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Growing public perception that cannabis is safer than tobacco
TOPLINE:
METHODOLOGY:
- While aggressive campaigns have led to a dramatic reduction in the prevalence of cigarette smoking and created safer smoke-free environments, regulation governing cannabis – which is associated with some health benefits but also many negative health outcomes – has been less restrictive.
- The study included a nationally representative sample of 5,035 mostly White U.S. adults, mean age 53.4 years, who completed three online surveys between 2017 and 2021 on the safety of tobacco and cannabis.
- In all three waves of the survey, respondents were asked to rate the safety of smoking one marijuana joint a day to smoking one cigarette a day, and of secondhand smoke from marijuana to that from tobacco.
- Respondents also expressed views on the safety of secondhand smoke exposure (of both marijuana and tobacco) on specific populations, including children, pregnant women, and adults (ratings were from “completely unsafe” to “completely safe”).
- Independent variables included age, sex, race, ethnicity, education level, annual income, employment status, marital status, and state of residence.
TAKEAWAY:
- There was a significant shift over time toward an increasingly favorable perception of cannabis; more respondents reported cannabis was “somewhat safer” or “much safer” than tobacco in 2021 than 2017 (44.3% vs. 36.7%; P < .001), and more believed secondhand smoke was somewhat or much safer for cannabis vs. tobacco in 2021 than in 2017 (40.2% vs. 35.1%; P < .001).
- More people endorsed the greater safety of secondhand smoke from cannabis vs. tobacco for children and pregnant women, and these perceptions remained similar over the study period.
- Younger and unmarried individuals were significantly more likely to move toward viewing smoking cannabis as safer than cigarettes, but legality of cannabis in respondents’ state of residence was not associated with change over time, suggesting the increasing perception of cannabis safety may be a national trend rather than a trend seen only in states with legalized cannabis.
IN PRACTICE:
“Understanding changing views on tobacco and cannabis risk is important given that increases in social acceptance and decreases in risk perception may be directly associated with public health and policies,” the investigators write.
SOURCE:
The study was conducted by Julia Chambers, MD, department of medicine, University of California, San Francisco, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The generalizability of the study may be limited by nonresponse and loss to follow-up over time. The wording of survey questions may have introduced bias in respondents. Participants were asked about safety of smoking cannabis joints vs. tobacco cigarettes and not to compare safety of other forms of smoked and vaped cannabis, tobacco, and nicotine.
DISCLOSURES:
The study received support from the California Tobacco-Related Disease Research Program. Dr. Chambers has no relevant conflicts of interest; author Katherine J. Hoggatt, PhD, MPH, department of medicine, UCSF, reported receiving grants from the Veterans Health Administration during the conduct of the study and grants from the National Institutes of Health, Rubin Family Foundation, and Veterans Health Administration outside the submitted work.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- While aggressive campaigns have led to a dramatic reduction in the prevalence of cigarette smoking and created safer smoke-free environments, regulation governing cannabis – which is associated with some health benefits but also many negative health outcomes – has been less restrictive.
- The study included a nationally representative sample of 5,035 mostly White U.S. adults, mean age 53.4 years, who completed three online surveys between 2017 and 2021 on the safety of tobacco and cannabis.
- In all three waves of the survey, respondents were asked to rate the safety of smoking one marijuana joint a day to smoking one cigarette a day, and of secondhand smoke from marijuana to that from tobacco.
- Respondents also expressed views on the safety of secondhand smoke exposure (of both marijuana and tobacco) on specific populations, including children, pregnant women, and adults (ratings were from “completely unsafe” to “completely safe”).
- Independent variables included age, sex, race, ethnicity, education level, annual income, employment status, marital status, and state of residence.
TAKEAWAY:
- There was a significant shift over time toward an increasingly favorable perception of cannabis; more respondents reported cannabis was “somewhat safer” or “much safer” than tobacco in 2021 than 2017 (44.3% vs. 36.7%; P < .001), and more believed secondhand smoke was somewhat or much safer for cannabis vs. tobacco in 2021 than in 2017 (40.2% vs. 35.1%; P < .001).
- More people endorsed the greater safety of secondhand smoke from cannabis vs. tobacco for children and pregnant women, and these perceptions remained similar over the study period.
- Younger and unmarried individuals were significantly more likely to move toward viewing smoking cannabis as safer than cigarettes, but legality of cannabis in respondents’ state of residence was not associated with change over time, suggesting the increasing perception of cannabis safety may be a national trend rather than a trend seen only in states with legalized cannabis.
IN PRACTICE:
“Understanding changing views on tobacco and cannabis risk is important given that increases in social acceptance and decreases in risk perception may be directly associated with public health and policies,” the investigators write.
SOURCE:
The study was conducted by Julia Chambers, MD, department of medicine, University of California, San Francisco, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The generalizability of the study may be limited by nonresponse and loss to follow-up over time. The wording of survey questions may have introduced bias in respondents. Participants were asked about safety of smoking cannabis joints vs. tobacco cigarettes and not to compare safety of other forms of smoked and vaped cannabis, tobacco, and nicotine.
DISCLOSURES:
The study received support from the California Tobacco-Related Disease Research Program. Dr. Chambers has no relevant conflicts of interest; author Katherine J. Hoggatt, PhD, MPH, department of medicine, UCSF, reported receiving grants from the Veterans Health Administration during the conduct of the study and grants from the National Institutes of Health, Rubin Family Foundation, and Veterans Health Administration outside the submitted work.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- While aggressive campaigns have led to a dramatic reduction in the prevalence of cigarette smoking and created safer smoke-free environments, regulation governing cannabis – which is associated with some health benefits but also many negative health outcomes – has been less restrictive.
- The study included a nationally representative sample of 5,035 mostly White U.S. adults, mean age 53.4 years, who completed three online surveys between 2017 and 2021 on the safety of tobacco and cannabis.
- In all three waves of the survey, respondents were asked to rate the safety of smoking one marijuana joint a day to smoking one cigarette a day, and of secondhand smoke from marijuana to that from tobacco.
- Respondents also expressed views on the safety of secondhand smoke exposure (of both marijuana and tobacco) on specific populations, including children, pregnant women, and adults (ratings were from “completely unsafe” to “completely safe”).
- Independent variables included age, sex, race, ethnicity, education level, annual income, employment status, marital status, and state of residence.
TAKEAWAY:
- There was a significant shift over time toward an increasingly favorable perception of cannabis; more respondents reported cannabis was “somewhat safer” or “much safer” than tobacco in 2021 than 2017 (44.3% vs. 36.7%; P < .001), and more believed secondhand smoke was somewhat or much safer for cannabis vs. tobacco in 2021 than in 2017 (40.2% vs. 35.1%; P < .001).
- More people endorsed the greater safety of secondhand smoke from cannabis vs. tobacco for children and pregnant women, and these perceptions remained similar over the study period.
- Younger and unmarried individuals were significantly more likely to move toward viewing smoking cannabis as safer than cigarettes, but legality of cannabis in respondents’ state of residence was not associated with change over time, suggesting the increasing perception of cannabis safety may be a national trend rather than a trend seen only in states with legalized cannabis.
IN PRACTICE:
“Understanding changing views on tobacco and cannabis risk is important given that increases in social acceptance and decreases in risk perception may be directly associated with public health and policies,” the investigators write.
SOURCE:
The study was conducted by Julia Chambers, MD, department of medicine, University of California, San Francisco, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The generalizability of the study may be limited by nonresponse and loss to follow-up over time. The wording of survey questions may have introduced bias in respondents. Participants were asked about safety of smoking cannabis joints vs. tobacco cigarettes and not to compare safety of other forms of smoked and vaped cannabis, tobacco, and nicotine.
DISCLOSURES:
The study received support from the California Tobacco-Related Disease Research Program. Dr. Chambers has no relevant conflicts of interest; author Katherine J. Hoggatt, PhD, MPH, department of medicine, UCSF, reported receiving grants from the Veterans Health Administration during the conduct of the study and grants from the National Institutes of Health, Rubin Family Foundation, and Veterans Health Administration outside the submitted work.
A version of this article first appeared on Medscape.com.
Autism tied to higher rates of self-harm, suicide
TOPLINE:
Even after accounting for sociodemographic factors, intellectual disabilities, and psychiatric diagnoses,
METHODOLOGY:
Evidence shows those with autism have over threefold greater odds than their counterparts without the disorder of self-injurious behavior, suicidal ideation, suicide attempt, or suicide death, but reasons for these elevated risks are unclear.
Using various linked databases in the province of Ontario, researchers identified all individuals with an autism diagnosis from April 1, 1988, to March 31, 2018, and matched each on age and sex to four nonautistic individuals for the comparison group.
Investigators created two cohorts to separately evaluate outcomes of self-harm events leading to emergency health care and suicide death with the accrual period for both cohorts beginning at a person’s 10th birthday.
The self-harm cohort included 379,630 individuals while the suicide cohort included 334,690 individuals.
TAKEAWAY:
Over 15 years, autistic females showed the highest cumulative self-harm events, followed by autistic males, nonautistic females, and nonautistic males; over 25 years, autistic males had the highest cumulative incidence of suicide death, followed by autistic females, nonautistic males, and nonautistic females.
Autism had independent associations with self-harm events (females: relative rate, 1.83 [95% confidence interval, 1.61-2.08]; males: RR, 1.47 [95% CI, 1.28-1.69]) even after accounting for sociodemographic factors (varied directions of associations), intellectual disabilities (associated with increased risks), and psychiatric diagnoses including mood and anxiety, psychotic, addiction, and personality disorders (associated with increased risks).
