Megan Brooks

Adults with celiac disease (CD) do not appear to be at increased risk of having a more severe disease course or worse outcomes from COVID-19, according to a new study.

Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.

There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.

The study was published online Nov. 11, 2021, in Gut.

To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.

After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.

Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).

After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).

Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).

The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.

Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.

“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.

They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.

“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.

The study had no specific funding. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Adults with celiac disease (CD) do not appear to be at increased risk of having a more severe disease course or worse outcomes from COVID-19, according to a new study.

Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.

There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.

The study was published online Nov. 11, 2021, in Gut.

To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.

After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.

Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).

After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).

Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).

The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.

Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.

“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.

They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.

“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.

The study had no specific funding. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Adults with celiac disease (CD) do not appear to be at increased risk of having a more severe disease course or worse outcomes from COVID-19, according to a new study.

Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.

There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.

The study was published online Nov. 11, 2021, in Gut.

To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.

After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.

Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).

After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).

Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).

The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.

Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.

“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.

They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.

“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.

The study had no specific funding. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A newly released position statement from the American Academy of Neurology (AAN) provides guidance to neurologists about counseling  patients with Alzheimer’s disease and their families about the controversial drug aducanumab (Aduhelm).

The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.

“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.

The statement was published online Nov. 17 in Neurology.
 

Open, honest communication

The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.

The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.

All of this should be communicated to patients, the AAN advises.

Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.

The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.

It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous. 

“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
 

‘New territory’ for neurologists

“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.

Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.

The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.

“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.

“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.

This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.

This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.

A version of this article first appeared on Medscape.com.

A newly released position statement from the American Academy of Neurology (AAN) provides guidance to neurologists about counseling  patients with Alzheimer’s disease and their families about the controversial drug aducanumab (Aduhelm).

The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.

“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.

The statement was published online Nov. 17 in Neurology.
 

Open, honest communication

The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.

The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.

All of this should be communicated to patients, the AAN advises.

Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.

The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.

It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous. 

“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
 

‘New territory’ for neurologists

“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.

Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.

The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.

“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.

“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.

This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.

This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.

A version of this article first appeared on Medscape.com.

A newly released position statement from the American Academy of Neurology (AAN) provides guidance to neurologists about counseling  patients with Alzheimer’s disease and their families about the controversial drug aducanumab (Aduhelm).

The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.

“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.

The statement was published online Nov. 17 in Neurology.
 

Open, honest communication

The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.

The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.

All of this should be communicated to patients, the AAN advises.

Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.

The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.

It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous. 

“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
 

‘New territory’ for neurologists

“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.

Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.

The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.

“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.

“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.

This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.

This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.

A version of this article first appeared on Medscape.com.

Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.

The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.

“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.

The study was published online JAMA Psychiatry.
 

Surprising findings

The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.

However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.

This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.

Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.

The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.

The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.

There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).

A total of 127 participants (24.5%) had suicide-related outcomes – 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
 

Caveats, cautionary notes

The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.

They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.

As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.

The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.

In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.

Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.

“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.

Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.

Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.

Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.

The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.

A version of this article first appeared on Medscape.com.

Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.

The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.

“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.

The study was published online JAMA Psychiatry.
 

Surprising findings

The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.

However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.

This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.

Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.

The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.

The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.

There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).

A total of 127 participants (24.5%) had suicide-related outcomes – 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
 

Caveats, cautionary notes

The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.

They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.

As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.

The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.

In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.

Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.

“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.

Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.

Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.

Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.

The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.

A version of this article first appeared on Medscape.com.

Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.

The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.

“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.

The study was published online JAMA Psychiatry.
 

Surprising findings

The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.

However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.

This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.

Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.

The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.

The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.

There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).

A total of 127 participants (24.5%) had suicide-related outcomes – 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
 

Caveats, cautionary notes

The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.

They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.

As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.

The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.

In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.

Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.

“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.

Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.

Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.

Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.

The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.

A version of this article first appeared on Medscape.com.

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

A version of this article first appeared on Medscape.com.

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

A version of this article first appeared on Medscape.com.

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

A version of this article first appeared on Medscape.com.

Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.

A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.

Data-driven approach

Investigators analyzed data from the Cerner Real World Data COVID-19 deidentified electronic health records database of 490,373 patients with COVID-19 across 87 health centers, including 3,401 patients who were prescribed SSRIs.

When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.

Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).

“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.

“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.

“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.

Urgent need

The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.

Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.

“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.

“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.

The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.

A version of this article first appeared on Medscape.com.

Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.

A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.

Data-driven approach

Investigators analyzed data from the Cerner Real World Data COVID-19 deidentified electronic health records database of 490,373 patients with COVID-19 across 87 health centers, including 3,401 patients who were prescribed SSRIs.

