commission, which will adopt a final decision regarding an European Union–wide marketing authorization. Once granted, each member state will make decisions about price and reimbursement, taking into account the potential role/use of baricitinib in the context of that country’s national health system.
A version of this story originally appeared on Medscape.com.
The
Baricitinib (Olumiant) is already approved in the European Union and the United States to treat moderate to severe active rheumatoid arthritis.
If approved in Europe, it will be the first Janus kinase (JAK) inhibitor and first oral medication indicated to treat patients with AD.
The CHMP’s positive opinion on baricitinib for AD was based on three phase 3, randomized, double-blind, placebo-controlled studies where the JAK inhibitor was used alone or in combination with topical treatments in adults with moderate to severe AD for whom topical treatments were insufficient or not tolerated. In all three studies, baricitinib was shown to be more effective than placebo in achieving skin that is “clear” or “almost clear” at 16 weeks.
“Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option,” Thomas Bieber, MD, PhD, professor of dermatology and allergy, University of Bonn (Germany), said in a company news release.
The most common side effects with baricitinib in clinical trials include increased LDL cholesterol, upper respiratory tract infections, and headache.
Patients receiving baricitinib, particularly in combination with immunosuppressants, are at risk of developing serious infections that may lead to hospitalization or death. If a serious infection develops, baricitinib should be stopped until the infection is controlled.
The CHMP’s positive opinion will be sent to the European Commission, which will adopt a final decision regarding an European Union–wide marketing authorization. Once granted, each member state will make decisions about price and reimbursement, taking into account the potential role/use of baricitinib in the context of that country’s national health system.
A version of this story originally appeared on Medscape.com.
The
Baricitinib (Olumiant) is already approved in the European Union and the United States to treat moderate to severe active rheumatoid arthritis.
If approved in Europe, it will be the first Janus kinase (JAK) inhibitor and first oral medication indicated to treat patients with AD.
The CHMP’s positive opinion on baricitinib for AD was based on three phase 3, randomized, double-blind, placebo-controlled studies where the JAK inhibitor was used alone or in combination with topical treatments in adults with moderate to severe AD for whom topical treatments were insufficient or not tolerated. In all three studies, baricitinib was shown to be more effective than placebo in achieving skin that is “clear” or “almost clear” at 16 weeks.
“Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option,” Thomas Bieber, MD, PhD, professor of dermatology and allergy, University of Bonn (Germany), said in a company news release.
The most common side effects with baricitinib in clinical trials include increased LDL cholesterol, upper respiratory tract infections, and headache.
Patients receiving baricitinib, particularly in combination with immunosuppressants, are at risk of developing serious infections that may lead to hospitalization or death. If a serious infection develops, baricitinib should be stopped until the infection is controlled.
The CHMP’s positive opinion will be sent to the European Commission, which will adopt a final decision regarding an European Union–wide marketing authorization. Once granted, each member state will make decisions about price and reimbursement, taking into account the potential role/use of baricitinib in the context of that country’s national health system.
A version of this story originally appeared on Medscape.com.
For BP screening, shorter rest time yields similar results
Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.
In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.
“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.
“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
A challenging recommendation
The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.
They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).
They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.
Overall, there was no significant difference in the average BP obtained at any of the rest periods.
After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.
When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.
However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
More efficient, economic
“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.
“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.
Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”
“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.
“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.
She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.
The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.
In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.
“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.
“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
A challenging recommendation
The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.
They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).
They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.
Overall, there was no significant difference in the average BP obtained at any of the rest periods.
After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.
When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.
However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
More efficient, economic
“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.
“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.
Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”
“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.
“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.
She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.
The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.
In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.
“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.
“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
A challenging recommendation
The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.
They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).
They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.
Overall, there was no significant difference in the average BP obtained at any of the rest periods.
After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.
When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.
However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
More efficient, economic
“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.
“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.
Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”
“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.
“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.
She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.
The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
FROM JOINT HYPERTENSION 2020
Many providers don’t follow hypertension guidelines
Many health care professionals are not following current, evidence-based guidelines to screen for and diagnose hypertension, and appear to have substantial gaps in knowledge, beliefs, and use of recommended practices, results from a large survey suggest.
“One surprising finding was that there was so much trust in the stethoscope, because the automated monitors are a better way to take blood pressure,” lead author Beverly Green, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, said in an interview.
The results of the survey were presented Sept. 10 at the virtual joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The U.S. Preventive Services Task Force (USPSTF) and the American Heart Association/American College of Cardiology recommend out-of-office blood pressure measurements – via ambulatory blood pressure monitoring (ABPM) or home BP monitoring – before making a new diagnosis of hypertension.
To gauge provider knowledge, beliefs, and practices related to BP diagnostic tests, the researchers surveyed 282 providers: 102 medical assistants (MA), 28 licensed practical nurses (LPNs), 33 registered nurses (RNs), 86 primary care physicians, and 33 advanced practitioners (APs).
More than three-quarters of providers (79%) felt that BP measured manually with a stethoscope and ABPM were “very or highly” accurate ways to measure BP when making a new diagnosis of hypertension.
Most did not think that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate.
Nearly all providers surveyed (96%) reported that they “always or almost always” rely on clinic BP measurements when diagnosing hypertension, but the majority of physicians/APs would prefer using ABPM (61%) if available.
The problem with ABPM, said Dr. Green, is “it’s just not very available or convenient for patients, and a lot of providers think that patients won’t tolerate it.” Yet, without it, there is a risk for misclassification, she said.
Karen A. Griffin, MD, who chairs the AHA Council on Hypertension, said it became “customary to use clinic BP since ABPM was not previously reimbursed for the routine diagnosis of hypertension.
“Now that the payment for ABPM has been expanded, the number of machines at most institutions is not adequate for the need. Consequently, it will take some time to catch up with the current guidelines for diagnosing hypertension,” she said in an interview.
The provider survey by Dr. Green and colleagues also shows slow uptake of updated thresholds for high blood pressure.
Eighty-four percent of physicians/APs and 68% of MA/LPN/RNs said they used a clinic BP threshold of at least 140/90 mm Hg for making a new diagnosis of hypertension.
Only 3.5% and 9.0%, respectively, reported using the updated threshold of at least 130/80 mm Hg put forth in 2017.
Dr. Griffin said part of this stems from the fact that the survey began before the updated guidelines were released in 2017, “not to mention the fact that some societies have opposed the new threshold of 130/80 mm Hg.”