For both females and males, final models showed autism per se was not significantly associated with suicide death, but certain correlates were linked to risk. Among both sexes, intellectual disabilities were associated with reduced risks and psychiatric diagnoses were associated with increased risks.
As a substantial proportion (28.4%) of the suicide cohort did not have data on self-harm, researchers were unable to examine the association of self-harm with suicide death.
IN PRACTICE:
That psychiatric diagnoses increased suicide risks among people with autism suggests supports to reduce such risks “should consider multifactorial mechanisms, with a particular focus on the prevention and timely treatment of psychiatric illnesses,” write the authors.
SOURCE:
The study was conducted by Meng-Chuan Lai, MD, PhD, Centre for Addiction and Mental Health, Toronto, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The autism cohort didn’t capture those diagnosed in private practices or with subtle presentations not yet diagnosed. Misclassification of autistic people in the nonautistic cohort may have resulted in underestimation of suicide-related outcomes. The administrative data don’t reliably identify diagnoses associated with suicide risks such as attention-deficit/hyperactivity disorder or subcategories of mood disorders, and don’t contain information about risk and protective mechanisms of suicide behaviors such as family history.
DISCLOSURES:
The study received support from ICES, an independent nonprofit research institute; the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; the Academic Scholars Award from the Department of Psychiatry, University of Toronto; and the Canadian Institutes of Health Research Sex and Gender Science Chair. Dr. Lai reported receiving personal fees from SAGE Publications as an editorial honorarium outside the submitted work. One coauthor reported receiving honoraria from the BMJ Group, Archives of Diseases in Childhood.
A version of this article first appeared on Medscape.com.
TOPLINE:
Even after accounting for sociodemographic factors, intellectual disabilities, and psychiatric diagnoses,
METHODOLOGY:
Evidence shows those with autism have over threefold greater odds than their counterparts without the disorder of self-injurious behavior, suicidal ideation, suicide attempt, or suicide death, but reasons for these elevated risks are unclear.
Using various linked databases in the province of Ontario, researchers identified all individuals with an autism diagnosis from April 1, 1988, to March 31, 2018, and matched each on age and sex to four nonautistic individuals for the comparison group.
Investigators created two cohorts to separately evaluate outcomes of self-harm events leading to emergency health care and suicide death with the accrual period for both cohorts beginning at a person’s 10th birthday.
The self-harm cohort included 379,630 individuals while the suicide cohort included 334,690 individuals.
TAKEAWAY:
Over 15 years, autistic females showed the highest cumulative self-harm events, followed by autistic males, nonautistic females, and nonautistic males; over 25 years, autistic males had the highest cumulative incidence of suicide death, followed by autistic females, nonautistic males, and nonautistic females.
Autism had independent associations with self-harm events (females: relative rate, 1.83 [95% confidence interval, 1.61-2.08]; males: RR, 1.47 [95% CI, 1.28-1.69]) even after accounting for sociodemographic factors (varied directions of associations), intellectual disabilities (associated with increased risks), and psychiatric diagnoses including mood and anxiety, psychotic, addiction, and personality disorders (associated with increased risks).
For both females and males, final models showed autism per se was not significantly associated with suicide death, but certain correlates were linked to risk. Among both sexes, intellectual disabilities were associated with reduced risks and psychiatric diagnoses were associated with increased risks.
As a substantial proportion (28.4%) of the suicide cohort did not have data on self-harm, researchers were unable to examine the association of self-harm with suicide death.
IN PRACTICE:
That psychiatric diagnoses increased suicide risks among people with autism suggests supports to reduce such risks “should consider multifactorial mechanisms, with a particular focus on the prevention and timely treatment of psychiatric illnesses,” write the authors.
SOURCE:
The study was conducted by Meng-Chuan Lai, MD, PhD, Centre for Addiction and Mental Health, Toronto, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The autism cohort didn’t capture those diagnosed in private practices or with subtle presentations not yet diagnosed. Misclassification of autistic people in the nonautistic cohort may have resulted in underestimation of suicide-related outcomes. The administrative data don’t reliably identify diagnoses associated with suicide risks such as attention-deficit/hyperactivity disorder or subcategories of mood disorders, and don’t contain information about risk and protective mechanisms of suicide behaviors such as family history.
DISCLOSURES:
The study received support from ICES, an independent nonprofit research institute; the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; the Academic Scholars Award from the Department of Psychiatry, University of Toronto; and the Canadian Institutes of Health Research Sex and Gender Science Chair. Dr. Lai reported receiving personal fees from SAGE Publications as an editorial honorarium outside the submitted work. One coauthor reported receiving honoraria from the BMJ Group, Archives of Diseases in Childhood.
A version of this article first appeared on Medscape.com.
TOPLINE:
Even after accounting for sociodemographic factors, intellectual disabilities, and psychiatric diagnoses,
METHODOLOGY:
Evidence shows those with autism have over threefold greater odds than their counterparts without the disorder of self-injurious behavior, suicidal ideation, suicide attempt, or suicide death, but reasons for these elevated risks are unclear.
Using various linked databases in the province of Ontario, researchers identified all individuals with an autism diagnosis from April 1, 1988, to March 31, 2018, and matched each on age and sex to four nonautistic individuals for the comparison group.
Investigators created two cohorts to separately evaluate outcomes of self-harm events leading to emergency health care and suicide death with the accrual period for both cohorts beginning at a person’s 10th birthday.
The self-harm cohort included 379,630 individuals while the suicide cohort included 334,690 individuals.
TAKEAWAY:
Over 15 years, autistic females showed the highest cumulative self-harm events, followed by autistic males, nonautistic females, and nonautistic males; over 25 years, autistic males had the highest cumulative incidence of suicide death, followed by autistic females, nonautistic males, and nonautistic females.
Autism had independent associations with self-harm events (females: relative rate, 1.83 [95% confidence interval, 1.61-2.08]; males: RR, 1.47 [95% CI, 1.28-1.69]) even after accounting for sociodemographic factors (varied directions of associations), intellectual disabilities (associated with increased risks), and psychiatric diagnoses including mood and anxiety, psychotic, addiction, and personality disorders (associated with increased risks).
For both females and males, final models showed autism per se was not significantly associated with suicide death, but certain correlates were linked to risk. Among both sexes, intellectual disabilities were associated with reduced risks and psychiatric diagnoses were associated with increased risks.
As a substantial proportion (28.4%) of the suicide cohort did not have data on self-harm, researchers were unable to examine the association of self-harm with suicide death.
IN PRACTICE:
That psychiatric diagnoses increased suicide risks among people with autism suggests supports to reduce such risks “should consider multifactorial mechanisms, with a particular focus on the prevention and timely treatment of psychiatric illnesses,” write the authors.
SOURCE:
The study was conducted by Meng-Chuan Lai, MD, PhD, Centre for Addiction and Mental Health, Toronto, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The autism cohort didn’t capture those diagnosed in private practices or with subtle presentations not yet diagnosed. Misclassification of autistic people in the nonautistic cohort may have resulted in underestimation of suicide-related outcomes. The administrative data don’t reliably identify diagnoses associated with suicide risks such as attention-deficit/hyperactivity disorder or subcategories of mood disorders, and don’t contain information about risk and protective mechanisms of suicide behaviors such as family history.
DISCLOSURES:
The study received support from ICES, an independent nonprofit research institute; the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; the Academic Scholars Award from the Department of Psychiatry, University of Toronto; and the Canadian Institutes of Health Research Sex and Gender Science Chair. Dr. Lai reported receiving personal fees from SAGE Publications as an editorial honorarium outside the submitted work. One coauthor reported receiving honoraria from the BMJ Group, Archives of Diseases in Childhood.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
New consensus on managing acetaminophen poisoning
TOPLINE:
An expert panel has updated recommendations for emergency department assessment, management, and treatment of acetaminophen poisoning.
METHODOLOGY:
The United States and Canada have no formal guidelines for managing acetaminophen poisoning, which is characterized by hepatocellular damage and potential liver failure, which can be life-threatening.
The past 25 years has seen the introduction of products that contain greater amounts of acetaminophen, extended-release preparations, and new drugs that combine acetaminophen with opioids or other ingredients.
From the medical literature and current poison control guidelines, the panel used a modified Delphi method to create a decision framework and determine appropriate management, including triage and laboratory evaluation, for acetaminophen poisoning, addressing scenarios such as extended-release and high-risk ingestion, co-ingestion of anticholinergics or opioids, pregnancy, weight greater than 100 kg, and criteria for consultation with a toxicologist.
TAKEAWAY:
The panel emphasized the role of the patient’s history; an inaccurate estimate of the time of ingestion, for example, can lead to the erroneous conclusion that acetylcysteine, a medication used to treat overdose, is not needed or can be discontinued prematurely – a potentially fatal mistake.
The initial dose of acetylcysteine should be administered as soon as the need becomes evident, with the panel recommending at least 300 mg/kg orally or intravenously during the first 20 or 24 hours of treatment.
Management of ingestion of extended-release preparations is the same, with the exception of obtaining a second acetaminophen blood concentration in some cases.
When acetaminophen is co-ingested with anticholinergic or opioid agonist medications, management is the same, except if the first acetaminophen concentration measured at 4-24 hours after ingestion is 10 mcg/mL or less, another measurement and acetylcysteine treatment are not needed.
IN PRACTICE:
“A guideline that provides management guidance could optimize patient outcomes, reduce disruption for patients and caregivers, and reduce costs by shortening the length of hospitalization,” write the authors.
