Federal Practitioner

The Food and Drug Administration has approved the first treatment for posttransplant cytomegalovirus (CMV) that is resistant to other drugs. The treatment, maribavir (Livtencity), is approved for adults and children 12 years and older who weigh at least 35 kg (77 pounds).

There are an estimated 200,000 adult transplants every year globally. CMV, a type of herpes virus, is one of the most common infections in transplant patients, occurring in 16%-56% of solid organ transplant recipients and 30%-70% of hematopoietic stem cell transplant recipients, according to Takeda Pharmaceutical Company Limited, the company that manufactures Livtencity. For immunosuppressed transplant patients, CMV infection can lead to complications that include loss of the transplanted or organ or even death.

“Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” John Farley, MD, MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

Livtencity, which is taken orally, works by preventing the activity of the enzyme responsible for virus replication. The approval, announced Nov. 23, was based on a phase 3 clinical trial that compared Livtencity with conventional antiviral treatments in the achievement of CMV DNA concentration levels below what is measurable in transplant patients with CMV infection that is refractory or treatment-resistant. After 8 weeks, of the 235 patients who received Livtencity, 56% achieved this primary endpoint, compared with 24% of the 117 patients who received conventional antiviral treatments, the press release says.

The most reported adverse reactions of Livtencity were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

“We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers,” Ramona Sequeira, president of the Takeda’s U.S. Business Unit and Global Portfolio Commercialization, said in a statement. “People undergoing transplants have a lengthy and complex health care journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease.”

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

The Food and Drug Administration has approved the first treatment for posttransplant cytomegalovirus (CMV) that is resistant to other drugs. The treatment, maribavir (Livtencity), is approved for adults and children 12 years and older who weigh at least 35 kg (77 pounds).

There are an estimated 200,000 adult transplants every year globally. CMV, a type of herpes virus, is one of the most common infections in transplant patients, occurring in 16%-56% of solid organ transplant recipients and 30%-70% of hematopoietic stem cell transplant recipients, according to Takeda Pharmaceutical Company Limited, the company that manufactures Livtencity. For immunosuppressed transplant patients, CMV infection can lead to complications that include loss of the transplanted or organ or even death.

“Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” John Farley, MD, MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

Livtencity, which is taken orally, works by preventing the activity of the enzyme responsible for virus replication. The approval, announced Nov. 23, was based on a phase 3 clinical trial that compared Livtencity with conventional antiviral treatments in the achievement of CMV DNA concentration levels below what is measurable in transplant patients with CMV infection that is refractory or treatment-resistant. After 8 weeks, of the 235 patients who received Livtencity, 56% achieved this primary endpoint, compared with 24% of the 117 patients who received conventional antiviral treatments, the press release says.

The most reported adverse reactions of Livtencity were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

“We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers,” Ramona Sequeira, president of the Takeda’s U.S. Business Unit and Global Portfolio Commercialization, said in a statement. “People undergoing transplants have a lengthy and complex health care journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease.”

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

The Food and Drug Administration has approved the first treatment for posttransplant cytomegalovirus (CMV) that is resistant to other drugs. The treatment, maribavir (Livtencity), is approved for adults and children 12 years and older who weigh at least 35 kg (77 pounds).

There are an estimated 200,000 adult transplants every year globally. CMV, a type of herpes virus, is one of the most common infections in transplant patients, occurring in 16%-56% of solid organ transplant recipients and 30%-70% of hematopoietic stem cell transplant recipients, according to Takeda Pharmaceutical Company Limited, the company that manufactures Livtencity. For immunosuppressed transplant patients, CMV infection can lead to complications that include loss of the transplanted or organ or even death.

“Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” John Farley, MD, MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

Livtencity, which is taken orally, works by preventing the activity of the enzyme responsible for virus replication. The approval, announced Nov. 23, was based on a phase 3 clinical trial that compared Livtencity with conventional antiviral treatments in the achievement of CMV DNA concentration levels below what is measurable in transplant patients with CMV infection that is refractory or treatment-resistant. After 8 weeks, of the 235 patients who received Livtencity, 56% achieved this primary endpoint, compared with 24% of the 117 patients who received conventional antiviral treatments, the press release says.

The most reported adverse reactions of Livtencity were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

“We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers,” Ramona Sequeira, president of the Takeda’s U.S. Business Unit and Global Portfolio Commercialization, said in a statement. “People undergoing transplants have a lengthy and complex health care journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease.”

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

Obesity rates among “emerging adults” aged 18-25 have soared in the United States in recent decades with the mean body mass index (BMI) for these young adults now in the overweight category, according to research highlighting troubling trends in an often-overlooked age group.

While similar patterns have been observed in other age groups, including adolescents (ages 12-19) and young adults (ages 20-39) across recent decades, emerging adulthood tends to get less attention in the evaluation of obesity trends.

“Emerging adulthood may be a key period for preventing and treating obesity given that habits formed during this period often persist through the remainder of the life course,” write the authors of the study, which was published online Nov. 23 in JAMA.  

“There is an urgent need for research on risk factors contributing to obesity during this developmental stage to inform the design of interventions as well as policies aimed at prevention,” they add.

They found that by 2018 a third of all young adults had obesity, compared with just 6% at the beginning of the study periods in 1976.

Studying the ages of transition

The findings are from an analysis of 8,015 emerging adults aged 18-25 in the cross-sectional National Health and Nutrition Examination Survey (NHANES), including NHANES II (1976-1980), NHANES III (1988-1994), and the continuous NHANES cycles from 1999 through 2018.

About half (3,965) of participants were female, 3,037 were non-Hispanic Black, and 2,386 met the criteria for household poverty.

