Women's Health

In Rochester, N.Y., a comprehensive community initiative that raised awareness about and delivered training in the use of long-acting reversible contraceptives (LARCs) significantly upped LARC adoption among sexually active female high schoolers.

JPC-PROD/Shutterstock

Over the course of the 3-year project, LARC use rose from about 4% to 24% in this group, a statistically significant increase (P less than .0001). During the same time period, LARC use increased nationally, as well, but at a lower rate, rising from 2% to 5% for the same population, while New York state saw LARC use rise from 2% to 5%.

In New York City, where an unrelated LARC awareness campaign was conducted, LARC use went from 3% to 5% over the study period for sexually active female high school students. Comparing the trend in LARC use in Rochester to the secular trend in these control groups showed significantly higher uptake over time in Rochester (P less than .0001).

Through a series of lunch-and-learn talks given to adults who work with adolescents in community-based settings and in medical settings, the Greater Rochester LARC Initiative reached more than 1,300 individuals during July 2014-June 2017, C. Andrew Aligne, MD, MPH, of the University of Rochester (N.Y.), and coauthors reported in the American Journal of Obstetrics and Gynecology.

Of the 81 total talks delivered, 50 were in medical settings, reaching 703 attendees ranging from front-office personnel to primary care physicians, advanced practice clinicians, and nurses; the talks in community-based settings reached 662 attendees.

“We use the term ‘community detailing’ to describe the design of the intervention because it was an innovative hybrid of academic detailing and community health education,” explained Dr. Aligne and colleagues. This approach is a unique, feasible, and effective approach to unintended adolescent pregnancy programs. “The community detailing approach could be a useful complement to programs for preventing unintended adolescent pregnancy.”

The study’s primary outcome measure was LARC use among sexually active female high school students as identified by responses on the U.S. Centers for Disease Control and Statistics’ Youth Risk Behavior Survey (YRBS).

YRBS data were examined for the years 2013, 2015, and 2017, spanning the period before and after the LARC initiative was begun. A separate question about LARC use wasn’t included in the 2013 YRBS survey, so the investigators used a generous estimate that two-thirds of respondents who reported using the “other” contraceptive category for that year were using LARCs. That category was chosen by a total of 6% of respondents, and encompassed LARC use along with use of the patch, ring, diaphragm, and fertility awareness, explained Dr. Aligne and collaborators.

Addressing the problem of failure to use a condom with LARC use, Dr. Aligne and collaborators found overall low rates of dual-method use, but higher rates in Rochester than in the comparison groups. In Rochester, 78% of respondents reported that they also did not use condoms. This figure was lower than the 91% reported for the United States as a whole, and also was lower than the 93% reported in New York City and the 85% reported in New York state. No increase in sexually transmitted infections was seen in Rochester’s sexually active high school females during the study period.

“Our main finding of increased LARC use is consistent with the literature demonstrating that many sexually active young women, including adolescents, will choose LARC if they are given access not only to birth control itself, but also to accurate information about various contraceptive methods,” concluded Dr. Aligne and his associates.

A practical strength of the Greater Rochester LARC initiative was that it capitalized on existing resources, such as New York state’s preexisting program for free access to contraception and similar provisions in the Affordable Care Act. Also, local Title X clinics that were enrolled in New York’s free contraception initiative already had practitioners who were trained and able to provide same-day LARC insertion.

Pediatricians engaged in the initiative were able to receive free training from LARC manufacturers, as mandated by the Food and Drug Administration. Through collaboration with implant manufacturers, Rochester LARC Initiative staff were able to piggyback on training sessions to add education about contraception counseling and the importance of offering access to all contraception methods.

Taken as a whole, the LARC Initiative could be scaled up, wrote Dr. Aligne and his coauthors, a potential boon in the 21 states where qualifying individuals younger than 19 years of age are eligible for Medicaid reimbursement for family planning services. “Even though easy LARC access is far from universal, there are vast areas of the nation where cost need not be seen as an insurmountable barrier.” Dr. Aligne and coauthors also addressed the fraught history of reproductive justice in the United States, cautioning that universal LARC adoption was not – and should not be – the goal of such initiatives. “There is a history of reproductive coercion in the U.S. including forced sterilization of women of color; therefore, it is critical that LARC methods not be imposed on any particular group. On the other hand, LARC should not be withheld deliberately from adolescents who want it, as this is another form of injustice,” they wrote. “The goal should be to empower individuals to decide what is right for them in a context of social and reproductive justice.”

Using the nationally administered YRBS was a significant strength of the study, commented Dr. Aligne and his collaborators. “This allowed us to employ the study design of pre-post with a nonrandomized control group,” the investigators noted, adding that the “relatively rigorous” methodology reduced the risk of problems with internal validity, and also allowed comparisons between changes in Rochester and those at the state and national level.

However, the researchers acknowledged that the study was not a randomized trial, and there’s always the possibility of unknown confounders contributing to LARC uptake during the study period. Also, the YRBS is a self-report instrument and only includes those enrolled in school.

Dr. Aligne reported that his spouse received compensation for providing contraceptive implant insertion training, as did two coauthors. The LARC initiative was supported by a grant from the Greater Rochester Health Foundation.

[email protected]

SOURCE: Aligne CA et al. Am J Obstet Gynecol. 2020 Jan 22. doi: 10.1016/j.ajog.2020.01.029.