SOURCE:
The study was conducted by Richard C. Dart, MD, PhD, Rocky Mountain Poison and Drug Safety, University of Colorado, Denver, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The work lacked high-quality data that address clinical decisions needed for managing acetaminophen poisoning. There were only a few well-controlled comparative studies, which focused on specific issues and not on patient management.
DISCLOSURES:
The work was supported by a grant from Johnson & Johnson Consumer Inc. Dr. Dart has reported receiving grants from Johnson & Johnson outside the submitted work. See paper for disclosures of other authors.
A version of this article appeared on Medscape.com.
TOPLINE:
An expert panel has updated recommendations for emergency department assessment, management, and treatment of acetaminophen poisoning.
METHODOLOGY:
The United States and Canada have no formal guidelines for managing acetaminophen poisoning, which is characterized by hepatocellular damage and potential liver failure, which can be life-threatening.
The past 25 years has seen the introduction of products that contain greater amounts of acetaminophen, extended-release preparations, and new drugs that combine acetaminophen with opioids or other ingredients.
From the medical literature and current poison control guidelines, the panel used a modified Delphi method to create a decision framework and determine appropriate management, including triage and laboratory evaluation, for acetaminophen poisoning, addressing scenarios such as extended-release and high-risk ingestion, co-ingestion of anticholinergics or opioids, pregnancy, weight greater than 100 kg, and criteria for consultation with a toxicologist.
TAKEAWAY:
The panel emphasized the role of the patient’s history; an inaccurate estimate of the time of ingestion, for example, can lead to the erroneous conclusion that acetylcysteine, a medication used to treat overdose, is not needed or can be discontinued prematurely – a potentially fatal mistake.
The initial dose of acetylcysteine should be administered as soon as the need becomes evident, with the panel recommending at least 300 mg/kg orally or intravenously during the first 20 or 24 hours of treatment.
Management of ingestion of extended-release preparations is the same, with the exception of obtaining a second acetaminophen blood concentration in some cases.
When acetaminophen is co-ingested with anticholinergic or opioid agonist medications, management is the same, except if the first acetaminophen concentration measured at 4-24 hours after ingestion is 10 mcg/mL or less, another measurement and acetylcysteine treatment are not needed.
IN PRACTICE:
“A guideline that provides management guidance could optimize patient outcomes, reduce disruption for patients and caregivers, and reduce costs by shortening the length of hospitalization,” write the authors.
SOURCE:
The study was conducted by Richard C. Dart, MD, PhD, Rocky Mountain Poison and Drug Safety, University of Colorado, Denver, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The work lacked high-quality data that address clinical decisions needed for managing acetaminophen poisoning. There were only a few well-controlled comparative studies, which focused on specific issues and not on patient management.
DISCLOSURES:
The work was supported by a grant from Johnson & Johnson Consumer Inc. Dr. Dart has reported receiving grants from Johnson & Johnson outside the submitted work. See paper for disclosures of other authors.
A version of this article appeared on Medscape.com.
TOPLINE:
An expert panel has updated recommendations for emergency department assessment, management, and treatment of acetaminophen poisoning.
METHODOLOGY:
The United States and Canada have no formal guidelines for managing acetaminophen poisoning, which is characterized by hepatocellular damage and potential liver failure, which can be life-threatening.
The past 25 years has seen the introduction of products that contain greater amounts of acetaminophen, extended-release preparations, and new drugs that combine acetaminophen with opioids or other ingredients.
From the medical literature and current poison control guidelines, the panel used a modified Delphi method to create a decision framework and determine appropriate management, including triage and laboratory evaluation, for acetaminophen poisoning, addressing scenarios such as extended-release and high-risk ingestion, co-ingestion of anticholinergics or opioids, pregnancy, weight greater than 100 kg, and criteria for consultation with a toxicologist.
TAKEAWAY:
The panel emphasized the role of the patient’s history; an inaccurate estimate of the time of ingestion, for example, can lead to the erroneous conclusion that acetylcysteine, a medication used to treat overdose, is not needed or can be discontinued prematurely – a potentially fatal mistake.
The initial dose of acetylcysteine should be administered as soon as the need becomes evident, with the panel recommending at least 300 mg/kg orally or intravenously during the first 20 or 24 hours of treatment.
Management of ingestion of extended-release preparations is the same, with the exception of obtaining a second acetaminophen blood concentration in some cases.
When acetaminophen is co-ingested with anticholinergic or opioid agonist medications, management is the same, except if the first acetaminophen concentration measured at 4-24 hours after ingestion is 10 mcg/mL or less, another measurement and acetylcysteine treatment are not needed.
IN PRACTICE:
“A guideline that provides management guidance could optimize patient outcomes, reduce disruption for patients and caregivers, and reduce costs by shortening the length of hospitalization,” write the authors.
SOURCE:
The study was conducted by Richard C. Dart, MD, PhD, Rocky Mountain Poison and Drug Safety, University of Colorado, Denver, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The work lacked high-quality data that address clinical decisions needed for managing acetaminophen poisoning. There were only a few well-controlled comparative studies, which focused on specific issues and not on patient management.
DISCLOSURES:
The work was supported by a grant from Johnson & Johnson Consumer Inc. Dr. Dart has reported receiving grants from Johnson & Johnson outside the submitted work. See paper for disclosures of other authors.
A version of this article appeared on Medscape.com.
Early or delayed AFib ablation after heart failure hospitalization?
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
FROM JACC: CLINICAL ELECTROPHYSIOLOGY
High-intensity interval training before major surgery may boost postoperative outcomes
TOPLINE:
It cuts the risk of postoperative complications and may shorten hospital length of stay and improve postoperative quality of life.
METHODOLOGY:
Evidence suggests CRF – which improves physical and cognitive function and is associated with a reduction in cardiovascular risk – can be enhanced before major surgeries, but reported postoperative outcomes in previous reviews have been inconsistent.
In the study, HIIT involved repeated aerobic high-intensity exercise intervals at about 80% of maximum heart rate, followed by active recovery.
The meta-analysis included 12 studies with 832 patients (mean age, 67) that compared preoperative HIIT – supervised at hospitals, gyms, or community or physical therapy centers, or unsupervised at home – with standard care for patients slated for major surgery, including liver, lung, colorectal, urologic, and mixed major abdominal operations.
The primary outcome was change in CRF by peak VO2 or 6-minute walk test; other endpoints included change in endurance time and postoperative outcomes.
TAKEAWAY:
Preoperative HIIT (median total, 160 minutes; range, 80-240 minutes; intense exercise during 6-40 sessions) was associated with an increase in peak oxygen consumption (VO2 peak) by 2.59 mL/kg/min (95% confidence interval, 1.52-3.65 mL/kg/min; P < .001), compared with standard care, which represents about a 10% increase in CRF.
In eight studies that involved 770 patients, there was moderate evidence that preoperative HIIT cut the odds ratio for postoperative complications by more than half (OR, 0.44; 95% CI, 0.32-0.60; P < .001); there was a similar apparent benefit in an analysis that was limited to patients who were slated for abdominal surgery (OR, 0.45; 95% CI, 0.29-0.68; P < .001).
An analysis that was limited to studies that reported hospital length of stay showed a clinically relevant but nonsignificant 3-day reduction among patients in the HIIT groups.
Most quality of life assessments did not show post-HIIT improvements; some showed a significant benefit 6 weeks after surgery.
IN PRACTICE:
The results suggest preoperative HIIT may improve postoperative outcomes. By extension, it could be cost-effective and “should be included in prehabilitation programs,” the report states.
SOURCE:
The study was carried out by Kari Clifford, PhD, Otago Medical School, University of Otago, Dunedin, New Zealand, and colleagues. It was published online June 30, 2023, in JAMA Network Open.
LIMITATIONS:
Included studies were heterogeneous in methodology; for example, HIIT definitions and protocols varied across almost every study. Data reporting was incomplete, the samples sizes in the studies were limited, and patients could not be blinded to their intervention. The patients could not be stratified on the basis of frailty. There were limited HIIT data from patients who underwent orthopedic surgeries.
DISCLOSURES:
The study received funding from the University of Otago. The authors reported no conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
It cuts the risk of postoperative complications and may shorten hospital length of stay and improve postoperative quality of life.
METHODOLOGY:
Evidence suggests CRF – which improves physical and cognitive function and is associated with a reduction in cardiovascular risk – can be enhanced before major surgeries, but reported postoperative outcomes in previous reviews have been inconsistent.
In the study, HIIT involved repeated aerobic high-intensity exercise intervals at about 80% of maximum heart rate, followed by active recovery.
The meta-analysis included 12 studies with 832 patients (mean age, 67) that compared preoperative HIIT – supervised at hospitals, gyms, or community or physical therapy centers, or unsupervised at home – with standard care for patients slated for major surgery, including liver, lung, colorectal, urologic, and mixed major abdominal operations.
The primary outcome was change in CRF by peak VO2 or 6-minute walk test; other endpoints included change in endurance time and postoperative outcomes.
TAKEAWAY:
Preoperative HIIT (median total, 160 minutes; range, 80-240 minutes; intense exercise during 6-40 sessions) was associated with an increase in peak oxygen consumption (VO2 peak) by 2.59 mL/kg/min (95% confidence interval, 1.52-3.65 mL/kg/min; P < .001), compared with standard care, which represents about a 10% increase in CRF.
In eight studies that involved 770 patients, there was moderate evidence that preoperative HIIT cut the odds ratio for postoperative complications by more than half (OR, 0.44; 95% CI, 0.32-0.60; P < .001); there was a similar apparent benefit in an analysis that was limited to patients who were slated for abdominal surgery (OR, 0.45; 95% CI, 0.29-0.68; P < .001).