When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.

Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).

“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.

“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.

“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.

Urgent need

The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.

Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.

“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.

“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.

The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.

A version of this article first appeared on Medscape.com.

Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.

A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.

Data-driven approach

Investigators analyzed data from the Cerner Real World Data COVID-19 deidentified electronic health records database of 490,373 patients with COVID-19 across 87 health centers, including 3,401 patients who were prescribed SSRIs.

When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.

Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).

“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.

“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.

“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.

Urgent need

The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.

Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.

“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.

“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.

The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.

A version of this article first appeared on Medscape.com.

At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against Biogen’s controversial Alzheimer’s drug aducanumab (Aduhelm), making it highly unlikely the drug will be recommended for approval at its December meeting.

In a news release issued Nov. 17, Biogen said the company received a “negative trend vote” on the aducanumab marketing authorization application in Europe.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease [AD],” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in the release.

The EMA committee is expected to adopt a formal opinion on the marketing application at its December meeting (Dec. 13-16, 2021).

“Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe,” the company said.

At the recent Clinical Trials on Alzheimer’s Disease conference, Biogen announced new phase 3 findings that “provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease,” the company said.
 

No clinically meaningful effect

In a statement from the nonprofit U.K. Science Media Centre, Prof. Robert Howard, from University College London, said the result of the CHMP vote “is absolutely the decision that we should have expected from the EMA’s expert advisory panel and is consistent with the FDA’s [U.S. Food and Drug Administration’s] Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE.”

“The FDA’s accelerated approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer’s disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its staff,” Prof. Howard noted.

He anticipates that when the EMA panel meets in December they will not grant a license to aducanumab.

“Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer’s disease, their families and those who care for them, EMA and MHRA [Medicines and Healthcare products Regulatory Agency] should not approve a license for aducanumab,” Prof. Howard said.

Also weighing in, David Thomas, head of policy at Alzheimer’s Research UK, said the need for new AD treatments is “urgent,” but added that “it’s vital that regulators judge that any new treatment is safe and effective.”

“Results of aducanumab’s phase 3 trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment,” Mr. Thomas noted.

“The FDA’s approval of aducanumab in the U.S. was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives,” Mr. Thomas said.

EMA is now undertaking its own review of the data and “it’s important that we wait for the committee’s official recommendation, which is expected next month. In the meantime, we must continue to work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS [National Health Service] will be ready to deliver them in the years ahead,” he added.
 

‘Reckless’ FDA decision

In related news, the Centers for Medicare and Medicaid Services (CMS) has announced that the Medicare Part B standard premium would rise to $170 per month for all enrollees, a 15% spike over the 2021 premium level.

“All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a statement.

“To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial evidence of cognitive benefit to Alzheimer’s disease patients,” Dr. Carome said.

A version of this article first appeared on Medscape.com.

At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against Biogen’s controversial Alzheimer’s drug aducanumab (Aduhelm), making it highly unlikely the drug will be recommended for approval at its December meeting.

In a news release issued Nov. 17, Biogen said the company received a “negative trend vote” on the aducanumab marketing authorization application in Europe.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease [AD],” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in the release.

The EMA committee is expected to adopt a formal opinion on the marketing application at its December meeting (Dec. 13-16, 2021).

“Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe,” the company said.

At the recent Clinical Trials on Alzheimer’s Disease conference, Biogen announced new phase 3 findings that “provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease,” the company said.
 

No clinically meaningful effect

In a statement from the nonprofit U.K. Science Media Centre, Prof. Robert Howard, from University College London, said the result of the CHMP vote “is absolutely the decision that we should have expected from the EMA’s expert advisory panel and is consistent with the FDA’s [U.S. Food and Drug Administration’s] Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE.”

“The FDA’s accelerated approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer’s disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its staff,” Prof. Howard noted.

He anticipates that when the EMA panel meets in December they will not grant a license to aducanumab.

“Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer’s disease, their families and those who care for them, EMA and MHRA [Medicines and Healthcare products Regulatory Agency] should not approve a license for aducanumab,” Prof. Howard said.

Also weighing in, David Thomas, head of policy at Alzheimer’s Research UK, said the need for new AD treatments is “urgent,” but added that “it’s vital that regulators judge that any new treatment is safe and effective.”

“Results of aducanumab’s phase 3 trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment,” Mr. Thomas noted.

“The FDA’s approval of aducanumab in the U.S. was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives,” Mr. Thomas said.

EMA is now undertaking its own review of the data and “it’s important that we wait for the committee’s official recommendation, which is expected next month. In the meantime, we must continue to work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS [National Health Service] will be ready to deliver them in the years ahead,” he added.
 