In Rochester, N.Y., a comprehensive community initiative that raised awareness about and delivered training in the use of long-acting reversible contraceptives (LARCs) significantly upped LARC adoption among sexually active female high schoolers.

JPC-PROD/Shutterstock

Over the course of the 3-year project, LARC use rose from about 4% to 24% in this group, a statistically significant increase (P less than .0001). During the same time period, LARC use increased nationally, as well, but at a lower rate, rising from 2% to 5% for the same population, while New York state saw LARC use rise from 2% to 5%.

In New York City, where an unrelated LARC awareness campaign was conducted, LARC use went from 3% to 5% over the study period for sexually active female high school students. Comparing the trend in LARC use in Rochester to the secular trend in these control groups showed significantly higher uptake over time in Rochester (P less than .0001).

Through a series of lunch-and-learn talks given to adults who work with adolescents in community-based settings and in medical settings, the Greater Rochester LARC Initiative reached more than 1,300 individuals during July 2014-June 2017, C. Andrew Aligne, MD, MPH, of the University of Rochester (N.Y.), and coauthors reported in the American Journal of Obstetrics and Gynecology.

Of the 81 total talks delivered, 50 were in medical settings, reaching 703 attendees ranging from front-office personnel to primary care physicians, advanced practice clinicians, and nurses; the talks in community-based settings reached 662 attendees.

“We use the term ‘community detailing’ to describe the design of the intervention because it was an innovative hybrid of academic detailing and community health education,” explained Dr. Aligne and colleagues. This approach is a unique, feasible, and effective approach to unintended adolescent pregnancy programs. “The community detailing approach could be a useful complement to programs for preventing unintended adolescent pregnancy.”

The study’s primary outcome measure was LARC use among sexually active female high school students as identified by responses on the U.S. Centers for Disease Control and Statistics’ Youth Risk Behavior Survey (YRBS).

YRBS data were examined for the years 2013, 2015, and 2017, spanning the period before and after the LARC initiative was begun. A separate question about LARC use wasn’t included in the 2013 YRBS survey, so the investigators used a generous estimate that two-thirds of respondents who reported using the “other” contraceptive category for that year were using LARCs. That category was chosen by a total of 6% of respondents, and encompassed LARC use along with use of the patch, ring, diaphragm, and fertility awareness, explained Dr. Aligne and collaborators.

Addressing the problem of failure to use a condom with LARC use, Dr. Aligne and collaborators found overall low rates of dual-method use, but higher rates in Rochester than in the comparison groups. In Rochester, 78% of respondents reported that they also did not use condoms. This figure was lower than the 91% reported for the United States as a whole, and also was lower than the 93% reported in New York City and the 85% reported in New York state. No increase in sexually transmitted infections was seen in Rochester’s sexually active high school females during the study period.

“Our main finding of increased LARC use is consistent with the literature demonstrating that many sexually active young women, including adolescents, will choose LARC if they are given access not only to birth control itself, but also to accurate information about various contraceptive methods,” concluded Dr. Aligne and his associates.

A practical strength of the Greater Rochester LARC initiative was that it capitalized on existing resources, such as New York state’s preexisting program for free access to contraception and similar provisions in the Affordable Care Act. Also, local Title X clinics that were enrolled in New York’s free contraception initiative already had practitioners who were trained and able to provide same-day LARC insertion.

Pediatricians engaged in the initiative were able to receive free training from LARC manufacturers, as mandated by the Food and Drug Administration. Through collaboration with implant manufacturers, Rochester LARC Initiative staff were able to piggyback on training sessions to add education about contraception counseling and the importance of offering access to all contraception methods.

Taken as a whole, the LARC Initiative could be scaled up, wrote Dr. Aligne and his coauthors, a potential boon in the 21 states where qualifying individuals younger than 19 years of age are eligible for Medicaid reimbursement for family planning services. “Even though easy LARC access is far from universal, there are vast areas of the nation where cost need not be seen as an insurmountable barrier.” Dr. Aligne and coauthors also addressed the fraught history of reproductive justice in the United States, cautioning that universal LARC adoption was not – and should not be – the goal of such initiatives. “There is a history of reproductive coercion in the U.S. including forced sterilization of women of color; therefore, it is critical that LARC methods not be imposed on any particular group. On the other hand, LARC should not be withheld deliberately from adolescents who want it, as this is another form of injustice,” they wrote. “The goal should be to empower individuals to decide what is right for them in a context of social and reproductive justice.”

Using the nationally administered YRBS was a significant strength of the study, commented Dr. Aligne and his collaborators. “This allowed us to employ the study design of pre-post with a nonrandomized control group,” the investigators noted, adding that the “relatively rigorous” methodology reduced the risk of problems with internal validity, and also allowed comparisons between changes in Rochester and those at the state and national level.

However, the researchers acknowledged that the study was not a randomized trial, and there’s always the possibility of unknown confounders contributing to LARC uptake during the study period. Also, the YRBS is a self-report instrument and only includes those enrolled in school.

Dr. Aligne reported that his spouse received compensation for providing contraceptive implant insertion training, as did two coauthors. The LARC initiative was supported by a grant from the Greater Rochester Health Foundation.

[email protected]

SOURCE: Aligne CA et al. Am J Obstet Gynecol. 2020 Jan 22. doi: 10.1016/j.ajog.2020.01.029.

