User login
Positive top-line phase 3 data for lecanemab in early Alzheimer’s
compared with placebo and decreased amyloid levels in the brain of adults enrolled in a phase 3 trial.
The Clarity AD trial included 1,795 adults with early AD and confirmed amyloid pathology in the brain. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
Treatment with lecanemab met the primary endpoint, reducing clinical decline on the global cognitive and functional scale, the Clinical Dementia Rating–Sum of Boxes (CDR-SB), at 18 months by 27%, compared with placebo, with a treatment difference in the score change of –0.45 (P = .00005), the companies reported.
Starting as early as 6 months, across all time points, treatment with lecanemab yielded highly statistically significant changes in CDR-SB from baseline, compared with placebo (all P < .01).
The study also met all key secondary endpoints with highly statistically significant results, compared with placebo (P < .01).
Key secondary endpoints, in comparison with placebo, were change from baseline at 18 months in amyloid levels in the brain measured by amyloid PET, the AD Assessment Scale–cognitive subscale14 (ADAS-cog14), the AD Composite Score (ADCOMS), and the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
Imaging abnormalities within expectations
Overall, rates of amyloid-related imaging abnormalities (ARIA) related to lecanemab were “within expectations,” the companies said.
The incidence of ARIA related to edema (ARIA-E) was 12.5% in the lecanemab group and 1.7% in the placebo group.
The incidence of symptomatic ARIA-E was 2.8% and 0.0%, respectively, and the rate of cerebral hemorrhage (ARIA-H) was 17.0% and 8.7%. The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group.
Full results of the Clarity AD trial will be presented in November at the Clinical Trials on Alzheimer’s Congress.
Incremental benefit
Responding to the findings, the Alzheimer’s Association said in a statement that it “enthusiastically welcomes” the positive findings. It noted that these are “the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date.
“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions,” the Alzheimer’s Association added.
Also weighing in, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a release that “the combination of the biomarker change – reduced amyloid – plus slowing of cognitive decline in this study is encouraging news for the 57 million patients around the world living with Alzheimer’s.
“However, amyloid-clearing drugs will provide an incremental benefit at best, and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging,” Dr. Fillit cautioned.
“We are optimistic about the future as many of these drugs are in development, with 75% of drugs in the pipeline now targeting nonamyloid pathways of neurodegeneration,” he added.
In July 2022, the Food and Drug Administration accepted Eisai’s biologics license application for lecanemab under the accelerated approval pathway and granted priority review. Lecanemab has a prescription Drugs User Fee Act action date of Jan. 6, 2023.
A version of this article first appeared on Medscape.com.
compared with placebo and decreased amyloid levels in the brain of adults enrolled in a phase 3 trial.
The Clarity AD trial included 1,795 adults with early AD and confirmed amyloid pathology in the brain. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
Treatment with lecanemab met the primary endpoint, reducing clinical decline on the global cognitive and functional scale, the Clinical Dementia Rating–Sum of Boxes (CDR-SB), at 18 months by 27%, compared with placebo, with a treatment difference in the score change of –0.45 (P = .00005), the companies reported.
Starting as early as 6 months, across all time points, treatment with lecanemab yielded highly statistically significant changes in CDR-SB from baseline, compared with placebo (all P < .01).
The study also met all key secondary endpoints with highly statistically significant results, compared with placebo (P < .01).
Key secondary endpoints, in comparison with placebo, were change from baseline at 18 months in amyloid levels in the brain measured by amyloid PET, the AD Assessment Scale–cognitive subscale14 (ADAS-cog14), the AD Composite Score (ADCOMS), and the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
Imaging abnormalities within expectations
Overall, rates of amyloid-related imaging abnormalities (ARIA) related to lecanemab were “within expectations,” the companies said.
The incidence of ARIA related to edema (ARIA-E) was 12.5% in the lecanemab group and 1.7% in the placebo group.
The incidence of symptomatic ARIA-E was 2.8% and 0.0%, respectively, and the rate of cerebral hemorrhage (ARIA-H) was 17.0% and 8.7%. The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group.
Full results of the Clarity AD trial will be presented in November at the Clinical Trials on Alzheimer’s Congress.
Incremental benefit
Responding to the findings, the Alzheimer’s Association said in a statement that it “enthusiastically welcomes” the positive findings. It noted that these are “the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date.
“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions,” the Alzheimer’s Association added.
Also weighing in, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a release that “the combination of the biomarker change – reduced amyloid – plus slowing of cognitive decline in this study is encouraging news for the 57 million patients around the world living with Alzheimer’s.
“However, amyloid-clearing drugs will provide an incremental benefit at best, and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging,” Dr. Fillit cautioned.
“We are optimistic about the future as many of these drugs are in development, with 75% of drugs in the pipeline now targeting nonamyloid pathways of neurodegeneration,” he added.
In July 2022, the Food and Drug Administration accepted Eisai’s biologics license application for lecanemab under the accelerated approval pathway and granted priority review. Lecanemab has a prescription Drugs User Fee Act action date of Jan. 6, 2023.
A version of this article first appeared on Medscape.com.
compared with placebo and decreased amyloid levels in the brain of adults enrolled in a phase 3 trial.
The Clarity AD trial included 1,795 adults with early AD and confirmed amyloid pathology in the brain. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
Treatment with lecanemab met the primary endpoint, reducing clinical decline on the global cognitive and functional scale, the Clinical Dementia Rating–Sum of Boxes (CDR-SB), at 18 months by 27%, compared with placebo, with a treatment difference in the score change of –0.45 (P = .00005), the companies reported.
Starting as early as 6 months, across all time points, treatment with lecanemab yielded highly statistically significant changes in CDR-SB from baseline, compared with placebo (all P < .01).
The study also met all key secondary endpoints with highly statistically significant results, compared with placebo (P < .01).
Key secondary endpoints, in comparison with placebo, were change from baseline at 18 months in amyloid levels in the brain measured by amyloid PET, the AD Assessment Scale–cognitive subscale14 (ADAS-cog14), the AD Composite Score (ADCOMS), and the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
Imaging abnormalities within expectations
Overall, rates of amyloid-related imaging abnormalities (ARIA) related to lecanemab were “within expectations,” the companies said.
The incidence of ARIA related to edema (ARIA-E) was 12.5% in the lecanemab group and 1.7% in the placebo group.