‘Reckless’ FDA decision

In related news, the Centers for Medicare and Medicaid Services (CMS) has announced that the Medicare Part B standard premium would rise to $170 per month for all enrollees, a 15% spike over the 2021 premium level.

“All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a statement.

“To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial evidence of cognitive benefit to Alzheimer’s disease patients,” Dr. Carome said.

A version of this article first appeared on Medscape.com.

At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against Biogen’s controversial Alzheimer’s drug aducanumab (Aduhelm), making it highly unlikely the drug will be recommended for approval at its December meeting.

In a news release issued Nov. 17, Biogen said the company received a “negative trend vote” on the aducanumab marketing authorization application in Europe.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease [AD],” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in the release.

The EMA committee is expected to adopt a formal opinion on the marketing application at its December meeting (Dec. 13-16, 2021).

“Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe,” the company said.

At the recent Clinical Trials on Alzheimer’s Disease conference, Biogen announced new phase 3 findings that “provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease,” the company said.
 

No clinically meaningful effect

In a statement from the nonprofit U.K. Science Media Centre, Prof. Robert Howard, from University College London, said the result of the CHMP vote “is absolutely the decision that we should have expected from the EMA’s expert advisory panel and is consistent with the FDA’s [U.S. Food and Drug Administration’s] Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE.”

“The FDA’s accelerated approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer’s disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its staff,” Prof. Howard noted.

He anticipates that when the EMA panel meets in December they will not grant a license to aducanumab.

“Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer’s disease, their families and those who care for them, EMA and MHRA [Medicines and Healthcare products Regulatory Agency] should not approve a license for aducanumab,” Prof. Howard said.

Also weighing in, David Thomas, head of policy at Alzheimer’s Research UK, said the need for new AD treatments is “urgent,” but added that “it’s vital that regulators judge that any new treatment is safe and effective.”

“Results of aducanumab’s phase 3 trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment,” Mr. Thomas noted.

“The FDA’s approval of aducanumab in the U.S. was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives,” Mr. Thomas said.

EMA is now undertaking its own review of the data and “it’s important that we wait for the committee’s official recommendation, which is expected next month. In the meantime, we must continue to work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS [National Health Service] will be ready to deliver them in the years ahead,” he added.
 

‘Reckless’ FDA decision

In related news, the Centers for Medicare and Medicaid Services (CMS) has announced that the Medicare Part B standard premium would rise to $170 per month for all enrollees, a 15% spike over the 2021 premium level.

“All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a statement.

“To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial evidence of cognitive benefit to Alzheimer’s disease patients,” Dr. Carome said.

A version of this article first appeared on Medscape.com.

A single infusion of ketamine rapidly improves distorted thinking and reasoning to reduce suicidal thoughts, independent of the drug’s effect on severe depression, new research shows.

“Previously it was shown that ketamine rapidly improved depression and that explained part of the rapid improvement in suicidal ideation,” senior author J. John Mann, MD, with Columbia University, New York, said in an interview.

“What was unclear was what else changed that could decrease suicidal ideation and the risk for suicidal behavior. This study identifies a second new domain of improvement – namely rapid improvement in several cognitive functions that can potentially reduce suicide risk,” said Dr. Mann.

The study was published online Nov. 2, 2021, in the Journal of Clinical Psychiatry.
 

Boosts cognitive function

A total of 78 adults with major depressive disorder and clinically significant suicidal ideation underwent neuropsychological testing before, and 1 day after, double-blind treatment with a single intravenous infusion of ketamine or midazolam.

“Ketamine produced rapid improvement in suicidal ideation and mood” compared with midazolam, the authors reported.

Ketamine was linked to specific improvement in reaction time and cognitive control/interference processing – a measure that has been associated with previous suicide attempt in depression.

A subgroup of patients whose suicidal ideation did not remit on midazolam were later treated with unblinded ketamine and retested. In these individuals, reaction time and cognitive control/interference processing also improved relative to preketamine assessments.

Neurocognitive improvement, however, was not correlated with changes in depression, suicidal thinking, or general mood, the researchers noted.

Nonetheless, they say ketamine had a “positive therapeutic effect” on neurocognition 1 day after treatment on at least one measure associated with suicidal behavior in the context of depression.

The results suggest “additional independent therapeutic effects for ketamine in the treatment of depressed patients at risk for suicidal behavior,” they wrote.

“Ketamine modulates many neurotransmitter systems including glutamate transmission which is crucial for learning and memory. It increases the number of synapses or connections between neurons. These effects are fundamental to cognition and are logical explanations of the beneficial effects observed in this study,” Dr. Mann said in an interview.