In Rochester, N.Y., a comprehensive community initiative that raised awareness about and delivered training in the use of long-acting reversible contraceptives (LARCs) significantly upped LARC adoption among sexually active female high schoolers.

JPC-PROD/Shutterstock

Over the course of the 3-year project, LARC use rose from about 4% to 24% in this group, a statistically significant increase (P less than .0001). During the same time period, LARC use increased nationally, as well, but at a lower rate, rising from 2% to 5% for the same population, while New York state saw LARC use rise from 2% to 5%.

In New York City, where an unrelated LARC awareness campaign was conducted, LARC use went from 3% to 5% over the study period for sexually active female high school students. Comparing the trend in LARC use in Rochester to the secular trend in these control groups showed significantly higher uptake over time in Rochester (P less than .0001).

Through a series of lunch-and-learn talks given to adults who work with adolescents in community-based settings and in medical settings, the Greater Rochester LARC Initiative reached more than 1,300 individuals during July 2014-June 2017, C. Andrew Aligne, MD, MPH, of the University of Rochester (N.Y.), and coauthors reported in the American Journal of Obstetrics and Gynecology.

Of the 81 total talks delivered, 50 were in medical settings, reaching 703 attendees ranging from front-office personnel to primary care physicians, advanced practice clinicians, and nurses; the talks in community-based settings reached 662 attendees.

“We use the term ‘community detailing’ to describe the design of the intervention because it was an innovative hybrid of academic detailing and community health education,” explained Dr. Aligne and colleagues. This approach is a unique, feasible, and effective approach to unintended adolescent pregnancy programs. “The community detailing approach could be a useful complement to programs for preventing unintended adolescent pregnancy.”

The study’s primary outcome measure was LARC use among sexually active female high school students as identified by responses on the U.S. Centers for Disease Control and Statistics’ Youth Risk Behavior Survey (YRBS).

YRBS data were examined for the years 2013, 2015, and 2017, spanning the period before and after the LARC initiative was begun. A separate question about LARC use wasn’t included in the 2013 YRBS survey, so the investigators used a generous estimate that two-thirds of respondents who reported using the “other” contraceptive category for that year were using LARCs. That category was chosen by a total of 6% of respondents, and encompassed LARC use along with use of the patch, ring, diaphragm, and fertility awareness, explained Dr. Aligne and collaborators.

Addressing the problem of failure to use a condom with LARC use, Dr. Aligne and collaborators found overall low rates of dual-method use, but higher rates in Rochester than in the comparison groups. In Rochester, 78% of respondents reported that they also did not use condoms. This figure was lower than the 91% reported for the United States as a whole, and also was lower than the 93% reported in New York City and the 85% reported in New York state. No increase in sexually transmitted infections was seen in Rochester’s sexually active high school females during the study period.

“Our main finding of increased LARC use is consistent with the literature demonstrating that many sexually active young women, including adolescents, will choose LARC if they are given access not only to birth control itself, but also to accurate information about various contraceptive methods,” concluded Dr. Aligne and his associates.

A practical strength of the Greater Rochester LARC initiative was that it capitalized on existing resources, such as New York state’s preexisting program for free access to contraception and similar provisions in the Affordable Care Act. Also, local Title X clinics that were enrolled in New York’s free contraception initiative already had practitioners who were trained and able to provide same-day LARC insertion.

Pediatricians engaged in the initiative were able to receive free training from LARC manufacturers, as mandated by the Food and Drug Administration. Through collaboration with implant manufacturers, Rochester LARC Initiative staff were able to piggyback on training sessions to add education about contraception counseling and the importance of offering access to all contraception methods.

Taken as a whole, the LARC Initiative could be scaled up, wrote Dr. Aligne and his coauthors, a potential boon in the 21 states where qualifying individuals younger than 19 years of age are eligible for Medicaid reimbursement for family planning services. “Even though easy LARC access is far from universal, there are vast areas of the nation where cost need not be seen as an insurmountable barrier.” Dr. Aligne and coauthors also addressed the fraught history of reproductive justice in the United States, cautioning that universal LARC adoption was not – and should not be – the goal of such initiatives. “There is a history of reproductive coercion in the U.S. including forced sterilization of women of color; therefore, it is critical that LARC methods not be imposed on any particular group. On the other hand, LARC should not be withheld deliberately from adolescents who want it, as this is another form of injustice,” they wrote. “The goal should be to empower individuals to decide what is right for them in a context of social and reproductive justice.”

Using the nationally administered YRBS was a significant strength of the study, commented Dr. Aligne and his collaborators. “This allowed us to employ the study design of pre-post with a nonrandomized control group,” the investigators noted, adding that the “relatively rigorous” methodology reduced the risk of problems with internal validity, and also allowed comparisons between changes in Rochester and those at the state and national level.

However, the researchers acknowledged that the study was not a randomized trial, and there’s always the possibility of unknown confounders contributing to LARC uptake during the study period. Also, the YRBS is a self-report instrument and only includes those enrolled in school.

Dr. Aligne reported that his spouse received compensation for providing contraceptive implant insertion training, as did two coauthors. The LARC initiative was supported by a grant from the Greater Rochester Health Foundation.

[email protected]

SOURCE: Aligne CA et al. Am J Obstet Gynecol. 2020 Jan 22. doi: 10.1016/j.ajog.2020.01.029.

