New research offers more insight into potentially dangerous racial disparities in cesarean deliveries: In first-time live births, healthy African-American and Hispanic mothers were 21% and 26% more likely than White mothers, respectively, to deliver by cesarean section despite being low risk. The higher number of cesareans appeared to boost their risk of morbidity.

“A 20% increased odds of cesarean among otherwise healthy, low-risk, nulliparous individuals at term – with limited medical or obstetric explanation – is a significant concern, especially when considering that cesarean is the most common surgical procedure in the U.S.,” said study author Michelle P. Debbink, MD, PhD, an assistant professor with the department of obstetrics and gynecology at the University of Utah, in an interview.

Dr. Debbink and colleagues launched the study, published in the Jan. 2022 issue of Obstetrics & Gynecology, to better understand the racial gap in cesarean sections, which are considered riskier than vaginal deliveries. “Several studies have shown that Black women undergo cesarean more frequently than non-Hispanic White women. Numerous studies also show that Hispanic/Latina women undergo cesarean more frequently than White women, although these data are a bit more mixed,” she said. “What we don’t know, however, is why these differences occur and whether there are clues in the data which can point us toward interventions to close the gap.”

One theory, she said, is that Black and Hispanic women have more comorbidities and therefore more cesareans. To test that idea, the researchers found a cohort of healthy women in a randomized trial that studied the induction of labor.

For the study, they focused on 5,759 women (24.3% Black, 30% Hispanic, 46.6% White). Major differences between the groups included maternal age (average = 21 for Black, 22 for Hispanic, and 26 for White, P < .001), private insurance (17% for Black and Hispanic, 75% for White; P < .001), and full or part-time employment (37% for Black, 31% for Hispanic, and 71% for White; P < .001).

A total of 1,158 of the women (20.1%) underwent cesarean deliveries, accounting for 23% of deliveries by Black women, 22.8% of those by Hispanic women, and 17.6% of those by White women (P < .001). Black women were 21% more likely than White women to give birth via cesarean (adjusted relative risk = 1.21, 95% CI: 1.03-1.42) and Hispanic women were 26% more likely (aRR = 1.26, 95% CI: 1.08-1.46).

The study doesn’t explore why Black and Hispanic women have more cesarean deliveries. However, Dr. Debbink said, “we hypothesize that the difference likely stems more from differing treatment of Black or Hispanic individuals during labor.” It’s unlikely, she said, that these women are more likely to prefer cesarean sections. For one thing, she said, other research hasn’t shown a difference in preferences by race.

The researchers also analyzed maternal morbidity, defined as “transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death.”

The study found that while few women (2.3%) suffered from morbidity, Black (aRR = 2.05, 95% CI: 1.21-3.47) and Hispanic (aRR = 1.92, 95% CI: 1.17-3.14) women were more likely to suffer from it than White women.

The researchers report that “cesarean birth accounted for an estimated 15.8% (95% CI: 2.1%-48.7%) and 16.5% (95% CI: 4.0%-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.”

“Both endometritis and wound complications are much more common among individuals with cesarean, and blood clots, hysterectomy, and ICU admission are also more common after cesarean compared with vaginal delivery,” Dr. Debbink said.

The message of the study, she said, is that the health care system “perpetuates gaps in cesarean delivery for Black and Hispanic individuals compared to White individuals” even in low-risk, first-time live births. “We do not yet know exactly what the right levers are to address this gap, but it is important that we ob-gyns examine our practice patterns and our hospitals’ practice patterns to ensure equity for all our patients.”

Rebecca Delafield, PhD, an assistant professor of Native Hawaiian Health at the University of Hawaii, praised the study as “well-conducted” in an interview. “I agree with the assessment that while the cesarean delivery accounts for a modest proportion of excess morbidity in this study, the impact at the population level is significant,” said Dr. Delafield, who studies health disparities and didn’t take part in the study. “Delivery is complex and the causes of disparities observed are likely multifactorial, therefore research such as this is necessary and compelling.”

She added: “It is becoming increasingly evident that studies investigating racial/ethnic disparities in cesarean delivery and other maternal health outcomes must look beyond maternal behavioral or medical risk factors – e.g., obesity or hypertension – and consider the contribution of a broader set of factors, including societal prejudices.”

The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. One study author reports funding from GlaxoSmithKline, Pfizer, Moderna, and UpToDate (contributor) and from the Centers for Disease Control and Prevention (via her institution). Dr. Debbink, the other authors, and Dr. Delafield report no disclosures.

New research offers more insight into potentially dangerous racial disparities in cesarean deliveries: In first-time live births, healthy African-American and Hispanic mothers were 21% and 26% more likely than White mothers, respectively, to deliver by cesarean section despite being low risk. The higher number of cesareans appeared to boost their risk of morbidity.

“A 20% increased odds of cesarean among otherwise healthy, low-risk, nulliparous individuals at term – with limited medical or obstetric explanation – is a significant concern, especially when considering that cesarean is the most common surgical procedure in the U.S.,” said study author Michelle P. Debbink, MD, PhD, an assistant professor with the department of obstetrics and gynecology at the University of Utah, in an interview.

Dr. Debbink and colleagues launched the study, published in the Jan. 2022 issue of Obstetrics & Gynecology, to better understand the racial gap in cesarean sections, which are considered riskier than vaginal deliveries. “Several studies have shown that Black women undergo cesarean more frequently than non-Hispanic White women. Numerous studies also show that Hispanic/Latina women undergo cesarean more frequently than White women, although these data are a bit more mixed,” she said. “What we don’t know, however, is why these differences occur and whether there are clues in the data which can point us toward interventions to close the gap.”

One theory, she said, is that Black and Hispanic women have more comorbidities and therefore more cesareans. To test that idea, the researchers found a cohort of healthy women in a randomized trial that studied the induction of labor.

For the study, they focused on 5,759 women (24.3% Black, 30% Hispanic, 46.6% White). Major differences between the groups included maternal age (average = 21 for Black, 22 for Hispanic, and 26 for White, P < .001), private insurance (17% for Black and Hispanic, 75% for White; P < .001), and full or part-time employment (37% for Black, 31% for Hispanic, and 71% for White; P < .001).

A total of 1,158 of the women (20.1%) underwent cesarean deliveries, accounting for 23% of deliveries by Black women, 22.8% of those by Hispanic women, and 17.6% of those by White women (P < .001). Black women were 21% more likely than White women to give birth via cesarean (adjusted relative risk = 1.21, 95% CI: 1.03-1.42) and Hispanic women were 26% more likely (aRR = 1.26, 95% CI: 1.08-1.46).

The study doesn’t explore why Black and Hispanic women have more cesarean deliveries. However, Dr. Debbink said, “we hypothesize that the difference likely stems more from differing treatment of Black or Hispanic individuals during labor.” It’s unlikely, she said, that these women are more likely to prefer cesarean sections. For one thing, she said, other research hasn’t shown a difference in preferences by race.

The researchers also analyzed maternal morbidity, defined as “transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death.”

The study found that while few women (2.3%) suffered from morbidity, Black (aRR = 2.05, 95% CI: 1.21-3.47) and Hispanic (aRR = 1.92, 95% CI: 1.17-3.14) women were more likely to suffer from it than White women.

The researchers report that “cesarean birth accounted for an estimated 15.8% (95% CI: 2.1%-48.7%) and 16.5% (95% CI: 4.0%-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.”

“Both endometritis and wound complications are much more common among individuals with cesarean, and blood clots, hysterectomy, and ICU admission are also more common after cesarean compared with vaginal delivery,” Dr. Debbink said.

The message of the study, she said, is that the health care system “perpetuates gaps in cesarean delivery for Black and Hispanic individuals compared to White individuals” even in low-risk, first-time live births. “We do not yet know exactly what the right levers are to address this gap, but it is important that we ob-gyns examine our practice patterns and our hospitals’ practice patterns to ensure equity for all our patients.”

Rebecca Delafield, PhD, an assistant professor of Native Hawaiian Health at the University of Hawaii, praised the study as “well-conducted” in an interview. “I agree with the assessment that while the cesarean delivery accounts for a modest proportion of excess morbidity in this study, the impact at the population level is significant,” said Dr. Delafield, who studies health disparities and didn’t take part in the study. “Delivery is complex and the causes of disparities observed are likely multifactorial, therefore research such as this is necessary and compelling.”

She added: “It is becoming increasingly evident that studies investigating racial/ethnic disparities in cesarean delivery and other maternal health outcomes must look beyond maternal behavioral or medical risk factors – e.g., obesity or hypertension – and consider the contribution of a broader set of factors, including societal prejudices.”

The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. One study author reports funding from GlaxoSmithKline, Pfizer, Moderna, and UpToDate (contributor) and from the Centers for Disease Control and Prevention (via her institution). Dr. Debbink, the other authors, and Dr. Delafield report no disclosures.

New research offers more insight into potentially dangerous racial disparities in cesarean deliveries: In first-time live births, healthy African-American and Hispanic mothers were 21% and 26% more likely than White mothers, respectively, to deliver by cesarean section despite being low risk. The higher number of cesareans appeared to boost their risk of morbidity.

“A 20% increased odds of cesarean among otherwise healthy, low-risk, nulliparous individuals at term – with limited medical or obstetric explanation – is a significant concern, especially when considering that cesarean is the most common surgical procedure in the U.S.,” said study author Michelle P. Debbink, MD, PhD, an assistant professor with the department of obstetrics and gynecology at the University of Utah, in an interview.