The incidence of symptomatic ARIA-E was 2.8% and 0.0%, respectively, and the rate of cerebral hemorrhage (ARIA-H) was 17.0% and 8.7%. The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group.
Full results of the Clarity AD trial will be presented in November at the Clinical Trials on Alzheimer’s Congress.
Incremental benefit
Responding to the findings, the Alzheimer’s Association said in a statement that it “enthusiastically welcomes” the positive findings. It noted that these are “the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date.
“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions,” the Alzheimer’s Association added.
Also weighing in, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a release that “the combination of the biomarker change – reduced amyloid – plus slowing of cognitive decline in this study is encouraging news for the 57 million patients around the world living with Alzheimer’s.
“However, amyloid-clearing drugs will provide an incremental benefit at best, and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging,” Dr. Fillit cautioned.
“We are optimistic about the future as many of these drugs are in development, with 75% of drugs in the pipeline now targeting nonamyloid pathways of neurodegeneration,” he added.
In July 2022, the Food and Drug Administration accepted Eisai’s biologics license application for lecanemab under the accelerated approval pathway and granted priority review. Lecanemab has a prescription Drugs User Fee Act action date of Jan. 6, 2023.
A version of this article first appeared on Medscape.com.
Coffee linked to reduced cardiovascular disease and mortality risk
Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.
Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.
“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.
“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.
“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.
“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.
The study was published online in the European Journal of Preventive Cardiology.
Clear cardiovascular benefits
A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.
During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.
Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).
Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.
Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).
Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.
Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).
“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.
Plausible mechanisms
There are a number of proposed mechanisms to explain the benefits of coffee on CVD.
“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.
Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.
“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.
“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.
“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
Direction of relationship unclear
Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”
However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.
Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.
“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.
The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.
Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.
“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.
“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.
“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.
“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.
The study was published online in the European Journal of Preventive Cardiology.
Clear cardiovascular benefits
A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.
During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.
Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).
Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.
Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).
Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.
Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).
“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.
Plausible mechanisms
There are a number of proposed mechanisms to explain the benefits of coffee on CVD.
“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.
Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.
“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.
“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.
“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
Direction of relationship unclear
Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”
However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.
Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.
“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.
The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.
Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.
“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.
“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.
“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.
“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.
The study was published online in the European Journal of Preventive Cardiology.
Clear cardiovascular benefits
A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.
During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.
Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).
Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.
Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).
Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.
Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).
“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.
Plausible mechanisms
There are a number of proposed mechanisms to explain the benefits of coffee on CVD.
“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.
Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.
“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.
“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.
“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
Direction of relationship unclear
Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”
However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.
Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.
“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.
The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY
Not just a bad dream: Nightmares may predict dementia
Results from a large cohort study showed that healthy middle-aged adults who had bad dreams at least once a week were four times more likely to experience cognitive decline over the following decade, and older adults were twice as likely to be diagnosed with dementia, compared with peers who never had bad dreams.
Frequent nightmares may “identify people who are at high risk of developing dementia in the future, several years or decades before the characteristic memory and thinking problems emerge,” study investigator Abidemi Otaiku, BMBS, University of Birmingham, England, said in an interview.
“This would be the optimum time for doctors to intervene to try and slow down or prevent dementia from developing,” Dr. Otaiku said.
The findings were published online in The Lancet journal eClinicalMedicine).
Distressing dreams
Distressing dreams have been previously associated with faster cognitive decline and increased dementia risk in patients with Parkinson’s disease (PD), but whether the same holds for individuals from the general population without PD is unknown.
To investigate, Dr. Otaiku examined data from three community-based cohorts in the United States. This included 605 middle-aged adults (aged 35-64 years) who were followed for up to 13 years and 2,600 adults aged 79 and older who were followed for up to 7 years. All were considered cognitively normal at baseline.
The prevalence of frequent distressing dreams, defined as occurring “once a week or more,” was higher in the older cohort compared with the middle-aged cohort (6.9% vs. 6.0%, respectively).
This is in line with other research that showed distressing dreams remain relatively stable throughout early adulthood and then progressively increase in prevalence from middle to older adulthood.
After adjustment for all covariates, a higher frequency of distressing dreams was linearly and statistically significantly associated with a higher risk for cognitive decline in middle-aged adults (P = .016) and a higher risk for dementia in older adults (P = .001).
In the fully adjusted model, compared with middle-aged adults who never had bad dreams, those who reported having one or more bad dreams weekly had a fourfold risk for cognitive decline (adjusted odds ratio [aOR], 3.99; 95% confidence interval [CI], 1.07-14.85).
Older adults who had one or more bad dreams weekly had a greater than twofold increased risk for developing dementia (aOR, 2.21; 95% CI, 1.35-3.62).
Early days
In sex-stratified analyses, distressing dreams were strongly and statistically significantly associated with cognitive decline and dementia in men, but were only weakly and nonsignificantly associated with cognitive decline and dementia in women.
Dr. Otaiku said he suspects some individuals in the preclinical phase of dementia have “subtle neurodegeneration occurring over time in the right frontal lobe: the area of the brain that helps to downregulate negative emotions whilst we are awake, and also whilst we are dreaming.”
This could result in “depression and anxiety in the day, and nightmares and bad dreams during the night,” he said.
It is possible that treatment for frequent nightmares may help to slow cognitive decline and delay or prevent dementia, Dr. Otaiku added.
He noted that prazosin is used to treat nightmares and has been shown to prevent memory decline and reduce amyloid B generation in preclinical studies of Alzheimer’s disease.
“This is an exciting prospect [but] it is still early days and we will need research to see whether treating nightmares might help to reduce dementia risk down the line,” Dr. Otaiku said.
Credible research
In an interview regarding these findings, Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said: “This is credible research consistent with the idea that sleep disturbances may be a risk factor or warning sign of cognitive decline.”
She added that “what’s novel here” is the researchers examined distressing dreams – not more physical sleep disturbances and disorders such as insomnia or apnea.
“However, nightmares can disturb sleep in the same way these disorders do by waking people up in the middle of the night,” said Dr. Carrillo, who was not involved with the study.
“Previous research has pointed to nightmares being indicative of potential changes in the brain that can precede other dementias like Parkinson’s disease. More research is needed to tease out what exactly is happening in the brain during nightmares that may be contributing to this increased risk,” she said.
Dr. Carrillo noted that “getting good sleep” is important for overall health, which includes brain health.
“The good news is there are treatments – both drug and nondrug – that can help address sleep disturbances,” she added.