MAUI, HAWAII – Osteoporosis affects about 15% of people with inflammatory bowel disease (IBD), but the disease pattern is different than in the general population, said gastroenterologist Millie Long, MD, from the Department of Medicine at the University of North Carolina in Chapel Hill.

In the general population, those who develop osteoporosis are typically women who are thin and postmenopausal, and family history, smoking status, and alcohol use usually play a role, Long said at the Gastroenterology Updates, IBD, Liver Disease Conference.

But in the population with IBD, the risk for osteoporosis is similar in women and men, age plays a large role, and corticosteroid use seems to be a driving factor in the development of the disease, she explained.

A previous study that looked at fractures in patients with IBD showed that the risk “is 40% greater than in the general population,” Long reported. In patients younger than 40 years, the risk for fracture was 37% higher than in the general population, and this rate increased with age.
 

Preventing fractures

Fractures to the hip and spine are linked to significant morbidity, including hospitalization, major surgery, and even death, Long noted. But they are one of the preventable downstream effects of IBD, and patients need to understand that there’s something they can do about their elevated risk.

Patients should be educated on the importance of weight-bearing exercise and quitting smoking, she said.

“We need to think of preventive measures for anyone on more than 5 mg of prednisone a day for a time period of about 3 months,” she added. “Unfortunately, most of our patients meet this criterion.”

Patients with IBD should undergo dual-energy x-ray absorptiometry (DXA) to calculate bone density and establish the need for calcium and vitamin D supplementation.

“One of the things I’m starting to do in my practice is check vitamin D levels annually on my patients. I do this in the springtime and try to optimize their levels,” Long said.
 

Higher risk for herpes zoster

The risk for infection is also elevated in patients with IBD, including the risk for herpes zoster, which is already high, affecting one in three people in the general population.

In fact, the risk for herpes zoster in patients with IBD in their 20s is similar to the risk for people in their 50s in the general population. This is “something we need to be addressing in all of our patients,” said Long.

Physicians should emphasize the need for zoster vaccination in patients at least 50 years of age, and potentially younger patients on certain therapies, she added.

But because the Shingrix shingles vaccine (GlaxoSmithKline) is so much more powerful than the previous live vaccine, some have wondered whether it could stimulate an immune response, causing the IBD to flare after vaccination, she said.

However, a recent study of IBD patients followed for 207 days after shingles vaccination showed that only one of the 67 study participants (1.5%) experienced a flare. But fever is fairly common after the shot.

“I counsel my patients that they may feel pretty wiped out for 24 hours; they may have myalgias,” Long reported. “If you have someone who has to travel for work, you want them to time this vaccination so they can have a day of rest afterward. It’s the real deal.”
 

Screening for TB

Screening to rule out latent tuberculosis (TB) is also important in IBD.

“We should be looking at whether they’ve had close contact with active TB or people from endemic areas,” said Long. “The reason we really care about this is that the risk of serious infection is doubled with anti-TNF therapy.”

The treatment of latent TB prior to the initiation of an anti-TNF “reduces the incidence of active TB by over 80%. This is why it’s imperative to screen prior to initiation, and then periodically based on risk factors,” she explained.

“It’s profound how much maintenance is required for patients with IBD,” said Christopher Stanke, MD, from the Oregon Medical Group in Eugene.

He said he is particularly struck by the collective risks for younger patients with IBD.

“Young people look to us as their only doctor. They don’t even see their primary care physicians very often. We have to take over a lot of this stuff,” he told Medscape Medical News.

And osteoporosis doesn’t often get the attention it needs in gastroenterologists’ offices, he acknowledged.

“I often check it on people as they get close to 50 or 60,” said Stanke, who added that Long’s presentation is a good reminder that younger patients, especially those who have been on steroids for a while, need more attention.

This article first appeared on Medscape.com.

MAUI, HAWAII – Osteoporosis affects about 15% of people with inflammatory bowel disease (IBD), but the disease pattern is different than in the general population, said gastroenterologist Millie Long, MD, from the Department of Medicine at the University of North Carolina in Chapel Hill.

In the general population, those who develop osteoporosis are typically women who are thin and postmenopausal, and family history, smoking status, and alcohol use usually play a role, Long said at the Gastroenterology Updates, IBD, Liver Disease Conference.

But in the population with IBD, the risk for osteoporosis is similar in women and men, age plays a large role, and corticosteroid use seems to be a driving factor in the development of the disease, she explained.

A previous study that looked at fractures in patients with IBD showed that the risk “is 40% greater than in the general population,” Long reported. In patients younger than 40 years, the risk for fracture was 37% higher than in the general population, and this rate increased with age.
 

Preventing fractures

Fractures to the hip and spine are linked to significant morbidity, including hospitalization, major surgery, and even death, Long noted. But they are one of the preventable downstream effects of IBD, and patients need to understand that there’s something they can do about their elevated risk.

Patients should be educated on the importance of weight-bearing exercise and quitting smoking, she said.

“We need to think of preventive measures for anyone on more than 5 mg of prednisone a day for a time period of about 3 months,” she added. “Unfortunately, most of our patients meet this criterion.”

Patients with IBD should undergo dual-energy x-ray absorptiometry (DXA) to calculate bone density and establish the need for calcium and vitamin D supplementation.

“One of the things I’m starting to do in my practice is check vitamin D levels annually on my patients. I do this in the springtime and try to optimize their levels,” Long said.
 