Dr. Debbink and colleagues launched the study, published in the Jan. 2022 issue of Obstetrics & Gynecology, to better understand the racial gap in cesarean sections, which are considered riskier than vaginal deliveries. “Several studies have shown that Black women undergo cesarean more frequently than non-Hispanic White women. Numerous studies also show that Hispanic/Latina women undergo cesarean more frequently than White women, although these data are a bit more mixed,” she said. “What we don’t know, however, is why these differences occur and whether there are clues in the data which can point us toward interventions to close the gap.”

One theory, she said, is that Black and Hispanic women have more comorbidities and therefore more cesareans. To test that idea, the researchers found a cohort of healthy women in a randomized trial that studied the induction of labor.

For the study, they focused on 5,759 women (24.3% Black, 30% Hispanic, 46.6% White). Major differences between the groups included maternal age (average = 21 for Black, 22 for Hispanic, and 26 for White, P < .001), private insurance (17% for Black and Hispanic, 75% for White; P < .001), and full or part-time employment (37% for Black, 31% for Hispanic, and 71% for White; P < .001).

A total of 1,158 of the women (20.1%) underwent cesarean deliveries, accounting for 23% of deliveries by Black women, 22.8% of those by Hispanic women, and 17.6% of those by White women (P < .001). Black women were 21% more likely than White women to give birth via cesarean (adjusted relative risk = 1.21, 95% CI: 1.03-1.42) and Hispanic women were 26% more likely (aRR = 1.26, 95% CI: 1.08-1.46).

The study doesn’t explore why Black and Hispanic women have more cesarean deliveries. However, Dr. Debbink said, “we hypothesize that the difference likely stems more from differing treatment of Black or Hispanic individuals during labor.” It’s unlikely, she said, that these women are more likely to prefer cesarean sections. For one thing, she said, other research hasn’t shown a difference in preferences by race.

The researchers also analyzed maternal morbidity, defined as “transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death.”

The study found that while few women (2.3%) suffered from morbidity, Black (aRR = 2.05, 95% CI: 1.21-3.47) and Hispanic (aRR = 1.92, 95% CI: 1.17-3.14) women were more likely to suffer from it than White women.

The researchers report that “cesarean birth accounted for an estimated 15.8% (95% CI: 2.1%-48.7%) and 16.5% (95% CI: 4.0%-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.”

“Both endometritis and wound complications are much more common among individuals with cesarean, and blood clots, hysterectomy, and ICU admission are also more common after cesarean compared with vaginal delivery,” Dr. Debbink said.

The message of the study, she said, is that the health care system “perpetuates gaps in cesarean delivery for Black and Hispanic individuals compared to White individuals” even in low-risk, first-time live births. “We do not yet know exactly what the right levers are to address this gap, but it is important that we ob-gyns examine our practice patterns and our hospitals’ practice patterns to ensure equity for all our patients.”

Rebecca Delafield, PhD, an assistant professor of Native Hawaiian Health at the University of Hawaii, praised the study as “well-conducted” in an interview. “I agree with the assessment that while the cesarean delivery accounts for a modest proportion of excess morbidity in this study, the impact at the population level is significant,” said Dr. Delafield, who studies health disparities and didn’t take part in the study. “Delivery is complex and the causes of disparities observed are likely multifactorial, therefore research such as this is necessary and compelling.”

She added: “It is becoming increasingly evident that studies investigating racial/ethnic disparities in cesarean delivery and other maternal health outcomes must look beyond maternal behavioral or medical risk factors – e.g., obesity or hypertension – and consider the contribution of a broader set of factors, including societal prejudices.”

The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. One study author reports funding from GlaxoSmithKline, Pfizer, Moderna, and UpToDate (contributor) and from the Centers for Disease Control and Prevention (via her institution). Dr. Debbink, the other authors, and Dr. Delafield report no disclosures.

Atopic dermatitis (AD) may be especially active and severe among older adults, and it may be associated with increased risk of comorbid conditions common in later stages of life, including osteoporosis, dementia, and cardiovascular disease.

During the Revolutionizing Atopic Dermatitis virtual symposium, Katrina Abuabara, MD, highlighted the epidemiology and burden of AD among older adults. She began by noting that the disease peaks in infancy and older adulthood. In an analysis that she and her colleagues made of physician-diagnosed AD among more than 8.6 million patients in the United Kingdom between 1994 and 2013, the mean prevalence in a given year was 12.3% among those aged 0-17 years, 5.1% among those age 18-74 years, and 8.7% among those age 75 and older.

“We saw what we expected in early infancy with very high rates of active disease,” said Dr. Abuabara, associate professor of dermatology and epidemiology at the University of California, San Francisco. “We also saw a second peak in older adulthood. This was more surprising to us because the disease hadn’t been as well studied in this population.” Researchers who analyzed data from the Global Burden of Disease Study, which evaluates disease-related morbidity and mortality worldwide, found a somewhat attenuated peak but a similar trend around the world. Its authors ranked AD as 15th among all nonfatal diseases.

In a separate analysis, Dr. Abuabara and colleagues evaluated records of more than 9.1 million primary care patients in the United Kingdom between 1994 and 2013, and who were followed for an average of 6 years. They examined AD activity and found that, based on doctor visits and prescriptions, AD appeared to be active in 48% of those aged 0-17 years, compared with 42% of those aged 18-74 years, and 60% of those aged 75 years and older. “Also, when we looked at the distribution of active disease in older adults, we saw that those who were older had more severe disease,” she said. When they evaluated the prevalence of AD by sociodemographic factors, AD increased with age among older adults (adjusted odd ratio, 1.06), while it decreased by 14% annually among children. In addition, female older adults had about three-fourths the odds of prevalent disease as their male counterparts (aOR, 0.73).

“We also looked at rural and urban differences and found that across ages it was more common in urban as compared to rural populations,” she said. “As for socioeconomic status, it tends to be more common among those of higher socioeconomic status in children and in the older adult group.”

In a study that drew from medical records of 3.85 million primary care patients in the United Kingdom, AD was more common in Asian and Black ethnic groups than in people of White ethnicity. In addition, higher socioeconomic status was associated with a greater incidence of eczema in infants aged younger than 2 years, but the reverse was seen for all other age groups.

To identify subtypes of atopic eczema based on patterns of disease activity through mid-adulthood, Dr. Abuabara and colleagues evaluated members of two population-based birth cohorts: the 1958 National Childhood Development Study and the 1970 British Cohort Study. The patients were classified into one of four patters of disease activity followed to age 50: rare/none, increasing, decreasing, and high. “We found that there was the early-onset decreasing subgroup, which tend to have a lower probability of AD over time,” Dr. Abuabara said. “We also found that there was a small subgroup that had a constant high probability of AD over time. But we were surprised to find a subgroup with increasing probability over time. This was a fairly sizable subgroup.”

In an earlier study, she and her colleagues examined whether there were differences based on whether people had adult-onset or childhood-onset disease in the same two cohorts of U.K. patients. Those with childhood-onset disease had stronger associations with known genetic risk factors and they tended to be of higher socioeconomic status. “They also tended to have more asthma and other allergic comorbidities,” Dr. Abuabara said. “On the other hand, the adult-onset group [after age 23] were more likely to be female, more likely to be smokers, and tended to have lower childhood socioeconomic status.”

According to the best available evidence, she continued, there is good data on higher relative risk of osteoporosis/fractures and dementia specifically among older adults with AD, and good data on associations with cardiometabolic disease and atopic disease among adults overall, as well as data showing that AD does not seem to be associated with cancer overall. In a study conducted by Jonathan I. Silverberg, MD, PhD, MPH, and Mohammed S. Shaheen, JD, the researchers used physician-diagnosed AD to investigate the associations of osteopenia and osteoporosis in two large U.S. databases: the 2006-2012 Nationwide Emergency Department Sample (NEDS) database and 2002-2012 National Inpatient Sample (NIS). Among patients aged 50 years and older, AD was associated with a higher odds of osteoporosis in NEDS (aOR, 1.31) and NIS (aOR, 1.25) and osteopenia in NEDS (aOR, 1.86).

In a separate matched cohort study, Dr. Abuabara and colleagues used U.K. primary care patient data to evaluate the association between AD and fracture and whether fracture risk varies with AD severity. Overall, they observed a 10% increase in fracture risk among people with AD, compared with those without, especially those of the hip, spine, pelvis, and wrist. “We found that there was a dose-response effect,” she said. “Those with more severe eczema had a much higher risk of fractures. When we looked at different age groups, we found a similar increased risk in the oldest adults as in younger adults.”

In a longitudinal cohort study of primary care medical records from more than 1.1 million individuals in the United Kingdom, AD was associated with an increased risk of vascular dementia (hazard ratio, 1.88), Alzheimer’s disease (HR, 1.69, and other/unspecified dementia (HR, 1.48; .269). “We found a nice dose response, where people with more severe AD had higher rates of dementia,” Dr. Abuabara said. Results from a more recent, smaller study of patients in Taiwan also found an increased risk between AD and the risk of dementia, but not a dose-response effect, likely because of a much smaller sample size.

Mounting research suggests that the risk for cardiovascular disease is also elevated in patients with AD. “There is some variability in the literature, but I think it’s important that when we’re talking about atopic dermatitis to think about the heterogeneity of the disease,” Dr. Abuabara said. In a meta-analysis and systematic review of 19 studies on the topic, she and her colleagues found that AD was associated with an increased risk of myocardial infarction (relative risk, 1.12), stroke (RR, 1.10), ischemic stroke (RR, 1.17), angina (RR, 1.18), and heart failure (RR, 1.26). “For all the different [cardiovascular disease] outcomes there was increasing risk with increasing disease severity,” she said.

She reported that UCSF receives research funding from Pfizer and Cosmetique Active International. She also receives consulting fees from Target RWE.