An analysis that was limited to studies that reported hospital length of stay showed a clinically relevant but nonsignificant 3-day reduction among patients in the HIIT groups.
Most quality of life assessments did not show post-HIIT improvements; some showed a significant benefit 6 weeks after surgery.
IN PRACTICE:
The results suggest preoperative HIIT may improve postoperative outcomes. By extension, it could be cost-effective and “should be included in prehabilitation programs,” the report states.
SOURCE:
The study was carried out by Kari Clifford, PhD, Otago Medical School, University of Otago, Dunedin, New Zealand, and colleagues. It was published online June 30, 2023, in JAMA Network Open.
LIMITATIONS:
Included studies were heterogeneous in methodology; for example, HIIT definitions and protocols varied across almost every study. Data reporting was incomplete, the samples sizes in the studies were limited, and patients could not be blinded to their intervention. The patients could not be stratified on the basis of frailty. There were limited HIIT data from patients who underwent orthopedic surgeries.
DISCLOSURES:
The study received funding from the University of Otago. The authors reported no conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
It cuts the risk of postoperative complications and may shorten hospital length of stay and improve postoperative quality of life.
METHODOLOGY:
Evidence suggests CRF – which improves physical and cognitive function and is associated with a reduction in cardiovascular risk – can be enhanced before major surgeries, but reported postoperative outcomes in previous reviews have been inconsistent.
In the study, HIIT involved repeated aerobic high-intensity exercise intervals at about 80% of maximum heart rate, followed by active recovery.
The meta-analysis included 12 studies with 832 patients (mean age, 67) that compared preoperative HIIT – supervised at hospitals, gyms, or community or physical therapy centers, or unsupervised at home – with standard care for patients slated for major surgery, including liver, lung, colorectal, urologic, and mixed major abdominal operations.
The primary outcome was change in CRF by peak VO2 or 6-minute walk test; other endpoints included change in endurance time and postoperative outcomes.
TAKEAWAY:
Preoperative HIIT (median total, 160 minutes; range, 80-240 minutes; intense exercise during 6-40 sessions) was associated with an increase in peak oxygen consumption (VO2 peak) by 2.59 mL/kg/min (95% confidence interval, 1.52-3.65 mL/kg/min; P < .001), compared with standard care, which represents about a 10% increase in CRF.
In eight studies that involved 770 patients, there was moderate evidence that preoperative HIIT cut the odds ratio for postoperative complications by more than half (OR, 0.44; 95% CI, 0.32-0.60; P < .001); there was a similar apparent benefit in an analysis that was limited to patients who were slated for abdominal surgery (OR, 0.45; 95% CI, 0.29-0.68; P < .001).
An analysis that was limited to studies that reported hospital length of stay showed a clinically relevant but nonsignificant 3-day reduction among patients in the HIIT groups.
Most quality of life assessments did not show post-HIIT improvements; some showed a significant benefit 6 weeks after surgery.
IN PRACTICE:
The results suggest preoperative HIIT may improve postoperative outcomes. By extension, it could be cost-effective and “should be included in prehabilitation programs,” the report states.
SOURCE:
The study was carried out by Kari Clifford, PhD, Otago Medical School, University of Otago, Dunedin, New Zealand, and colleagues. It was published online June 30, 2023, in JAMA Network Open.
LIMITATIONS:
Included studies were heterogeneous in methodology; for example, HIIT definitions and protocols varied across almost every study. Data reporting was incomplete, the samples sizes in the studies were limited, and patients could not be blinded to their intervention. The patients could not be stratified on the basis of frailty. There were limited HIIT data from patients who underwent orthopedic surgeries.
DISCLOSURES:
The study received funding from the University of Otago. The authors reported no conflicts.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Gut and oral flora linked to subclinical CAD, inflammation
TOPLINE:
in a population-based observational study.
METHODOLOGY:
Links between gut microbiota and coronary atherosclerosis have been studied primarily in symptomatic patients who were likely receiving therapies that may have shifted the balance of different organisms; there are fewer data from people with asymptomatic coronary disease.
Oral bacterial species are commonly transmitted to the gut, suggesting that gut and oral microbiota profiles are related and, further, that the gut may allow oral pathogenic bacteria to enter the circulation.
The current study included 8,973 adults (53.7% women) without cardiovascular (CV) disease for whom adequate imaging and other data were available from the Swedish Cardiopulmonary Bioimage Study (SCAPIS) and the Malmö Offspring Study (MOS).
Researchers looked for associations between coronary artery calcium (CAC) scores (an index of atherosclerosis), gut bacterial species (identified in fecal samples), oral flora and pathologies, and systemic inflammatory biomarkers.
TAKEAWAY:
Among the 64 species that correlated with CAC scores independently of CV risk factors, 51 showed a positive association, especially S. anginosus and S. oralis subsp oralis; patients with higher levels of those two species generally had more CV risk factors.
Twenty-five bacterial species that correlated with CAC scores were also associated with any coronary plaque by CT angiography. Five such species were associated with coronary stenosis greater than 50%, 39 with the modified Duke index, and five with carotid plaques (P < .05).
Of 54 species positively associated with CAC scores, 13 also tracked with C-reactive protein levels by high-sensitivity assay, 10 with leukocyte counts, and 11 with neutrophil counts (P < .05).
Bacterial species common in the oral cavity made up most of the species that correlated with all three inflammatory biomarkers; they included the streptococci most strongly correlating with CAC scores, that is, S. anginosus, S. oralis subsp oralis, and S. parasanguinis.
IN PRACTICE:
If the associations between gut bacterial species and markers of coronary atherosclerosis are found to be causal, such bacteria may “contribute to atherogenesis by direct infection or by altering host metabolism,” the report states. “Future studies will show whether these species can be used as potential biomarkers or treatment targets.”
SOURCE:
The study was conducted by Sergi Sayols-Baixeras, PhD, Uppsala University, Sweden, and Instituto de Salud Carlos III, Madrid, and colleagues. It was published online July 12, 2023, in Circulation.
LIMITATIONS:
Few participants had a high degree of subclinical atherosclerosis, which may reduce statistical power. Fecal samples disclose organisms primarily from the distal colon, but “microbial composition can vary extensively throughout the gastrointestinal tract.” The investigators did not consider potential synergistic interactions among bacterial species that could influence their relationship to coronary atherosclerosis. Captured data regarding antibiotic therapy didn’t account for any in-hospital treatment. The study’s cross-sectional design precludes inferences about causation.
DISCLOSURES:
The study received funding from the European Research Council, the Swedish Research Council, the Swedish Heart-Lung Foundation, the Novo Nordisk Foundation, the Swedish Diabetes Foundation, the Swedish Foundation for Strategic Research, the G
A version of this article first appeared on Medscape.com.
TOPLINE:
in a population-based observational study.
METHODOLOGY:
Links between gut microbiota and coronary atherosclerosis have been studied primarily in symptomatic patients who were likely receiving therapies that may have shifted the balance of different organisms; there are fewer data from people with asymptomatic coronary disease.
Oral bacterial species are commonly transmitted to the gut, suggesting that gut and oral microbiota profiles are related and, further, that the gut may allow oral pathogenic bacteria to enter the circulation.
The current study included 8,973 adults (53.7% women) without cardiovascular (CV) disease for whom adequate imaging and other data were available from the Swedish Cardiopulmonary Bioimage Study (SCAPIS) and the Malmö Offspring Study (MOS).
Researchers looked for associations between coronary artery calcium (CAC) scores (an index of atherosclerosis), gut bacterial species (identified in fecal samples), oral flora and pathologies, and systemic inflammatory biomarkers.
TAKEAWAY:
Among the 64 species that correlated with CAC scores independently of CV risk factors, 51 showed a positive association, especially S. anginosus and S. oralis subsp oralis; patients with higher levels of those two species generally had more CV risk factors.
Twenty-five bacterial species that correlated with CAC scores were also associated with any coronary plaque by CT angiography. Five such species were associated with coronary stenosis greater than 50%, 39 with the modified Duke index, and five with carotid plaques (P < .05).
Of 54 species positively associated with CAC scores, 13 also tracked with C-reactive protein levels by high-sensitivity assay, 10 with leukocyte counts, and 11 with neutrophil counts (P < .05).
Bacterial species common in the oral cavity made up most of the species that correlated with all three inflammatory biomarkers; they included the streptococci most strongly correlating with CAC scores, that is, S. anginosus, S. oralis subsp oralis, and S. parasanguinis.
IN PRACTICE:
If the associations between gut bacterial species and markers of coronary atherosclerosis are found to be causal, such bacteria may “contribute to atherogenesis by direct infection or by altering host metabolism,” the report states. “Future studies will show whether these species can be used as potential biomarkers or treatment targets.”
SOURCE:
The study was conducted by Sergi Sayols-Baixeras, PhD, Uppsala University, Sweden, and Instituto de Salud Carlos III, Madrid, and colleagues. It was published online July 12, 2023, in Circulation.
LIMITATIONS:
Few participants had a high degree of subclinical atherosclerosis, which may reduce statistical power. Fecal samples disclose organisms primarily from the distal colon, but “microbial composition can vary extensively throughout the gastrointestinal tract.” The investigators did not consider potential synergistic interactions among bacterial species that could influence their relationship to coronary atherosclerosis. Captured data regarding antibiotic therapy didn’t account for any in-hospital treatment. The study’s cross-sectional design precludes inferences about causation.
DISCLOSURES:
The study received funding from the European Research Council, the Swedish Research Council, the Swedish Heart-Lung Foundation, the Novo Nordisk Foundation, the Swedish Diabetes Foundation, the Swedish Foundation for Strategic Research, the G
A version of this article first appeared on Medscape.com.