Higher risk for herpes zoster

The risk for infection is also elevated in patients with IBD, including the risk for herpes zoster, which is already high, affecting one in three people in the general population.

In fact, the risk for herpes zoster in patients with IBD in their 20s is similar to the risk for people in their 50s in the general population. This is “something we need to be addressing in all of our patients,” said Long.

Physicians should emphasize the need for zoster vaccination in patients at least 50 years of age, and potentially younger patients on certain therapies, she added.

But because the Shingrix shingles vaccine (GlaxoSmithKline) is so much more powerful than the previous live vaccine, some have wondered whether it could stimulate an immune response, causing the IBD to flare after vaccination, she said.

However, a recent study of IBD patients followed for 207 days after shingles vaccination showed that only one of the 67 study participants (1.5%) experienced a flare. But fever is fairly common after the shot.

“I counsel my patients that they may feel pretty wiped out for 24 hours; they may have myalgias,” Long reported. “If you have someone who has to travel for work, you want them to time this vaccination so they can have a day of rest afterward. It’s the real deal.”
 

Screening for TB

Screening to rule out latent tuberculosis (TB) is also important in IBD.

“We should be looking at whether they’ve had close contact with active TB or people from endemic areas,” said Long. “The reason we really care about this is that the risk of serious infection is doubled with anti-TNF therapy.”

The treatment of latent TB prior to the initiation of an anti-TNF “reduces the incidence of active TB by over 80%. This is why it’s imperative to screen prior to initiation, and then periodically based on risk factors,” she explained.

“It’s profound how much maintenance is required for patients with IBD,” said Christopher Stanke, MD, from the Oregon Medical Group in Eugene.

He said he is particularly struck by the collective risks for younger patients with IBD.

“Young people look to us as their only doctor. They don’t even see their primary care physicians very often. We have to take over a lot of this stuff,” he told Medscape Medical News.

And osteoporosis doesn’t often get the attention it needs in gastroenterologists’ offices, he acknowledged.

“I often check it on people as they get close to 50 or 60,” said Stanke, who added that Long’s presentation is a good reminder that younger patients, especially those who have been on steroids for a while, need more attention.

This article first appeared on Medscape.com.

MAUI, HAWAII – Osteoporosis affects about 15% of people with inflammatory bowel disease (IBD), but the disease pattern is different than in the general population, said gastroenterologist Millie Long, MD, from the Department of Medicine at the University of North Carolina in Chapel Hill.

In the general population, those who develop osteoporosis are typically women who are thin and postmenopausal, and family history, smoking status, and alcohol use usually play a role, Long said at the Gastroenterology Updates, IBD, Liver Disease Conference.

But in the population with IBD, the risk for osteoporosis is similar in women and men, age plays a large role, and corticosteroid use seems to be a driving factor in the development of the disease, she explained.

A previous study that looked at fractures in patients with IBD showed that the risk “is 40% greater than in the general population,” Long reported. In patients younger than 40 years, the risk for fracture was 37% higher than in the general population, and this rate increased with age.
 

Preventing fractures

Fractures to the hip and spine are linked to significant morbidity, including hospitalization, major surgery, and even death, Long noted. But they are one of the preventable downstream effects of IBD, and patients need to understand that there’s something they can do about their elevated risk.

Patients should be educated on the importance of weight-bearing exercise and quitting smoking, she said.

“We need to think of preventive measures for anyone on more than 5 mg of prednisone a day for a time period of about 3 months,” she added. “Unfortunately, most of our patients meet this criterion.”

Patients with IBD should undergo dual-energy x-ray absorptiometry (DXA) to calculate bone density and establish the need for calcium and vitamin D supplementation.

“One of the things I’m starting to do in my practice is check vitamin D levels annually on my patients. I do this in the springtime and try to optimize their levels,” Long said.
 

Higher risk for herpes zoster

The risk for infection is also elevated in patients with IBD, including the risk for herpes zoster, which is already high, affecting one in three people in the general population.

In fact, the risk for herpes zoster in patients with IBD in their 20s is similar to the risk for people in their 50s in the general population. This is “something we need to be addressing in all of our patients,” said Long.

Physicians should emphasize the need for zoster vaccination in patients at least 50 years of age, and potentially younger patients on certain therapies, she added.

But because the Shingrix shingles vaccine (GlaxoSmithKline) is so much more powerful than the previous live vaccine, some have wondered whether it could stimulate an immune response, causing the IBD to flare after vaccination, she said.

However, a recent study of IBD patients followed for 207 days after shingles vaccination showed that only one of the 67 study participants (1.5%) experienced a flare. But fever is fairly common after the shot.

“I counsel my patients that they may feel pretty wiped out for 24 hours; they may have myalgias,” Long reported. “If you have someone who has to travel for work, you want them to time this vaccination so they can have a day of rest afterward. It’s the real deal.”
 

Screening for TB

Screening to rule out latent tuberculosis (TB) is also important in IBD.

“We should be looking at whether they’ve had close contact with active TB or people from endemic areas,” said Long. “The reason we really care about this is that the risk of serious infection is doubled with anti-TNF therapy.”

The treatment of latent TB prior to the initiation of an anti-TNF “reduces the incidence of active TB by over 80%. This is why it’s imperative to screen prior to initiation, and then periodically based on risk factors,” she explained.