The results showed substantial increases in mean BMI among emerging adults from a level in the normal range, at 23.1 kg/m2, in 1976-1980, increasing to 27.7 kg/m2 (overweight) in 2017-2018 (P = .006).

The prevalence of obesity (BMI 30.0 kg/m2 or higher) in the emerging adult age group soared from 6.2% between 1976-1980 to 32.7% in 2017-2018 (P = .007).

Meanwhile, the rate of those with normal/healthy weight (BMI 18.5-24.9 kg/m2) dropped from 68.7% to 37.5% (P = .005) over the same period.

Sensitivity analyses that were limited to continuous NHANES cycles showed similar results.

First author Alejandra Ellison-Barnes, MD, MPH, said the trends are consistent with rising obesity rates in the population as a whole – other studies have shown increases in obesity among children, adolescents, and adults over the same period – but are nevertheless striking, she stressed.
 

Young adults now fall into overweight category

“While we were not surprised by the general trend, given what is known about the increasing prevalence of obesity in both children and adults, we were surprised by the magnitude of the increase in prevalence and that the mean BMI in this age group now falls in the overweight range,” Dr. Ellison-Barnes, of the Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, told this news organization.

She said she is not aware of other studies that have looked at obesity trends specifically among emerging adults.

However, considering the substantial life changes and growing independence, the life stage is important to understand in terms of dietary/lifestyle patterns.

“We theorize that emerging adulthood is a critical period for obesity development given that it is a time when individuals are often undergoing major life transitions such as leaving home, attending higher education, entering the workforce, and developing new relationships,” she emphasized.

As far as causes are concerned, “societal and cultural trends in these areas over the past several decades may have played a role in the observed changes,” she speculated.

The study population was limited to non-Hispanic Black and non-Hispanic White individuals due to changes in how NHANES assessed race and ethnicity over time. Therefore, a study limitation is that the patterns observed may not be generalizable to other races and ethnicities, the authors note.

However, considering the influence lifestyle changes can have, early adulthood “may be an ideal time to intervene in the clinical setting to prevent, manage, or reverse obesity to prevent adverse health outcomes in the future,” Dr. Ellison-Barnes said.

Dr. Ellison-Barnes has reported no relevant financial relationships.

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

Obesity rates among “emerging adults” aged 18-25 have soared in the United States in recent decades with the mean body mass index (BMI) for these young adults now in the overweight category, according to research highlighting troubling trends in an often-overlooked age group.

While similar patterns have been observed in other age groups, including adolescents (ages 12-19) and young adults (ages 20-39) across recent decades, emerging adulthood tends to get less attention in the evaluation of obesity trends.

“Emerging adulthood may be a key period for preventing and treating obesity given that habits formed during this period often persist through the remainder of the life course,” write the authors of the study, which was published online Nov. 23 in JAMA.  

“There is an urgent need for research on risk factors contributing to obesity during this developmental stage to inform the design of interventions as well as policies aimed at prevention,” they add.

They found that by 2018 a third of all young adults had obesity, compared with just 6% at the beginning of the study periods in 1976.

Studying the ages of transition

The findings are from an analysis of 8,015 emerging adults aged 18-25 in the cross-sectional National Health and Nutrition Examination Survey (NHANES), including NHANES II (1976-1980), NHANES III (1988-1994), and the continuous NHANES cycles from 1999 through 2018.

About half (3,965) of participants were female, 3,037 were non-Hispanic Black, and 2,386 met the criteria for household poverty.

The results showed substantial increases in mean BMI among emerging adults from a level in the normal range, at 23.1 kg/m2, in 1976-1980, increasing to 27.7 kg/m2 (overweight) in 2017-2018 (P = .006).

The prevalence of obesity (BMI 30.0 kg/m2 or higher) in the emerging adult age group soared from 6.2% between 1976-1980 to 32.7% in 2017-2018 (P = .007).

Meanwhile, the rate of those with normal/healthy weight (BMI 18.5-24.9 kg/m2) dropped from 68.7% to 37.5% (P = .005) over the same period.

Sensitivity analyses that were limited to continuous NHANES cycles showed similar results.

First author Alejandra Ellison-Barnes, MD, MPH, said the trends are consistent with rising obesity rates in the population as a whole – other studies have shown increases in obesity among children, adolescents, and adults over the same period – but are nevertheless striking, she stressed.
 

Young adults now fall into overweight category

“While we were not surprised by the general trend, given what is known about the increasing prevalence of obesity in both children and adults, we were surprised by the magnitude of the increase in prevalence and that the mean BMI in this age group now falls in the overweight range,” Dr. Ellison-Barnes, of the Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, told this news organization.

She said she is not aware of other studies that have looked at obesity trends specifically among emerging adults.

However, considering the substantial life changes and growing independence, the life stage is important to understand in terms of dietary/lifestyle patterns.

“We theorize that emerging adulthood is a critical period for obesity development given that it is a time when individuals are often undergoing major life transitions such as leaving home, attending higher education, entering the workforce, and developing new relationships,” she emphasized.

As far as causes are concerned, “societal and cultural trends in these areas over the past several decades may have played a role in the observed changes,” she speculated.

The study population was limited to non-Hispanic Black and non-Hispanic White individuals due to changes in how NHANES assessed race and ethnicity over time. Therefore, a study limitation is that the patterns observed may not be generalizable to other races and ethnicities, the authors note.

However, considering the influence lifestyle changes can have, early adulthood “may be an ideal time to intervene in the clinical setting to prevent, manage, or reverse obesity to prevent adverse health outcomes in the future,” Dr. Ellison-Barnes said.

Dr. Ellison-Barnes has reported no relevant financial relationships.