This study received no external funding. Dr. Otaiku and Dr. Carrillo have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a large cohort study showed that healthy middle-aged adults who had bad dreams at least once a week were four times more likely to experience cognitive decline over the following decade, and older adults were twice as likely to be diagnosed with dementia, compared with peers who never had bad dreams.
Frequent nightmares may “identify people who are at high risk of developing dementia in the future, several years or decades before the characteristic memory and thinking problems emerge,” study investigator Abidemi Otaiku, BMBS, University of Birmingham, England, said in an interview.
“This would be the optimum time for doctors to intervene to try and slow down or prevent dementia from developing,” Dr. Otaiku said.
The findings were published online in The Lancet journal eClinicalMedicine).
Distressing dreams
Distressing dreams have been previously associated with faster cognitive decline and increased dementia risk in patients with Parkinson’s disease (PD), but whether the same holds for individuals from the general population without PD is unknown.
To investigate, Dr. Otaiku examined data from three community-based cohorts in the United States. This included 605 middle-aged adults (aged 35-64 years) who were followed for up to 13 years and 2,600 adults aged 79 and older who were followed for up to 7 years. All were considered cognitively normal at baseline.
The prevalence of frequent distressing dreams, defined as occurring “once a week or more,” was higher in the older cohort compared with the middle-aged cohort (6.9% vs. 6.0%, respectively).
This is in line with other research that showed distressing dreams remain relatively stable throughout early adulthood and then progressively increase in prevalence from middle to older adulthood.
After adjustment for all covariates, a higher frequency of distressing dreams was linearly and statistically significantly associated with a higher risk for cognitive decline in middle-aged adults (P = .016) and a higher risk for dementia in older adults (P = .001).
In the fully adjusted model, compared with middle-aged adults who never had bad dreams, those who reported having one or more bad dreams weekly had a fourfold risk for cognitive decline (adjusted odds ratio [aOR], 3.99; 95% confidence interval [CI], 1.07-14.85).
Older adults who had one or more bad dreams weekly had a greater than twofold increased risk for developing dementia (aOR, 2.21; 95% CI, 1.35-3.62).
Early days
In sex-stratified analyses, distressing dreams were strongly and statistically significantly associated with cognitive decline and dementia in men, but were only weakly and nonsignificantly associated with cognitive decline and dementia in women.
Dr. Otaiku said he suspects some individuals in the preclinical phase of dementia have “subtle neurodegeneration occurring over time in the right frontal lobe: the area of the brain that helps to downregulate negative emotions whilst we are awake, and also whilst we are dreaming.”
This could result in “depression and anxiety in the day, and nightmares and bad dreams during the night,” he said.
It is possible that treatment for frequent nightmares may help to slow cognitive decline and delay or prevent dementia, Dr. Otaiku added.
He noted that prazosin is used to treat nightmares and has been shown to prevent memory decline and reduce amyloid B generation in preclinical studies of Alzheimer’s disease.
“This is an exciting prospect [but] it is still early days and we will need research to see whether treating nightmares might help to reduce dementia risk down the line,” Dr. Otaiku said.
Credible research
In an interview regarding these findings, Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said: “This is credible research consistent with the idea that sleep disturbances may be a risk factor or warning sign of cognitive decline.”
She added that “what’s novel here” is the researchers examined distressing dreams – not more physical sleep disturbances and disorders such as insomnia or apnea.
“However, nightmares can disturb sleep in the same way these disorders do by waking people up in the middle of the night,” said Dr. Carrillo, who was not involved with the study.
“Previous research has pointed to nightmares being indicative of potential changes in the brain that can precede other dementias like Parkinson’s disease. More research is needed to tease out what exactly is happening in the brain during nightmares that may be contributing to this increased risk,” she said.
Dr. Carrillo noted that “getting good sleep” is important for overall health, which includes brain health.
“The good news is there are treatments – both drug and nondrug – that can help address sleep disturbances,” she added.
This study received no external funding. Dr. Otaiku and Dr. Carrillo have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a large cohort study showed that healthy middle-aged adults who had bad dreams at least once a week were four times more likely to experience cognitive decline over the following decade, and older adults were twice as likely to be diagnosed with dementia, compared with peers who never had bad dreams.
Frequent nightmares may “identify people who are at high risk of developing dementia in the future, several years or decades before the characteristic memory and thinking problems emerge,” study investigator Abidemi Otaiku, BMBS, University of Birmingham, England, said in an interview.
“This would be the optimum time for doctors to intervene to try and slow down or prevent dementia from developing,” Dr. Otaiku said.
The findings were published online in The Lancet journal eClinicalMedicine).
Distressing dreams
Distressing dreams have been previously associated with faster cognitive decline and increased dementia risk in patients with Parkinson’s disease (PD), but whether the same holds for individuals from the general population without PD is unknown.
To investigate, Dr. Otaiku examined data from three community-based cohorts in the United States. This included 605 middle-aged adults (aged 35-64 years) who were followed for up to 13 years and 2,600 adults aged 79 and older who were followed for up to 7 years. All were considered cognitively normal at baseline.
The prevalence of frequent distressing dreams, defined as occurring “once a week or more,” was higher in the older cohort compared with the middle-aged cohort (6.9% vs. 6.0%, respectively).
This is in line with other research that showed distressing dreams remain relatively stable throughout early adulthood and then progressively increase in prevalence from middle to older adulthood.
After adjustment for all covariates, a higher frequency of distressing dreams was linearly and statistically significantly associated with a higher risk for cognitive decline in middle-aged adults (P = .016) and a higher risk for dementia in older adults (P = .001).
In the fully adjusted model, compared with middle-aged adults who never had bad dreams, those who reported having one or more bad dreams weekly had a fourfold risk for cognitive decline (adjusted odds ratio [aOR], 3.99; 95% confidence interval [CI], 1.07-14.85).
Older adults who had one or more bad dreams weekly had a greater than twofold increased risk for developing dementia (aOR, 2.21; 95% CI, 1.35-3.62).
Early days
In sex-stratified analyses, distressing dreams were strongly and statistically significantly associated with cognitive decline and dementia in men, but were only weakly and nonsignificantly associated with cognitive decline and dementia in women.
Dr. Otaiku said he suspects some individuals in the preclinical phase of dementia have “subtle neurodegeneration occurring over time in the right frontal lobe: the area of the brain that helps to downregulate negative emotions whilst we are awake, and also whilst we are dreaming.”