“It’s profound how much maintenance is required for patients with IBD,” said Christopher Stanke, MD, from the Oregon Medical Group in Eugene.

He said he is particularly struck by the collective risks for younger patients with IBD.

“Young people look to us as their only doctor. They don’t even see their primary care physicians very often. We have to take over a lot of this stuff,” he told Medscape Medical News.

And osteoporosis doesn’t often get the attention it needs in gastroenterologists’ offices, he acknowledged.

“I often check it on people as they get close to 50 or 60,” said Stanke, who added that Long’s presentation is a good reminder that younger patients, especially those who have been on steroids for a while, need more attention.

This article first appeared on Medscape.com.

Children exposed to macrolides during the first trimester of pregnancy had an increased risk of major malformations, compared with first-trimester penicillin exposure, according to an observational study.

Creatas Images

Use of antibiotics is common in pregnancy, and macrolides commonly are used if a penicillin allergy is reported.

Hypospadias and other genital malformations also were more likely with exposure during any trimester to macrolides, although this association lost significance when limited to the first trimester. The researchers did not identify any associations with macrolides exposure and neurodevelopmental disorders.

The observational study could not establish causality, but the researchers calculated an estimate of likely excess malformations if the association were found to be causal: “For every 1,000 mothers prescribed macrolides instead of penicillins during the first trimester, an additional 4.1 children would have cardiovascular malformations,” Heng Fan, a PhD student at the University College London, and colleagues wrote in the BMJ. “The corresponding figures for prescriptions during any trimester and genital malformations would be 1.7.”

The researchers used records from the U.K. Clinical Practice Research Datalink to analyze outcomes in 104,605 children born between 1990 and 2016 to mothers who received at least one prescription of erythromycin, clarithromycin, azithromycin, or penicillin monotherapy between their fourth week of pregnancy and delivery. Women prescribed any known teratogenic medications were excluded.

The majority of the mothers (92%) had been prescribed penicillin once, and 8% were prescribed a macrolide antibiotic once during pregnancy.

The researchers tallied and calculated the children’s risk of major malformations; cerebral palsy; epilepsy; ADHD; autism spectrum disorder; and any nervous, cardiovascular, gastrointestinal, genital, or urinary malformations. The children were tracked through a median 6 years of age.

In comparing risk of malformations or neurodevelopmental disorders among children, the researchers chose to compare exposure to macrolides and penicillin to reduce the likelihood of confounding by indication for infections. (They also included two negative control groups: unexposed siblings and women prescribed antibiotics before conception.) The authors acknowledged, however, that residual confounding still may occur “if macrolides were prescribed for specific indications (e.g., chlamydia), or when potential risk factors for malformations or neurodevelopmental outcomes differed between treatment groups.”

The overall rate of malformations was 22 per 1,000 children prenatally exposed to macrolides (28 in first trimester and 20 in second or third trimester) and 17 per 1,000 children prenatally exposed to penicillin. The risk and type of malformations varied, however, according to the trimester.

The researchers made adjustments to account for differences in a wide range of maternal factors: age at delivery, calendar year of delivery, alcohol misuse, illegal drug use, tobacco use, obesity, hypertension, diabetes, anxiety, depression, and epilepsy. They also adjusted for parity, multiples, and chronic medical treatments, as well as genitourinary tract infections or STIs during pregnancy, both of which are linked to preterm labor.

Compared with children exposed to penicillin during the first trimester of pregnancy, risk of malformations was 1.6 times greater in those exposed to macrolides in the first trimester (risk ratio, 1.55; 28 vs. 18 per 1,000). Erythromycin exposure in the first trimester also was linked to a 50% greater likelihood of any major malformation compared with penicillin (RR, 1.5; 27 vs. 18 per 1,000).

Cardiovascular malformations in particular were more likely in those exposed to macrolides (11 per 1,000), compared with penicillin (7 per 1,000) in the first trimester (RR, 1.62). Meanwhile, genital malformations, primarily hypospadias, occurred more frequently in children whose mothers were prescribed macrolides (5 per 1,000), compared with penicillin (3 per 1,000) in any trimester (RR, 1.58).

No increased risk of major malformations was associated with macrolides prescribed only in the second or third trimester, although a borderline significant association existed with gastrointestinal malformations. The authors also found no links between macrolides exposure and increased risk of cerebral palsy, epilepsy, ADHD, or autism spectrum disorder.

The findings did not change in several sensitivity analyses, including one that restricted analysis to antibiotics prescribed only for respiratory tract infections.

Dr. Fan and associates discussed several potential biological mechanisms for causation, including the arrhythmic effect of macrolides that may relate to cardiovascular malformations or contribute to fetal hypoxia. They noted that “macrolide prescribing during pregnancy warrants caution,” and recommend including on drug safety labels “that there is uncertainty about the safety of macrolides, including erythromycin” and alternative antibiotics should be used when possible.

Iris Krishna, MD, MPH, assistant professor of maternal-fetal medicine at Emory University, Atlanta, agreed with the study authors that use of macrolides in the first trimester warrants further investigation, and if an appropriate alternative antibiotic is available, then it should be preferentially considered when treating infections in the first trimester.

“However, if macrolides are the only treatment option, pregnant women can be reassured that the absolute risk of a birth defect is low, and this should not discourage them from taking a macrolide when needed as untreated infections pose a greater risk in pregnancy,” she said in an interview.