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

Obesity rates among “emerging adults” aged 18-25 have soared in the United States in recent decades with the mean body mass index (BMI) for these young adults now in the overweight category, according to research highlighting troubling trends in an often-overlooked age group.

While similar patterns have been observed in other age groups, including adolescents (ages 12-19) and young adults (ages 20-39) across recent decades, emerging adulthood tends to get less attention in the evaluation of obesity trends.

“Emerging adulthood may be a key period for preventing and treating obesity given that habits formed during this period often persist through the remainder of the life course,” write the authors of the study, which was published online Nov. 23 in JAMA.  

“There is an urgent need for research on risk factors contributing to obesity during this developmental stage to inform the design of interventions as well as policies aimed at prevention,” they add.

They found that by 2018 a third of all young adults had obesity, compared with just 6% at the beginning of the study periods in 1976.

Studying the ages of transition

The findings are from an analysis of 8,015 emerging adults aged 18-25 in the cross-sectional National Health and Nutrition Examination Survey (NHANES), including NHANES II (1976-1980), NHANES III (1988-1994), and the continuous NHANES cycles from 1999 through 2018.

About half (3,965) of participants were female, 3,037 were non-Hispanic Black, and 2,386 met the criteria for household poverty.

The results showed substantial increases in mean BMI among emerging adults from a level in the normal range, at 23.1 kg/m2, in 1976-1980, increasing to 27.7 kg/m2 (overweight) in 2017-2018 (P = .006).

The prevalence of obesity (BMI 30.0 kg/m2 or higher) in the emerging adult age group soared from 6.2% between 1976-1980 to 32.7% in 2017-2018 (P = .007).

Meanwhile, the rate of those with normal/healthy weight (BMI 18.5-24.9 kg/m2) dropped from 68.7% to 37.5% (P = .005) over the same period.

Sensitivity analyses that were limited to continuous NHANES cycles showed similar results.

First author Alejandra Ellison-Barnes, MD, MPH, said the trends are consistent with rising obesity rates in the population as a whole – other studies have shown increases in obesity among children, adolescents, and adults over the same period – but are nevertheless striking, she stressed.
 

Young adults now fall into overweight category

“While we were not surprised by the general trend, given what is known about the increasing prevalence of obesity in both children and adults, we were surprised by the magnitude of the increase in prevalence and that the mean BMI in this age group now falls in the overweight range,” Dr. Ellison-Barnes, of the Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, told this news organization.

She said she is not aware of other studies that have looked at obesity trends specifically among emerging adults.

However, considering the substantial life changes and growing independence, the life stage is important to understand in terms of dietary/lifestyle patterns.

“We theorize that emerging adulthood is a critical period for obesity development given that it is a time when individuals are often undergoing major life transitions such as leaving home, attending higher education, entering the workforce, and developing new relationships,” she emphasized.

As far as causes are concerned, “societal and cultural trends in these areas over the past several decades may have played a role in the observed changes,” she speculated.

The study population was limited to non-Hispanic Black and non-Hispanic White individuals due to changes in how NHANES assessed race and ethnicity over time. Therefore, a study limitation is that the patterns observed may not be generalizable to other races and ethnicities, the authors note.

However, considering the influence lifestyle changes can have, early adulthood “may be an ideal time to intervene in the clinical setting to prevent, manage, or reverse obesity to prevent adverse health outcomes in the future,” Dr. Ellison-Barnes said.

Dr. Ellison-Barnes has reported no relevant financial relationships.

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

            Racial and ethnic disparities in prostate cancer diagnosis and treatment are well recognized. Prostate magnetic resonance imaging (MRI) as part of a diagnostic approach for people with elevated PSA may decrease unnecessary biopsies or better direct biopsies based on results, and its use is increasing significantly. Abashidze et al examined Medicare claims between 2011 and 2017 to determine if racial disparities were present with respect to the use of prostate MRI. Compared with White men, Black, Asian, and Hispanic men were less likely to have a prostate MRI within 180 days after an elevated PSA (results stratified at 2.5, 4, or 10 ng/mL). The differences were most pronounced for patients with a PSA at 4 ng/mL or higher. The results suggest that providers should be aware of potential system and individual factors that influence racial and ethnic disparities in the use of prostate MRI.

            Studies designed to evaluate germline and somatic genomic abnormalities in prostate cancer have come to the forefront in the last decade. Lynch syndrome is an inherited cancer syndrome of abnormalities in at least one of the commonly recognized mismatch repair genes: MLH1, MSH2, MSH6, or PMS2. While testing for mismatch repair deficiency is recommended in the advanced setting where systemic therapy is being considered, such testing outside of known family history is unclear in the setting of screening for prostate cancer. Bancroft et al compared PSA levels (and prostate cancer incidence) as part of baseline screening between carriers of one of mismatch repair genes (MLH1, MSH2, MSH6) and non-carrier controls. Carriers of MLH1 and MSH6 variants had a higher incidence of prostate cancer compared with controls. While not yet recommended for standard practice, further studies will be needed to verify these compelling results.

            Racial and ethnic disparities in prostate cancer diagnosis and treatment are well recognized. Prostate magnetic resonance imaging (MRI) as part of a diagnostic approach for people with elevated PSA may decrease unnecessary biopsies or better direct biopsies based on results, and its use is increasing significantly. Abashidze et al examined Medicare claims between 2011 and 2017 to determine if racial disparities were present with respect to the use of prostate MRI. Compared with White men, Black, Asian, and Hispanic men were less likely to have a prostate MRI within 180 days after an elevated PSA (results stratified at 2.5, 4, or 10 ng/mL). The differences were most pronounced for patients with a PSA at 4 ng/mL or higher. The results suggest that providers should be aware of potential system and individual factors that influence racial and ethnic disparities in the use of prostate MRI.