TOPLINE:
in a population-based observational study.
METHODOLOGY:
Links between gut microbiota and coronary atherosclerosis have been studied primarily in symptomatic patients who were likely receiving therapies that may have shifted the balance of different organisms; there are fewer data from people with asymptomatic coronary disease.
Oral bacterial species are commonly transmitted to the gut, suggesting that gut and oral microbiota profiles are related and, further, that the gut may allow oral pathogenic bacteria to enter the circulation.
The current study included 8,973 adults (53.7% women) without cardiovascular (CV) disease for whom adequate imaging and other data were available from the Swedish Cardiopulmonary Bioimage Study (SCAPIS) and the Malmö Offspring Study (MOS).
Researchers looked for associations between coronary artery calcium (CAC) scores (an index of atherosclerosis), gut bacterial species (identified in fecal samples), oral flora and pathologies, and systemic inflammatory biomarkers.
TAKEAWAY:
Among the 64 species that correlated with CAC scores independently of CV risk factors, 51 showed a positive association, especially S. anginosus and S. oralis subsp oralis; patients with higher levels of those two species generally had more CV risk factors.
Twenty-five bacterial species that correlated with CAC scores were also associated with any coronary plaque by CT angiography. Five such species were associated with coronary stenosis greater than 50%, 39 with the modified Duke index, and five with carotid plaques (P < .05).
Of 54 species positively associated with CAC scores, 13 also tracked with C-reactive protein levels by high-sensitivity assay, 10 with leukocyte counts, and 11 with neutrophil counts (P < .05).
Bacterial species common in the oral cavity made up most of the species that correlated with all three inflammatory biomarkers; they included the streptococci most strongly correlating with CAC scores, that is, S. anginosus, S. oralis subsp oralis, and S. parasanguinis.
IN PRACTICE:
If the associations between gut bacterial species and markers of coronary atherosclerosis are found to be causal, such bacteria may “contribute to atherogenesis by direct infection or by altering host metabolism,” the report states. “Future studies will show whether these species can be used as potential biomarkers or treatment targets.”
SOURCE:
The study was conducted by Sergi Sayols-Baixeras, PhD, Uppsala University, Sweden, and Instituto de Salud Carlos III, Madrid, and colleagues. It was published online July 12, 2023, in Circulation.
LIMITATIONS:
Few participants had a high degree of subclinical atherosclerosis, which may reduce statistical power. Fecal samples disclose organisms primarily from the distal colon, but “microbial composition can vary extensively throughout the gastrointestinal tract.” The investigators did not consider potential synergistic interactions among bacterial species that could influence their relationship to coronary atherosclerosis. Captured data regarding antibiotic therapy didn’t account for any in-hospital treatment. The study’s cross-sectional design precludes inferences about causation.
DISCLOSURES:
The study received funding from the European Research Council, the Swedish Research Council, the Swedish Heart-Lung Foundation, the Novo Nordisk Foundation, the Swedish Diabetes Foundation, the Swedish Foundation for Strategic Research, the G
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Promising phase 3 results for Alzheimer’s drug donanemab
results of a phase 3 study showed.
“This trial demonstrates that an antiamyloid drug significantly slows the disease and provides meaningful benefit to patients, and we’re hoping that with approval, we will be able to make that drug available,” said Mark Mintun, MD, VP, pain and neurodegeneration research, Eli Lilly.
At a press briefing highlighting the new results, Maria Carrillo, PhD, chief science officer, Alzheimer’s Association, noted the “palpable excitement” surrounding this new study, which follows on the heels of other promising antiamyloid research. “This is the decade of Alzheimer’s disease, and it will get better from here,” she said.
The findings were presented at the Alzheimer’s Association International Conference and were published online in JAMA.
Primary, secondary endpoints met
The TRAILBLAZER-ALZ 2 study included 1,736 patients with mild cognitive impairment (MCI) or mild dementia for whom PET showed evidence of amyloid and tau pathology. The mean age of the participants was 73 years, and most of the participants were White.
Participants were randomly assigned to receive either placebo or donanemab, an investigational IgG1 monoclonal antibody directed against an insoluble, modified, N-terminal, truncated form of beta-amyloid. Donanemab was administered at a dose of 700 mg for the first three doses and 1,400 mg thereafter. The drug was administered intravenously every 4 weeks for up to 72 weeks.
Researchers stratified patients on the basis of the amount of tau, a biomarker for Alzheimer’s disease progression, into a low/medium tau group and a combined tau group (low/medium and high tau).
The primary endpoint was change from baseline to 76 weeks on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures cognition and activities of daily living.
In those with low/medium tau levels, the least squares mean (LSM) change in iADRS score was −6.02 (95% confidence interval, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25; 95% CI, 1.88 – 4.62; P < .001), representing a 35.1% slowing of disease progression.
In the combined (tau) population, LSM change in iADRS was −10.19 (95% CI, −11.22 to −9.16) in the donanemab group and −13.11 (95% CI, −14.10 to −12.13) in the placebo group (difference, 2.92; 95% CI, 1.51 – 4.33; P < .001), representing a 22.3% slowing of disease progression.
The study also met all secondary endpoints regarding measurements of cognitive and functional decline, including the Clinical Dementia Rating–Sum of Boxes (CDR-SB), which showed 36% slowing of decline (P < .0001) over 18 months.
The authors noted that the changes on these scales were clinically meaningful (considered to be > 20% slowing of clinical progression) for both the low/medium tau and combined populations.
Greater benefit with lower tau
However, patients with low/medium tau generally demonstrated effect size estimates that were larger than those of the overall population, which suggests there’s greater benefit when amyloid-lowering therapies are initiated at an earlier disease stage, the investigators noted.
Additional support for clinical relevance was a 38.6% risk reduction of disease progression, as measured on the CDR–Global Score.
In addition, participants who received the active drug benefited in terms of activities of daily living, as demonstrated by 40% less decline (P < .0001) on the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory.
Donanemab significantly reduced brain amyloid plaque: 80% (low/medium tau population) and 76% (combined population) of participants achieved amyloid clearance at 76 weeks. The intervention was also associated with a greater decrease in whole-brain volume.
The treatment effect continued to widen after patients were switched to placebo, as evidenced on PET scan at 6 or 12 months, said Dr. Mintun.
The effects of the drug were similar among men and women but were especially pronounced among younger participants, with a 48% slowing on iADRS and a 45% slowing on CDR-SB in those younger than 75 years.
Safety issues
However, the drug is not without some safety concerns. Amyloid-related imaging abnormalities (ARIAs) occurred in 36.8% of the treatment group versus 14.9% of the placebo group, and in 40.6% of patients who were homozygous for apo E4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group versus 12.5% in the placebo group.
Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug related among participants who developed serious ARIAs or brain bleeding and swelling.
An important study limitation was that it enrolled primarily White patients (91.5%), which may limit generalizability to other populations, and the age limit was 85 years, which some believe is an inadequate representation of older adults. In addition, the 18-month treatment window limits the long-term understanding of donanemab’s benefits and side effects.
Eli Lilly has filed a submission to the Food and Drug Administration. If approved, donanemab will be the third antiamyloid monoclonal antibody to receive this status, following aducanumab (Aduhelm) and lecanemab (Leqembi).
Strongest data yet
Commenting on the study findings, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said these new results are “very, very exciting” and represent “the strongest data to-date” for antiamyloid monoclonal antibodies in Alzheimer’s disease.
“A good percentage of individuals on the drug actually saw a complete clearance of amyloid, and some had to be taken off the drug, because if you’re on an antiamyloid drug and there’s no amyloid, what are you going for?”
He noted that the study had some unique aspects, including using tau-PET “to see whether or not the drug is more effective in subpopulations.”
Access to this and other antiamyloid therapies should be a priority, said Dr. Griffin. “We have to make sure people who have the potential to benefit from these treatments do.”
The Alzheimer’s Association is calling for Medicare beneficiaries who are living with the disease to receive the same coverage afforded to those with other diseases.
“The Centers for Medicare & Medicaid Services policy to block Medicare access to FDA-approved Alzheimer’s disease treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said in a press release.
Also important is tracking the longitudinal performance of these drugs outside of clinical trials, said Dr. Griffin. “Not everyone is going to be in that Goldilocks zone of being able to see a doctor whenever they want and have access to these PET and MRI tools and other things used in clinical trials.”
He noted that the Alzheimer’s Association is leading a network for diagnostics and therapeutics (ALZ-NET) that will track the performance of novel FDA-approved Alzheimer’s disease therapies “in the real world.”
While these are exciting findings for antiamyloid therapy, “we can’t take our foot off the gas, we need more therapies that target different aspects of the disease biology,” said Dr. Griffin.
A version of this article appeared on Medscape.com.
results of a phase 3 study showed.
“This trial demonstrates that an antiamyloid drug significantly slows the disease and provides meaningful benefit to patients, and we’re hoping that with approval, we will be able to make that drug available,” said Mark Mintun, MD, VP, pain and neurodegeneration research, Eli Lilly.
At a press briefing highlighting the new results, Maria Carrillo, PhD, chief science officer, Alzheimer’s Association, noted the “palpable excitement” surrounding this new study, which follows on the heels of other promising antiamyloid research. “This is the decade of Alzheimer’s disease, and it will get better from here,” she said.
The findings were presented at the Alzheimer’s Association International Conference and were published online in JAMA.
Primary, secondary endpoints met
The TRAILBLAZER-ALZ 2 study included 1,736 patients with mild cognitive impairment (MCI) or mild dementia for whom PET showed evidence of amyloid and tau pathology. The mean age of the participants was 73 years, and most of the participants were White.