This could result in “depression and anxiety in the day, and nightmares and bad dreams during the night,” he said.
It is possible that treatment for frequent nightmares may help to slow cognitive decline and delay or prevent dementia, Dr. Otaiku added.
He noted that prazosin is used to treat nightmares and has been shown to prevent memory decline and reduce amyloid B generation in preclinical studies of Alzheimer’s disease.
“This is an exciting prospect [but] it is still early days and we will need research to see whether treating nightmares might help to reduce dementia risk down the line,” Dr. Otaiku said.
Credible research
In an interview regarding these findings, Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said: “This is credible research consistent with the idea that sleep disturbances may be a risk factor or warning sign of cognitive decline.”
She added that “what’s novel here” is the researchers examined distressing dreams – not more physical sleep disturbances and disorders such as insomnia or apnea.
“However, nightmares can disturb sleep in the same way these disorders do by waking people up in the middle of the night,” said Dr. Carrillo, who was not involved with the study.
“Previous research has pointed to nightmares being indicative of potential changes in the brain that can precede other dementias like Parkinson’s disease. More research is needed to tease out what exactly is happening in the brain during nightmares that may be contributing to this increased risk,” she said.
Dr. Carrillo noted that “getting good sleep” is important for overall health, which includes brain health.
“The good news is there are treatments – both drug and nondrug – that can help address sleep disturbances,” she added.
This study received no external funding. Dr. Otaiku and Dr. Carrillo have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ECLINICALMEDICINE
Uncontrolled BP linked to one-third of ED visits for CVD
A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.
In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.
Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.
The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.
The study was published online in the Journal of the American Heart Association.
Nationwide sample
The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.
In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.
In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).
In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).
On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.
“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”
He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
Sex differences in outcomes
The study found that outcomes from the emergency CVD visits were slightly different for men and women.
Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.
In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.
Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found.
“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.
The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.
Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.
“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization.
The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.
In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.
Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.
The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.
The study was published online in the Journal of the American Heart Association.
Nationwide sample
The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.
In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.
In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).
In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).
On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.
“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”
He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
Sex differences in outcomes
The study found that outcomes from the emergency CVD visits were slightly different for men and women.
Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.
In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.
Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found.
“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.
The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.
Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.
“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization.
The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.
In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.
Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.
The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.
The study was published online in the Journal of the American Heart Association.
Nationwide sample
The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.
In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.
In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).
In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).
On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.
“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”
He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
Sex differences in outcomes
The study found that outcomes from the emergency CVD visits were slightly different for men and women.
Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.
In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.
Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found.
“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.
The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.
Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.
“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization.
The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Experts issue health warning about giving melatonin to children
The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.
“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
Spike in poisoning calls
Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.
With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.
Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.
More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.
The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.
Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.
Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.
In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.
“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.
“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
Keep out of reach
The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.
Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.
If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.
“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.
A version of this article first appeared on Medscape.com.
The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.
“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
Spike in poisoning calls
Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.
With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.
Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.
More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.
The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.
Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.
Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.
In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.
“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.
“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
Keep out of reach
The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.
Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.
If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.
“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.
A version of this article first appeared on Medscape.com.
The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.
“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
Spike in poisoning calls
Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.
With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.
Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.
More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.
The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.
Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.
Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.
In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.
“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.
“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
Keep out of reach
The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.
Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.
If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.
“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.
A version of this article first appeared on Medscape.com.
Minorities hit especially hard by overdose deaths during COVID
The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.
The study was published online in JAMA Network Open.
‘Urgent need’ for education
From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.
Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.
To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.
Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.
For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.
The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).
Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).
Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).
Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).
The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.
Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.
Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.
This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.
The study was published online in JAMA Network Open.
‘Urgent need’ for education
From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.
Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.
To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.
Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.
For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.
The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).
Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).
Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).
Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).
The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.
Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.
Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.
This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.
The study was published online in JAMA Network Open.
‘Urgent need’ for education
From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.
Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.
To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.
Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.
For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.
The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).
Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).
Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).
Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).
The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.
Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.
Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.
This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
‘Concerning’ rate of benzo/Z-drug use in IBD
Patients with inflammatory bowel disease (IBD) are 70% more likely to use benzodiazepines and “Z-drugs” than are the general population, a large study from Canada suggests.
Mood/anxiety disorders and sleep disorders are common in patients with IBD, but few studies have looked at use of benzodiazepines and Z-drugs (such as zolpidem, zaleplon, and eszopiclone) in this patient population.
The results are “concerning, and especially as the IBD population ages, these drugs are associated with health risks, including something as simple as falls,” first author Charles Bernstein, MD, of the IBD clinical and research centre, University of Manitoba, Winnipeg, told this news organization.
“Clinicians need to find better strategies to deal with anxiety disorders and sleep disorders in the IBD population,” Dr. Bernstein said.
The study was published online in the American Journal of Gastroenterology.
High burden of use
Using administrative data from Manitoba, Dr. Bernstein and colleagues identified 5,741 patients with IBD (2,381 with Crohn’s disease and 3,360 with ulcerative colitis) and matched them (1:5) to 28,661 population controls without IBD.
Over a 20-year period (1997-2017), there was a “high burden” of benzodiazepine and Z-drug use in the IBD population. In 2017, roughly 20% of Manitobans with IBD were using benzodiazepines, and 20% were using Z-drugs, the study team reports.
The benzodiazepine use rate (per 1,000) was 28.06 in the IBD cohort vs. 16.83 in the non-IBD population (adjusted rate ratio, 1.67). The use rate for Z-drugs was 21.07 in the IBD cohort vs. 11.26 in the non-IBD population (adjusted RR, 1.87).
Benzodiazepine use declined from 1997 to 2016, but it remained at least 50% higher in patients with IBD than in the general population over this period, the researchers found. The rate of Z-drug use also was higher in the IBD population than in the general population but remained stable over the 20-year study period.
Regardless of age, men and women had similarly high use rates for benzodiazepines, Z-drugs, and joint use of benzodiazepines and Z-drugs. The highest incidence rates for joint benzodiazepine and Z-drug use were in young adults (age 18-44 years), and these rates were similar among men and women.
Patients with IBD and a mood/anxiety disorder also were more likely to use benzodiazepines and Z-drugs and to be continuous users than were those without a mood/anxiety disorder.
Mental health and IBD go hand in hand
“The results are not very surprising, but they highlight the importance of mental health and mood disturbances in patients with IBD,” Ashwin Ananthakrishnan, MBBS, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.