“Our study helped us gain a better understanding of how ketamine works in the brain and how quickly it can improve distorted thinking. Being able to think more clearly can make someone feel less suicidal,” study investigator Ravi. N. Shah, MD, chief innovation officer, Columbia Psychiatry, said in a news release.
 

Important research with caveats

In a comment, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai in New York, said the study is important and “adds to a growing understanding of how ketamine affects brain systems and thinking in the context of depression and suicide risk.”

“One reason this study is significant is that prior studies have shown that ketamine can have harmful effects on cognitive functioning in the context of ketamine misuse and exposures to high doses for long periods of time,” Dr. Murrough, who wasn’t involved in the study, said in an interview.

“In contrast in this study, a single low-dose treatment of ketamine can have the opposite effects, actually boosting some markers of cognitive functioning, at least in the short-term,” he noted.

Dr. Murrough said one caveat to the study is that it only examined the effect of ketamine on cognition once, 1 day after a single treatment.

“While this is an important initial observation, we don’t yet have any understanding of how persistent this effect on cognition is, or how this observed change may be related to any benefit ketamine may have on depression or suicide risk,” Dr. Murrough said.

“In fact, the researchers found that there was no association between change in cognitive functioning following ketamine and change in depression or suicidal thinking. The patients who showed improved cognitive function following ketamine did not differ in terms of mood or suicide risk compared to patients who did not show an improvement in cognition,” Dr. Murrough noted.

“This raises the important question of what is the relevance of change in cognition to the potential benefits of ketamine. This is an important area and should be the focus of future research in order to improve outcomes for patients with depression and who are at risk for suicide,” he added.

Also weighing in, Roger S. McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit, University of Toronto, said the study is “very interesting and in keeping” with some previous work that he and his colleagues have done showing that ketamine “seems to benefit aspects of cognition which is a core element in depression.”

“It’s a testable hypothesis that the improvement in cognition now being reported and replicated could play some role in the improved quality of life and functioning with this treatment and as well reduce reducing suicide,” said Dr. McIntyre.

This study was supported by the National Institute of Mental Health. Dr. Mann receives royalties for commercial use of the Columbia-Suicide Severity Rating Scale, which was not used in this study. Dr. Murrough’s institution was involved in research involving esketamine (Spravato) for treatment-resistant depression and receives financial remuneration from the manufacturer of esketamine. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

A version of this article first appeared on Medscape.com.

A single infusion of ketamine rapidly improves distorted thinking and reasoning to reduce suicidal thoughts, independent of the drug’s effect on severe depression, new research shows.

“Previously it was shown that ketamine rapidly improved depression and that explained part of the rapid improvement in suicidal ideation,” senior author J. John Mann, MD, with Columbia University, New York, said in an interview.

“What was unclear was what else changed that could decrease suicidal ideation and the risk for suicidal behavior. This study identifies a second new domain of improvement – namely rapid improvement in several cognitive functions that can potentially reduce suicide risk,” said Dr. Mann.

The study was published online Nov. 2, 2021, in the Journal of Clinical Psychiatry.
 

Boosts cognitive function

A total of 78 adults with major depressive disorder and clinically significant suicidal ideation underwent neuropsychological testing before, and 1 day after, double-blind treatment with a single intravenous infusion of ketamine or midazolam.

“Ketamine produced rapid improvement in suicidal ideation and mood” compared with midazolam, the authors reported.

Ketamine was linked to specific improvement in reaction time and cognitive control/interference processing – a measure that has been associated with previous suicide attempt in depression.

A subgroup of patients whose suicidal ideation did not remit on midazolam were later treated with unblinded ketamine and retested. In these individuals, reaction time and cognitive control/interference processing also improved relative to preketamine assessments.

Neurocognitive improvement, however, was not correlated with changes in depression, suicidal thinking, or general mood, the researchers noted.

Nonetheless, they say ketamine had a “positive therapeutic effect” on neurocognition 1 day after treatment on at least one measure associated with suicidal behavior in the context of depression.

The results suggest “additional independent therapeutic effects for ketamine in the treatment of depressed patients at risk for suicidal behavior,” they wrote.

“Ketamine modulates many neurotransmitter systems including glutamate transmission which is crucial for learning and memory. It increases the number of synapses or connections between neurons. These effects are fundamental to cognition and are logical explanations of the beneficial effects observed in this study,” Dr. Mann said in an interview.

“Our study helped us gain a better understanding of how ketamine works in the brain and how quickly it can improve distorted thinking. Being able to think more clearly can make someone feel less suicidal,” study investigator Ravi. N. Shah, MD, chief innovation officer, Columbia Psychiatry, said in a news release.
 