“I think, with time, the data on morbidity and mortality associated with the goal of 130/80 mm Hg will hopefully convince those who have not yet implemented these new guidelines that it is a safe and effective BP goal,” Dr. Griffin said.
This research had no specific funding. Dr. Green and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Many health care professionals are not following current, evidence-based guidelines to screen for and diagnose hypertension, and appear to have substantial gaps in knowledge, beliefs, and use of recommended practices, results from a large survey suggest.
“One surprising finding was that there was so much trust in the stethoscope, because the automated monitors are a better way to take blood pressure,” lead author Beverly Green, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, said in an interview.
The results of the survey were presented Sept. 10 at the virtual joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The U.S. Preventive Services Task Force (USPSTF) and the American Heart Association/American College of Cardiology recommend out-of-office blood pressure measurements – via ambulatory blood pressure monitoring (ABPM) or home BP monitoring – before making a new diagnosis of hypertension.
To gauge provider knowledge, beliefs, and practices related to BP diagnostic tests, the researchers surveyed 282 providers: 102 medical assistants (MA), 28 licensed practical nurses (LPNs), 33 registered nurses (RNs), 86 primary care physicians, and 33 advanced practitioners (APs).
More than three-quarters of providers (79%) felt that BP measured manually with a stethoscope and ABPM were “very or highly” accurate ways to measure BP when making a new diagnosis of hypertension.
Most did not think that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate.
Nearly all providers surveyed (96%) reported that they “always or almost always” rely on clinic BP measurements when diagnosing hypertension, but the majority of physicians/APs would prefer using ABPM (61%) if available.
The problem with ABPM, said Dr. Green, is “it’s just not very available or convenient for patients, and a lot of providers think that patients won’t tolerate it.” Yet, without it, there is a risk for misclassification, she said.
Karen A. Griffin, MD, who chairs the AHA Council on Hypertension, said it became “customary to use clinic BP since ABPM was not previously reimbursed for the routine diagnosis of hypertension.
“Now that the payment for ABPM has been expanded, the number of machines at most institutions is not adequate for the need. Consequently, it will take some time to catch up with the current guidelines for diagnosing hypertension,” she said in an interview.
The provider survey by Dr. Green and colleagues also shows slow uptake of updated thresholds for high blood pressure.
Eighty-four percent of physicians/APs and 68% of MA/LPN/RNs said they used a clinic BP threshold of at least 140/90 mm Hg for making a new diagnosis of hypertension.
Only 3.5% and 9.0%, respectively, reported using the updated threshold of at least 130/80 mm Hg put forth in 2017.
Dr. Griffin said part of this stems from the fact that the survey began before the updated guidelines were released in 2017, “not to mention the fact that some societies have opposed the new threshold of 130/80 mm Hg.”
“I think, with time, the data on morbidity and mortality associated with the goal of 130/80 mm Hg will hopefully convince those who have not yet implemented these new guidelines that it is a safe and effective BP goal,” Dr. Griffin said.
This research had no specific funding. Dr. Green and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Many health care professionals are not following current, evidence-based guidelines to screen for and diagnose hypertension, and appear to have substantial gaps in knowledge, beliefs, and use of recommended practices, results from a large survey suggest.
“One surprising finding was that there was so much trust in the stethoscope, because the automated monitors are a better way to take blood pressure,” lead author Beverly Green, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, said in an interview.
The results of the survey were presented Sept. 10 at the virtual joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The U.S. Preventive Services Task Force (USPSTF) and the American Heart Association/American College of Cardiology recommend out-of-office blood pressure measurements – via ambulatory blood pressure monitoring (ABPM) or home BP monitoring – before making a new diagnosis of hypertension.
To gauge provider knowledge, beliefs, and practices related to BP diagnostic tests, the researchers surveyed 282 providers: 102 medical assistants (MA), 28 licensed practical nurses (LPNs), 33 registered nurses (RNs), 86 primary care physicians, and 33 advanced practitioners (APs).
More than three-quarters of providers (79%) felt that BP measured manually with a stethoscope and ABPM were “very or highly” accurate ways to measure BP when making a new diagnosis of hypertension.
Most did not think that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate.
Nearly all providers surveyed (96%) reported that they “always or almost always” rely on clinic BP measurements when diagnosing hypertension, but the majority of physicians/APs would prefer using ABPM (61%) if available.
The problem with ABPM, said Dr. Green, is “it’s just not very available or convenient for patients, and a lot of providers think that patients won’t tolerate it.” Yet, without it, there is a risk for misclassification, she said.
Karen A. Griffin, MD, who chairs the AHA Council on Hypertension, said it became “customary to use clinic BP since ABPM was not previously reimbursed for the routine diagnosis of hypertension.
“Now that the payment for ABPM has been expanded, the number of machines at most institutions is not adequate for the need. Consequently, it will take some time to catch up with the current guidelines for diagnosing hypertension,” she said in an interview.
The provider survey by Dr. Green and colleagues also shows slow uptake of updated thresholds for high blood pressure.
Eighty-four percent of physicians/APs and 68% of MA/LPN/RNs said they used a clinic BP threshold of at least 140/90 mm Hg for making a new diagnosis of hypertension.
Only 3.5% and 9.0%, respectively, reported using the updated threshold of at least 130/80 mm Hg put forth in 2017.
Dr. Griffin said part of this stems from the fact that the survey began before the updated guidelines were released in 2017, “not to mention the fact that some societies have opposed the new threshold of 130/80 mm Hg.”
“I think, with time, the data on morbidity and mortality associated with the goal of 130/80 mm Hg will hopefully convince those who have not yet implemented these new guidelines that it is a safe and effective BP goal,” Dr. Griffin said.
This research had no specific funding. Dr. Green and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Vascepa maker loses patent appeal, plans ‘vigorous’ fight
Amarin’s hopes of fending off generic competition for its blockbuster high-strength eicosapentaenoic acid product, icosapent ethyl (Vascepa), have dimmed following a decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation.
The court upheld the March ruling by the District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications (ANDAs) for the product.
Amarin said it is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current decision by the full panel of 12 active judges at the Court of Appeals for the Federal Circuit.
“We are extremely disappointed with [the] ruling and plan to vigorously pursue available remedies,” John Thero, Amarin president and chief executive officer, said in a statement.
In 2012, Vascepa became the first and only prescription treatment approved by the Food and Drug Administration made up solely of the active ingredient icosapent ethyl, a unique form of eicosapentaenoic acid. It was initially approved for the reduction of very high triglyceride levels (≥500 mg/dL).