“It is important for treating physicians to be aware of the important mental health implications of IBD diagnosis and disease activity, to screen patients for these disturbances, and to institute early effective interventions,” Dr. Ananthakrishnan said.
Also offering perspective, Laurie Keefer, PhD, academic health psychologist and director of psychobehavioral research within the division of gastroenterology, Mount Sinai Health System, New York, said that she is “concerned but not surprised” by the results of this study.
“One in three patients with IBD meets criteria for an anxiety disorder,” Dr. Keefer told this news organization.
And with the ongoing mental health crisis and shortage of mental health providers, “gastroenterologists are, unfortunately, in the position where they may have to manage these issues,” she said.
Dr. Keefer noted that when patients are first diagnosed with IBD, they will likely be on prednisone, and “an antidote” for the side effects of prednisone are benzodiazepines and sleeping medications because prednisone itself causes insomnia. “However, that’s really just a band-aid,” she said.
A major concern, said Dr. Keefer, is that young men and women who are diagnosed with IBD in their 20s may start using these drugs and become reliant on them.
“People do build up a tolerance to these drugs, so they need more and more to receive the same effect,” she said.
A better approach is to figure out why patients are so anxious and teach them skills to manage their anxiety and sleep problems so that they’re not dependent on these drugs, Dr. Keefer said.
“There are behavioral strategies that can help. These are harder to do, and they’re not a quick fix. However, they are skills you can learn in your 20s and so when you have an IBD flare at 50, you have the skills to deal with it,” she said.
“We just have to be a little more proactive in really encouraging patients to learn disease management skills,” Dr. Keefer added.
The study was funded by the Canadian Institutes of Health Research and Crohn’s and Colitis Canada. Dr. Bernstein has disclosed relationships with AbbVie Canada, Amgen Canada, Bristol-Myers Squibb Canada, Roche Canada, Janssen Canada, Sandoz Canada, Takeda and Takeda Canada, Pfizer Canada, Mylan Pharmaceuticals, and Medtronic Canada. Dr. Ananthakrishnan and Dr. Keefer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients with inflammatory bowel disease (IBD) are 70% more likely to use benzodiazepines and “Z-drugs” than are the general population, a large study from Canada suggests.
Mood/anxiety disorders and sleep disorders are common in patients with IBD, but few studies have looked at use of benzodiazepines and Z-drugs (such as zolpidem, zaleplon, and eszopiclone) in this patient population.
The results are “concerning, and especially as the IBD population ages, these drugs are associated with health risks, including something as simple as falls,” first author Charles Bernstein, MD, of the IBD clinical and research centre, University of Manitoba, Winnipeg, told this news organization.
“Clinicians need to find better strategies to deal with anxiety disorders and sleep disorders in the IBD population,” Dr. Bernstein said.
The study was published online in the American Journal of Gastroenterology.
High burden of use
Using administrative data from Manitoba, Dr. Bernstein and colleagues identified 5,741 patients with IBD (2,381 with Crohn’s disease and 3,360 with ulcerative colitis) and matched them (1:5) to 28,661 population controls without IBD.
Over a 20-year period (1997-2017), there was a “high burden” of benzodiazepine and Z-drug use in the IBD population. In 2017, roughly 20% of Manitobans with IBD were using benzodiazepines, and 20% were using Z-drugs, the study team reports.
The benzodiazepine use rate (per 1,000) was 28.06 in the IBD cohort vs. 16.83 in the non-IBD population (adjusted rate ratio, 1.67). The use rate for Z-drugs was 21.07 in the IBD cohort vs. 11.26 in the non-IBD population (adjusted RR, 1.87).
Benzodiazepine use declined from 1997 to 2016, but it remained at least 50% higher in patients with IBD than in the general population over this period, the researchers found. The rate of Z-drug use also was higher in the IBD population than in the general population but remained stable over the 20-year study period.
Regardless of age, men and women had similarly high use rates for benzodiazepines, Z-drugs, and joint use of benzodiazepines and Z-drugs. The highest incidence rates for joint benzodiazepine and Z-drug use were in young adults (age 18-44 years), and these rates were similar among men and women.
Patients with IBD and a mood/anxiety disorder also were more likely to use benzodiazepines and Z-drugs and to be continuous users than were those without a mood/anxiety disorder.
Mental health and IBD go hand in hand
“The results are not very surprising, but they highlight the importance of mental health and mood disturbances in patients with IBD,” Ashwin Ananthakrishnan, MBBS, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.
“It is important for treating physicians to be aware of the important mental health implications of IBD diagnosis and disease activity, to screen patients for these disturbances, and to institute early effective interventions,” Dr. Ananthakrishnan said.
Also offering perspective, Laurie Keefer, PhD, academic health psychologist and director of psychobehavioral research within the division of gastroenterology, Mount Sinai Health System, New York, said that she is “concerned but not surprised” by the results of this study.
“One in three patients with IBD meets criteria for an anxiety disorder,” Dr. Keefer told this news organization.
And with the ongoing mental health crisis and shortage of mental health providers, “gastroenterologists are, unfortunately, in the position where they may have to manage these issues,” she said.
Dr. Keefer noted that when patients are first diagnosed with IBD, they will likely be on prednisone, and “an antidote” for the side effects of prednisone are benzodiazepines and sleeping medications because prednisone itself causes insomnia. “However, that’s really just a band-aid,” she said.
A major concern, said Dr. Keefer, is that young men and women who are diagnosed with IBD in their 20s may start using these drugs and become reliant on them.
“People do build up a tolerance to these drugs, so they need more and more to receive the same effect,” she said.
A better approach is to figure out why patients are so anxious and teach them skills to manage their anxiety and sleep problems so that they’re not dependent on these drugs, Dr. Keefer said.
“There are behavioral strategies that can help. These are harder to do, and they’re not a quick fix. However, they are skills you can learn in your 20s and so when you have an IBD flare at 50, you have the skills to deal with it,” she said.
“We just have to be a little more proactive in really encouraging patients to learn disease management skills,” Dr. Keefer added.
The study was funded by the Canadian Institutes of Health Research and Crohn’s and Colitis Canada. Dr. Bernstein has disclosed relationships with AbbVie Canada, Amgen Canada, Bristol-Myers Squibb Canada, Roche Canada, Janssen Canada, Sandoz Canada, Takeda and Takeda Canada, Pfizer Canada, Mylan Pharmaceuticals, and Medtronic Canada. Dr. Ananthakrishnan and Dr. Keefer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients with inflammatory bowel disease (IBD) are 70% more likely to use benzodiazepines and “Z-drugs” than are the general population, a large study from Canada suggests.