            Studies designed to evaluate germline and somatic genomic abnormalities in prostate cancer have come to the forefront in the last decade. Lynch syndrome is an inherited cancer syndrome of abnormalities in at least one of the commonly recognized mismatch repair genes: MLH1, MSH2, MSH6, or PMS2. While testing for mismatch repair deficiency is recommended in the advanced setting where systemic therapy is being considered, such testing outside of known family history is unclear in the setting of screening for prostate cancer. Bancroft et al compared PSA levels (and prostate cancer incidence) as part of baseline screening between carriers of one of mismatch repair genes (MLH1, MSH2, MSH6) and non-carrier controls. Carriers of MLH1 and MSH6 variants had a higher incidence of prostate cancer compared with controls. While not yet recommended for standard practice, further studies will be needed to verify these compelling results.

            Racial and ethnic disparities in prostate cancer diagnosis and treatment are well recognized. Prostate magnetic resonance imaging (MRI) as part of a diagnostic approach for people with elevated PSA may decrease unnecessary biopsies or better direct biopsies based on results, and its use is increasing significantly. Abashidze et al examined Medicare claims between 2011 and 2017 to determine if racial disparities were present with respect to the use of prostate MRI. Compared with White men, Black, Asian, and Hispanic men were less likely to have a prostate MRI within 180 days after an elevated PSA (results stratified at 2.5, 4, or 10 ng/mL). The differences were most pronounced for patients with a PSA at 4 ng/mL or higher. The results suggest that providers should be aware of potential system and individual factors that influence racial and ethnic disparities in the use of prostate MRI.

            Studies designed to evaluate germline and somatic genomic abnormalities in prostate cancer have come to the forefront in the last decade. Lynch syndrome is an inherited cancer syndrome of abnormalities in at least one of the commonly recognized mismatch repair genes: MLH1, MSH2, MSH6, or PMS2. While testing for mismatch repair deficiency is recommended in the advanced setting where systemic therapy is being considered, such testing outside of known family history is unclear in the setting of screening for prostate cancer. Bancroft et al compared PSA levels (and prostate cancer incidence) as part of baseline screening between carriers of one of mismatch repair genes (MLH1, MSH2, MSH6) and non-carrier controls. Carriers of MLH1 and MSH6 variants had a higher incidence of prostate cancer compared with controls. While not yet recommended for standard practice, further studies will be needed to verify these compelling results.

Human papillomavirus (HPV) vaccination helps prevent cervical cancer and saves lives, new nationwide data suggest.

The analysis adds to a growing body of evidence demonstrating vaccine-associated changes in cervical cancer incidence and mortality.

Previous data from the United Kingdom, published earlier in November, showed that cervical cancer rates were 87% lower among girls who received the HPV vaccine compared to previously unvaccinated generations. Based on the analysis, the authors concluded that the UK’s HPV immunization program “almost eliminated cervical cancer” in women born since September 1995.

The latest study, published Nov. 29 in JAMA Pediatrics , reports a 38% drop in cervical cancer incidence and a 43% decline in mortality among young women and girls after HPV vaccination was introduced in the United States.

“These results are encouraging,” Peter Sasieni, MD, of King’s College London, and senior author on the U.K. study, told this news organization in an email.

The difference in incidence rates between the U.K. and U.S. studies, Dr. Sasieni explained, is likely due to HPV vaccine coverage not expanding as significantly in the United States as it has in the United Kingdom, and “thus one would anticipate a lower impact on the population in the U.S.”

In the U.S. analysis, Justin Barnes, MD, a radiation oncology resident at Washington University, St. Louis, and colleagues examined cervical cancer incidence between January 2001 and December 2017 using Surveillance, Epidemiology, and End Results and National Program of Cancer Registries data as well as mortality data from the National Center for Health Statistics.

Dr. Barnes and colleagues then compared changes in cervical cancer incidence and mortality between prevaccination years (January 2001 to December 2005) and postvaccination years (January 2010 to December 2017) among three age cohorts – 15-24 years, 25-29 years, and 30-39 years.

“The older 2 groups were included as comparison, given their low vaccination rates,” Dr. Barnes and colleagues explained.

Results show that between the prevaccination and postvaccination periods, the incidence of cervical cancer dropped by 38% in the youngest cohort and by only 16% in the middle-aged group and 8% in the oldest cohort.

Women and girls in the youngest group saw a striking drop in mortality: a 43% decline, which translated to a mortality rate of 0.6 per 100,000.

On the other hand, the authors report a 4.7% decline in mortality in the oldest group and a 4.3% increase in mortality in the middle-aged group – translating to a mortality rate of 1.89 per 100,000 and 0.57 per 100,000, respectively.

Overall, “these nationwide data showed decreased cervical cancer incidence and mortality among women and girls aged 15-24 years after HPV vaccine introduction,” Dr. Barnes and colleagues wrote. The changes in cervical cancer incidence and mortality observed in the youngest age group “were greater than changes in those aged 25 to 29 years and 30 to 39 years, suggesting possible associations with HPV vaccination.”

This analysis lines up with previous evidence from U.S. epidemiologic data, which “have shown decreased cervical cancer incidence after vaccine implementation in women and girls aged 15 to 24 years but not older women.”

Although “the number of deaths and hence the number of potentially averted deaths in young women and girls was small,” the study adds to the current literature by “providing suggestive evidence for vaccine-associated decreases in cervical cancer mortality,” investigators concluded.

The authors have disclosed no relevant financial relationships.

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

Human papillomavirus (HPV) vaccination helps prevent cervical cancer and saves lives, new nationwide data suggest.