In late 2019, the FDA extended the indication to reduce the risk for cardiovascular events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors.
The extended indication was based on results of the landmark REDUCE-IT trial, which showed a 25% relative risk reduction in major adverse CV events with icosapent ethyl, compared with placebo, in patients with triglyceride levels above 135 mg/dL and who had CV disease (70% of the study population), or who were high-risk primary-prevention patients with diabetes and one additional risk factor (30% of the study population).
According to Amarin, since its launch, Vascepa has been prescribed more than 8 million times.
The company said demand for the product in the United States remains “strong” and indicated that, despite the legal setback, it would continue promotional efforts. The company is also seeking additional regulatory approvals in China, Europe, and additional countries in the Middle East.
“We are particularly excited about the anticipated commercialization opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021,” Mr. Thero said.
The company anticipates 10 years of market protection because of regulatory exclusivity in the European Union once approved, and said patent protection could extend into 2039.
Only Vascepa sold in the United States is subject to this litigation and judgment. No generic litigation is pending outside the United States, Amarin said.
A version of this article originally appeared on Medscape.com.
Amarin’s hopes of fending off generic competition for its blockbuster high-strength eicosapentaenoic acid product, icosapent ethyl (Vascepa), have dimmed following a decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation.
The court upheld the March ruling by the District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications (ANDAs) for the product.
Amarin said it is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current decision by the full panel of 12 active judges at the Court of Appeals for the Federal Circuit.
“We are extremely disappointed with [the] ruling and plan to vigorously pursue available remedies,” John Thero, Amarin president and chief executive officer, said in a statement.
In 2012, Vascepa became the first and only prescription treatment approved by the Food and Drug Administration made up solely of the active ingredient icosapent ethyl, a unique form of eicosapentaenoic acid. It was initially approved for the reduction of very high triglyceride levels (≥500 mg/dL).
In late 2019, the FDA extended the indication to reduce the risk for cardiovascular events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors.
The extended indication was based on results of the landmark REDUCE-IT trial, which showed a 25% relative risk reduction in major adverse CV events with icosapent ethyl, compared with placebo, in patients with triglyceride levels above 135 mg/dL and who had CV disease (70% of the study population), or who were high-risk primary-prevention patients with diabetes and one additional risk factor (30% of the study population).
According to Amarin, since its launch, Vascepa has been prescribed more than 8 million times.
The company said demand for the product in the United States remains “strong” and indicated that, despite the legal setback, it would continue promotional efforts. The company is also seeking additional regulatory approvals in China, Europe, and additional countries in the Middle East.
“We are particularly excited about the anticipated commercialization opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021,” Mr. Thero said.
The company anticipates 10 years of market protection because of regulatory exclusivity in the European Union once approved, and said patent protection could extend into 2039.
Only Vascepa sold in the United States is subject to this litigation and judgment. No generic litigation is pending outside the United States, Amarin said.
A version of this article originally appeared on Medscape.com.
Amarin’s hopes of fending off generic competition for its blockbuster high-strength eicosapentaenoic acid product, icosapent ethyl (Vascepa), have dimmed following a decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation.
The court upheld the March ruling by the District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications (ANDAs) for the product.
Amarin said it is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current decision by the full panel of 12 active judges at the Court of Appeals for the Federal Circuit.
“We are extremely disappointed with [the] ruling and plan to vigorously pursue available remedies,” John Thero, Amarin president and chief executive officer, said in a statement.
In 2012, Vascepa became the first and only prescription treatment approved by the Food and Drug Administration made up solely of the active ingredient icosapent ethyl, a unique form of eicosapentaenoic acid. It was initially approved for the reduction of very high triglyceride levels (≥500 mg/dL).
In late 2019, the FDA extended the indication to reduce the risk for cardiovascular events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors.
The extended indication was based on results of the landmark REDUCE-IT trial, which showed a 25% relative risk reduction in major adverse CV events with icosapent ethyl, compared with placebo, in patients with triglyceride levels above 135 mg/dL and who had CV disease (70% of the study population), or who were high-risk primary-prevention patients with diabetes and one additional risk factor (30% of the study population).
According to Amarin, since its launch, Vascepa has been prescribed more than 8 million times.
The company said demand for the product in the United States remains “strong” and indicated that, despite the legal setback, it would continue promotional efforts. The company is also seeking additional regulatory approvals in China, Europe, and additional countries in the Middle East.
“We are particularly excited about the anticipated commercialization opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021,” Mr. Thero said.
The company anticipates 10 years of market protection because of regulatory exclusivity in the European Union once approved, and said patent protection could extend into 2039.
Only Vascepa sold in the United States is subject to this litigation and judgment. No generic litigation is pending outside the United States, Amarin said.
A version of this article originally appeared on Medscape.com.
Drug combo slows functional decline in ALS
, according to results of the phase 2/3 CENTAUR study.
Patients with a fast-progressing form of ALS who were treated with AMX0035 “retained higher levels of physical function over 6 months compared with those who received placebo,” reported principal investigator Sabrina Paganoni, MD, PhD, of the Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital, Boston.
“This is very hopeful news for people affected by ALS, especially because we were able to see a treatment effect in a relatively short period of time,” Dr. Paganoni said.
The study was published online Sept. 3 in the New England Journal of Medicine.
In this study, AMX0035 demonstrated a “clinically meaningful benefit and a favorable safety profile for people living with ALS,” Josh Cohen, co-CEO, chairman, and cofounder at Amylyx, said in a news release. The company is “working collaboratively and expeditiously with agencies worldwide to bring this potential new treatment option forward.”
“The data ... makes a clear and compelling case that AMX0035 should be made available to people with ALS as soon as possible,” Calaneet Balas, president and CEO of The ALS Association, said in the release.
The CENTAUR trial
Sodium phenylbutyrate and taurursodiol have been found to reduce neuronal death in experimental models. AMX0035 combines 3 g sodium phenylbutyrate and 1 g of taurursodiol.
The CENTAUR trial tested AMX0035 against placebo in 137 ALS patients with symptom onset within the prior 18 months, with 89 patients in the AMX0035 group and 48 in the placebo group. AMX0035 or matching placebo were administered once daily for 3 weeks and then twice daily for a planned duration of 24 weeks.