Mood/anxiety disorders and sleep disorders are common in patients with IBD, but few studies have looked at use of benzodiazepines and Z-drugs (such as zolpidem, zaleplon, and eszopiclone) in this patient population.
The results are “concerning, and especially as the IBD population ages, these drugs are associated with health risks, including something as simple as falls,” first author Charles Bernstein, MD, of the IBD clinical and research centre, University of Manitoba, Winnipeg, told this news organization.
“Clinicians need to find better strategies to deal with anxiety disorders and sleep disorders in the IBD population,” Dr. Bernstein said.
The study was published online in the American Journal of Gastroenterology.
High burden of use
Using administrative data from Manitoba, Dr. Bernstein and colleagues identified 5,741 patients with IBD (2,381 with Crohn’s disease and 3,360 with ulcerative colitis) and matched them (1:5) to 28,661 population controls without IBD.
Over a 20-year period (1997-2017), there was a “high burden” of benzodiazepine and Z-drug use in the IBD population. In 2017, roughly 20% of Manitobans with IBD were using benzodiazepines, and 20% were using Z-drugs, the study team reports.
The benzodiazepine use rate (per 1,000) was 28.06 in the IBD cohort vs. 16.83 in the non-IBD population (adjusted rate ratio, 1.67). The use rate for Z-drugs was 21.07 in the IBD cohort vs. 11.26 in the non-IBD population (adjusted RR, 1.87).
Benzodiazepine use declined from 1997 to 2016, but it remained at least 50% higher in patients with IBD than in the general population over this period, the researchers found. The rate of Z-drug use also was higher in the IBD population than in the general population but remained stable over the 20-year study period.
Regardless of age, men and women had similarly high use rates for benzodiazepines, Z-drugs, and joint use of benzodiazepines and Z-drugs. The highest incidence rates for joint benzodiazepine and Z-drug use were in young adults (age 18-44 years), and these rates were similar among men and women.
Patients with IBD and a mood/anxiety disorder also were more likely to use benzodiazepines and Z-drugs and to be continuous users than were those without a mood/anxiety disorder.
Mental health and IBD go hand in hand
“The results are not very surprising, but they highlight the importance of mental health and mood disturbances in patients with IBD,” Ashwin Ananthakrishnan, MBBS, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.
“It is important for treating physicians to be aware of the important mental health implications of IBD diagnosis and disease activity, to screen patients for these disturbances, and to institute early effective interventions,” Dr. Ananthakrishnan said.
Also offering perspective, Laurie Keefer, PhD, academic health psychologist and director of psychobehavioral research within the division of gastroenterology, Mount Sinai Health System, New York, said that she is “concerned but not surprised” by the results of this study.
“One in three patients with IBD meets criteria for an anxiety disorder,” Dr. Keefer told this news organization.
And with the ongoing mental health crisis and shortage of mental health providers, “gastroenterologists are, unfortunately, in the position where they may have to manage these issues,” she said.
Dr. Keefer noted that when patients are first diagnosed with IBD, they will likely be on prednisone, and “an antidote” for the side effects of prednisone are benzodiazepines and sleeping medications because prednisone itself causes insomnia. “However, that’s really just a band-aid,” she said.
A major concern, said Dr. Keefer, is that young men and women who are diagnosed with IBD in their 20s may start using these drugs and become reliant on them.
“People do build up a tolerance to these drugs, so they need more and more to receive the same effect,” she said.
A better approach is to figure out why patients are so anxious and teach them skills to manage their anxiety and sleep problems so that they’re not dependent on these drugs, Dr. Keefer said.
“There are behavioral strategies that can help. These are harder to do, and they’re not a quick fix. However, they are skills you can learn in your 20s and so when you have an IBD flare at 50, you have the skills to deal with it,” she said.
“We just have to be a little more proactive in really encouraging patients to learn disease management skills,” Dr. Keefer added.
The study was funded by the Canadian Institutes of Health Research and Crohn’s and Colitis Canada. Dr. Bernstein has disclosed relationships with AbbVie Canada, Amgen Canada, Bristol-Myers Squibb Canada, Roche Canada, Janssen Canada, Sandoz Canada, Takeda and Takeda Canada, Pfizer Canada, Mylan Pharmaceuticals, and Medtronic Canada. Dr. Ananthakrishnan and Dr. Keefer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AMERICAN JOURNAL OF GASTROENTEROLOGY
Urgent need for research into psychedelic therapy for older adults
new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
A ‘setback’ for anti-inflammatory treatment in depression
In the MinoTRD trial, 6 weeks of minocycline 200 mg daily added to stable antidepressant therapy did not show a statistically significant advantage over placebo on the overall course of depressive symptoms.
“The failure of minocycline treatment to reduce depressive symptoms in a naturalistic sample of patients with TRD is a setback for anti-inflammatory treatment strategies in this clinical population,” Julian Hellmann-Regen, MD, department of psychiatry and neurosciences, Charité – Universitätsmedizin Berlin, and colleagues wrote.
The findings were published online in JAMA Network Open.
No additional benefit
The “inflammatory hypothesis” of depression maintains that depression arises from increased immune activation and neurotrophic mechanisms.
This view is supported by observations that depression is accompanied by increased levels of proinflammatory cytokines. In addition, low-grade inflammatory processes may interfere with response to typical antidepressant medications.
Minocycline has been put forth as a novel antidepressant, and a few small trials have hinted at a benefit.
In the MinoTRD trial, 168 patients (mean age, 46 years; 53% men) with TRD were randomly allocated minocycline 200 mg/day or matching placebo in addition to usual antidepressant treatment for 6 weeks.
Results showed minocycline was well tolerated but was not superior to placebo in reducing depressive symptoms, the researchers report.
Overall, the mean Montgomery-Åsberg Depression Rating Scale (MADRS) score at baseline was 26.5. There was no significant between-group difference in mean change in MADRS score from baseline to 6 weeks, the primary outcome.
After 6 weeks of treatment, the mean reduction in MADRS score was 8.46 points in the minocycline group versus 8.01 points in the placebo group, and the difference of 1.46 points was not significant (P = .25).