“This study does not establish that macrolide antibiotics cause birth defects, but it suggests a potential association. Previous studies examining the use of macrolides, such as erythromycin, have not demonstrated a consistent pattern of birth defects, and heart defects identified were classified as mostly mild. The authors suggest that the potential biologic mechanism based on rat models may be that macrolides might induce fetal cardiac arrhythmias and short-term fetal hypoxia. This study was underpowered to examine macrolide exposure for specific malformations. To avoid underpowered comparisons, the authors’ categorized malformations by organ systems, so the spectrum of cardiac defects is unclear,” commented Dr. Krishna, who also is a member of the Ob.Gyn. News editorial advisory board.

“Current recommendations for macrolide antibiotic use in pregnancy in the second and third trimester of pregnancy, and in particular when used for obstetric indications, such as prelabor rupture of membranes to prolong the latency period to delivery, should not be altered based on the findings of this study,” she concluded.

The research was funded by Child Health Research CIO Trust, the China Scholarship Council, Health Data Research UK, and the National Institute for Health Research. Dr. Fan and associates had no industry disclosures. Dr. Krishna had no relevant financial disclosures.

SOURCE: Fan H et al. BMJ. 2020;368:m331.

Children exposed to macrolides during the first trimester of pregnancy had an increased risk of major malformations, compared with first-trimester penicillin exposure, according to an observational study.

Creatas Images

Use of antibiotics is common in pregnancy, and macrolides commonly are used if a penicillin allergy is reported.

Hypospadias and other genital malformations also were more likely with exposure during any trimester to macrolides, although this association lost significance when limited to the first trimester. The researchers did not identify any associations with macrolides exposure and neurodevelopmental disorders.

The observational study could not establish causality, but the researchers calculated an estimate of likely excess malformations if the association were found to be causal: “For every 1,000 mothers prescribed macrolides instead of penicillins during the first trimester, an additional 4.1 children would have cardiovascular malformations,” Heng Fan, a PhD student at the University College London, and colleagues wrote in the BMJ. “The corresponding figures for prescriptions during any trimester and genital malformations would be 1.7.”

The researchers used records from the U.K. Clinical Practice Research Datalink to analyze outcomes in 104,605 children born between 1990 and 2016 to mothers who received at least one prescription of erythromycin, clarithromycin, azithromycin, or penicillin monotherapy between their fourth week of pregnancy and delivery. Women prescribed any known teratogenic medications were excluded.

The majority of the mothers (92%) had been prescribed penicillin once, and 8% were prescribed a macrolide antibiotic once during pregnancy.

The researchers tallied and calculated the children’s risk of major malformations; cerebral palsy; epilepsy; ADHD; autism spectrum disorder; and any nervous, cardiovascular, gastrointestinal, genital, or urinary malformations. The children were tracked through a median 6 years of age.

In comparing risk of malformations or neurodevelopmental disorders among children, the researchers chose to compare exposure to macrolides and penicillin to reduce the likelihood of confounding by indication for infections. (They also included two negative control groups: unexposed siblings and women prescribed antibiotics before conception.) The authors acknowledged, however, that residual confounding still may occur “if macrolides were prescribed for specific indications (e.g., chlamydia), or when potential risk factors for malformations or neurodevelopmental outcomes differed between treatment groups.”

The overall rate of malformations was 22 per 1,000 children prenatally exposed to macrolides (28 in first trimester and 20 in second or third trimester) and 17 per 1,000 children prenatally exposed to penicillin. The risk and type of malformations varied, however, according to the trimester.

The researchers made adjustments to account for differences in a wide range of maternal factors: age at delivery, calendar year of delivery, alcohol misuse, illegal drug use, tobacco use, obesity, hypertension, diabetes, anxiety, depression, and epilepsy. They also adjusted for parity, multiples, and chronic medical treatments, as well as genitourinary tract infections or STIs during pregnancy, both of which are linked to preterm labor.

Compared with children exposed to penicillin during the first trimester of pregnancy, risk of malformations was 1.6 times greater in those exposed to macrolides in the first trimester (risk ratio, 1.55; 28 vs. 18 per 1,000). Erythromycin exposure in the first trimester also was linked to a 50% greater likelihood of any major malformation compared with penicillin (RR, 1.5; 27 vs. 18 per 1,000).

Cardiovascular malformations in particular were more likely in those exposed to macrolides (11 per 1,000), compared with penicillin (7 per 1,000) in the first trimester (RR, 1.62). Meanwhile, genital malformations, primarily hypospadias, occurred more frequently in children whose mothers were prescribed macrolides (5 per 1,000), compared with penicillin (3 per 1,000) in any trimester (RR, 1.58).

No increased risk of major malformations was associated with macrolides prescribed only in the second or third trimester, although a borderline significant association existed with gastrointestinal malformations. The authors also found no links between macrolides exposure and increased risk of cerebral palsy, epilepsy, ADHD, or autism spectrum disorder.

The findings did not change in several sensitivity analyses, including one that restricted analysis to antibiotics prescribed only for respiratory tract infections.

Dr. Fan and associates discussed several potential biological mechanisms for causation, including the arrhythmic effect of macrolides that may relate to cardiovascular malformations or contribute to fetal hypoxia. They noted that “macrolide prescribing during pregnancy warrants caution,” and recommend including on drug safety labels “that there is uncertainty about the safety of macrolides, including erythromycin” and alternative antibiotics should be used when possible.