In a modified intention-to-treat analysis, the mean rate of change in the Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised (ALSFRS-R) score was −1.24 points per month with AMX0035 and −1.66 points per month with placebo (difference, 0.42 points per month; 95% CI, 0.03 - 0.81; P = .03). After 24 weeks, patients treated with AMX0035 scored on average 2.32 points higher on the ALSFRS-R than their peers on placebo group (P = .03).
“The score, consisting of four subdomains, showed a change that was most prominent for the fine-motor subscale and less apparent for the other subscales,” the investigators said.
Treatment with AMX0035 led to slowing of disease progression in a population in which many participants were receiving riluzole (Tiglutik), edaravone (Radicava) or both, they pointed out.
The secondary outcomes were rate of decline in isometric muscle strength and breathing function; change in plasma phosphorylated axonal neurofilament H subunit (pNF-H) levels; and the time to composite events of death, tracheostomy, permanent ventilation, and hospitalization. These outcomes did not differ significantly between the two groups.
Open-label extension ongoing
AMX0035 was generally well tolerated. Nearly all patients in both groups had one or more adverse events. Events occurring at 2% or greater frequency in the AMX0035 group were primarily gastrointestinal (diarrhea, nausea, salivary hypersecretion, and abdominal discomfort). Serious adverse events were more common in the placebo group (19% vs. 12%). The incidence of respiratory serious adverse events was 8% in the placebo group and 3% in the AMX0035 group.
More patients on active treatment than placebo (19% vs. 8%) stopped the trial regimen early owing to adverse events. The most common adverse events leading to discontinuation of the trial regimen were diarrhea and respiratory failure.
The trial was “too short for us to detect an effect on survival,” Dr. Paganoni said in an interview. Most of the participants who completed the trial elected to enroll in an open-label extension study and receive AMX0035 long-term. “This is important because it will teach us about the impact of AMX0035 on survival,” said Dr. Paganoni.
Interim data from the ongoing open-label extension study are being submitted to a peer-reviewed journal shortly and will be published in the coming months.
A cause for hope
“There has been understandable frustration with the slow pace of development of therapy for ALS,” Michael Benatar, MD, PhD, University of Miami, and Michael McDermott, PhD, University of Rochester (N.Y.), said in an accompanying editorial.
“Despite dozens of trials, few pharmacologic agents have emerged that affect functional decline or survival – and all only modestly so. Although the effects of sodium phenylbutyrate–taurursodiol are similarly modest, the incremental gains that they provide in the battle against ALS are a cause for hope,” they wrote.
They caution, however, that this study was enriched for patients with more rapidly progressive disease, which “raises questions about generalizability to the broader population of patients with ALS.
“Although the patients who were enrolled in the trial may not be biologically different from the broader population of patients with ALS, the magnitude of therapeutic effect may be smaller in the latter,” Dr. Benatar and Dr. McDermott noted.
They said that in light of “residual questions about efficacy and the ability of patients to continue taking the drug,” they agree with the authors’ conclusion that “longer and larger trials are needed to evaluate the efficacy and safety of sodium phenylbutyrate–taurursodiol in persons with ALS.”
Given these “tantalizing preliminary data,” Dr. Benatar and Dr. McDermott said they look forward to “a confirmatory phase 3 trial.”
The study was supported by Amylyx Pharmaceuticals, the ALS Finding a Cure Foundation, and the ALS Association. Dr. Paganoni has received grants from Revalesio, Ra Pharma, Biohaven, Clene, and Prilenia. A complete list of disclosures for authors and editorialists is available with the original article.
A version of this article originally appeared on Medscape.com.
, according to results of the phase 2/3 CENTAUR study.
Patients with a fast-progressing form of ALS who were treated with AMX0035 “retained higher levels of physical function over 6 months compared with those who received placebo,” reported principal investigator Sabrina Paganoni, MD, PhD, of the Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital, Boston.
“This is very hopeful news for people affected by ALS, especially because we were able to see a treatment effect in a relatively short period of time,” Dr. Paganoni said.
The study was published online Sept. 3 in the New England Journal of Medicine.
In this study, AMX0035 demonstrated a “clinically meaningful benefit and a favorable safety profile for people living with ALS,” Josh Cohen, co-CEO, chairman, and cofounder at Amylyx, said in a news release. The company is “working collaboratively and expeditiously with agencies worldwide to bring this potential new treatment option forward.”
“The data ... makes a clear and compelling case that AMX0035 should be made available to people with ALS as soon as possible,” Calaneet Balas, president and CEO of The ALS Association, said in the release.
The CENTAUR trial
Sodium phenylbutyrate and taurursodiol have been found to reduce neuronal death in experimental models. AMX0035 combines 3 g sodium phenylbutyrate and 1 g of taurursodiol.
The CENTAUR trial tested AMX0035 against placebo in 137 ALS patients with symptom onset within the prior 18 months, with 89 patients in the AMX0035 group and 48 in the placebo group. AMX0035 or matching placebo were administered once daily for 3 weeks and then twice daily for a planned duration of 24 weeks.
In a modified intention-to-treat analysis, the mean rate of change in the Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised (ALSFRS-R) score was −1.24 points per month with AMX0035 and −1.66 points per month with placebo (difference, 0.42 points per month; 95% CI, 0.03 - 0.81; P = .03). After 24 weeks, patients treated with AMX0035 scored on average 2.32 points higher on the ALSFRS-R than their peers on placebo group (P = .03).
“The score, consisting of four subdomains, showed a change that was most prominent for the fine-motor subscale and less apparent for the other subscales,” the investigators said.
Treatment with AMX0035 led to slowing of disease progression in a population in which many participants were receiving riluzole (Tiglutik), edaravone (Radicava) or both, they pointed out.
The secondary outcomes were rate of decline in isometric muscle strength and breathing function; change in plasma phosphorylated axonal neurofilament H subunit (pNF-H) levels; and the time to composite events of death, tracheostomy, permanent ventilation, and hospitalization. These outcomes did not differ significantly between the two groups.
Open-label extension ongoing
AMX0035 was generally well tolerated. Nearly all patients in both groups had one or more adverse events. Events occurring at 2% or greater frequency in the AMX0035 group were primarily gastrointestinal (diarrhea, nausea, salivary hypersecretion, and abdominal discomfort). Serious adverse events were more common in the placebo group (19% vs. 12%). The incidence of respiratory serious adverse events was 8% in the placebo group and 3% in the AMX0035 group.
More patients on active treatment than placebo (19% vs. 8%) stopped the trial regimen early owing to adverse events. The most common adverse events leading to discontinuation of the trial regimen were diarrhea and respiratory failure.