Participants were randomly assigned to receive either placebo or donanemab, an investigational IgG1 monoclonal antibody directed against an insoluble, modified, N-terminal, truncated form of beta-amyloid. Donanemab was administered at a dose of 700 mg for the first three doses and 1,400 mg thereafter. The drug was administered intravenously every 4 weeks for up to 72 weeks.
Researchers stratified patients on the basis of the amount of tau, a biomarker for Alzheimer’s disease progression, into a low/medium tau group and a combined tau group (low/medium and high tau).
The primary endpoint was change from baseline to 76 weeks on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures cognition and activities of daily living.
In those with low/medium tau levels, the least squares mean (LSM) change in iADRS score was −6.02 (95% confidence interval, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25; 95% CI, 1.88 – 4.62; P < .001), representing a 35.1% slowing of disease progression.
In the combined (tau) population, LSM change in iADRS was −10.19 (95% CI, −11.22 to −9.16) in the donanemab group and −13.11 (95% CI, −14.10 to −12.13) in the placebo group (difference, 2.92; 95% CI, 1.51 – 4.33; P < .001), representing a 22.3% slowing of disease progression.
The study also met all secondary endpoints regarding measurements of cognitive and functional decline, including the Clinical Dementia Rating–Sum of Boxes (CDR-SB), which showed 36% slowing of decline (P < .0001) over 18 months.
The authors noted that the changes on these scales were clinically meaningful (considered to be > 20% slowing of clinical progression) for both the low/medium tau and combined populations.
Greater benefit with lower tau
However, patients with low/medium tau generally demonstrated effect size estimates that were larger than those of the overall population, which suggests there’s greater benefit when amyloid-lowering therapies are initiated at an earlier disease stage, the investigators noted.
Additional support for clinical relevance was a 38.6% risk reduction of disease progression, as measured on the CDR–Global Score.
In addition, participants who received the active drug benefited in terms of activities of daily living, as demonstrated by 40% less decline (P < .0001) on the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory.
Donanemab significantly reduced brain amyloid plaque: 80% (low/medium tau population) and 76% (combined population) of participants achieved amyloid clearance at 76 weeks. The intervention was also associated with a greater decrease in whole-brain volume.
The treatment effect continued to widen after patients were switched to placebo, as evidenced on PET scan at 6 or 12 months, said Dr. Mintun.
The effects of the drug were similar among men and women but were especially pronounced among younger participants, with a 48% slowing on iADRS and a 45% slowing on CDR-SB in those younger than 75 years.
Safety issues
However, the drug is not without some safety concerns. Amyloid-related imaging abnormalities (ARIAs) occurred in 36.8% of the treatment group versus 14.9% of the placebo group, and in 40.6% of patients who were homozygous for apo E4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group versus 12.5% in the placebo group.
Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug related among participants who developed serious ARIAs or brain bleeding and swelling.
An important study limitation was that it enrolled primarily White patients (91.5%), which may limit generalizability to other populations, and the age limit was 85 years, which some believe is an inadequate representation of older adults. In addition, the 18-month treatment window limits the long-term understanding of donanemab’s benefits and side effects.
Eli Lilly has filed a submission to the Food and Drug Administration. If approved, donanemab will be the third antiamyloid monoclonal antibody to receive this status, following aducanumab (Aduhelm) and lecanemab (Leqembi).
Strongest data yet
Commenting on the study findings, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said these new results are “very, very exciting” and represent “the strongest data to-date” for antiamyloid monoclonal antibodies in Alzheimer’s disease.
“A good percentage of individuals on the drug actually saw a complete clearance of amyloid, and some had to be taken off the drug, because if you’re on an antiamyloid drug and there’s no amyloid, what are you going for?”
He noted that the study had some unique aspects, including using tau-PET “to see whether or not the drug is more effective in subpopulations.”
Access to this and other antiamyloid therapies should be a priority, said Dr. Griffin. “We have to make sure people who have the potential to benefit from these treatments do.”
The Alzheimer’s Association is calling for Medicare beneficiaries who are living with the disease to receive the same coverage afforded to those with other diseases.
“The Centers for Medicare & Medicaid Services policy to block Medicare access to FDA-approved Alzheimer’s disease treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said in a press release.
Also important is tracking the longitudinal performance of these drugs outside of clinical trials, said Dr. Griffin. “Not everyone is going to be in that Goldilocks zone of being able to see a doctor whenever they want and have access to these PET and MRI tools and other things used in clinical trials.”
He noted that the Alzheimer’s Association is leading a network for diagnostics and therapeutics (ALZ-NET) that will track the performance of novel FDA-approved Alzheimer’s disease therapies “in the real world.”
While these are exciting findings for antiamyloid therapy, “we can’t take our foot off the gas, we need more therapies that target different aspects of the disease biology,” said Dr. Griffin.
A version of this article appeared on Medscape.com.
results of a phase 3 study showed.
“This trial demonstrates that an antiamyloid drug significantly slows the disease and provides meaningful benefit to patients, and we’re hoping that with approval, we will be able to make that drug available,” said Mark Mintun, MD, VP, pain and neurodegeneration research, Eli Lilly.
At a press briefing highlighting the new results, Maria Carrillo, PhD, chief science officer, Alzheimer’s Association, noted the “palpable excitement” surrounding this new study, which follows on the heels of other promising antiamyloid research. “This is the decade of Alzheimer’s disease, and it will get better from here,” she said.
The findings were presented at the Alzheimer’s Association International Conference and were published online in JAMA.
Primary, secondary endpoints met
The TRAILBLAZER-ALZ 2 study included 1,736 patients with mild cognitive impairment (MCI) or mild dementia for whom PET showed evidence of amyloid and tau pathology. The mean age of the participants was 73 years, and most of the participants were White.
Participants were randomly assigned to receive either placebo or donanemab, an investigational IgG1 monoclonal antibody directed against an insoluble, modified, N-terminal, truncated form of beta-amyloid. Donanemab was administered at a dose of 700 mg for the first three doses and 1,400 mg thereafter. The drug was administered intravenously every 4 weeks for up to 72 weeks.
Researchers stratified patients on the basis of the amount of tau, a biomarker for Alzheimer’s disease progression, into a low/medium tau group and a combined tau group (low/medium and high tau).
The primary endpoint was change from baseline to 76 weeks on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures cognition and activities of daily living.
In those with low/medium tau levels, the least squares mean (LSM) change in iADRS score was −6.02 (95% confidence interval, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25; 95% CI, 1.88 – 4.62; P < .001), representing a 35.1% slowing of disease progression.
In the combined (tau) population, LSM change in iADRS was −10.19 (95% CI, −11.22 to −9.16) in the donanemab group and −13.11 (95% CI, −14.10 to −12.13) in the placebo group (difference, 2.92; 95% CI, 1.51 – 4.33; P < .001), representing a 22.3% slowing of disease progression.
The study also met all secondary endpoints regarding measurements of cognitive and functional decline, including the Clinical Dementia Rating–Sum of Boxes (CDR-SB), which showed 36% slowing of decline (P < .0001) over 18 months.
The authors noted that the changes on these scales were clinically meaningful (considered to be > 20% slowing of clinical progression) for both the low/medium tau and combined populations.
Greater benefit with lower tau
However, patients with low/medium tau generally demonstrated effect size estimates that were larger than those of the overall population, which suggests there’s greater benefit when amyloid-lowering therapies are initiated at an earlier disease stage, the investigators noted.
Additional support for clinical relevance was a 38.6% risk reduction of disease progression, as measured on the CDR–Global Score.
In addition, participants who received the active drug benefited in terms of activities of daily living, as demonstrated by 40% less decline (P < .0001) on the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory.
Donanemab significantly reduced brain amyloid plaque: 80% (low/medium tau population) and 76% (combined population) of participants achieved amyloid clearance at 76 weeks. The intervention was also associated with a greater decrease in whole-brain volume.
The treatment effect continued to widen after patients were switched to placebo, as evidenced on PET scan at 6 or 12 months, said Dr. Mintun.
The effects of the drug were similar among men and women but were especially pronounced among younger participants, with a 48% slowing on iADRS and a 45% slowing on CDR-SB in those younger than 75 years.
Safety issues
However, the drug is not without some safety concerns. Amyloid-related imaging abnormalities (ARIAs) occurred in 36.8% of the treatment group versus 14.9% of the placebo group, and in 40.6% of patients who were homozygous for apo E4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group versus 12.5% in the placebo group.
Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug related among participants who developed serious ARIAs or brain bleeding and swelling.
An important study limitation was that it enrolled primarily White patients (91.5%), which may limit generalizability to other populations, and the age limit was 85 years, which some believe is an inadequate representation of older adults. In addition, the 18-month treatment window limits the long-term understanding of donanemab’s benefits and side effects.
Eli Lilly has filed a submission to the Food and Drug Administration. If approved, donanemab will be the third antiamyloid monoclonal antibody to receive this status, following aducanumab (Aduhelm) and lecanemab (Leqembi).
Strongest data yet
Commenting on the study findings, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said these new results are “very, very exciting” and represent “the strongest data to-date” for antiamyloid monoclonal antibodies in Alzheimer’s disease.
“A good percentage of individuals on the drug actually saw a complete clearance of amyloid, and some had to be taken off the drug, because if you’re on an antiamyloid drug and there’s no amyloid, what are you going for?”
He noted that the study had some unique aspects, including using tau-PET “to see whether or not the drug is more effective in subpopulations.”
Access to this and other antiamyloid therapies should be a priority, said Dr. Griffin. “We have to make sure people who have the potential to benefit from these treatments do.”