The analysis adds to a growing body of evidence demonstrating vaccine-associated changes in cervical cancer incidence and mortality.

Previous data from the United Kingdom, published earlier in November, showed that cervical cancer rates were 87% lower among girls who received the HPV vaccine compared to previously unvaccinated generations. Based on the analysis, the authors concluded that the UK’s HPV immunization program “almost eliminated cervical cancer” in women born since September 1995.

The latest study, published Nov. 29 in JAMA Pediatrics , reports a 38% drop in cervical cancer incidence and a 43% decline in mortality among young women and girls after HPV vaccination was introduced in the United States.

“These results are encouraging,” Peter Sasieni, MD, of King’s College London, and senior author on the U.K. study, told this news organization in an email.

The difference in incidence rates between the U.K. and U.S. studies, Dr. Sasieni explained, is likely due to HPV vaccine coverage not expanding as significantly in the United States as it has in the United Kingdom, and “thus one would anticipate a lower impact on the population in the U.S.”

In the U.S. analysis, Justin Barnes, MD, a radiation oncology resident at Washington University, St. Louis, and colleagues examined cervical cancer incidence between January 2001 and December 2017 using Surveillance, Epidemiology, and End Results and National Program of Cancer Registries data as well as mortality data from the National Center for Health Statistics.

Dr. Barnes and colleagues then compared changes in cervical cancer incidence and mortality between prevaccination years (January 2001 to December 2005) and postvaccination years (January 2010 to December 2017) among three age cohorts – 15-24 years, 25-29 years, and 30-39 years.

“The older 2 groups were included as comparison, given their low vaccination rates,” Dr. Barnes and colleagues explained.

Results show that between the prevaccination and postvaccination periods, the incidence of cervical cancer dropped by 38% in the youngest cohort and by only 16% in the middle-aged group and 8% in the oldest cohort.

Women and girls in the youngest group saw a striking drop in mortality: a 43% decline, which translated to a mortality rate of 0.6 per 100,000.

On the other hand, the authors report a 4.7% decline in mortality in the oldest group and a 4.3% increase in mortality in the middle-aged group – translating to a mortality rate of 1.89 per 100,000 and 0.57 per 100,000, respectively.

Overall, “these nationwide data showed decreased cervical cancer incidence and mortality among women and girls aged 15-24 years after HPV vaccine introduction,” Dr. Barnes and colleagues wrote. The changes in cervical cancer incidence and mortality observed in the youngest age group “were greater than changes in those aged 25 to 29 years and 30 to 39 years, suggesting possible associations with HPV vaccination.”

This analysis lines up with previous evidence from U.S. epidemiologic data, which “have shown decreased cervical cancer incidence after vaccine implementation in women and girls aged 15 to 24 years but not older women.”

Although “the number of deaths and hence the number of potentially averted deaths in young women and girls was small,” the study adds to the current literature by “providing suggestive evidence for vaccine-associated decreases in cervical cancer mortality,” investigators concluded.

The authors have disclosed no relevant financial relationships.

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

Human papillomavirus (HPV) vaccination helps prevent cervical cancer and saves lives, new nationwide data suggest.

The analysis adds to a growing body of evidence demonstrating vaccine-associated changes in cervical cancer incidence and mortality.

Previous data from the United Kingdom, published earlier in November, showed that cervical cancer rates were 87% lower among girls who received the HPV vaccine compared to previously unvaccinated generations. Based on the analysis, the authors concluded that the UK’s HPV immunization program “almost eliminated cervical cancer” in women born since September 1995.

The latest study, published Nov. 29 in JAMA Pediatrics , reports a 38% drop in cervical cancer incidence and a 43% decline in mortality among young women and girls after HPV vaccination was introduced in the United States.

“These results are encouraging,” Peter Sasieni, MD, of King’s College London, and senior author on the U.K. study, told this news organization in an email.

The difference in incidence rates between the U.K. and U.S. studies, Dr. Sasieni explained, is likely due to HPV vaccine coverage not expanding as significantly in the United States as it has in the United Kingdom, and “thus one would anticipate a lower impact on the population in the U.S.”

In the U.S. analysis, Justin Barnes, MD, a radiation oncology resident at Washington University, St. Louis, and colleagues examined cervical cancer incidence between January 2001 and December 2017 using Surveillance, Epidemiology, and End Results and National Program of Cancer Registries data as well as mortality data from the National Center for Health Statistics.

Dr. Barnes and colleagues then compared changes in cervical cancer incidence and mortality between prevaccination years (January 2001 to December 2005) and postvaccination years (January 2010 to December 2017) among three age cohorts – 15-24 years, 25-29 years, and 30-39 years.

“The older 2 groups were included as comparison, given their low vaccination rates,” Dr. Barnes and colleagues explained.

Results show that between the prevaccination and postvaccination periods, the incidence of cervical cancer dropped by 38% in the youngest cohort and by only 16% in the middle-aged group and 8% in the oldest cohort.

Women and girls in the youngest group saw a striking drop in mortality: a 43% decline, which translated to a mortality rate of 0.6 per 100,000.

On the other hand, the authors report a 4.7% decline in mortality in the oldest group and a 4.3% increase in mortality in the middle-aged group – translating to a mortality rate of 1.89 per 100,000 and 0.57 per 100,000, respectively.

Overall, “these nationwide data showed decreased cervical cancer incidence and mortality among women and girls aged 15-24 years after HPV vaccine introduction,” Dr. Barnes and colleagues wrote. The changes in cervical cancer incidence and mortality observed in the youngest age group “were greater than changes in those aged 25 to 29 years and 30 to 39 years, suggesting possible associations with HPV vaccination.”

This analysis lines up with previous evidence from U.S. epidemiologic data, which “have shown decreased cervical cancer incidence after vaccine implementation in women and girls aged 15 to 24 years but not older women.”