The trial was “too short for us to detect an effect on survival,” Dr. Paganoni said in an interview. Most of the participants who completed the trial elected to enroll in an open-label extension study and receive AMX0035 long-term. “This is important because it will teach us about the impact of AMX0035 on survival,” said Dr. Paganoni.
Interim data from the ongoing open-label extension study are being submitted to a peer-reviewed journal shortly and will be published in the coming months.
A cause for hope
“There has been understandable frustration with the slow pace of development of therapy for ALS,” Michael Benatar, MD, PhD, University of Miami, and Michael McDermott, PhD, University of Rochester (N.Y.), said in an accompanying editorial.
“Despite dozens of trials, few pharmacologic agents have emerged that affect functional decline or survival – and all only modestly so. Although the effects of sodium phenylbutyrate–taurursodiol are similarly modest, the incremental gains that they provide in the battle against ALS are a cause for hope,” they wrote.
They caution, however, that this study was enriched for patients with more rapidly progressive disease, which “raises questions about generalizability to the broader population of patients with ALS.
“Although the patients who were enrolled in the trial may not be biologically different from the broader population of patients with ALS, the magnitude of therapeutic effect may be smaller in the latter,” Dr. Benatar and Dr. McDermott noted.
They said that in light of “residual questions about efficacy and the ability of patients to continue taking the drug,” they agree with the authors’ conclusion that “longer and larger trials are needed to evaluate the efficacy and safety of sodium phenylbutyrate–taurursodiol in persons with ALS.”
Given these “tantalizing preliminary data,” Dr. Benatar and Dr. McDermott said they look forward to “a confirmatory phase 3 trial.”
The study was supported by Amylyx Pharmaceuticals, the ALS Finding a Cure Foundation, and the ALS Association. Dr. Paganoni has received grants from Revalesio, Ra Pharma, Biohaven, Clene, and Prilenia. A complete list of disclosures for authors and editorialists is available with the original article.
A version of this article originally appeared on Medscape.com.
, according to results of the phase 2/3 CENTAUR study.
Patients with a fast-progressing form of ALS who were treated with AMX0035 “retained higher levels of physical function over 6 months compared with those who received placebo,” reported principal investigator Sabrina Paganoni, MD, PhD, of the Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital, Boston.
“This is very hopeful news for people affected by ALS, especially because we were able to see a treatment effect in a relatively short period of time,” Dr. Paganoni said.
The study was published online Sept. 3 in the New England Journal of Medicine.
In this study, AMX0035 demonstrated a “clinically meaningful benefit and a favorable safety profile for people living with ALS,” Josh Cohen, co-CEO, chairman, and cofounder at Amylyx, said in a news release. The company is “working collaboratively and expeditiously with agencies worldwide to bring this potential new treatment option forward.”
“The data ... makes a clear and compelling case that AMX0035 should be made available to people with ALS as soon as possible,” Calaneet Balas, president and CEO of The ALS Association, said in the release.
The CENTAUR trial
Sodium phenylbutyrate and taurursodiol have been found to reduce neuronal death in experimental models. AMX0035 combines 3 g sodium phenylbutyrate and 1 g of taurursodiol.
The CENTAUR trial tested AMX0035 against placebo in 137 ALS patients with symptom onset within the prior 18 months, with 89 patients in the AMX0035 group and 48 in the placebo group. AMX0035 or matching placebo were administered once daily for 3 weeks and then twice daily for a planned duration of 24 weeks.
In a modified intention-to-treat analysis, the mean rate of change in the Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised (ALSFRS-R) score was −1.24 points per month with AMX0035 and −1.66 points per month with placebo (difference, 0.42 points per month; 95% CI, 0.03 - 0.81; P = .03). After 24 weeks, patients treated with AMX0035 scored on average 2.32 points higher on the ALSFRS-R than their peers on placebo group (P = .03).
“The score, consisting of four subdomains, showed a change that was most prominent for the fine-motor subscale and less apparent for the other subscales,” the investigators said.
Treatment with AMX0035 led to slowing of disease progression in a population in which many participants were receiving riluzole (Tiglutik), edaravone (Radicava) or both, they pointed out.
The secondary outcomes were rate of decline in isometric muscle strength and breathing function; change in plasma phosphorylated axonal neurofilament H subunit (pNF-H) levels; and the time to composite events of death, tracheostomy, permanent ventilation, and hospitalization. These outcomes did not differ significantly between the two groups.
Open-label extension ongoing
AMX0035 was generally well tolerated. Nearly all patients in both groups had one or more adverse events. Events occurring at 2% or greater frequency in the AMX0035 group were primarily gastrointestinal (diarrhea, nausea, salivary hypersecretion, and abdominal discomfort). Serious adverse events were more common in the placebo group (19% vs. 12%). The incidence of respiratory serious adverse events was 8% in the placebo group and 3% in the AMX0035 group.
More patients on active treatment than placebo (19% vs. 8%) stopped the trial regimen early owing to adverse events. The most common adverse events leading to discontinuation of the trial regimen were diarrhea and respiratory failure.
The trial was “too short for us to detect an effect on survival,” Dr. Paganoni said in an interview. Most of the participants who completed the trial elected to enroll in an open-label extension study and receive AMX0035 long-term. “This is important because it will teach us about the impact of AMX0035 on survival,” said Dr. Paganoni.
Interim data from the ongoing open-label extension study are being submitted to a peer-reviewed journal shortly and will be published in the coming months.
A cause for hope
“There has been understandable frustration with the slow pace of development of therapy for ALS,” Michael Benatar, MD, PhD, University of Miami, and Michael McDermott, PhD, University of Rochester (N.Y.), said in an accompanying editorial.
“Despite dozens of trials, few pharmacologic agents have emerged that affect functional decline or survival – and all only modestly so. Although the effects of sodium phenylbutyrate–taurursodiol are similarly modest, the incremental gains that they provide in the battle against ALS are a cause for hope,” they wrote.
They caution, however, that this study was enriched for patients with more rapidly progressive disease, which “raises questions about generalizability to the broader population of patients with ALS.
“Although the patients who were enrolled in the trial may not be biologically different from the broader population of patients with ALS, the magnitude of therapeutic effect may be smaller in the latter,” Dr. Benatar and Dr. McDermott noted.
They said that in light of “residual questions about efficacy and the ability of patients to continue taking the drug,” they agree with the authors’ conclusion that “longer and larger trials are needed to evaluate the efficacy and safety of sodium phenylbutyrate–taurursodiol in persons with ALS.”