The Alzheimer’s Association is calling for Medicare beneficiaries who are living with the disease to receive the same coverage afforded to those with other diseases.
“The Centers for Medicare & Medicaid Services policy to block Medicare access to FDA-approved Alzheimer’s disease treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said in a press release.
Also important is tracking the longitudinal performance of these drugs outside of clinical trials, said Dr. Griffin. “Not everyone is going to be in that Goldilocks zone of being able to see a doctor whenever they want and have access to these PET and MRI tools and other things used in clinical trials.”
He noted that the Alzheimer’s Association is leading a network for diagnostics and therapeutics (ALZ-NET) that will track the performance of novel FDA-approved Alzheimer’s disease therapies “in the real world.”
While these are exciting findings for antiamyloid therapy, “we can’t take our foot off the gas, we need more therapies that target different aspects of the disease biology,” said Dr. Griffin.
A version of this article appeared on Medscape.com.
FROM AAIC 2023
U.S. states, counties with highest Alzheimer’s prevalence rates identified
Investigators at Rush University in Chicago found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore city, and Bronx County in New York were among the U.S. counties with the highest prevalence of the disease.
Such geographical variations may be caused by the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, said in an interview.
Dr. Rajan presented the research at the Alzheimer’s Association International Conference.
High-impact research
An estimated 6.7 million Americans are living with AD, a figure that’s expected to double by 2050. Estimating the prevalence of Alzheimer’s across states’ counties can provide a better understanding of region-specific disease burden and have policy implications for resource allocation, Dr. Rajan noted.
To determine the state- and county-specific prevalence of AD, the researchers applied AD data from the Chicago Health and Aging Project, a population-based study that’s about 60% African American, to county- and state-level data from the National Center for Health Statistics.
“We used estimates in our study in Chicago, which began in the 1990s and has approximately 10,800 people, and projected those estimates to county-level populations to see what the variations look like,” said Dr. Rajan.
Of 3,142 counties in 50 states, the East and Southeastern regions of the United States had the highest AD prevalence. For states, the highest rates were in Maryland (12.9%), New York (12.7%), Mississippi (12.5%), and Florida (12.5%).
California and Illinois were also among the top 10 states with the highest prevalence of Alzheimer’s.
California had the highest number of residents, with 719,000 (95% confidence interval, 665,000-774,400), followed by Florida with 579,000 (95% CI, 539,900 to 620,000), and Texas with 459,000 (95% CI, 422,700 to 496,000).
The three counties with the highest prevalence, all with 16.6%, were Miami-Dade County, Baltimore city, and Bronx County.
One county in the top 10 for AD prevalence was El Paso, Tex., which Dr. Rajan found “a bit surprising,” as Texas was not among the top four states with the highest prevalence.
In addition to older age, what’s likely driving elevated AD prevalence in these areas is the substantially larger proportion of minority populations who are at higher risk for AD, possibly due to health disparities, said Dr. Rajan.
Determining local-level estimates of AD should have “a very high impact” on public health programs aimed at AD prevention, detection, and treatment, he said. In addition, as more AD drugs are approved, there will likely be county-level and even state-level implications for Medicare coverage.
In addition, these new findings could help physicians treating or caring for minority populations “understand the landscape of what the disease looks like,” said Dr. Rajan.
A limitation of the study was that it was based on data from a single study, he noted.
The next step is to expand this research. Dr. Rajan and others are establishing the Regional and Ethnic Variations in Alzheimer’s and Cognitive Health Consortium, with the goal of gaining a better understanding of AD prevalence across six U.S. regions.
Optimal resource distribution
In a comment, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said the research provides useful information about AD prevalence at the local level.
“We need to understand how specific demographics and characteristics can help explain some of the high prevalence in certain areas.”
Compared with White Americans, Dr. Griffin noted that Black Americans are twice as likely to have AD, and older Hispanic Americans are 1.5 times as likely.
This new data will help pinpoint areas of high risk and high need so that funding, staffing, and other resources for those with AD and other dementias can be optimally distributed, he said.
“It gives us that kind of geographic specificity in terms of the prevalence so we can dig deeper and better allocate resources on a county level,” he added.
The Alzheimer’s Association “is fully committed to working with local agencies and being in the communities to assist them in their efforts to intervene in this disease.”
The study also highlights the need for more research to determine what factors other than age and race – such as potential environmental factors – might affect regional AD prevalence, he said.
The study received funding from the National Institutes of Health. Dr. Rajan and Dr. Griffin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators at Rush University in Chicago found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore city, and Bronx County in New York were among the U.S. counties with the highest prevalence of the disease.
Such geographical variations may be caused by the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, said in an interview.
Dr. Rajan presented the research at the Alzheimer’s Association International Conference.
High-impact research
An estimated 6.7 million Americans are living with AD, a figure that’s expected to double by 2050. Estimating the prevalence of Alzheimer’s across states’ counties can provide a better understanding of region-specific disease burden and have policy implications for resource allocation, Dr. Rajan noted.
To determine the state- and county-specific prevalence of AD, the researchers applied AD data from the Chicago Health and Aging Project, a population-based study that’s about 60% African American, to county- and state-level data from the National Center for Health Statistics.
“We used estimates in our study in Chicago, which began in the 1990s and has approximately 10,800 people, and projected those estimates to county-level populations to see what the variations look like,” said Dr. Rajan.
Of 3,142 counties in 50 states, the East and Southeastern regions of the United States had the highest AD prevalence. For states, the highest rates were in Maryland (12.9%), New York (12.7%), Mississippi (12.5%), and Florida (12.5%).
California and Illinois were also among the top 10 states with the highest prevalence of Alzheimer’s.
California had the highest number of residents, with 719,000 (95% confidence interval, 665,000-774,400), followed by Florida with 579,000 (95% CI, 539,900 to 620,000), and Texas with 459,000 (95% CI, 422,700 to 496,000).
The three counties with the highest prevalence, all with 16.6%, were Miami-Dade County, Baltimore city, and Bronx County.
One county in the top 10 for AD prevalence was El Paso, Tex., which Dr. Rajan found “a bit surprising,” as Texas was not among the top four states with the highest prevalence.
In addition to older age, what’s likely driving elevated AD prevalence in these areas is the substantially larger proportion of minority populations who are at higher risk for AD, possibly due to health disparities, said Dr. Rajan.
Determining local-level estimates of AD should have “a very high impact” on public health programs aimed at AD prevention, detection, and treatment, he said. In addition, as more AD drugs are approved, there will likely be county-level and even state-level implications for Medicare coverage.
In addition, these new findings could help physicians treating or caring for minority populations “understand the landscape of what the disease looks like,” said Dr. Rajan.
A limitation of the study was that it was based on data from a single study, he noted.
The next step is to expand this research. Dr. Rajan and others are establishing the Regional and Ethnic Variations in Alzheimer’s and Cognitive Health Consortium, with the goal of gaining a better understanding of AD prevalence across six U.S. regions.
Optimal resource distribution
In a comment, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said the research provides useful information about AD prevalence at the local level.
“We need to understand how specific demographics and characteristics can help explain some of the high prevalence in certain areas.”
Compared with White Americans, Dr. Griffin noted that Black Americans are twice as likely to have AD, and older Hispanic Americans are 1.5 times as likely.
This new data will help pinpoint areas of high risk and high need so that funding, staffing, and other resources for those with AD and other dementias can be optimally distributed, he said.
“It gives us that kind of geographic specificity in terms of the prevalence so we can dig deeper and better allocate resources on a county level,” he added.
The Alzheimer’s Association “is fully committed to working with local agencies and being in the communities to assist them in their efforts to intervene in this disease.”
The study also highlights the need for more research to determine what factors other than age and race – such as potential environmental factors – might affect regional AD prevalence, he said.
The study received funding from the National Institutes of Health. Dr. Rajan and Dr. Griffin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators at Rush University in Chicago found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore city, and Bronx County in New York were among the U.S. counties with the highest prevalence of the disease.
Such geographical variations may be caused by the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, said in an interview.
Dr. Rajan presented the research at the Alzheimer’s Association International Conference.
High-impact research
An estimated 6.7 million Americans are living with AD, a figure that’s expected to double by 2050. Estimating the prevalence of Alzheimer’s across states’ counties can provide a better understanding of region-specific disease burden and have policy implications for resource allocation, Dr. Rajan noted.
To determine the state- and county-specific prevalence of AD, the researchers applied AD data from the Chicago Health and Aging Project, a population-based study that’s about 60% African American, to county- and state-level data from the National Center for Health Statistics.
“We used estimates in our study in Chicago, which began in the 1990s and has approximately 10,800 people, and projected those estimates to county-level populations to see what the variations look like,” said Dr. Rajan.
Of 3,142 counties in 50 states, the East and Southeastern regions of the United States had the highest AD prevalence. For states, the highest rates were in Maryland (12.9%), New York (12.7%), Mississippi (12.5%), and Florida (12.5%).
California and Illinois were also among the top 10 states with the highest prevalence of Alzheimer’s.
California had the highest number of residents, with 719,000 (95% confidence interval, 665,000-774,400), followed by Florida with 579,000 (95% CI, 539,900 to 620,000), and Texas with 459,000 (95% CI, 422,700 to 496,000).
The three counties with the highest prevalence, all with 16.6%, were Miami-Dade County, Baltimore city, and Bronx County.
One county in the top 10 for AD prevalence was El Paso, Tex., which Dr. Rajan found “a bit surprising,” as Texas was not among the top four states with the highest prevalence.