Six weeks of minocycline treatment did not alter the course of depression severity, compared with placebo, the investigators noted.
Minocycline treatment also showed no statistically significant effect on secondary outcomes of response, remission, and various other clinical rating scales.
Caveats and cautionary notes
The researchers noted that one explanation for the null result of the MinoTRD trial could be that the 6-week treatment duration was not long enough to reveal detectable differences. They point to a small study that showed a strong effect of minocycline, compared with placebo by and after 8 weeks of treatment.
However, a closer look at that study suggests the overall effect in the minocycline group was caused by an almost-complete lack of improvement in the placebo group, “which is very unusual,” the investigators wrote.
In the MinoTRD trial, the magnitude of improvement for placebo was as expected from similar trials in TRD, they pointed out.
They also noted that, unlike some other trials, the MinoTRD trial purposely recruited a naturalistic population of TRD, assuming (but not confirming) elevated baseline inflammation as a potential underlying cause in at least a subgroup of the patients.
Post hoc stratification by baseline CRP levels in MinoTRD participants did not yield any results supporting the hypothesis of minocycline treatment possibly being more effective in participants with higher-grade baseline inflammation, the researchers reported.
“Our results from this large randomized controlled trial of a pleiotropic anti-inflammatory drug in this difficult-to-treat patient population are of great clinical importance, robustly demonstrating that minocycline add-on treatment does not outperform placebo, not even in those participants with elevated levels of CRP prior to treatment initiation,” they wrote.
The trial was funded by a grant from the German Federal Ministry of Education and Research within the Consortium Optimizing Treatment of Depression, as part of the Research Network for Psychiatric Disorders. Dr. Hellmann-Regen reported no relevant financial relationship.
A version of this article first appeared on Medscape.com.
In the MinoTRD trial, 6 weeks of minocycline 200 mg daily added to stable antidepressant therapy did not show a statistically significant advantage over placebo on the overall course of depressive symptoms.
“The failure of minocycline treatment to reduce depressive symptoms in a naturalistic sample of patients with TRD is a setback for anti-inflammatory treatment strategies in this clinical population,” Julian Hellmann-Regen, MD, department of psychiatry and neurosciences, Charité – Universitätsmedizin Berlin, and colleagues wrote.
The findings were published online in JAMA Network Open.
No additional benefit
The “inflammatory hypothesis” of depression maintains that depression arises from increased immune activation and neurotrophic mechanisms.
This view is supported by observations that depression is accompanied by increased levels of proinflammatory cytokines. In addition, low-grade inflammatory processes may interfere with response to typical antidepressant medications.
Minocycline has been put forth as a novel antidepressant, and a few small trials have hinted at a benefit.
In the MinoTRD trial, 168 patients (mean age, 46 years; 53% men) with TRD were randomly allocated minocycline 200 mg/day or matching placebo in addition to usual antidepressant treatment for 6 weeks.
Results showed minocycline was well tolerated but was not superior to placebo in reducing depressive symptoms, the researchers report.
Overall, the mean Montgomery-Åsberg Depression Rating Scale (MADRS) score at baseline was 26.5. There was no significant between-group difference in mean change in MADRS score from baseline to 6 weeks, the primary outcome.
After 6 weeks of treatment, the mean reduction in MADRS score was 8.46 points in the minocycline group versus 8.01 points in the placebo group, and the difference of 1.46 points was not significant (P = .25).
Six weeks of minocycline treatment did not alter the course of depression severity, compared with placebo, the investigators noted.
Minocycline treatment also showed no statistically significant effect on secondary outcomes of response, remission, and various other clinical rating scales.
Caveats and cautionary notes
The researchers noted that one explanation for the null result of the MinoTRD trial could be that the 6-week treatment duration was not long enough to reveal detectable differences. They point to a small study that showed a strong effect of minocycline, compared with placebo by and after 8 weeks of treatment.
However, a closer look at that study suggests the overall effect in the minocycline group was caused by an almost-complete lack of improvement in the placebo group, “which is very unusual,” the investigators wrote.
In the MinoTRD trial, the magnitude of improvement for placebo was as expected from similar trials in TRD, they pointed out.
They also noted that, unlike some other trials, the MinoTRD trial purposely recruited a naturalistic population of TRD, assuming (but not confirming) elevated baseline inflammation as a potential underlying cause in at least a subgroup of the patients.
Post hoc stratification by baseline CRP levels in MinoTRD participants did not yield any results supporting the hypothesis of minocycline treatment possibly being more effective in participants with higher-grade baseline inflammation, the researchers reported.
“Our results from this large randomized controlled trial of a pleiotropic anti-inflammatory drug in this difficult-to-treat patient population are of great clinical importance, robustly demonstrating that minocycline add-on treatment does not outperform placebo, not even in those participants with elevated levels of CRP prior to treatment initiation,” they wrote.
The trial was funded by a grant from the German Federal Ministry of Education and Research within the Consortium Optimizing Treatment of Depression, as part of the Research Network for Psychiatric Disorders. Dr. Hellmann-Regen reported no relevant financial relationship.
A version of this article first appeared on Medscape.com.
In the MinoTRD trial, 6 weeks of minocycline 200 mg daily added to stable antidepressant therapy did not show a statistically significant advantage over placebo on the overall course of depressive symptoms.
“The failure of minocycline treatment to reduce depressive symptoms in a naturalistic sample of patients with TRD is a setback for anti-inflammatory treatment strategies in this clinical population,” Julian Hellmann-Regen, MD, department of psychiatry and neurosciences, Charité – Universitätsmedizin Berlin, and colleagues wrote.
The findings were published online in JAMA Network Open.
No additional benefit
The “inflammatory hypothesis” of depression maintains that depression arises from increased immune activation and neurotrophic mechanisms.
This view is supported by observations that depression is accompanied by increased levels of proinflammatory cytokines. In addition, low-grade inflammatory processes may interfere with response to typical antidepressant medications.
Minocycline has been put forth as a novel antidepressant, and a few small trials have hinted at a benefit.
In the MinoTRD trial, 168 patients (mean age, 46 years; 53% men) with TRD were randomly allocated minocycline 200 mg/day or matching placebo in addition to usual antidepressant treatment for 6 weeks.
Results showed minocycline was well tolerated but was not superior to placebo in reducing depressive symptoms, the researchers report.
Overall, the mean Montgomery-Åsberg Depression Rating Scale (MADRS) score at baseline was 26.5. There was no significant between-group difference in mean change in MADRS score from baseline to 6 weeks, the primary outcome.