[email protected]

Atopic dermatitis (AD) may be especially active and severe among older adults, and it may be associated with increased risk of comorbid conditions common in later stages of life, including osteoporosis, dementia, and cardiovascular disease.

During the Revolutionizing Atopic Dermatitis virtual symposium, Katrina Abuabara, MD, highlighted the epidemiology and burden of AD among older adults. She began by noting that the disease peaks in infancy and older adulthood. In an analysis that she and her colleagues made of physician-diagnosed AD among more than 8.6 million patients in the United Kingdom between 1994 and 2013, the mean prevalence in a given year was 12.3% among those aged 0-17 years, 5.1% among those age 18-74 years, and 8.7% among those age 75 and older.

“We saw what we expected in early infancy with very high rates of active disease,” said Dr. Abuabara, associate professor of dermatology and epidemiology at the University of California, San Francisco. “We also saw a second peak in older adulthood. This was more surprising to us because the disease hadn’t been as well studied in this population.” Researchers who analyzed data from the Global Burden of Disease Study, which evaluates disease-related morbidity and mortality worldwide, found a somewhat attenuated peak but a similar trend around the world. Its authors ranked AD as 15th among all nonfatal diseases.

In a separate analysis, Dr. Abuabara and colleagues evaluated records of more than 9.1 million primary care patients in the United Kingdom between 1994 and 2013, and who were followed for an average of 6 years. They examined AD activity and found that, based on doctor visits and prescriptions, AD appeared to be active in 48% of those aged 0-17 years, compared with 42% of those aged 18-74 years, and 60% of those aged 75 years and older. “Also, when we looked at the distribution of active disease in older adults, we saw that those who were older had more severe disease,” she said. When they evaluated the prevalence of AD by sociodemographic factors, AD increased with age among older adults (adjusted odd ratio, 1.06), while it decreased by 14% annually among children. In addition, female older adults had about three-fourths the odds of prevalent disease as their male counterparts (aOR, 0.73).

“We also looked at rural and urban differences and found that across ages it was more common in urban as compared to rural populations,” she said. “As for socioeconomic status, it tends to be more common among those of higher socioeconomic status in children and in the older adult group.”

In a study that drew from medical records of 3.85 million primary care patients in the United Kingdom, AD was more common in Asian and Black ethnic groups than in people of White ethnicity. In addition, higher socioeconomic status was associated with a greater incidence of eczema in infants aged younger than 2 years, but the reverse was seen for all other age groups.

To identify subtypes of atopic eczema based on patterns of disease activity through mid-adulthood, Dr. Abuabara and colleagues evaluated members of two population-based birth cohorts: the 1958 National Childhood Development Study and the 1970 British Cohort Study. The patients were classified into one of four patters of disease activity followed to age 50: rare/none, increasing, decreasing, and high. “We found that there was the early-onset decreasing subgroup, which tend to have a lower probability of AD over time,” Dr. Abuabara said. “We also found that there was a small subgroup that had a constant high probability of AD over time. But we were surprised to find a subgroup with increasing probability over time. This was a fairly sizable subgroup.”

In an earlier study, she and her colleagues examined whether there were differences based on whether people had adult-onset or childhood-onset disease in the same two cohorts of U.K. patients. Those with childhood-onset disease had stronger associations with known genetic risk factors and they tended to be of higher socioeconomic status. “They also tended to have more asthma and other allergic comorbidities,” Dr. Abuabara said. “On the other hand, the adult-onset group [after age 23] were more likely to be female, more likely to be smokers, and tended to have lower childhood socioeconomic status.”

According to the best available evidence, she continued, there is good data on higher relative risk of osteoporosis/fractures and dementia specifically among older adults with AD, and good data on associations with cardiometabolic disease and atopic disease among adults overall, as well as data showing that AD does not seem to be associated with cancer overall. In a study conducted by Jonathan I. Silverberg, MD, PhD, MPH, and Mohammed S. Shaheen, JD, the researchers used physician-diagnosed AD to investigate the associations of osteopenia and osteoporosis in two large U.S. databases: the 2006-2012 Nationwide Emergency Department Sample (NEDS) database and 2002-2012 National Inpatient Sample (NIS). Among patients aged 50 years and older, AD was associated with a higher odds of osteoporosis in NEDS (aOR, 1.31) and NIS (aOR, 1.25) and osteopenia in NEDS (aOR, 1.86).

In a separate matched cohort study, Dr. Abuabara and colleagues used U.K. primary care patient data to evaluate the association between AD and fracture and whether fracture risk varies with AD severity. Overall, they observed a 10% increase in fracture risk among people with AD, compared with those without, especially those of the hip, spine, pelvis, and wrist. “We found that there was a dose-response effect,” she said. “Those with more severe eczema had a much higher risk of fractures. When we looked at different age groups, we found a similar increased risk in the oldest adults as in younger adults.”

In a longitudinal cohort study of primary care medical records from more than 1.1 million individuals in the United Kingdom, AD was associated with an increased risk of vascular dementia (hazard ratio, 1.88), Alzheimer’s disease (HR, 1.69, and other/unspecified dementia (HR, 1.48; .269). “We found a nice dose response, where people with more severe AD had higher rates of dementia,” Dr. Abuabara said. Results from a more recent, smaller study of patients in Taiwan also found an increased risk between AD and the risk of dementia, but not a dose-response effect, likely because of a much smaller sample size.

Mounting research suggests that the risk for cardiovascular disease is also elevated in patients with AD. “There is some variability in the literature, but I think it’s important that when we’re talking about atopic dermatitis to think about the heterogeneity of the disease,” Dr. Abuabara said. In a meta-analysis and systematic review of 19 studies on the topic, she and her colleagues found that AD was associated with an increased risk of myocardial infarction (relative risk, 1.12), stroke (RR, 1.10), ischemic stroke (RR, 1.17), angina (RR, 1.18), and heart failure (RR, 1.26). “For all the different [cardiovascular disease] outcomes there was increasing risk with increasing disease severity,” she said.

She reported that UCSF receives research funding from Pfizer and Cosmetique Active International. She also receives consulting fees from Target RWE.

[email protected]

Atopic dermatitis (AD) may be especially active and severe among older adults, and it may be associated with increased risk of comorbid conditions common in later stages of life, including osteoporosis, dementia, and cardiovascular disease.

During the Revolutionizing Atopic Dermatitis virtual symposium, Katrina Abuabara, MD, highlighted the epidemiology and burden of AD among older adults. She began by noting that the disease peaks in infancy and older adulthood. In an analysis that she and her colleagues made of physician-diagnosed AD among more than 8.6 million patients in the United Kingdom between 1994 and 2013, the mean prevalence in a given year was 12.3% among those aged 0-17 years, 5.1% among those age 18-74 years, and 8.7% among those age 75 and older.

“We saw what we expected in early infancy with very high rates of active disease,” said Dr. Abuabara, associate professor of dermatology and epidemiology at the University of California, San Francisco. “We also saw a second peak in older adulthood. This was more surprising to us because the disease hadn’t been as well studied in this population.” Researchers who analyzed data from the Global Burden of Disease Study, which evaluates disease-related morbidity and mortality worldwide, found a somewhat attenuated peak but a similar trend around the world. Its authors ranked AD as 15th among all nonfatal diseases.

In a separate analysis, Dr. Abuabara and colleagues evaluated records of more than 9.1 million primary care patients in the United Kingdom between 1994 and 2013, and who were followed for an average of 6 years. They examined AD activity and found that, based on doctor visits and prescriptions, AD appeared to be active in 48% of those aged 0-17 years, compared with 42% of those aged 18-74 years, and 60% of those aged 75 years and older. “Also, when we looked at the distribution of active disease in older adults, we saw that those who were older had more severe disease,” she said. When they evaluated the prevalence of AD by sociodemographic factors, AD increased with age among older adults (adjusted odd ratio, 1.06), while it decreased by 14% annually among children. In addition, female older adults had about three-fourths the odds of prevalent disease as their male counterparts (aOR, 0.73).

“We also looked at rural and urban differences and found that across ages it was more common in urban as compared to rural populations,” she said. “As for socioeconomic status, it tends to be more common among those of higher socioeconomic status in children and in the older adult group.”

In a study that drew from medical records of 3.85 million primary care patients in the United Kingdom, AD was more common in Asian and Black ethnic groups than in people of White ethnicity. In addition, higher socioeconomic status was associated with a greater incidence of eczema in infants aged younger than 2 years, but the reverse was seen for all other age groups.

To identify subtypes of atopic eczema based on patterns of disease activity through mid-adulthood, Dr. Abuabara and colleagues evaluated members of two population-based birth cohorts: the 1958 National Childhood Development Study and the 1970 British Cohort Study. The patients were classified into one of four patters of disease activity followed to age 50: rare/none, increasing, decreasing, and high. “We found that there was the early-onset decreasing subgroup, which tend to have a lower probability of AD over time,” Dr. Abuabara said. “We also found that there was a small subgroup that had a constant high probability of AD over time. But we were surprised to find a subgroup with increasing probability over time. This was a fairly sizable subgroup.”

In an earlier study, she and her colleagues examined whether there were differences based on whether people had adult-onset or childhood-onset disease in the same two cohorts of U.K. patients. Those with childhood-onset disease had stronger associations with known genetic risk factors and they tended to be of higher socioeconomic status. “They also tended to have more asthma and other allergic comorbidities,” Dr. Abuabara said. “On the other hand, the adult-onset group [after age 23] were more likely to be female, more likely to be smokers, and tended to have lower childhood socioeconomic status.”