Although “the number of deaths and hence the number of potentially averted deaths in young women and girls was small,” the study adds to the current literature by “providing suggestive evidence for vaccine-associated decreases in cervical cancer mortality,” investigators concluded.

The authors have disclosed no relevant financial relationships.

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

A head-to-head comparison of immune checkpoint inhibitors atezolizumab and nivolumab and the chemotherapy drug docetaxel in patients with advanced non–small cell lung cancer (NSCLC), finds that atezolizumab was associated with a significantly longer overall survival than docetaxel and was on par with nivolumab.

The findings were reported in JAMA Network Open.

“Until recently, chemotherapy with platinum doublet was the standard first-line option for most patients with advanced NSCLC who did not have these genetic drivers or were not tested for them and remains the first choice in many parts of the world,” wrote the authors of the study which was led by Sreeram Ramagopalan, PhD, of F. Hoffmann-La Roche in Switzerland which funded the study.

Atezolizumab (Tecentriq, Genentech), which was approved in October by the U.S. Food and Drug Administration, is a monoclonal antibody that targets programmed cell death ligand 1 (PD-L1). It is also approved as monotherapy for patients with advanced NSCLC whose disease progressed despite treatment with platinum-based chemotherapy.

This is the first-known analysis that compares atezolizumab, nivolumab (Opdivo, Bristol Myers Squibb), and docetaxel (Taxotere, Sanofi) in patients outside of clinical trials, said Vivek Subbiah, MD, of MD Anderson Cancer Center and the study’s first author. “We have several new immune checkpoint inhibitors approved for treatment for NSCLC. Head-to-head comparison of the effectiveness of these agents in the real world are lacking,” he said.

Treatment with immune checkpoint inhibitors has shown improvement in the survival of patients with advanced NSCLC who failed chemotherapy treatment.

This study included 3,336 patients (mean age 67 years, 54.6% men) with advanced NSCLC who were treated with platinum-based chemotherapy. Data were collected from more than 1,000 clinics in the United States. Of the patients, 206 received atezolizumab, 500 received docetaxel, and 2,630 received nivolumab.

Patients were followed between May 2011 and March 2020. Atezolizumab and nivolumab showed a similar overall survival in these patients, but atezolizumab showed a longer overall survival, compared with docetaxel.

“Compared with docetaxel, atezolizumab was associated with significantly longer survival in the overall population and across all subgroups analyzed,” including patients with stage IIIB or IV cancer at diagnosis and nonsquamous NSCLC, the authors wrote. “Atezolizumab was associated with longer overall survival compared with docetaxel and was on par with nivolumab, supporting current clinical guidelines for systemic therapy for patients with advanced NSCLC in the U.S.”

Limitations of the study included its observational design and a small number of patients receiving atezolizumab. The authors suggested that studies using larger sample sizes are needed.

This study was funded by F. Hoffmann-La Roche. Genentech is a subsidiary of F. Hoffmann-La Roche.

A head-to-head comparison of immune checkpoint inhibitors atezolizumab and nivolumab and the chemotherapy drug docetaxel in patients with advanced non–small cell lung cancer (NSCLC), finds that atezolizumab was associated with a significantly longer overall survival than docetaxel and was on par with nivolumab.

The findings were reported in JAMA Network Open.

“Until recently, chemotherapy with platinum doublet was the standard first-line option for most patients with advanced NSCLC who did not have these genetic drivers or were not tested for them and remains the first choice in many parts of the world,” wrote the authors of the study which was led by Sreeram Ramagopalan, PhD, of F. Hoffmann-La Roche in Switzerland which funded the study.

Atezolizumab (Tecentriq, Genentech), which was approved in October by the U.S. Food and Drug Administration, is a monoclonal antibody that targets programmed cell death ligand 1 (PD-L1). It is also approved as monotherapy for patients with advanced NSCLC whose disease progressed despite treatment with platinum-based chemotherapy.

This is the first-known analysis that compares atezolizumab, nivolumab (Opdivo, Bristol Myers Squibb), and docetaxel (Taxotere, Sanofi) in patients outside of clinical trials, said Vivek Subbiah, MD, of MD Anderson Cancer Center and the study’s first author. “We have several new immune checkpoint inhibitors approved for treatment for NSCLC. Head-to-head comparison of the effectiveness of these agents in the real world are lacking,” he said.

Treatment with immune checkpoint inhibitors has shown improvement in the survival of patients with advanced NSCLC who failed chemotherapy treatment.

This study included 3,336 patients (mean age 67 years, 54.6% men) with advanced NSCLC who were treated with platinum-based chemotherapy. Data were collected from more than 1,000 clinics in the United States. Of the patients, 206 received atezolizumab, 500 received docetaxel, and 2,630 received nivolumab.

Patients were followed between May 2011 and March 2020. Atezolizumab and nivolumab showed a similar overall survival in these patients, but atezolizumab showed a longer overall survival, compared with docetaxel.

“Compared with docetaxel, atezolizumab was associated with significantly longer survival in the overall population and across all subgroups analyzed,” including patients with stage IIIB or IV cancer at diagnosis and nonsquamous NSCLC, the authors wrote. “Atezolizumab was associated with longer overall survival compared with docetaxel and was on par with nivolumab, supporting current clinical guidelines for systemic therapy for patients with advanced NSCLC in the U.S.”

Limitations of the study included its observational design and a small number of patients receiving atezolizumab. The authors suggested that studies using larger sample sizes are needed.

This study was funded by F. Hoffmann-La Roche. Genentech is a subsidiary of F. Hoffmann-La Roche.