Given these “tantalizing preliminary data,” Dr. Benatar and Dr. McDermott said they look forward to “a confirmatory phase 3 trial.”
The study was supported by Amylyx Pharmaceuticals, the ALS Finding a Cure Foundation, and the ALS Association. Dr. Paganoni has received grants from Revalesio, Ra Pharma, Biohaven, Clene, and Prilenia. A complete list of disclosures for authors and editorialists is available with the original article.
A version of this article originally appeared on Medscape.com.
From New England Journal of Medicine
‘No mobile phone’ phobia tied to sleep problems in college students
In a study of more than 300 college students, nearly 9 in 10 (89%) were classified as having moderate to severe nomophobia. Greater levels of nomophobia were significantly linked to daytime sleepiness and more behaviors associated with poor sleep hygiene.
“My undergraduate research team came up with the idea for this study,” said study investigator Jennifer Peszka, PhD, professor of psychology at Hendrix College, Conway, Ark. She explained that her students had been looking at the impact of technology use in the 2 hours before bed, and hypothesized that ‘cell phone addiction’ might play a role in sleep problems.
Incidentally, “that group of students were all pretty high on nomophobia themselves so they were really interested in the outcome,” Dr. Peszka said.
The study findings were presented at the virtual annual meeting of the Associated Professional Sleep Societies.
A likely suspect
The study involved 327 undergraduates (mean age, 19.7 years) recruited from introductory psychology courses and campus newsletters. They completed several questionnaires, including the Nomophobia Questionnaire, the Epworth Sleepiness Scale, and the Sleep Hygiene Index.
Nomophobia was prevalent, with mild, moderate, and severe nomophobia reported by 10%, 83%, and 7% of students, respectively. Only one student reported no nomophobia at all. Dr. Peszka said the fact that 89% of students had moderate or severe nomophobia is “concerning,” given a 2012 study suggesting that 77% of 18- to 24-year-olds had nomophobia. This phobia “very well may be on a rapid rise,” she lamented.
Greater severity of nomophobia was significantly correlated with greater sleepiness measured by both the Epworth Sleepiness Scale (P < .05) and the Associated Features of Poor Sleep Hygiene daytime sleepiness item (P < .05). More severe nomophobia was also related to decreased motivation (a commonly reported symptom of insufficient sleep) and with more maladaptive sleep hygiene behaviors (including using technology during sleep time, long daytime naps, inconsistent wake and bed times, using bed for nonsleep purposes, uncomfortable bed, and bedtime cognitive rumination).
Prior research has shown that smartphones may lead to compulsive “checking” habits, compulsive usage, increased distress, and potentially addictive behaviors. Active phone use at bedtime has also been implicated in disrupted sleep. Nomophobia is likely to be an important consideration when treating sleep disorders and/or making any sleep hygiene recommendations, Dr. Peszka said.
Proliferation of ‘night owls’
Reached for comment, Rajkumar (Raj) Dasgupta, MD, University of Southern California, Los Angeles, said this is a “very timely study with COVID-19. Right now, more than ever, technology is a double-edged sword. I’m a father of three kids and, for now, technology is the only way some kids are going to be socializing and learning.”
Yet a foundation of good sleep hygiene is keeping a nightly sleep routine, said Dr. Dasgupta, who was not involved in the study. “Right now, it seems like all my sleep patients are becoming night owls and sleep time is becoming more and more delayed because there is so much news to keep up with. Also, you may be stressed at night and you may not have the motivation to wake up early in the morning.”
He said it is important to counsel patients to “put technology away at night. That goes for kids and adults.”
Support for the study was provided by Hendrix College Charles Brewer Fund for Psychology. Dr. Peszka and Dr. Dasgupta disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In a study of more than 300 college students, nearly 9 in 10 (89%) were classified as having moderate to severe nomophobia. Greater levels of nomophobia were significantly linked to daytime sleepiness and more behaviors associated with poor sleep hygiene.
“My undergraduate research team came up with the idea for this study,” said study investigator Jennifer Peszka, PhD, professor of psychology at Hendrix College, Conway, Ark. She explained that her students had been looking at the impact of technology use in the 2 hours before bed, and hypothesized that ‘cell phone addiction’ might play a role in sleep problems.
Incidentally, “that group of students were all pretty high on nomophobia themselves so they were really interested in the outcome,” Dr. Peszka said.
The study findings were presented at the virtual annual meeting of the Associated Professional Sleep Societies.
A likely suspect
The study involved 327 undergraduates (mean age, 19.7 years) recruited from introductory psychology courses and campus newsletters. They completed several questionnaires, including the Nomophobia Questionnaire, the Epworth Sleepiness Scale, and the Sleep Hygiene Index.
Nomophobia was prevalent, with mild, moderate, and severe nomophobia reported by 10%, 83%, and 7% of students, respectively. Only one student reported no nomophobia at all. Dr. Peszka said the fact that 89% of students had moderate or severe nomophobia is “concerning,” given a 2012 study suggesting that 77% of 18- to 24-year-olds had nomophobia. This phobia “very well may be on a rapid rise,” she lamented.
Greater severity of nomophobia was significantly correlated with greater sleepiness measured by both the Epworth Sleepiness Scale (P < .05) and the Associated Features of Poor Sleep Hygiene daytime sleepiness item (P < .05). More severe nomophobia was also related to decreased motivation (a commonly reported symptom of insufficient sleep) and with more maladaptive sleep hygiene behaviors (including using technology during sleep time, long daytime naps, inconsistent wake and bed times, using bed for nonsleep purposes, uncomfortable bed, and bedtime cognitive rumination).
Prior research has shown that smartphones may lead to compulsive “checking” habits, compulsive usage, increased distress, and potentially addictive behaviors. Active phone use at bedtime has also been implicated in disrupted sleep. Nomophobia is likely to be an important consideration when treating sleep disorders and/or making any sleep hygiene recommendations, Dr. Peszka said.
Proliferation of ‘night owls’
Reached for comment, Rajkumar (Raj) Dasgupta, MD, University of Southern California, Los Angeles, said this is a “very timely study with COVID-19. Right now, more than ever, technology is a double-edged sword. I’m a father of three kids and, for now, technology is the only way some kids are going to be socializing and learning.”
Yet a foundation of good sleep hygiene is keeping a nightly sleep routine, said Dr. Dasgupta, who was not involved in the study. “Right now, it seems like all my sleep patients are becoming night owls and sleep time is becoming more and more delayed because there is so much news to keep up with. Also, you may be stressed at night and you may not have the motivation to wake up early in the morning.”