According to the best available evidence, she continued, there is good data on higher relative risk of osteoporosis/fractures and dementia specifically among older adults with AD, and good data on associations with cardiometabolic disease and atopic disease among adults overall, as well as data showing that AD does not seem to be associated with cancer overall. In a study conducted by Jonathan I. Silverberg, MD, PhD, MPH, and Mohammed S. Shaheen, JD, the researchers used physician-diagnosed AD to investigate the associations of osteopenia and osteoporosis in two large U.S. databases: the 2006-2012 Nationwide Emergency Department Sample (NEDS) database and 2002-2012 National Inpatient Sample (NIS). Among patients aged 50 years and older, AD was associated with a higher odds of osteoporosis in NEDS (aOR, 1.31) and NIS (aOR, 1.25) and osteopenia in NEDS (aOR, 1.86).

In a separate matched cohort study, Dr. Abuabara and colleagues used U.K. primary care patient data to evaluate the association between AD and fracture and whether fracture risk varies with AD severity. Overall, they observed a 10% increase in fracture risk among people with AD, compared with those without, especially those of the hip, spine, pelvis, and wrist. “We found that there was a dose-response effect,” she said. “Those with more severe eczema had a much higher risk of fractures. When we looked at different age groups, we found a similar increased risk in the oldest adults as in younger adults.”

In a longitudinal cohort study of primary care medical records from more than 1.1 million individuals in the United Kingdom, AD was associated with an increased risk of vascular dementia (hazard ratio, 1.88), Alzheimer’s disease (HR, 1.69, and other/unspecified dementia (HR, 1.48; .269). “We found a nice dose response, where people with more severe AD had higher rates of dementia,” Dr. Abuabara said. Results from a more recent, smaller study of patients in Taiwan also found an increased risk between AD and the risk of dementia, but not a dose-response effect, likely because of a much smaller sample size.

Mounting research suggests that the risk for cardiovascular disease is also elevated in patients with AD. “There is some variability in the literature, but I think it’s important that when we’re talking about atopic dermatitis to think about the heterogeneity of the disease,” Dr. Abuabara said. In a meta-analysis and systematic review of 19 studies on the topic, she and her colleagues found that AD was associated with an increased risk of myocardial infarction (relative risk, 1.12), stroke (RR, 1.10), ischemic stroke (RR, 1.17), angina (RR, 1.18), and heart failure (RR, 1.26). “For all the different [cardiovascular disease] outcomes there was increasing risk with increasing disease severity,” she said.

She reported that UCSF receives research funding from Pfizer and Cosmetique Active International. She also receives consulting fees from Target RWE.

[email protected]

A new meta-analysis suggests the risk for violence is higher in patients with schizophrenia, but some experts beg to differ, calling out study limitations and urging caution when interpreting the findings.

The study suggests patients with schizophrenia spectrum disorder (SSD) are 4.5 times more likely than individuals in the general population to perpetrate violence against others.

While the results showed comorbid substance misuse was associated with a significantly increased risk for violence in those with SSD, data on medication nonadherence, prior exposure to violence, childhood trauma, or other known risk factors were not included in the study.

“I think one of the main implications of this study is that prevention of violence outcomes really should be a focus for clinical services, because these are important outcomes to prevent and many of the factors that increase risk are modifiable, such as substance misuse and treatment adherence,” study coinvestigator Seena Fazel, MD, professor of forensic psychiatry at the University of Oxford (England), said in an interview.

Still, some experts urge caution when interpreting the findings, which they fear could perpetuate stigma against individuals with serious mental illness if not taken in the context of a study that shows association, not causation.

“While potential for violence is certainly a relevant consideration in assessing persons with schizophrenia spectrum disorder, it would be wrong to conclude from this study that schizophrenia spectrum disorders per se cause people to become violent,” said Ronald W. Pies, MD, professor emeritus of psychiatry at the State University of New York, Syracuse, who commented on the findings.

The findings were published online Dec. 22, 2021, in JAMA Psychiatry.
 

No causal link

The meta-analysis included 24 studies involving 51,309 individuals with SSD from 15 countries over 4 decades.

Risk for violence perpetrated by men with schizophrenia was 4.5 times higher (95% confidence interval, 3.6-5.6) than their counterparts in the general population. Among women, the rate was 10.2 times higher (95% CI, 7.1-14.6) versus those without SSD.

The odds of perpetrating sexual offenses (odds ratio, 5.1; 95% CI, 3.8-6.8) and homicide (OR, 17.7; 95% CI, 13.9-22.6) were also increased.

When restricting analysis to studies that used outcomes only from register-based sources, indicating a criminal arrest or conviction, absolute risks of violence perpetration ranged from 2.3% to 24.7% in men with SSD and from 0% to 5.4% in women up to a 35-year follow-up.

“That means that over a 35-year period most men are not going to be involved in these criminal register-based violent outcomes,” Dr. Fazel said. “And at least 90% of the women are not going to have any register-based violent outcomes.”

When accounting for substance use comorbidity, risk for violence perpetration dropped sharply. Those with no substance misuse were 3.5 times more likely than those in the general population to commit acts of violence versus 9.9 times in those with substance misuse comorbidity.

“In these subgroup studies of people with dual diagnoses of schizophrenia and substance misuse, the risk was increased 10-fold,” Dr. Fazel said. “If you look at people without substance misuse comorbidity, there remains a risk there of between three- to fourfold increase. It doesn’t explain the association completely.”

The investigators were quick to point out that this new study identifies an association between SSD and violence, and not causation.

“One important way to consider the association is to think of clinical services for people presenting with a schizophrenia spectrum disorder: Does the evidence suggest that violence is an important enough potential adverse outcome, for a minority of those individuals, such that support for this clinical need should be improved?” study investigator Daniel Whiting, BM BCh, a doctoral research fellow in psychiatry at the University of Oxford, said in an interview. “We highlight this as an implication of the findings.”

Whether the association would change if researchers controlled for substance misuse in both the study and control groups is unknown. Also unclear from this study is what impact other risk factors may have on increasing violent outcomes in individuals with SSD.
 

Education, treatment adherence important

Dr. Pies pointed out that, “notably, the risk for violence in the study population declined more than sixfold when comorbid substance abuse was excluded from the analysis.”

That aligns with an earlier study conducted in Sweden by Dr. Fazel, which showed that, after controlling for substance misuse, the rate of violent crime among individuals with schizophrenia was only slightly higher than in the general population.

“The fact is that people with schizophrenia who are compliant with proper medication do not commit violent acts any more than those in the general population,” Lynn DeLisi, MD, professor of psychiatry at Harvard Medical School, Boston, and founding editor of Schizophrenia Research, said in a comment.

Indeed, Dr. Fazel’s own research suggests treatment with antipsychotics cuts in half the risk for violent crime by patients with severe mental illness.

“The goal should be education of school officials, families, and primary care physicians to detect this illness early and treat it. Programs that make sure patients comply with medication once they begin it are equally important,” Dr. DeLisi said.

Treatment adherence is important, but the first step toward violence prevention is high-quality risk assessment, said Dr. Fazel. His research team has developed a web-based, free risk calculator shown to help clinicians evaluate the risk that a patient might become violent.

Dr. Pies agreed with the importance of comprehensive, clinical assessments of modifiable risk factors, including substance use, homelessness, medication adherence, and conflictual relationships.

This kind of assessment, “in my experience, is rarely carried out in most evaluations of persons with psychotic symptoms or SSD,” he said.
 

Perpetuating stigma?

Another concern raised by Dr. Pies and Dr. DeLisi is how the findings might perpetuate stigma toward individuals with serious mental illness. Results from a recently published study showed that, although attitudes toward those with major depression have improved in the United States over the past few decades, stigma toward those with schizophrenia has actually worsened.

The most effective approach to reducing stigma is to “face up to the evidence, then try and prevent the negative outcomes,” Dr. Fazel said.

“The conclusion of this paper is that it’s all pointing toward a strategy toward prevention by developing high-quality risk assessment and then developing high-quality treatment programs that include not just pharmacological treatments but psychosocial treatments and beyond,” he added. “We know that’s the way it works for other disorders as well.”

Although mental illness stigma is a serious problem, Dr. Pies noted, “the risk is not so much that studies of this sort are carried out and then covered in the media, but that they are decontextualized and reduced to ‘bumper sticker’ headlines.”

“The public needs context and perspective,” he said. “It needs to be informed that violent behavior is relatively rare among persons with psychiatric illness, including persons with schizophrenia and related disorders who do not also have a substance use disorder.”

Indeed, some studies have shown that individuals with mental illness are more often the victims of violence than the perpetrators.

“Frankly, the public is much more at risk from the neighborhood lout who drinks heavily and repeatedly starts bar fights than from the average patient with a schizophrenia spectrum disorder,” Dr. Pies said.

Dr. Fazel reported receiving funding from the Wellcome Trust. Dr. DeLisi and Dr. Pies disclosed no relevant financial relationships.

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

A new meta-analysis suggests the risk for violence is higher in patients with schizophrenia, but some experts beg to differ, calling out study limitations and urging caution when interpreting the findings.

The study suggests patients with schizophrenia spectrum disorder (SSD) are 4.5 times more likely than individuals in the general population to perpetrate violence against others.

While the results showed comorbid substance misuse was associated with a significantly increased risk for violence in those with SSD, data on medication nonadherence, prior exposure to violence, childhood trauma, or other known risk factors were not included in the study.

“I think one of the main implications of this study is that prevention of violence outcomes really should be a focus for clinical services, because these are important outcomes to prevent and many of the factors that increase risk are modifiable, such as substance misuse and treatment adherence,” study coinvestigator Seena Fazel, MD, professor of forensic psychiatry at the University of Oxford (England), said in an interview.