A head-to-head comparison of immune checkpoint inhibitors atezolizumab and nivolumab and the chemotherapy drug docetaxel in patients with advanced non–small cell lung cancer (NSCLC), finds that atezolizumab was associated with a significantly longer overall survival than docetaxel and was on par with nivolumab.

The findings were reported in JAMA Network Open.

“Until recently, chemotherapy with platinum doublet was the standard first-line option for most patients with advanced NSCLC who did not have these genetic drivers or were not tested for them and remains the first choice in many parts of the world,” wrote the authors of the study which was led by Sreeram Ramagopalan, PhD, of F. Hoffmann-La Roche in Switzerland which funded the study.

Atezolizumab (Tecentriq, Genentech), which was approved in October by the U.S. Food and Drug Administration, is a monoclonal antibody that targets programmed cell death ligand 1 (PD-L1). It is also approved as monotherapy for patients with advanced NSCLC whose disease progressed despite treatment with platinum-based chemotherapy.

This is the first-known analysis that compares atezolizumab, nivolumab (Opdivo, Bristol Myers Squibb), and docetaxel (Taxotere, Sanofi) in patients outside of clinical trials, said Vivek Subbiah, MD, of MD Anderson Cancer Center and the study’s first author. “We have several new immune checkpoint inhibitors approved for treatment for NSCLC. Head-to-head comparison of the effectiveness of these agents in the real world are lacking,” he said.

Treatment with immune checkpoint inhibitors has shown improvement in the survival of patients with advanced NSCLC who failed chemotherapy treatment.

This study included 3,336 patients (mean age 67 years, 54.6% men) with advanced NSCLC who were treated with platinum-based chemotherapy. Data were collected from more than 1,000 clinics in the United States. Of the patients, 206 received atezolizumab, 500 received docetaxel, and 2,630 received nivolumab.

Patients were followed between May 2011 and March 2020. Atezolizumab and nivolumab showed a similar overall survival in these patients, but atezolizumab showed a longer overall survival, compared with docetaxel.

“Compared with docetaxel, atezolizumab was associated with significantly longer survival in the overall population and across all subgroups analyzed,” including patients with stage IIIB or IV cancer at diagnosis and nonsquamous NSCLC, the authors wrote. “Atezolizumab was associated with longer overall survival compared with docetaxel and was on par with nivolumab, supporting current clinical guidelines for systemic therapy for patients with advanced NSCLC in the U.S.”

Limitations of the study included its observational design and a small number of patients receiving atezolizumab. The authors suggested that studies using larger sample sizes are needed.

This study was funded by F. Hoffmann-La Roche. Genentech is a subsidiary of F. Hoffmann-La Roche.

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

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

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

The study was published online October 28 in Gastroenterology .

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

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

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

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

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

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

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

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

Concerning but not surprising

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

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

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

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

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

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

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

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

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

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

The study was published online October 28 in Gastroenterology .

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

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

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

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

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

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

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

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

Concerning but not surprising

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

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

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

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

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

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

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

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

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

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

The study was published online October 28 in Gastroenterology .

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

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

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

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

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

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

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

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

Concerning but not surprising

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

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

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

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

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

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

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

Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Laparoscopic HCC resections are increasing worldwide. Ivanics et al. report on a retrospective single-institution experience in North America that involves 149 patients who were matched by propensity score. Laparoscopic liver resection was performed in 57, and open liver resection was completed in 92. The laparoscopic liver resection group experienced a lower number of serious complications (14% vs 29%; P = .01). The 1-year overall survival (OS) rate was 90.9% vs 91.3% in the laparoscopic liver resection versus open liver resection group, while 3-year OS was 79.3% vs 88.5%, and 5-year OS was 70.5% vs 83.1% (P = .26). The cumulative incidence of recurrence at 1 year was 31.1% vs 18.9% in the laparoscopic liver resection versus open liver resection group, at 3 years was 59.7% vs 40.6%, and at 5 years was 62.9% vs 49.2% (P = .06). The authors concluded that laparoscopic HCC resection had fewer short-term complications, and statistically equivalent tumor control, compared to open liver resection, and should be considered as an option for treatment of patients with resectable liver cancer.

Radioembolization is a common treatment for liver-dominant HCC. Selective internal radiation therapy (SIRT) has a high objective response rate, but has yet to demonstrate a OS benefit. This could be due to incidental damage to the healthy liver, resulting in scarring, liver decompensation and a shorter survival. Van Doom et al. retrospectively analyzed 69 patients with advanced HCC who underwent SIRT. The primary outcome was the percentage of patients who developed Child-Pugh (CP) ≥ B7 liver disease after SIRT. The secondary outcomes were OS and response. After a median follow-up of 30 months, 38/69 patients (55%) developed CP ≥ B7. A lower ALBI score at baseline was significantly associated with a better outcome. The median OS in the SIRT-treated patients was 18 months (95% CI 14–22) compared to a case-matched cohort of 300 patients treated with sorafenib between 2007 and 2016 where the median OS was 8 months (95% CI 6–12; p = 0.0027). The authors concluded that patients with intermediate- or advanced-stage HCC treated with SIRT have a substantial risk of developing liver decompensation, but improved patient selection using the ALBI score may mitigate this risk. Note is made that the sorafenib patients were treated at a time when limited systemic options were available.

Finally, Peng et al. analyzed 699 adults with newly diagnosed HCC who were initially treated with transarterial chemoembolization (TACE) between 2010 and 2013. Initial treatment with TACE resulted in a complete response (CR) in 22.3% of the patients. The patients with a CR had a better OS than those who did not achieve CR (35.8 vs 24.0 months, P < 0.001). Predictors of lower likelihood of CR included CP B cirrhosis, higher tumor load, bilobar tumor, alpha-fetoprotein (AFP) level ≥20, and platelet counts >150,000. The authors concluded that TACE is an excellent treatment for selected patients with localized HCC.