He said it is important to counsel patients to “put technology away at night. That goes for kids and adults.”
Support for the study was provided by Hendrix College Charles Brewer Fund for Psychology. Dr. Peszka and Dr. Dasgupta disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In a study of more than 300 college students, nearly 9 in 10 (89%) were classified as having moderate to severe nomophobia. Greater levels of nomophobia were significantly linked to daytime sleepiness and more behaviors associated with poor sleep hygiene.
“My undergraduate research team came up with the idea for this study,” said study investigator Jennifer Peszka, PhD, professor of psychology at Hendrix College, Conway, Ark. She explained that her students had been looking at the impact of technology use in the 2 hours before bed, and hypothesized that ‘cell phone addiction’ might play a role in sleep problems.
Incidentally, “that group of students were all pretty high on nomophobia themselves so they were really interested in the outcome,” Dr. Peszka said.
The study findings were presented at the virtual annual meeting of the Associated Professional Sleep Societies.
A likely suspect
The study involved 327 undergraduates (mean age, 19.7 years) recruited from introductory psychology courses and campus newsletters. They completed several questionnaires, including the Nomophobia Questionnaire, the Epworth Sleepiness Scale, and the Sleep Hygiene Index.
Nomophobia was prevalent, with mild, moderate, and severe nomophobia reported by 10%, 83%, and 7% of students, respectively. Only one student reported no nomophobia at all. Dr. Peszka said the fact that 89% of students had moderate or severe nomophobia is “concerning,” given a 2012 study suggesting that 77% of 18- to 24-year-olds had nomophobia. This phobia “very well may be on a rapid rise,” she lamented.
Greater severity of nomophobia was significantly correlated with greater sleepiness measured by both the Epworth Sleepiness Scale (P < .05) and the Associated Features of Poor Sleep Hygiene daytime sleepiness item (P < .05). More severe nomophobia was also related to decreased motivation (a commonly reported symptom of insufficient sleep) and with more maladaptive sleep hygiene behaviors (including using technology during sleep time, long daytime naps, inconsistent wake and bed times, using bed for nonsleep purposes, uncomfortable bed, and bedtime cognitive rumination).
Prior research has shown that smartphones may lead to compulsive “checking” habits, compulsive usage, increased distress, and potentially addictive behaviors. Active phone use at bedtime has also been implicated in disrupted sleep. Nomophobia is likely to be an important consideration when treating sleep disorders and/or making any sleep hygiene recommendations, Dr. Peszka said.
Proliferation of ‘night owls’
Reached for comment, Rajkumar (Raj) Dasgupta, MD, University of Southern California, Los Angeles, said this is a “very timely study with COVID-19. Right now, more than ever, technology is a double-edged sword. I’m a father of three kids and, for now, technology is the only way some kids are going to be socializing and learning.”
Yet a foundation of good sleep hygiene is keeping a nightly sleep routine, said Dr. Dasgupta, who was not involved in the study. “Right now, it seems like all my sleep patients are becoming night owls and sleep time is becoming more and more delayed because there is so much news to keep up with. Also, you may be stressed at night and you may not have the motivation to wake up early in the morning.”
He said it is important to counsel patients to “put technology away at night. That goes for kids and adults.”
Support for the study was provided by Hendrix College Charles Brewer Fund for Psychology. Dr. Peszka and Dr. Dasgupta disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM SLEEP 2020
Experts advocate for the elimination of daylight savings time
In the interest of public health and safety, – a recommendation that has garnered strong support from multiple medical and other high-profile organizations.
“Permanent, year-round standard time is the best choice to most closely match our circadian sleep-wake cycle,” M. Adeel Rishi, MD, lead author of the AASM position statement, said in a news release. “Daylight saving time results in more darkness in the morning and more light in the evening, disrupting the body’s natural rhythm,” said Dr. Rishi, of the department of pulmonology, critical care, and sleep medicine, Mayo Clinic, Eau Claire, Wis., and vice chair of the AASM Public Safety Committee.
The position statement was published Aug. 26 in the Journal of Clinical Sleep Medicine to coincide with the virtual annual meeting of the Associated Professional Sleep Societies .
Significant health risks
In the United States, the annual “spring forward” to daylight saving time and “fall back” to standard time is required by law, although under the statute some exceptions are permitted.
There has been intense debate over the last several years about transitioning between standard and daylight saving time. The AASM says there is “an abundance of evidence” to indicate that quick transition from standard time to daylight saving time incurs significant public health and safety risks, including increased risk of heart attack, stroke, mood disorders, and car crashes.
“Although chronic effects of remaining in daylight saving time year-round have not been well-studied, daylight saving time is less aligned with human circadian biology – which, because of the impacts of the delayed natural light/dark cycle on human activity, could result in circadian misalignment, which has been associated in some studies with increased cardiovascular disease risk, metabolic syndrome and other health risks,” the authors wrote.
A recent study also showed an increase in medical errors in the week after switching to daylight saving time.
“Because the adoption of permanent standard time would be beneficial for public health and safety, the AASM will be advocating at the federal level for this legislative change,” said AASM President Kannan Ramar, MBBS, MD, with the Mayo Clinic in Rochester, Minn.
It seems that many Americans are in favor of the change. In July, an AASM survey of roughly 2,000 U.S. adults showed that two-thirds support doing away with the seasonal time change. Only 11% opposed it. In addition, the academy’s 2019 survey showed more than half of adults feel extremely, or somewhat, tired after the springing ahead to daylight saving time.
Strong support
The position statement has been endorsed by 19 organizations, including the American Academy of Cardiovascular Sleep Medicine, American College of Chest Physicians (CHEST), American College of Occupational and Environmental Medicine, National PTA, National Safety Council, Society of Anesthesia and Sleep Medicine, and the Society of Behavioral Sleep Medicine.
Weighing in on the issue, Saul Rothenberg, PhD, from the Sleep Center at Greenwich Hospital, Conn., said the literature on daylight saving time has grown over the past 20 years. He said he was ”humbled” by the research that shows that a “relatively small” misalignment of biological and social clocks has a measurable impact on human health and behavior.
“Because misalignment is associated with negative health and performance outcomes, keeping one set of hours year-round is promoted to minimize misalignment and associated consequences,” he added.
In light of this research, the recommendation to dispense with daylight saving time seems “quite reasonable” from a public health perspective. “I am left with a strengthened view on the importance of regular adequate sleep as a way to enhance health, performance, and quality of life,” he added.