Still, some experts urge caution when interpreting the findings, which they fear could perpetuate stigma against individuals with serious mental illness if not taken in the context of a study that shows association, not causation.

“While potential for violence is certainly a relevant consideration in assessing persons with schizophrenia spectrum disorder, it would be wrong to conclude from this study that schizophrenia spectrum disorders per se cause people to become violent,” said Ronald W. Pies, MD, professor emeritus of psychiatry at the State University of New York, Syracuse, who commented on the findings.

The findings were published online Dec. 22, 2021, in JAMA Psychiatry.
 

No causal link

The meta-analysis included 24 studies involving 51,309 individuals with SSD from 15 countries over 4 decades.

Risk for violence perpetrated by men with schizophrenia was 4.5 times higher (95% confidence interval, 3.6-5.6) than their counterparts in the general population. Among women, the rate was 10.2 times higher (95% CI, 7.1-14.6) versus those without SSD.

The odds of perpetrating sexual offenses (odds ratio, 5.1; 95% CI, 3.8-6.8) and homicide (OR, 17.7; 95% CI, 13.9-22.6) were also increased.

When restricting analysis to studies that used outcomes only from register-based sources, indicating a criminal arrest or conviction, absolute risks of violence perpetration ranged from 2.3% to 24.7% in men with SSD and from 0% to 5.4% in women up to a 35-year follow-up.

“That means that over a 35-year period most men are not going to be involved in these criminal register-based violent outcomes,” Dr. Fazel said. “And at least 90% of the women are not going to have any register-based violent outcomes.”

When accounting for substance use comorbidity, risk for violence perpetration dropped sharply. Those with no substance misuse were 3.5 times more likely than those in the general population to commit acts of violence versus 9.9 times in those with substance misuse comorbidity.

“In these subgroup studies of people with dual diagnoses of schizophrenia and substance misuse, the risk was increased 10-fold,” Dr. Fazel said. “If you look at people without substance misuse comorbidity, there remains a risk there of between three- to fourfold increase. It doesn’t explain the association completely.”

The investigators were quick to point out that this new study identifies an association between SSD and violence, and not causation.

“One important way to consider the association is to think of clinical services for people presenting with a schizophrenia spectrum disorder: Does the evidence suggest that violence is an important enough potential adverse outcome, for a minority of those individuals, such that support for this clinical need should be improved?” study investigator Daniel Whiting, BM BCh, a doctoral research fellow in psychiatry at the University of Oxford, said in an interview. “We highlight this as an implication of the findings.”

Whether the association would change if researchers controlled for substance misuse in both the study and control groups is unknown. Also unclear from this study is what impact other risk factors may have on increasing violent outcomes in individuals with SSD.
 

Education, treatment adherence important

Dr. Pies pointed out that, “notably, the risk for violence in the study population declined more than sixfold when comorbid substance abuse was excluded from the analysis.”

That aligns with an earlier study conducted in Sweden by Dr. Fazel, which showed that, after controlling for substance misuse, the rate of violent crime among individuals with schizophrenia was only slightly higher than in the general population.

“The fact is that people with schizophrenia who are compliant with proper medication do not commit violent acts any more than those in the general population,” Lynn DeLisi, MD, professor of psychiatry at Harvard Medical School, Boston, and founding editor of Schizophrenia Research, said in a comment.

Indeed, Dr. Fazel’s own research suggests treatment with antipsychotics cuts in half the risk for violent crime by patients with severe mental illness.

“The goal should be education of school officials, families, and primary care physicians to detect this illness early and treat it. Programs that make sure patients comply with medication once they begin it are equally important,” Dr. DeLisi said.

Treatment adherence is important, but the first step toward violence prevention is high-quality risk assessment, said Dr. Fazel. His research team has developed a web-based, free risk calculator shown to help clinicians evaluate the risk that a patient might become violent.

Dr. Pies agreed with the importance of comprehensive, clinical assessments of modifiable risk factors, including substance use, homelessness, medication adherence, and conflictual relationships.

This kind of assessment, “in my experience, is rarely carried out in most evaluations of persons with psychotic symptoms or SSD,” he said.
 

Perpetuating stigma?

Another concern raised by Dr. Pies and Dr. DeLisi is how the findings might perpetuate stigma toward individuals with serious mental illness. Results from a recently published study showed that, although attitudes toward those with major depression have improved in the United States over the past few decades, stigma toward those with schizophrenia has actually worsened.

The most effective approach to reducing stigma is to “face up to the evidence, then try and prevent the negative outcomes,” Dr. Fazel said.

“The conclusion of this paper is that it’s all pointing toward a strategy toward prevention by developing high-quality risk assessment and then developing high-quality treatment programs that include not just pharmacological treatments but psychosocial treatments and beyond,” he added. “We know that’s the way it works for other disorders as well.”

Although mental illness stigma is a serious problem, Dr. Pies noted, “the risk is not so much that studies of this sort are carried out and then covered in the media, but that they are decontextualized and reduced to ‘bumper sticker’ headlines.”

“The public needs context and perspective,” he said. “It needs to be informed that violent behavior is relatively rare among persons with psychiatric illness, including persons with schizophrenia and related disorders who do not also have a substance use disorder.”

Indeed, some studies have shown that individuals with mental illness are more often the victims of violence than the perpetrators.

“Frankly, the public is much more at risk from the neighborhood lout who drinks heavily and repeatedly starts bar fights than from the average patient with a schizophrenia spectrum disorder,” Dr. Pies said.

Dr. Fazel reported receiving funding from the Wellcome Trust. Dr. DeLisi and Dr. Pies disclosed no relevant financial relationships.

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

A new meta-analysis suggests the risk for violence is higher in patients with schizophrenia, but some experts beg to differ, calling out study limitations and urging caution when interpreting the findings.

The study suggests patients with schizophrenia spectrum disorder (SSD) are 4.5 times more likely than individuals in the general population to perpetrate violence against others.

While the results showed comorbid substance misuse was associated with a significantly increased risk for violence in those with SSD, data on medication nonadherence, prior exposure to violence, childhood trauma, or other known risk factors were not included in the study.

“I think one of the main implications of this study is that prevention of violence outcomes really should be a focus for clinical services, because these are important outcomes to prevent and many of the factors that increase risk are modifiable, such as substance misuse and treatment adherence,” study coinvestigator Seena Fazel, MD, professor of forensic psychiatry at the University of Oxford (England), said in an interview.

Still, some experts urge caution when interpreting the findings, which they fear could perpetuate stigma against individuals with serious mental illness if not taken in the context of a study that shows association, not causation.

“While potential for violence is certainly a relevant consideration in assessing persons with schizophrenia spectrum disorder, it would be wrong to conclude from this study that schizophrenia spectrum disorders per se cause people to become violent,” said Ronald W. Pies, MD, professor emeritus of psychiatry at the State University of New York, Syracuse, who commented on the findings.

The findings were published online Dec. 22, 2021, in JAMA Psychiatry.
 

No causal link

The meta-analysis included 24 studies involving 51,309 individuals with SSD from 15 countries over 4 decades.

Risk for violence perpetrated by men with schizophrenia was 4.5 times higher (95% confidence interval, 3.6-5.6) than their counterparts in the general population. Among women, the rate was 10.2 times higher (95% CI, 7.1-14.6) versus those without SSD.

The odds of perpetrating sexual offenses (odds ratio, 5.1; 95% CI, 3.8-6.8) and homicide (OR, 17.7; 95% CI, 13.9-22.6) were also increased.

When restricting analysis to studies that used outcomes only from register-based sources, indicating a criminal arrest or conviction, absolute risks of violence perpetration ranged from 2.3% to 24.7% in men with SSD and from 0% to 5.4% in women up to a 35-year follow-up.

“That means that over a 35-year period most men are not going to be involved in these criminal register-based violent outcomes,” Dr. Fazel said. “And at least 90% of the women are not going to have any register-based violent outcomes.”

When accounting for substance use comorbidity, risk for violence perpetration dropped sharply. Those with no substance misuse were 3.5 times more likely than those in the general population to commit acts of violence versus 9.9 times in those with substance misuse comorbidity.

“In these subgroup studies of people with dual diagnoses of schizophrenia and substance misuse, the risk was increased 10-fold,” Dr. Fazel said. “If you look at people without substance misuse comorbidity, there remains a risk there of between three- to fourfold increase. It doesn’t explain the association completely.”

The investigators were quick to point out that this new study identifies an association between SSD and violence, and not causation.

“One important way to consider the association is to think of clinical services for people presenting with a schizophrenia spectrum disorder: Does the evidence suggest that violence is an important enough potential adverse outcome, for a minority of those individuals, such that support for this clinical need should be improved?” study investigator Daniel Whiting, BM BCh, a doctoral research fellow in psychiatry at the University of Oxford, said in an interview. “We highlight this as an implication of the findings.”

Whether the association would change if researchers controlled for substance misuse in both the study and control groups is unknown. Also unclear from this study is what impact other risk factors may have on increasing violent outcomes in individuals with SSD.
 

Education, treatment adherence important

Dr. Pies pointed out that, “notably, the risk for violence in the study population declined more than sixfold when comorbid substance abuse was excluded from the analysis.”

That aligns with an earlier study conducted in Sweden by Dr. Fazel, which showed that, after controlling for substance misuse, the rate of violent crime among individuals with schizophrenia was only slightly higher than in the general population.

“The fact is that people with schizophrenia who are compliant with proper medication do not commit violent acts any more than those in the general population,” Lynn DeLisi, MD, professor of psychiatry at Harvard Medical School, Boston, and founding editor of Schizophrenia Research, said in a comment.

Indeed, Dr. Fazel’s own research suggests treatment with antipsychotics cuts in half the risk for violent crime by patients with severe mental illness.