Important research with caveats

In a comment, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai in New York, said the study is important and “adds to a growing understanding of how ketamine affects brain systems and thinking in the context of depression and suicide risk.”

“One reason this study is significant is that prior studies have shown that ketamine can have harmful effects on cognitive functioning in the context of ketamine misuse and exposures to high doses for long periods of time,” Dr. Murrough, who wasn’t involved in the study, said in an interview.

“In contrast in this study, a single low-dose treatment of ketamine can have the opposite effects, actually boosting some markers of cognitive functioning, at least in the short-term,” he noted.

Dr. Murrough said one caveat to the study is that it only examined the effect of ketamine on cognition once, 1 day after a single treatment.

“While this is an important initial observation, we don’t yet have any understanding of how persistent this effect on cognition is, or how this observed change may be related to any benefit ketamine may have on depression or suicide risk,” Dr. Murrough said.

“In fact, the researchers found that there was no association between change in cognitive functioning following ketamine and change in depression or suicidal thinking. The patients who showed improved cognitive function following ketamine did not differ in terms of mood or suicide risk compared to patients who did not show an improvement in cognition,” Dr. Murrough noted.

“This raises the important question of what is the relevance of change in cognition to the potential benefits of ketamine. This is an important area and should be the focus of future research in order to improve outcomes for patients with depression and who are at risk for suicide,” he added.

Also weighing in, Roger S. McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit, University of Toronto, said the study is “very interesting and in keeping” with some previous work that he and his colleagues have done showing that ketamine “seems to benefit aspects of cognition which is a core element in depression.”

“It’s a testable hypothesis that the improvement in cognition now being reported and replicated could play some role in the improved quality of life and functioning with this treatment and as well reduce reducing suicide,” said Dr. McIntyre.

This study was supported by the National Institute of Mental Health. Dr. Mann receives royalties for commercial use of the Columbia-Suicide Severity Rating Scale, which was not used in this study. Dr. Murrough’s institution was involved in research involving esketamine (Spravato) for treatment-resistant depression and receives financial remuneration from the manufacturer of esketamine. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

A version of this article first appeared on Medscape.com.

A single infusion of ketamine rapidly improves distorted thinking and reasoning to reduce suicidal thoughts, independent of the drug’s effect on severe depression, new research shows.

“Previously it was shown that ketamine rapidly improved depression and that explained part of the rapid improvement in suicidal ideation,” senior author J. John Mann, MD, with Columbia University, New York, said in an interview.

“What was unclear was what else changed that could decrease suicidal ideation and the risk for suicidal behavior. This study identifies a second new domain of improvement – namely rapid improvement in several cognitive functions that can potentially reduce suicide risk,” said Dr. Mann.

The study was published online Nov. 2, 2021, in the Journal of Clinical Psychiatry.
 

Boosts cognitive function

A total of 78 adults with major depressive disorder and clinically significant suicidal ideation underwent neuropsychological testing before, and 1 day after, double-blind treatment with a single intravenous infusion of ketamine or midazolam.

“Ketamine produced rapid improvement in suicidal ideation and mood” compared with midazolam, the authors reported.

Ketamine was linked to specific improvement in reaction time and cognitive control/interference processing – a measure that has been associated with previous suicide attempt in depression.

A subgroup of patients whose suicidal ideation did not remit on midazolam were later treated with unblinded ketamine and retested. In these individuals, reaction time and cognitive control/interference processing also improved relative to preketamine assessments.

Neurocognitive improvement, however, was not correlated with changes in depression, suicidal thinking, or general mood, the researchers noted.

Nonetheless, they say ketamine had a “positive therapeutic effect” on neurocognition 1 day after treatment on at least one measure associated with suicidal behavior in the context of depression.

The results suggest “additional independent therapeutic effects for ketamine in the treatment of depressed patients at risk for suicidal behavior,” they wrote.

“Ketamine modulates many neurotransmitter systems including glutamate transmission which is crucial for learning and memory. It increases the number of synapses or connections between neurons. These effects are fundamental to cognition and are logical explanations of the beneficial effects observed in this study,” Dr. Mann said in an interview.

“Our study helped us gain a better understanding of how ketamine works in the brain and how quickly it can improve distorted thinking. Being able to think more clearly can make someone feel less suicidal,” study investigator Ravi. N. Shah, MD, chief innovation officer, Columbia Psychiatry, said in a news release.
 

Important research with caveats

In a comment, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai in New York, said the study is important and “adds to a growing understanding of how ketamine affects brain systems and thinking in the context of depression and suicide risk.”