In addition to older age, what’s likely driving elevated AD prevalence in these areas is the substantially larger proportion of minority populations who are at higher risk for AD, possibly due to health disparities, said Dr. Rajan.
Determining local-level estimates of AD should have “a very high impact” on public health programs aimed at AD prevention, detection, and treatment, he said. In addition, as more AD drugs are approved, there will likely be county-level and even state-level implications for Medicare coverage.
In addition, these new findings could help physicians treating or caring for minority populations “understand the landscape of what the disease looks like,” said Dr. Rajan.
A limitation of the study was that it was based on data from a single study, he noted.
The next step is to expand this research. Dr. Rajan and others are establishing the Regional and Ethnic Variations in Alzheimer’s and Cognitive Health Consortium, with the goal of gaining a better understanding of AD prevalence across six U.S. regions.
Optimal resource distribution
In a comment, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said the research provides useful information about AD prevalence at the local level.
“We need to understand how specific demographics and characteristics can help explain some of the high prevalence in certain areas.”
Compared with White Americans, Dr. Griffin noted that Black Americans are twice as likely to have AD, and older Hispanic Americans are 1.5 times as likely.
This new data will help pinpoint areas of high risk and high need so that funding, staffing, and other resources for those with AD and other dementias can be optimally distributed, he said.
“It gives us that kind of geographic specificity in terms of the prevalence so we can dig deeper and better allocate resources on a county level,” he added.
The Alzheimer’s Association “is fully committed to working with local agencies and being in the communities to assist them in their efforts to intervene in this disease.”
The study also highlights the need for more research to determine what factors other than age and race – such as potential environmental factors – might affect regional AD prevalence, he said.
The study received funding from the National Institutes of Health. Dr. Rajan and Dr. Griffin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAIC 2023
Group mindfulness programs tied to reduced stress
TOPLINE:
METHODOLOGY:
Evidence suggests the effect of MBPs, which combine elements of meditation, body awareness, and modern psychology, vary as a function of individual, participant-level differences.
After a literature search, researchers selected 13 trials of in-person, teacher-led group-based MBPs that had a passive control group such as no intervention, a waitlist, or treatment-as-usual, in a total of 2,371 community adults (median age, 34 years; 71% female) who reported psychological distress levels.
Researchers conducted a systematic review and individual-participant data (IPD) meta-analysis, which allowed them to explore how intervention effects vary as a function of individual differences.
The primary outcome was self-reported psychological distress, which includes anxiety and depression, measured between 1 and 6 months after program completion using psychometrically valid questionnaires.
TAKEAWAY:
The trials were conducted across eight countries, had a cohort size ranging from 44 to 670 participants, and represented diverse populations including university students, law enforcement officers, and health care professionals.
Compared with passive control groups, MBPs reduced distress (standardized mean difference, –0.32; 95% CI, –0.41 to –0.24; P < .001; 95% prediction interval, –0.41 to –0.24), with no evidence of statistical heterogeneity.
Results were similar for psychological distress measured less than a month after completing the program and beyond 6 months.
There was no clear indication that baseline distress, gender, age, education level, or dispositional mindfulness (a construct reflecting an individual’s focus and quality of attention) modified the effect of MBPs on the primary outcome.
IN PRACTICE:
The results “encourage implementation of teacher-led MBPs for adults in nonclinical settings,” said the authors, noting that while it was difficult to ascertain clinical significance of the results because different instruments were combined, the effect size was within the range of being minimally important.
SOURCE:
The study was conducted by Julieta Galante, PhD, department of psychiatry, University of Cambridge (England), and colleagues. It was published online July 10 in Nature Mental Health.
LIMITATIONS:
The findings are limited to voluntary MBPs and don’t extend to self-guided MBPs such as those delivered through smartphone applications. Individuals with less than 12 years of education, men, and those over age 70 years were underrepresented in the dataset. The analysis was unable to consider certain effect modifiers such as participant expectations and beliefs, and personality and cognitive factors. There is risk of bias regarding the lack of blinding and self-reported outcomes, and psychological distress is an inherently subjective outcome.
DISCLOSURES:
The study received funding from the National Institute for Health Research. Dr. Galante has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
Evidence suggests the effect of MBPs, which combine elements of meditation, body awareness, and modern psychology, vary as a function of individual, participant-level differences.
After a literature search, researchers selected 13 trials of in-person, teacher-led group-based MBPs that had a passive control group such as no intervention, a waitlist, or treatment-as-usual, in a total of 2,371 community adults (median age, 34 years; 71% female) who reported psychological distress levels.
Researchers conducted a systematic review and individual-participant data (IPD) meta-analysis, which allowed them to explore how intervention effects vary as a function of individual differences.
The primary outcome was self-reported psychological distress, which includes anxiety and depression, measured between 1 and 6 months after program completion using psychometrically valid questionnaires.
TAKEAWAY:
The trials were conducted across eight countries, had a cohort size ranging from 44 to 670 participants, and represented diverse populations including university students, law enforcement officers, and health care professionals.
Compared with passive control groups, MBPs reduced distress (standardized mean difference, –0.32; 95% CI, –0.41 to –0.24; P < .001; 95% prediction interval, –0.41 to –0.24), with no evidence of statistical heterogeneity.
Results were similar for psychological distress measured less than a month after completing the program and beyond 6 months.
There was no clear indication that baseline distress, gender, age, education level, or dispositional mindfulness (a construct reflecting an individual’s focus and quality of attention) modified the effect of MBPs on the primary outcome.
IN PRACTICE:
The results “encourage implementation of teacher-led MBPs for adults in nonclinical settings,” said the authors, noting that while it was difficult to ascertain clinical significance of the results because different instruments were combined, the effect size was within the range of being minimally important.
SOURCE:
The study was conducted by Julieta Galante, PhD, department of psychiatry, University of Cambridge (England), and colleagues. It was published online July 10 in Nature Mental Health.
LIMITATIONS:
The findings are limited to voluntary MBPs and don’t extend to self-guided MBPs such as those delivered through smartphone applications. Individuals with less than 12 years of education, men, and those over age 70 years were underrepresented in the dataset. The analysis was unable to consider certain effect modifiers such as participant expectations and beliefs, and personality and cognitive factors. There is risk of bias regarding the lack of blinding and self-reported outcomes, and psychological distress is an inherently subjective outcome.
DISCLOSURES:
The study received funding from the National Institute for Health Research. Dr. Galante has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
Evidence suggests the effect of MBPs, which combine elements of meditation, body awareness, and modern psychology, vary as a function of individual, participant-level differences.
After a literature search, researchers selected 13 trials of in-person, teacher-led group-based MBPs that had a passive control group such as no intervention, a waitlist, or treatment-as-usual, in a total of 2,371 community adults (median age, 34 years; 71% female) who reported psychological distress levels.
Researchers conducted a systematic review and individual-participant data (IPD) meta-analysis, which allowed them to explore how intervention effects vary as a function of individual differences.
The primary outcome was self-reported psychological distress, which includes anxiety and depression, measured between 1 and 6 months after program completion using psychometrically valid questionnaires.
TAKEAWAY:
The trials were conducted across eight countries, had a cohort size ranging from 44 to 670 participants, and represented diverse populations including university students, law enforcement officers, and health care professionals.
Compared with passive control groups, MBPs reduced distress (standardized mean difference, –0.32; 95% CI, –0.41 to –0.24; P < .001; 95% prediction interval, –0.41 to –0.24), with no evidence of statistical heterogeneity.
Results were similar for psychological distress measured less than a month after completing the program and beyond 6 months.
There was no clear indication that baseline distress, gender, age, education level, or dispositional mindfulness (a construct reflecting an individual’s focus and quality of attention) modified the effect of MBPs on the primary outcome.
IN PRACTICE:
The results “encourage implementation of teacher-led MBPs for adults in nonclinical settings,” said the authors, noting that while it was difficult to ascertain clinical significance of the results because different instruments were combined, the effect size was within the range of being minimally important.
SOURCE:
The study was conducted by Julieta Galante, PhD, department of psychiatry, University of Cambridge (England), and colleagues. It was published online July 10 in Nature Mental Health.
LIMITATIONS:
The findings are limited to voluntary MBPs and don’t extend to self-guided MBPs such as those delivered through smartphone applications. Individuals with less than 12 years of education, men, and those over age 70 years were underrepresented in the dataset. The analysis was unable to consider certain effect modifiers such as participant expectations and beliefs, and personality and cognitive factors. There is risk of bias regarding the lack of blinding and self-reported outcomes, and psychological distress is an inherently subjective outcome.
DISCLOSURES:
The study received funding from the National Institute for Health Research. Dr. Galante has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Men and women react differently to acute stress
Topline
Methodology
- The study included 80 healthy participants, mean age 24 years.
- Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
- Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
- Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
- Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.
Takeaway
- In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
- In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
- Direct stress effects on ER were smaller than expected.
In practice
The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.
Source
The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.
Limitations
The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.
Disclosures
The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.
A version of this article originally appeared on Medscape.com.
Topline
Methodology
- The study included 80 healthy participants, mean age 24 years.
- Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
- Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
- Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
- Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.
Takeaway
- In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
- In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
- Direct stress effects on ER were smaller than expected.
In practice
The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.
Source
The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.
Limitations
The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.
Disclosures
The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.
A version of this article originally appeared on Medscape.com.
Topline
Methodology
- The study included 80 healthy participants, mean age 24 years.
- Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
- Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
- Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
- Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.
Takeaway
- In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
- In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
- Direct stress effects on ER were smaller than expected.
In practice
The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.
Source
The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.
Limitations
The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.
Disclosures
The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.
A version of this article originally appeared on Medscape.com.