“The goal should be education of school officials, families, and primary care physicians to detect this illness early and treat it. Programs that make sure patients comply with medication once they begin it are equally important,” Dr. DeLisi said.

Treatment adherence is important, but the first step toward violence prevention is high-quality risk assessment, said Dr. Fazel. His research team has developed a web-based, free risk calculator shown to help clinicians evaluate the risk that a patient might become violent.

Dr. Pies agreed with the importance of comprehensive, clinical assessments of modifiable risk factors, including substance use, homelessness, medication adherence, and conflictual relationships.

This kind of assessment, “in my experience, is rarely carried out in most evaluations of persons with psychotic symptoms or SSD,” he said.
 

Perpetuating stigma?

Another concern raised by Dr. Pies and Dr. DeLisi is how the findings might perpetuate stigma toward individuals with serious mental illness. Results from a recently published study showed that, although attitudes toward those with major depression have improved in the United States over the past few decades, stigma toward those with schizophrenia has actually worsened.

The most effective approach to reducing stigma is to “face up to the evidence, then try and prevent the negative outcomes,” Dr. Fazel said.

“The conclusion of this paper is that it’s all pointing toward a strategy toward prevention by developing high-quality risk assessment and then developing high-quality treatment programs that include not just pharmacological treatments but psychosocial treatments and beyond,” he added. “We know that’s the way it works for other disorders as well.”

Although mental illness stigma is a serious problem, Dr. Pies noted, “the risk is not so much that studies of this sort are carried out and then covered in the media, but that they are decontextualized and reduced to ‘bumper sticker’ headlines.”

“The public needs context and perspective,” he said. “It needs to be informed that violent behavior is relatively rare among persons with psychiatric illness, including persons with schizophrenia and related disorders who do not also have a substance use disorder.”

Indeed, some studies have shown that individuals with mental illness are more often the victims of violence than the perpetrators.

“Frankly, the public is much more at risk from the neighborhood lout who drinks heavily and repeatedly starts bar fights than from the average patient with a schizophrenia spectrum disorder,” Dr. Pies said.

Dr. Fazel reported receiving funding from the Wellcome Trust. Dr. DeLisi and Dr. Pies disclosed no relevant financial relationships.

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

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

FROM THE LANCET PSYCHIATRY

Cessation of opioid agonist therapy (OAT) significantly increases the risk of self-harm and death by suicide in the first month after stopping the treatment in new findings that highlight the need for “advanced safety planning” during this critical time.

Investigators found that 4 weeks after stopping OAT, the risk of death by suicide was almost five times higher and the risk of hospital admission for self-harm was almost three times higher during this period, compared with the 4 weeks after initiation of OAT to treatment end.

These results highlight the importance of a “transition” period when stopping OAT and highlight the need for better supports for patients coming off this treatment, study investigator Prianka Padmanathan, MD, PhD candidate, Population Health Sciences, University of Bristol (England), told this news organization.

She noted the study supports previous findings that OAT “has an important role” in suicide prevention.

“Suicide and self-harm risk is greatly increased during treatment cessation, and advanced safety planning and additional psychosocial support during this time may be required,” Dr. Padmanathan said.

The findings were published online Dec. 15 in The Lancet Psychiatry.

Suicide, self-harm risk

Previous research shows an increased risk for overdose deaths and death in general during the first few weeks of starting and stopping treatment for opioid dependence.

“We wanted to see if the risk of dying by suicide was also elevated during these times,” said Dr. Padmanathan. As suicides are relatively rare, the researchers also looked at self-harm, “which is an important risk factor for suicide.”

The investigators used linked health care databases to gather information on mortality and hospital admissions among primary care patients in England prescribed OAT, particularly buprenorphine or methadone.

“We tried to exclude people prescribed these drugs for pain and focused specifically on their prescription for opioid dependence,” Dr. Padmanathan said.

They estimated rates and adjusted risk ratios of hospital admissions for nonfatal self-harm and completed suicide during treatment initiation, maintenance, and cessation.

The study included 8,070 patients (69.3% men; mean baseline age, 33.3 years) who received OAT at least once from January 1998 through November 2018. The median treatment time was 84 days. Most of the participants lived in the most deprived neighborhoods and were White.

There were 807 hospital admissions for self-harm (1.99 per 100 person-years) and 46 suicides (0.11 per 100 person-years).

The investigators examined age, sex, socioeconomic status, number of previous OAT treatment episodes, previous self-harm, previous mental illness, and major chronic illness scores as potential confounders.

Need for psychosocial care

Results showed the risk for self-harm was significantly increased while off OAT (aRR, 1.5; 95% confidence interval, 1.21-1.88).

The overall age- and sex-standardized mortality ratio for suicide was 7.5 times higher (95% CI, 5.5-10) in the study cohort, compared with the general population in England between 1998 and 2017.

There was insufficient evidence to show the risk for suicide was higher off, versus on, treatment, but this may be because suicides are relatively rare, Dr. Padmanathan noted.

“The sample may have been too small to enable a difference to be detected. In contrast, self-harm is more common, so there was power to detect a difference there,” she said.

Risk for self-harm was more than double in the first 4 weeks after stopping OAT versus stable periods on treatment (aRR, 2.60; 95% CI, 1.83-3.7). Risk for suicide more than quadrupled during this period (aRR, 4.68; 95% CI, 1.63-13.42).

These new results suggest additional interventions may be in order, Dr. Padmanathan noted.

“We already knew that extra care – for example, providing naloxone when coming off OAT – was important to prevent overdoses. But this study suggests providing psychosocial care and other extra care may also be important to prevent suicides,” she said.

There was no statistical evidence of difference between buprenorphine and methadone in terms of self-harm and suicide risks. However, this may be because the sample was not large enough to detect a difference, said Dr. Padmanathan.

Although there are currently no guidelines to indicate an ideal OAT period, previous study results have suggested extending treatment to 2 years may be beneficial, perhaps reducing self-harm and, therefore, suicides, she noted.

“We think most of these adverse outcomes likely occur during short treatment episodes with an unplanned ending. Extending OAT sufficiently to enable a planned ending might help to reduce these risks,” she added.

‘A window of vulnerability’

Authors of an accompanying editorial note the study “adds weight” to the evidence that OAT is a “lifesaving” treatment.

“It’s critical to recognize that transitions in and out of care are vulnerable periods” when it comes to suicide, the coauthor of the editorial, Paul S. Nestadt, MD, department of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, told this news organization.

Official suicide statistics may not reflect the entire story, as many deaths that occur because of overdose after treatment cessation are not counted as suicides, he said. “It can be difficult for medical examiners to determine if an overdose was intentional or not,” Dr. Nestadt added.

After treatment has been established, physicians “would be wise to delay treatment cessation” until the patient is in a stable condition and can be closely followed by mental health professionals, the editorialists note.

“We must consider the month following OAT cessation to be a window of vulnerability, not just for relapse but also for suicide,” they write.

The finding that patients prescribed OAT have such a high rate of suicide, compared with the general population, is “troubling” and “highlights the importance of interventions which address both opioid use and suicide risk,” they add.

The editorialists point out the median treatment period of 84 days is less than what is generally recommended, raising the question of whether longer treatment might lower suicide risk after treatment discontinuation.

They also emphasized the need for further study to test potential suicide prevention interventions in the period after treatment cessation.

Dr. Nestadt added the new findings are “quite generalizable outside of the U.K.” and referred to similar studies carried out in Australia and elsewhere.

The study was funded by the Medical Research Council. Dr. Padmanathan was a coapplicant on an a grant awarded to University of Bristol by Bristol and Weston Hospital Charity focusing on suicide prevention for patients presenting to the emergency department with self-harm and harmful substance use. Dr. Nestadt has reported no relevant financial relationships.

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

FROM THE LANCET PSYCHIATRY

Cessation of opioid agonist therapy (OAT) significantly increases the risk of self-harm and death by suicide in the first month after stopping the treatment in new findings that highlight the need for “advanced safety planning” during this critical time.

Investigators found that 4 weeks after stopping OAT, the risk of death by suicide was almost five times higher and the risk of hospital admission for self-harm was almost three times higher during this period, compared with the 4 weeks after initiation of OAT to treatment end.

These results highlight the importance of a “transition” period when stopping OAT and highlight the need for better supports for patients coming off this treatment, study investigator Prianka Padmanathan, MD, PhD candidate, Population Health Sciences, University of Bristol (England), told this news organization.

She noted the study supports previous findings that OAT “has an important role” in suicide prevention.

“Suicide and self-harm risk is greatly increased during treatment cessation, and advanced safety planning and additional psychosocial support during this time may be required,” Dr. Padmanathan said.

The findings were published online Dec. 15 in The Lancet Psychiatry.

Suicide, self-harm risk

Previous research shows an increased risk for overdose deaths and death in general during the first few weeks of starting and stopping treatment for opioid dependence.

“We wanted to see if the risk of dying by suicide was also elevated during these times,” said Dr. Padmanathan. As suicides are relatively rare, the researchers also looked at self-harm, “which is an important risk factor for suicide.”

The investigators used linked health care databases to gather information on mortality and hospital admissions among primary care patients in England prescribed OAT, particularly buprenorphine or methadone.

“We tried to exclude people prescribed these drugs for pain and focused specifically on their prescription for opioid dependence,” Dr. Padmanathan said.

They estimated rates and adjusted risk ratios of hospital admissions for nonfatal self-harm and completed suicide during treatment initiation, maintenance, and cessation.

The study included 8,070 patients (69.3% men; mean baseline age, 33.3 years) who received OAT at least once from January 1998 through November 2018. The median treatment time was 84 days. Most of the participants lived in the most deprived neighborhoods and were White.