After 6 weeks of treatment, the mean reduction in MADRS score was 8.46 points in the minocycline group versus 8.01 points in the placebo group, and the difference of 1.46 points was not significant (P = .25).
Six weeks of minocycline treatment did not alter the course of depression severity, compared with placebo, the investigators noted.
Minocycline treatment also showed no statistically significant effect on secondary outcomes of response, remission, and various other clinical rating scales.
Caveats and cautionary notes
The researchers noted that one explanation for the null result of the MinoTRD trial could be that the 6-week treatment duration was not long enough to reveal detectable differences. They point to a small study that showed a strong effect of minocycline, compared with placebo by and after 8 weeks of treatment.
However, a closer look at that study suggests the overall effect in the minocycline group was caused by an almost-complete lack of improvement in the placebo group, “which is very unusual,” the investigators wrote.
In the MinoTRD trial, the magnitude of improvement for placebo was as expected from similar trials in TRD, they pointed out.
They also noted that, unlike some other trials, the MinoTRD trial purposely recruited a naturalistic population of TRD, assuming (but not confirming) elevated baseline inflammation as a potential underlying cause in at least a subgroup of the patients.
Post hoc stratification by baseline CRP levels in MinoTRD participants did not yield any results supporting the hypothesis of minocycline treatment possibly being more effective in participants with higher-grade baseline inflammation, the researchers reported.
“Our results from this large randomized controlled trial of a pleiotropic anti-inflammatory drug in this difficult-to-treat patient population are of great clinical importance, robustly demonstrating that minocycline add-on treatment does not outperform placebo, not even in those participants with elevated levels of CRP prior to treatment initiation,” they wrote.
The trial was funded by a grant from the German Federal Ministry of Education and Research within the Consortium Optimizing Treatment of Depression, as part of the Research Network for Psychiatric Disorders. Dr. Hellmann-Regen reported no relevant financial relationship.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
FDA okays terlipressin (Terlivaz) injection for hepatorenal syndrome
The Food and Drug Administration has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS).
HRS is characterized by progressive deterioration in kidney function in people with advanced liver disease.
Terlipressin is an injectable synthetic vasopressin analogue indicated for patients with HRS who are experiencing rapid deterioration of kidney function (type 1 HRS). The condition affects an estimated 35,000 Americans annually.
The safety and efficacy of terlipressin for type 1 HRS was assessed in the phase 3 CONFIRM trial, which involved 300 patients in the United States and Canada.
Patients received an injection of terlipressin (0.85 mg) or placebo every 6 hours for a maximum of 14 days. The dose was adjusted on the basis of changes in kidney function.
Twenty-nine percent of patients in the terlipressin group experienced improvement in kidney function, vs. 16% in the placebo group.
The CONFIRM trial met its primary endpoint of verified HRS reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival (P = .012).
To achieve this endpoint, patients had to have two consecutive serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 2 hours apart by day 14 or be discharged from the hospital.
The most commonly observed adverse reactions that occurred in at least 4% of patients treated with terlipressin were abdominal pain (19.5%), nausea (16%), respiratory failure (15.5%), diarrhea (13%), and dyspnea (12.5%).
Results of the CONFIRM trial were published in The New England Journal of Medicine.
“Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it,” said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, which makes the drug.
“Terlivaz gives physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Dr. Romano said.
The company plans to launch the product in the coming weeks.
The application for terlipressin for HRS was granted priority review and fast-track status, as well as orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS).
HRS is characterized by progressive deterioration in kidney function in people with advanced liver disease.
Terlipressin is an injectable synthetic vasopressin analogue indicated for patients with HRS who are experiencing rapid deterioration of kidney function (type 1 HRS). The condition affects an estimated 35,000 Americans annually.
The safety and efficacy of terlipressin for type 1 HRS was assessed in the phase 3 CONFIRM trial, which involved 300 patients in the United States and Canada.
Patients received an injection of terlipressin (0.85 mg) or placebo every 6 hours for a maximum of 14 days. The dose was adjusted on the basis of changes in kidney function.
Twenty-nine percent of patients in the terlipressin group experienced improvement in kidney function, vs. 16% in the placebo group.
The CONFIRM trial met its primary endpoint of verified HRS reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival (P = .012).
To achieve this endpoint, patients had to have two consecutive serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 2 hours apart by day 14 or be discharged from the hospital.
The most commonly observed adverse reactions that occurred in at least 4% of patients treated with terlipressin were abdominal pain (19.5%), nausea (16%), respiratory failure (15.5%), diarrhea (13%), and dyspnea (12.5%).
Results of the CONFIRM trial were published in The New England Journal of Medicine.
“Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it,” said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, which makes the drug.
“Terlivaz gives physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Dr. Romano said.
The company plans to launch the product in the coming weeks.
The application for terlipressin for HRS was granted priority review and fast-track status, as well as orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS).
HRS is characterized by progressive deterioration in kidney function in people with advanced liver disease.
Terlipressin is an injectable synthetic vasopressin analogue indicated for patients with HRS who are experiencing rapid deterioration of kidney function (type 1 HRS). The condition affects an estimated 35,000 Americans annually.
The safety and efficacy of terlipressin for type 1 HRS was assessed in the phase 3 CONFIRM trial, which involved 300 patients in the United States and Canada.
Patients received an injection of terlipressin (0.85 mg) or placebo every 6 hours for a maximum of 14 days. The dose was adjusted on the basis of changes in kidney function.
Twenty-nine percent of patients in the terlipressin group experienced improvement in kidney function, vs. 16% in the placebo group.
The CONFIRM trial met its primary endpoint of verified HRS reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival (P = .012).
To achieve this endpoint, patients had to have two consecutive serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 2 hours apart by day 14 or be discharged from the hospital.
The most commonly observed adverse reactions that occurred in at least 4% of patients treated with terlipressin were abdominal pain (19.5%), nausea (16%), respiratory failure (15.5%), diarrhea (13%), and dyspnea (12.5%).
Results of the CONFIRM trial were published in The New England Journal of Medicine.
“Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it,” said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, which makes the drug.
“Terlivaz gives physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Dr. Romano said.
The company plans to launch the product in the coming weeks.
The application for terlipressin for HRS was granted priority review and fast-track status, as well as orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
A version of this article first appeared on Medscape.com.