This research had no commercial funding. Dr. Rishi and Dr. Rothenberg have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In the interest of public health and safety, – a recommendation that has garnered strong support from multiple medical and other high-profile organizations.
“Permanent, year-round standard time is the best choice to most closely match our circadian sleep-wake cycle,” M. Adeel Rishi, MD, lead author of the AASM position statement, said in a news release. “Daylight saving time results in more darkness in the morning and more light in the evening, disrupting the body’s natural rhythm,” said Dr. Rishi, of the department of pulmonology, critical care, and sleep medicine, Mayo Clinic, Eau Claire, Wis., and vice chair of the AASM Public Safety Committee.
The position statement was published Aug. 26 in the Journal of Clinical Sleep Medicine to coincide with the virtual annual meeting of the Associated Professional Sleep Societies .
Significant health risks
In the United States, the annual “spring forward” to daylight saving time and “fall back” to standard time is required by law, although under the statute some exceptions are permitted.
There has been intense debate over the last several years about transitioning between standard and daylight saving time. The AASM says there is “an abundance of evidence” to indicate that quick transition from standard time to daylight saving time incurs significant public health and safety risks, including increased risk of heart attack, stroke, mood disorders, and car crashes.
“Although chronic effects of remaining in daylight saving time year-round have not been well-studied, daylight saving time is less aligned with human circadian biology – which, because of the impacts of the delayed natural light/dark cycle on human activity, could result in circadian misalignment, which has been associated in some studies with increased cardiovascular disease risk, metabolic syndrome and other health risks,” the authors wrote.
A recent study also showed an increase in medical errors in the week after switching to daylight saving time.
“Because the adoption of permanent standard time would be beneficial for public health and safety, the AASM will be advocating at the federal level for this legislative change,” said AASM President Kannan Ramar, MBBS, MD, with the Mayo Clinic in Rochester, Minn.
It seems that many Americans are in favor of the change. In July, an AASM survey of roughly 2,000 U.S. adults showed that two-thirds support doing away with the seasonal time change. Only 11% opposed it. In addition, the academy’s 2019 survey showed more than half of adults feel extremely, or somewhat, tired after the springing ahead to daylight saving time.
Strong support
The position statement has been endorsed by 19 organizations, including the American Academy of Cardiovascular Sleep Medicine, American College of Chest Physicians (CHEST), American College of Occupational and Environmental Medicine, National PTA, National Safety Council, Society of Anesthesia and Sleep Medicine, and the Society of Behavioral Sleep Medicine.
Weighing in on the issue, Saul Rothenberg, PhD, from the Sleep Center at Greenwich Hospital, Conn., said the literature on daylight saving time has grown over the past 20 years. He said he was ”humbled” by the research that shows that a “relatively small” misalignment of biological and social clocks has a measurable impact on human health and behavior.
“Because misalignment is associated with negative health and performance outcomes, keeping one set of hours year-round is promoted to minimize misalignment and associated consequences,” he added.
In light of this research, the recommendation to dispense with daylight saving time seems “quite reasonable” from a public health perspective. “I am left with a strengthened view on the importance of regular adequate sleep as a way to enhance health, performance, and quality of life,” he added.
This research had no commercial funding. Dr. Rishi and Dr. Rothenberg have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In the interest of public health and safety, – a recommendation that has garnered strong support from multiple medical and other high-profile organizations.
“Permanent, year-round standard time is the best choice to most closely match our circadian sleep-wake cycle,” M. Adeel Rishi, MD, lead author of the AASM position statement, said in a news release. “Daylight saving time results in more darkness in the morning and more light in the evening, disrupting the body’s natural rhythm,” said Dr. Rishi, of the department of pulmonology, critical care, and sleep medicine, Mayo Clinic, Eau Claire, Wis., and vice chair of the AASM Public Safety Committee.
The position statement was published Aug. 26 in the Journal of Clinical Sleep Medicine to coincide with the virtual annual meeting of the Associated Professional Sleep Societies .
Significant health risks
In the United States, the annual “spring forward” to daylight saving time and “fall back” to standard time is required by law, although under the statute some exceptions are permitted.
There has been intense debate over the last several years about transitioning between standard and daylight saving time. The AASM says there is “an abundance of evidence” to indicate that quick transition from standard time to daylight saving time incurs significant public health and safety risks, including increased risk of heart attack, stroke, mood disorders, and car crashes.
“Although chronic effects of remaining in daylight saving time year-round have not been well-studied, daylight saving time is less aligned with human circadian biology – which, because of the impacts of the delayed natural light/dark cycle on human activity, could result in circadian misalignment, which has been associated in some studies with increased cardiovascular disease risk, metabolic syndrome and other health risks,” the authors wrote.
A recent study also showed an increase in medical errors in the week after switching to daylight saving time.
“Because the adoption of permanent standard time would be beneficial for public health and safety, the AASM will be advocating at the federal level for this legislative change,” said AASM President Kannan Ramar, MBBS, MD, with the Mayo Clinic in Rochester, Minn.
It seems that many Americans are in favor of the change. In July, an AASM survey of roughly 2,000 U.S. adults showed that two-thirds support doing away with the seasonal time change. Only 11% opposed it. In addition, the academy’s 2019 survey showed more than half of adults feel extremely, or somewhat, tired after the springing ahead to daylight saving time.
Strong support
The position statement has been endorsed by 19 organizations, including the American Academy of Cardiovascular Sleep Medicine, American College of Chest Physicians (CHEST), American College of Occupational and Environmental Medicine, National PTA, National Safety Council, Society of Anesthesia and Sleep Medicine, and the Society of Behavioral Sleep Medicine.
Weighing in on the issue, Saul Rothenberg, PhD, from the Sleep Center at Greenwich Hospital, Conn., said the literature on daylight saving time has grown over the past 20 years. He said he was ”humbled” by the research that shows that a “relatively small” misalignment of biological and social clocks has a measurable impact on human health and behavior.
“Because misalignment is associated with negative health and performance outcomes, keeping one set of hours year-round is promoted to minimize misalignment and associated consequences,” he added.
In light of this research, the recommendation to dispense with daylight saving time seems “quite reasonable” from a public health perspective. “I am left with a strengthened view on the importance of regular adequate sleep as a way to enhance health, performance, and quality of life,” he added.
This research had no commercial funding. Dr. Rishi and Dr. Rothenberg have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM SLEEP 2020