There were 807 hospital admissions for self-harm (1.99 per 100 person-years) and 46 suicides (0.11 per 100 person-years).

The investigators examined age, sex, socioeconomic status, number of previous OAT treatment episodes, previous self-harm, previous mental illness, and major chronic illness scores as potential confounders.

Need for psychosocial care

Results showed the risk for self-harm was significantly increased while off OAT (aRR, 1.5; 95% confidence interval, 1.21-1.88).

The overall age- and sex-standardized mortality ratio for suicide was 7.5 times higher (95% CI, 5.5-10) in the study cohort, compared with the general population in England between 1998 and 2017.

There was insufficient evidence to show the risk for suicide was higher off, versus on, treatment, but this may be because suicides are relatively rare, Dr. Padmanathan noted.

“The sample may have been too small to enable a difference to be detected. In contrast, self-harm is more common, so there was power to detect a difference there,” she said.

Risk for self-harm was more than double in the first 4 weeks after stopping OAT versus stable periods on treatment (aRR, 2.60; 95% CI, 1.83-3.7). Risk for suicide more than quadrupled during this period (aRR, 4.68; 95% CI, 1.63-13.42).

These new results suggest additional interventions may be in order, Dr. Padmanathan noted.

“We already knew that extra care – for example, providing naloxone when coming off OAT – was important to prevent overdoses. But this study suggests providing psychosocial care and other extra care may also be important to prevent suicides,” she said.

There was no statistical evidence of difference between buprenorphine and methadone in terms of self-harm and suicide risks. However, this may be because the sample was not large enough to detect a difference, said Dr. Padmanathan.

Although there are currently no guidelines to indicate an ideal OAT period, previous study results have suggested extending treatment to 2 years may be beneficial, perhaps reducing self-harm and, therefore, suicides, she noted.

“We think most of these adverse outcomes likely occur during short treatment episodes with an unplanned ending. Extending OAT sufficiently to enable a planned ending might help to reduce these risks,” she added.

‘A window of vulnerability’

Authors of an accompanying editorial note the study “adds weight” to the evidence that OAT is a “lifesaving” treatment.

“It’s critical to recognize that transitions in and out of care are vulnerable periods” when it comes to suicide, the coauthor of the editorial, Paul S. Nestadt, MD, department of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, told this news organization.

Official suicide statistics may not reflect the entire story, as many deaths that occur because of overdose after treatment cessation are not counted as suicides, he said. “It can be difficult for medical examiners to determine if an overdose was intentional or not,” Dr. Nestadt added.

After treatment has been established, physicians “would be wise to delay treatment cessation” until the patient is in a stable condition and can be closely followed by mental health professionals, the editorialists note.

“We must consider the month following OAT cessation to be a window of vulnerability, not just for relapse but also for suicide,” they write.

The finding that patients prescribed OAT have such a high rate of suicide, compared with the general population, is “troubling” and “highlights the importance of interventions which address both opioid use and suicide risk,” they add.

The editorialists point out the median treatment period of 84 days is less than what is generally recommended, raising the question of whether longer treatment might lower suicide risk after treatment discontinuation.

They also emphasized the need for further study to test potential suicide prevention interventions in the period after treatment cessation.

Dr. Nestadt added the new findings are “quite generalizable outside of the U.K.” and referred to similar studies carried out in Australia and elsewhere.

The study was funded by the Medical Research Council. Dr. Padmanathan was a coapplicant on an a grant awarded to University of Bristol by Bristol and Weston Hospital Charity focusing on suicide prevention for patients presenting to the emergency department with self-harm and harmful substance use. Dr. Nestadt has reported no relevant financial relationships.

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

FROM THE LANCET PSYCHIATRY

Cessation of opioid agonist therapy (OAT) significantly increases the risk of self-harm and death by suicide in the first month after stopping the treatment in new findings that highlight the need for “advanced safety planning” during this critical time.

Investigators found that 4 weeks after stopping OAT, the risk of death by suicide was almost five times higher and the risk of hospital admission for self-harm was almost three times higher during this period, compared with the 4 weeks after initiation of OAT to treatment end.

These results highlight the importance of a “transition” period when stopping OAT and highlight the need for better supports for patients coming off this treatment, study investigator Prianka Padmanathan, MD, PhD candidate, Population Health Sciences, University of Bristol (England), told this news organization.

She noted the study supports previous findings that OAT “has an important role” in suicide prevention.

“Suicide and self-harm risk is greatly increased during treatment cessation, and advanced safety planning and additional psychosocial support during this time may be required,” Dr. Padmanathan said.

The findings were published online Dec. 15 in The Lancet Psychiatry.

Suicide, self-harm risk

Previous research shows an increased risk for overdose deaths and death in general during the first few weeks of starting and stopping treatment for opioid dependence.

“We wanted to see if the risk of dying by suicide was also elevated during these times,” said Dr. Padmanathan. As suicides are relatively rare, the researchers also looked at self-harm, “which is an important risk factor for suicide.”

The investigators used linked health care databases to gather information on mortality and hospital admissions among primary care patients in England prescribed OAT, particularly buprenorphine or methadone.

“We tried to exclude people prescribed these drugs for pain and focused specifically on their prescription for opioid dependence,” Dr. Padmanathan said.

They estimated rates and adjusted risk ratios of hospital admissions for nonfatal self-harm and completed suicide during treatment initiation, maintenance, and cessation.

The study included 8,070 patients (69.3% men; mean baseline age, 33.3 years) who received OAT at least once from January 1998 through November 2018. The median treatment time was 84 days. Most of the participants lived in the most deprived neighborhoods and were White.

There were 807 hospital admissions for self-harm (1.99 per 100 person-years) and 46 suicides (0.11 per 100 person-years).

The investigators examined age, sex, socioeconomic status, number of previous OAT treatment episodes, previous self-harm, previous mental illness, and major chronic illness scores as potential confounders.

Need for psychosocial care

Results showed the risk for self-harm was significantly increased while off OAT (aRR, 1.5; 95% confidence interval, 1.21-1.88).

The overall age- and sex-standardized mortality ratio for suicide was 7.5 times higher (95% CI, 5.5-10) in the study cohort, compared with the general population in England between 1998 and 2017.

There was insufficient evidence to show the risk for suicide was higher off, versus on, treatment, but this may be because suicides are relatively rare, Dr. Padmanathan noted.

“The sample may have been too small to enable a difference to be detected. In contrast, self-harm is more common, so there was power to detect a difference there,” she said.

Risk for self-harm was more than double in the first 4 weeks after stopping OAT versus stable periods on treatment (aRR, 2.60; 95% CI, 1.83-3.7). Risk for suicide more than quadrupled during this period (aRR, 4.68; 95% CI, 1.63-13.42).

These new results suggest additional interventions may be in order, Dr. Padmanathan noted.

“We already knew that extra care – for example, providing naloxone when coming off OAT – was important to prevent overdoses. But this study suggests providing psychosocial care and other extra care may also be important to prevent suicides,” she said.

There was no statistical evidence of difference between buprenorphine and methadone in terms of self-harm and suicide risks. However, this may be because the sample was not large enough to detect a difference, said Dr. Padmanathan.

Although there are currently no guidelines to indicate an ideal OAT period, previous study results have suggested extending treatment to 2 years may be beneficial, perhaps reducing self-harm and, therefore, suicides, she noted.

“We think most of these adverse outcomes likely occur during short treatment episodes with an unplanned ending. Extending OAT sufficiently to enable a planned ending might help to reduce these risks,” she added.

‘A window of vulnerability’

Authors of an accompanying editorial note the study “adds weight” to the evidence that OAT is a “lifesaving” treatment.

“It’s critical to recognize that transitions in and out of care are vulnerable periods” when it comes to suicide, the coauthor of the editorial, Paul S. Nestadt, MD, department of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, told this news organization.

Official suicide statistics may not reflect the entire story, as many deaths that occur because of overdose after treatment cessation are not counted as suicides, he said. “It can be difficult for medical examiners to determine if an overdose was intentional or not,” Dr. Nestadt added.

After treatment has been established, physicians “would be wise to delay treatment cessation” until the patient is in a stable condition and can be closely followed by mental health professionals, the editorialists note.

“We must consider the month following OAT cessation to be a window of vulnerability, not just for relapse but also for suicide,” they write.

The finding that patients prescribed OAT have such a high rate of suicide, compared with the general population, is “troubling” and “highlights the importance of interventions which address both opioid use and suicide risk,” they add.

The editorialists point out the median treatment period of 84 days is less than what is generally recommended, raising the question of whether longer treatment might lower suicide risk after treatment discontinuation.

They also emphasized the need for further study to test potential suicide prevention interventions in the period after treatment cessation.

Dr. Nestadt added the new findings are “quite generalizable outside of the U.K.” and referred to similar studies carried out in Australia and elsewhere.

The study was funded by the Medical Research Council. Dr. Padmanathan was a coapplicant on an a grant awarded to University of Bristol by Bristol and Weston Hospital Charity focusing on suicide prevention for patients presenting to the emergency department with self-harm and harmful substance use. Dr. Nestadt has reported no relevant financial relationships.

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

Low vitamin D is common in patients with first-episode psychosis (FEP), but supplementation does not appear to improve mental or physical symptoms, new data show.

“Previous work, our own and others, has shown that people with psychosis, even soon after their first diagnosis, have low vitamin D levels, but it was not known whether supplementing with vitamin D in people with early psychosis would improve health outcomes,” study investigator Fiona Gaughran, MD, with the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, told this news organization.