“One reason this study is significant is that prior studies have shown that ketamine can have harmful effects on cognitive functioning in the context of ketamine misuse and exposures to high doses for long periods of time,” Dr. Murrough, who wasn’t involved in the study, said in an interview.

“In contrast in this study, a single low-dose treatment of ketamine can have the opposite effects, actually boosting some markers of cognitive functioning, at least in the short-term,” he noted.

Dr. Murrough said one caveat to the study is that it only examined the effect of ketamine on cognition once, 1 day after a single treatment.

“While this is an important initial observation, we don’t yet have any understanding of how persistent this effect on cognition is, or how this observed change may be related to any benefit ketamine may have on depression or suicide risk,” Dr. Murrough said.

“In fact, the researchers found that there was no association between change in cognitive functioning following ketamine and change in depression or suicidal thinking. The patients who showed improved cognitive function following ketamine did not differ in terms of mood or suicide risk compared to patients who did not show an improvement in cognition,” Dr. Murrough noted.

“This raises the important question of what is the relevance of change in cognition to the potential benefits of ketamine. This is an important area and should be the focus of future research in order to improve outcomes for patients with depression and who are at risk for suicide,” he added.

Also weighing in, Roger S. McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit, University of Toronto, said the study is “very interesting and in keeping” with some previous work that he and his colleagues have done showing that ketamine “seems to benefit aspects of cognition which is a core element in depression.”

“It’s a testable hypothesis that the improvement in cognition now being reported and replicated could play some role in the improved quality of life and functioning with this treatment and as well reduce reducing suicide,” said Dr. McIntyre.

This study was supported by the National Institute of Mental Health. Dr. Mann receives royalties for commercial use of the Columbia-Suicide Severity Rating Scale, which was not used in this study. Dr. Murrough’s institution was involved in research involving esketamine (Spravato) for treatment-resistant depression and receives financial remuneration from the manufacturer of esketamine. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

A version of this article first appeared on Medscape.com.

The death rate from Parkinson’s disease has increased by about 63% over the past 2 decades in the United States, according to what investigators say is the most comprehensive study in the nation of temporal trends in Parkinson’s disease mortality.

“The reason behind the rising death rates from Parkinson’s disease is not clear at present and warrants further investigation,” Wei Bao, MD, PhD, associate professor in the department of epidemiology at the University of Iowa College of Public Health, in Iowa City, said in an interview. “We know that people are living longer and the general population is getting older, but that doesn’t fully explain the increase we saw in the death rate in people with Parkinson’s disease,” Dr. Bao added in a statement.

“Understanding why more people are dying from this disease is critical if we are going to reverse the trend,” Dr. Bao said.

The study was published online Oct. 27 in Neurology.

Long-term data

The researchers used data from the National Vital Statistics System to determine national trends in Parkinson’s disease mortality overall and in several key subgroups. The analyses included 479,059 people who died of Parkinson’s disease between 1999 and 2019.

Over the 21-year period, the age-adjusted mortality from Parkinson’s disease rose from 5.4 per 100,000 in 1999 to 8.8 per 100,000 in 2019. The average annual percent change (APC) was 2.4% for the entire period.

During the study period, the number of deaths from Parkinson’s disease more than doubled, from 14,593 to 35,311.

The death rate from Parkinson’s disease increased significantly across all age groups. The average APC was 5.0% among adults younger than 65 years, 1.9% among those aged 65-74 years, 2.2% among those 75-84 years, and 2.7% among those 85 and older.

The death rate increased in both men and women, but age-adjusted Parkinson’s disease mortality was twice as high in men as in women. The researchers say one possible explanation for the sex difference is estrogen, which leads to higher dopamine levels in areas of the brain that control motor responses and may protect women from Parkinson’s disease.

The study also showed that White people are more likely to die from Parkinson’s disease than persons of other racial and ethnic groups. In 2019, the death rate per 100,000 was 9.7 for Whites, 6.5 for Hispanics, and 4.7 for non-Hispanic Blacks.

Previous studies have shown that compared with White people, Black and Hispanic people are less likely to see a neurologist, owing to socioeconomic barriers. This suggests that White people may be more likely to receive a Parkinson’s disease diagnosis, the researchers noted.

“It’s important to continue to evaluate long-term trends in Parkinson’s death rates,” Dr. Bao said.

“This can inform future research that may help pinpoint why more people are dying of the disease. Also, updating vital statistics about Parkinson’s death rates may be used for priority setting and financing of health care and policy,” Dr. Bao added.
 