Laparoscopic HCC resections are increasing worldwide. Ivanics et al. report on a retrospective single-institution experience in North America that involves 149 patients who were matched by propensity score. Laparoscopic liver resection was performed in 57, and open liver resection was completed in 92. The laparoscopic liver resection group experienced a lower number of serious complications (14% vs 29%; P = .01). The 1-year overall survival (OS) rate was 90.9% vs 91.3% in the laparoscopic liver resection versus open liver resection group, while 3-year OS was 79.3% vs 88.5%, and 5-year OS was 70.5% vs 83.1% (P = .26). The cumulative incidence of recurrence at 1 year was 31.1% vs 18.9% in the laparoscopic liver resection versus open liver resection group, at 3 years was 59.7% vs 40.6%, and at 5 years was 62.9% vs 49.2% (P = .06). The authors concluded that laparoscopic HCC resection had fewer short-term complications, and statistically equivalent tumor control, compared to open liver resection, and should be considered as an option for treatment of patients with resectable liver cancer.

Radioembolization is a common treatment for liver-dominant HCC. Selective internal radiation therapy (SIRT) has a high objective response rate, but has yet to demonstrate a OS benefit. This could be due to incidental damage to the healthy liver, resulting in scarring, liver decompensation and a shorter survival. Van Doom et al. retrospectively analyzed 69 patients with advanced HCC who underwent SIRT. The primary outcome was the percentage of patients who developed Child-Pugh (CP) ≥ B7 liver disease after SIRT. The secondary outcomes were OS and response. After a median follow-up of 30 months, 38/69 patients (55%) developed CP ≥ B7. A lower ALBI score at baseline was significantly associated with a better outcome. The median OS in the SIRT-treated patients was 18 months (95% CI 14–22) compared to a case-matched cohort of 300 patients treated with sorafenib between 2007 and 2016 where the median OS was 8 months (95% CI 6–12; p = 0.0027). The authors concluded that patients with intermediate- or advanced-stage HCC treated with SIRT have a substantial risk of developing liver decompensation, but improved patient selection using the ALBI score may mitigate this risk. Note is made that the sorafenib patients were treated at a time when limited systemic options were available.

Finally, Peng et al. analyzed 699 adults with newly diagnosed HCC who were initially treated with transarterial chemoembolization (TACE) between 2010 and 2013. Initial treatment with TACE resulted in a complete response (CR) in 22.3% of the patients. The patients with a CR had a better OS than those who did not achieve CR (35.8 vs 24.0 months, P < 0.001). Predictors of lower likelihood of CR included CP B cirrhosis, higher tumor load, bilobar tumor, alpha-fetoprotein (AFP) level ≥20, and platelet counts >150,000. The authors concluded that TACE is an excellent treatment for selected patients with localized HCC.

Laparoscopic HCC resections are increasing worldwide. Ivanics et al. report on a retrospective single-institution experience in North America that involves 149 patients who were matched by propensity score. Laparoscopic liver resection was performed in 57, and open liver resection was completed in 92. The laparoscopic liver resection group experienced a lower number of serious complications (14% vs 29%; P = .01). The 1-year overall survival (OS) rate was 90.9% vs 91.3% in the laparoscopic liver resection versus open liver resection group, while 3-year OS was 79.3% vs 88.5%, and 5-year OS was 70.5% vs 83.1% (P = .26). The cumulative incidence of recurrence at 1 year was 31.1% vs 18.9% in the laparoscopic liver resection versus open liver resection group, at 3 years was 59.7% vs 40.6%, and at 5 years was 62.9% vs 49.2% (P = .06). The authors concluded that laparoscopic HCC resection had fewer short-term complications, and statistically equivalent tumor control, compared to open liver resection, and should be considered as an option for treatment of patients with resectable liver cancer.

Radioembolization is a common treatment for liver-dominant HCC. Selective internal radiation therapy (SIRT) has a high objective response rate, but has yet to demonstrate a OS benefit. This could be due to incidental damage to the healthy liver, resulting in scarring, liver decompensation and a shorter survival. Van Doom et al. retrospectively analyzed 69 patients with advanced HCC who underwent SIRT. The primary outcome was the percentage of patients who developed Child-Pugh (CP) ≥ B7 liver disease after SIRT. The secondary outcomes were OS and response. After a median follow-up of 30 months, 38/69 patients (55%) developed CP ≥ B7. A lower ALBI score at baseline was significantly associated with a better outcome. The median OS in the SIRT-treated patients was 18 months (95% CI 14–22) compared to a case-matched cohort of 300 patients treated with sorafenib between 2007 and 2016 where the median OS was 8 months (95% CI 6–12; p = 0.0027). The authors concluded that patients with intermediate- or advanced-stage HCC treated with SIRT have a substantial risk of developing liver decompensation, but improved patient selection using the ALBI score may mitigate this risk. Note is made that the sorafenib patients were treated at a time when limited systemic options were available.

Finally, Peng et al. analyzed 699 adults with newly diagnosed HCC who were initially treated with transarterial chemoembolization (TACE) between 2010 and 2013. Initial treatment with TACE resulted in a complete response (CR) in 22.3% of the patients. The patients with a CR had a better OS than those who did not achieve CR (35.8 vs 24.0 months, P < 0.001). Predictors of lower likelihood of CR included CP B cirrhosis, higher tumor load, bilobar tumor, alpha-fetoprotein (AFP) level ≥20, and platelet counts >150,000. The authors concluded that TACE is an excellent treatment for selected patients with localized HCC.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.