“While we did not demonstrate a benefit of supplementation over 6 months, these very high rates of vitamin deficiency and insufficiency may have longer-term negative health impacts which we have not measured, so raising awareness of the need to optimize vitamin D in people with psychosis is important,” said Dr. Gaughran.

The results of the randomized clinical trial were published online Dec. 28 in JAMA Network Open.

Thoughtful approach, negative result

Participants included 149 adults within 3 years of a first presentation with a functional psychotic disorder. The cohort’s mean age was 28 years, 60% were men, 44% were Black or of other racial and ethnic minority groups, and 56% were White.

Seventy-five participants were randomly assigned to receive 120,000 IU of cholecalciferol or matching placebo administered by the researchers in monthly doses with an oral syringe.

“We chose a dose of 120,000 IU monthly (equivalent to 4,000 IU daily) which was expected to safely increase vitamin D levels. The regimen was discussed with experts with lived experience, and took into account that a daily preparation would add to the significant medication load that people with psychosis already carry,” said Dr. Gaughran.

Vitamin D supplementation as administered in this study was safe and led to a significant increase in 25-hydroxyvitamin D concentrations.

However, there was no significant difference between vitamin D and placebo in the primary outcome of total Positive and Negative Syndrome Scale (PANSS) score at 6 months (mean difference, 3.57; 95% confidence interval, –1.11 to 8.25; P = .13).

There was also no apparent benefit of vitamin D supplementation on any secondary outcome, including the PANSS subscores of global function and depression or cardiometabolic risk factors.

“With respect to clinical practice, we cannot now recommend monthly treatments with 120,000 IU of cholecalciferol in FEP,” the investigators note.

The prevalence of vitamin D insufficiency and deficiency was high in the population – 74.6% overall and 93.4% among ethnic minorities.

“Thus, the sample was well suited to detecting any potential benefits that may have arisen from correcting this. However, even in this subgroup, there was no evidence to support the guiding hypothesis” that vitamin D supplementation would improve outcomes in patients with early psychosis, the researchers note.

They suggest that future studies examine the association of vitamin D with brain-related outcomes based on periods of treatment longer than 6 months and administered as daily rather than bolus treatments.

“Future public health strategies should acknowledge the high prevalence of vitamin D insufficiency and deficiency in people with psychosis and consider any reasonable adjustments which may be needed to address this over and above general population guidance,” said Dr. Gaughran.

The study was funded by the Stanley Medical Research Institute and received support from the National Institute for Health Research Maudsley Biomedical Research Centre, King’s College London, and the NIHR Applied Research Collaboration South London. Dr. Gaughran reported receiving speaking honoraria from Otsuka Lundbeck outside the submitted work. A complete list of author disclosures is available with the original article.

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

Low vitamin D is common in patients with first-episode psychosis (FEP), but supplementation does not appear to improve mental or physical symptoms, new data show.

“Previous work, our own and others, has shown that people with psychosis, even soon after their first diagnosis, have low vitamin D levels, but it was not known whether supplementing with vitamin D in people with early psychosis would improve health outcomes,” study investigator Fiona Gaughran, MD, with the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, told this news organization.

“While we did not demonstrate a benefit of supplementation over 6 months, these very high rates of vitamin deficiency and insufficiency may have longer-term negative health impacts which we have not measured, so raising awareness of the need to optimize vitamin D in people with psychosis is important,” said Dr. Gaughran.

The results of the randomized clinical trial were published online Dec. 28 in JAMA Network Open.

Thoughtful approach, negative result

Participants included 149 adults within 3 years of a first presentation with a functional psychotic disorder. The cohort’s mean age was 28 years, 60% were men, 44% were Black or of other racial and ethnic minority groups, and 56% were White.

Seventy-five participants were randomly assigned to receive 120,000 IU of cholecalciferol or matching placebo administered by the researchers in monthly doses with an oral syringe.

“We chose a dose of 120,000 IU monthly (equivalent to 4,000 IU daily) which was expected to safely increase vitamin D levels. The regimen was discussed with experts with lived experience, and took into account that a daily preparation would add to the significant medication load that people with psychosis already carry,” said Dr. Gaughran.

Vitamin D supplementation as administered in this study was safe and led to a significant increase in 25-hydroxyvitamin D concentrations.

However, there was no significant difference between vitamin D and placebo in the primary outcome of total Positive and Negative Syndrome Scale (PANSS) score at 6 months (mean difference, 3.57; 95% confidence interval, –1.11 to 8.25; P = .13).

There was also no apparent benefit of vitamin D supplementation on any secondary outcome, including the PANSS subscores of global function and depression or cardiometabolic risk factors.

“With respect to clinical practice, we cannot now recommend monthly treatments with 120,000 IU of cholecalciferol in FEP,” the investigators note.

The prevalence of vitamin D insufficiency and deficiency was high in the population – 74.6% overall and 93.4% among ethnic minorities.

“Thus, the sample was well suited to detecting any potential benefits that may have arisen from correcting this. However, even in this subgroup, there was no evidence to support the guiding hypothesis” that vitamin D supplementation would improve outcomes in patients with early psychosis, the researchers note.

They suggest that future studies examine the association of vitamin D with brain-related outcomes based on periods of treatment longer than 6 months and administered as daily rather than bolus treatments.

“Future public health strategies should acknowledge the high prevalence of vitamin D insufficiency and deficiency in people with psychosis and consider any reasonable adjustments which may be needed to address this over and above general population guidance,” said Dr. Gaughran.

The study was funded by the Stanley Medical Research Institute and received support from the National Institute for Health Research Maudsley Biomedical Research Centre, King’s College London, and the NIHR Applied Research Collaboration South London. Dr. Gaughran reported receiving speaking honoraria from Otsuka Lundbeck outside the submitted work. A complete list of author disclosures is available with the original article.

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

Low vitamin D is common in patients with first-episode psychosis (FEP), but supplementation does not appear to improve mental or physical symptoms, new data show.

“Previous work, our own and others, has shown that people with psychosis, even soon after their first diagnosis, have low vitamin D levels, but it was not known whether supplementing with vitamin D in people with early psychosis would improve health outcomes,” study investigator Fiona Gaughran, MD, with the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, told this news organization.

“While we did not demonstrate a benefit of supplementation over 6 months, these very high rates of vitamin deficiency and insufficiency may have longer-term negative health impacts which we have not measured, so raising awareness of the need to optimize vitamin D in people with psychosis is important,” said Dr. Gaughran.

The results of the randomized clinical trial were published online Dec. 28 in JAMA Network Open.

Thoughtful approach, negative result

Participants included 149 adults within 3 years of a first presentation with a functional psychotic disorder. The cohort’s mean age was 28 years, 60% were men, 44% were Black or of other racial and ethnic minority groups, and 56% were White.

Seventy-five participants were randomly assigned to receive 120,000 IU of cholecalciferol or matching placebo administered by the researchers in monthly doses with an oral syringe.

“We chose a dose of 120,000 IU monthly (equivalent to 4,000 IU daily) which was expected to safely increase vitamin D levels. The regimen was discussed with experts with lived experience, and took into account that a daily preparation would add to the significant medication load that people with psychosis already carry,” said Dr. Gaughran.

Vitamin D supplementation as administered in this study was safe and led to a significant increase in 25-hydroxyvitamin D concentrations.

However, there was no significant difference between vitamin D and placebo in the primary outcome of total Positive and Negative Syndrome Scale (PANSS) score at 6 months (mean difference, 3.57; 95% confidence interval, –1.11 to 8.25; P = .13).

There was also no apparent benefit of vitamin D supplementation on any secondary outcome, including the PANSS subscores of global function and depression or cardiometabolic risk factors.

“With respect to clinical practice, we cannot now recommend monthly treatments with 120,000 IU of cholecalciferol in FEP,” the investigators note.

The prevalence of vitamin D insufficiency and deficiency was high in the population – 74.6% overall and 93.4% among ethnic minorities.

“Thus, the sample was well suited to detecting any potential benefits that may have arisen from correcting this. However, even in this subgroup, there was no evidence to support the guiding hypothesis” that vitamin D supplementation would improve outcomes in patients with early psychosis, the researchers note.

They suggest that future studies examine the association of vitamin D with brain-related outcomes based on periods of treatment longer than 6 months and administered as daily rather than bolus treatments.

“Future public health strategies should acknowledge the high prevalence of vitamin D insufficiency and deficiency in people with psychosis and consider any reasonable adjustments which may be needed to address this over and above general population guidance,” said Dr. Gaughran.

The study was funded by the Stanley Medical Research Institute and received support from the National Institute for Health Research Maudsley Biomedical Research Centre, King’s College London, and the NIHR Applied Research Collaboration South London. Dr. Gaughran reported receiving speaking honoraria from Otsuka Lundbeck outside the submitted work. A complete list of author disclosures is available with the original article.

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

Both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective at improving hepatic steatosis in type 2 diabetes patients, according to a new analysis of a randomized, controlled trial.

Both procedures resulted in near elimination of liver fat 1 year after the surgery, but the effect on liver fibrosis was less clear. The authors called for more research to examine longer-term effects on fibrosis.

Both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective at improving hepatic steatosis in type 2 diabetes patients, according to a new analysis of a randomized, controlled trial.

Both procedures resulted in near elimination of liver fat 1 year after the surgery, but the effect on liver fibrosis was less clear. The authors called for more research to examine longer-term effects on fibrosis.

Both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective at improving hepatic steatosis in type 2 diabetes patients, according to a new analysis of a randomized, controlled trial.

Both procedures resulted in near elimination of liver fat 1 year after the surgery, but the effect on liver fibrosis was less clear. The authors called for more research to examine longer-term effects on fibrosis.