1.2 million patients by 2030

Reached for comment, James Beck, PhD, chief scientific officer for the Parkinson’s Foundation, said these findings are not surprising. “They are aligned with the work the Parkinson’s Foundation has done to show that the number of people with Parkinson’s disease has increased over time. We are working on an improved estimate of Parkinson’s disease incidence and predict that Parkinson’s disease will continue to rise as the population ages, so an increase in mortality rates would be expected,” Dr. Beck said.

He noted that much of the public health statistics regarding Parkinson’s disease are outdated and that the Parkinson’s Foundation has been partnering with others to update them.

“For instance, to calculate an accurate estimate of the prevalence of Parkinson’s disease, the Parkinson’s Foundation Prevalence Project was formed. The findings from this group demonstrated that the number of people living with Parkinson’s disease will rise to nearly 1.2 million by 2030, a substantial increase from the estimate of 930,000 for 2020,” Dr. Beck said.

“The overarching message is that more people are being diagnosed with Parkinson’s disease, not that more people are dying from the disease,” he added.

“Over the last 20 years, our understanding of Parkinson’s disease has changed and developed, so clinicians are more aware and better able to properly diagnose Parkinson’s disease. This could mean that the cause is likely due to an increase in diagnosis rates and better recognition of Parkinson’s disease, which would lead to higher rates of identifying Parkinson’s disease as a cause of death,” said Dr. Beck.

The study had no targeted funding. Dr. Bao and Dr. Beck have indicated no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The death rate from Parkinson’s disease has increased by about 63% over the past 2 decades in the United States, according to what investigators say is the most comprehensive study in the nation of temporal trends in Parkinson’s disease mortality.

“The reason behind the rising death rates from Parkinson’s disease is not clear at present and warrants further investigation,” Wei Bao, MD, PhD, associate professor in the department of epidemiology at the University of Iowa College of Public Health, in Iowa City, said in an interview. “We know that people are living longer and the general population is getting older, but that doesn’t fully explain the increase we saw in the death rate in people with Parkinson’s disease,” Dr. Bao added in a statement.

“Understanding why more people are dying from this disease is critical if we are going to reverse the trend,” Dr. Bao said.

The study was published online Oct. 27 in Neurology.

Long-term data

The researchers used data from the National Vital Statistics System to determine national trends in Parkinson’s disease mortality overall and in several key subgroups. The analyses included 479,059 people who died of Parkinson’s disease between 1999 and 2019.

Over the 21-year period, the age-adjusted mortality from Parkinson’s disease rose from 5.4 per 100,000 in 1999 to 8.8 per 100,000 in 2019. The average annual percent change (APC) was 2.4% for the entire period.

During the study period, the number of deaths from Parkinson’s disease more than doubled, from 14,593 to 35,311.

The death rate from Parkinson’s disease increased significantly across all age groups. The average APC was 5.0% among adults younger than 65 years, 1.9% among those aged 65-74 years, 2.2% among those 75-84 years, and 2.7% among those 85 and older.

The death rate increased in both men and women, but age-adjusted Parkinson’s disease mortality was twice as high in men as in women. The researchers say one possible explanation for the sex difference is estrogen, which leads to higher dopamine levels in areas of the brain that control motor responses and may protect women from Parkinson’s disease.

The study also showed that White people are more likely to die from Parkinson’s disease than persons of other racial and ethnic groups. In 2019, the death rate per 100,000 was 9.7 for Whites, 6.5 for Hispanics, and 4.7 for non-Hispanic Blacks.

Previous studies have shown that compared with White people, Black and Hispanic people are less likely to see a neurologist, owing to socioeconomic barriers. This suggests that White people may be more likely to receive a Parkinson’s disease diagnosis, the researchers noted.

“It’s important to continue to evaluate long-term trends in Parkinson’s death rates,” Dr. Bao said.

“This can inform future research that may help pinpoint why more people are dying of the disease. Also, updating vital statistics about Parkinson’s death rates may be used for priority setting and financing of health care and policy,” Dr. Bao added.
 

1.2 million patients by 2030

Reached for comment, James Beck, PhD, chief scientific officer for the Parkinson’s Foundation, said these findings are not surprising. “They are aligned with the work the Parkinson’s Foundation has done to show that the number of people with Parkinson’s disease has increased over time. We are working on an improved estimate of Parkinson’s disease incidence and predict that Parkinson’s disease will continue to rise as the population ages, so an increase in mortality rates would be expected,” Dr. Beck said.

He noted that much of the public health statistics regarding Parkinson’s disease are outdated and that the Parkinson’s Foundation has been partnering with others to update them.

“For instance, to calculate an accurate estimate of the prevalence of Parkinson’s disease, the Parkinson’s Foundation Prevalence Project was formed. The findings from this group demonstrated that the number of people living with Parkinson’s disease will rise to nearly 1.2 million by 2030, a substantial increase from the estimate of 930,000 for 2020,” Dr. Beck said.

“The overarching message is that more people are being diagnosed with Parkinson’s disease, not that more people are dying from the disease,” he added.

“Over the last 20 years, our understanding of Parkinson’s disease has changed and developed, so clinicians are more aware and better able to properly diagnose Parkinson’s disease. This could mean that the cause is likely due to an increase in diagnosis rates and better recognition of Parkinson’s disease, which would lead to higher rates of identifying Parkinson’s disease as a cause of death,” said Dr. Beck.

The study had no targeted funding. Dr. Bao and Dr. Beck have indicated no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The death rate from Parkinson’s disease has increased by about 63% over the past 2 decades in the United States, according to what investigators say is the most comprehensive study in the nation of temporal trends in Parkinson’s disease mortality.

“The reason behind the rising death rates from Parkinson’s disease is not clear at present and warrants further investigation,” Wei Bao, MD, PhD, associate professor in the department of epidemiology at the University of Iowa College of Public Health, in Iowa City, said in an interview. “We know that people are living longer and the general population is getting older, but that doesn’t fully explain the increase we saw in the death rate in people with Parkinson’s disease,” Dr. Bao added in a statement.

“Understanding why more people are dying from this disease is critical if we are going to reverse the trend,” Dr. Bao said.

The study was published online Oct. 27 in Neurology.

Long-term data

The researchers used data from the National Vital Statistics System to determine national trends in Parkinson’s disease mortality overall and in several key subgroups. The analyses included 479,059 people who died of Parkinson’s disease between 1999 and 2019.

Over the 21-year period, the age-adjusted mortality from Parkinson’s disease rose from 5.4 per 100,000 in 1999 to 8.8 per 100,000 in 2019. The average annual percent change (APC) was 2.4% for the entire period.

During the study period, the number of deaths from Parkinson’s disease more than doubled, from 14,593 to 35,311.

The death rate from Parkinson’s disease increased significantly across all age groups. The average APC was 5.0% among adults younger than 65 years, 1.9% among those aged 65-74 years, 2.2% among those 75-84 years, and 2.7% among those 85 and older.

The death rate increased in both men and women, but age-adjusted Parkinson’s disease mortality was twice as high in men as in women. The researchers say one possible explanation for the sex difference is estrogen, which leads to higher dopamine levels in areas of the brain that control motor responses and may protect women from Parkinson’s disease.

The study also showed that White people are more likely to die from Parkinson’s disease than persons of other racial and ethnic groups. In 2019, the death rate per 100,000 was 9.7 for Whites, 6.5 for Hispanics, and 4.7 for non-Hispanic Blacks.

Previous studies have shown that compared with White people, Black and Hispanic people are less likely to see a neurologist, owing to socioeconomic barriers. This suggests that White people may be more likely to receive a Parkinson’s disease diagnosis, the researchers noted.

“It’s important to continue to evaluate long-term trends in Parkinson’s death rates,” Dr. Bao said.

“This can inform future research that may help pinpoint why more people are dying of the disease. Also, updating vital statistics about Parkinson’s death rates may be used for priority setting and financing of health care and policy,” Dr. Bao added.
 

1.2 million patients by 2030

Reached for comment, James Beck, PhD, chief scientific officer for the Parkinson’s Foundation, said these findings are not surprising. “They are aligned with the work the Parkinson’s Foundation has done to show that the number of people with Parkinson’s disease has increased over time. We are working on an improved estimate of Parkinson’s disease incidence and predict that Parkinson’s disease will continue to rise as the population ages, so an increase in mortality rates would be expected,” Dr. Beck said.

He noted that much of the public health statistics regarding Parkinson’s disease are outdated and that the Parkinson’s Foundation has been partnering with others to update them.

“For instance, to calculate an accurate estimate of the prevalence of Parkinson’s disease, the Parkinson’s Foundation Prevalence Project was formed. The findings from this group demonstrated that the number of people living with Parkinson’s disease will rise to nearly 1.2 million by 2030, a substantial increase from the estimate of 930,000 for 2020,” Dr. Beck said.

“The overarching message is that more people are being diagnosed with Parkinson’s disease, not that more people are dying from the disease,” he added.

“Over the last 20 years, our understanding of Parkinson’s disease has changed and developed, so clinicians are more aware and better able to properly diagnose Parkinson’s disease. This could mean that the cause is likely due to an increase in diagnosis rates and better recognition of Parkinson’s disease, which would lead to higher rates of identifying Parkinson’s disease as a cause of death,” said Dr. Beck.

The study had no targeted funding. Dr. Bao and Dr. Beck have indicated no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.