Iris Krishna, MD, MPH, assistant professor of maternal-fetal medicine at Emory University, Atlanta, agreed with the study authors that use of macrolides in the first trimester warrants further investigation, and if an appropriate alternative antibiotic is available, then it should be preferentially considered when treating infections in the first trimester.

“However, if macrolides are the only treatment option, pregnant women can be reassured that the absolute risk of a birth defect is low, and this should not discourage them from taking a macrolide when needed as untreated infections pose a greater risk in pregnancy,” she said in an interview.

“This study does not establish that macrolide antibiotics cause birth defects, but it suggests a potential association. Previous studies examining the use of macrolides, such as erythromycin, have not demonstrated a consistent pattern of birth defects, and heart defects identified were classified as mostly mild. The authors suggest that the potential biologic mechanism based on rat models may be that macrolides might induce fetal cardiac arrhythmias and short-term fetal hypoxia. This study was underpowered to examine macrolide exposure for specific malformations. To avoid underpowered comparisons, the authors’ categorized malformations by organ systems, so the spectrum of cardiac defects is unclear,” commented Dr. Krishna, who also is a member of the Ob.Gyn. News editorial advisory board.

“Current recommendations for macrolide antibiotic use in pregnancy in the second and third trimester of pregnancy, and in particular when used for obstetric indications, such as prelabor rupture of membranes to prolong the latency period to delivery, should not be altered based on the findings of this study,” she concluded.

The research was funded by Child Health Research CIO Trust, the China Scholarship Council, Health Data Research UK, and the National Institute for Health Research. Dr. Fan and associates had no industry disclosures. Dr. Krishna had no relevant financial disclosures.

SOURCE: Fan H et al. BMJ. 2020;368:m331.

Children exposed to macrolides during the first trimester of pregnancy had an increased risk of major malformations, compared with first-trimester penicillin exposure, according to an observational study.

Creatas Images

Use of antibiotics is common in pregnancy, and macrolides commonly are used if a penicillin allergy is reported.

Hypospadias and other genital malformations also were more likely with exposure during any trimester to macrolides, although this association lost significance when limited to the first trimester. The researchers did not identify any associations with macrolides exposure and neurodevelopmental disorders.

The observational study could not establish causality, but the researchers calculated an estimate of likely excess malformations if the association were found to be causal: “For every 1,000 mothers prescribed macrolides instead of penicillins during the first trimester, an additional 4.1 children would have cardiovascular malformations,” Heng Fan, a PhD student at the University College London, and colleagues wrote in the BMJ. “The corresponding figures for prescriptions during any trimester and genital malformations would be 1.7.”

The researchers used records from the U.K. Clinical Practice Research Datalink to analyze outcomes in 104,605 children born between 1990 and 2016 to mothers who received at least one prescription of erythromycin, clarithromycin, azithromycin, or penicillin monotherapy between their fourth week of pregnancy and delivery. Women prescribed any known teratogenic medications were excluded.

The majority of the mothers (92%) had been prescribed penicillin once, and 8% were prescribed a macrolide antibiotic once during pregnancy.

The researchers tallied and calculated the children’s risk of major malformations; cerebral palsy; epilepsy; ADHD; autism spectrum disorder; and any nervous, cardiovascular, gastrointestinal, genital, or urinary malformations. The children were tracked through a median 6 years of age.

In comparing risk of malformations or neurodevelopmental disorders among children, the researchers chose to compare exposure to macrolides and penicillin to reduce the likelihood of confounding by indication for infections. (They also included two negative control groups: unexposed siblings and women prescribed antibiotics before conception.) The authors acknowledged, however, that residual confounding still may occur “if macrolides were prescribed for specific indications (e.g., chlamydia), or when potential risk factors for malformations or neurodevelopmental outcomes differed between treatment groups.”

The overall rate of malformations was 22 per 1,000 children prenatally exposed to macrolides (28 in first trimester and 20 in second or third trimester) and 17 per 1,000 children prenatally exposed to penicillin. The risk and type of malformations varied, however, according to the trimester.

The researchers made adjustments to account for differences in a wide range of maternal factors: age at delivery, calendar year of delivery, alcohol misuse, illegal drug use, tobacco use, obesity, hypertension, diabetes, anxiety, depression, and epilepsy. They also adjusted for parity, multiples, and chronic medical treatments, as well as genitourinary tract infections or STIs during pregnancy, both of which are linked to preterm labor.

Compared with children exposed to penicillin during the first trimester of pregnancy, risk of malformations was 1.6 times greater in those exposed to macrolides in the first trimester (risk ratio, 1.55; 28 vs. 18 per 1,000). Erythromycin exposure in the first trimester also was linked to a 50% greater likelihood of any major malformation compared with penicillin (RR, 1.5; 27 vs. 18 per 1,000).

Cardiovascular malformations in particular were more likely in those exposed to macrolides (11 per 1,000), compared with penicillin (7 per 1,000) in the first trimester (RR, 1.62). Meanwhile, genital malformations, primarily hypospadias, occurred more frequently in children whose mothers were prescribed macrolides (5 per 1,000), compared with penicillin (3 per 1,000) in any trimester (RR, 1.58).

No increased risk of major malformations was associated with macrolides prescribed only in the second or third trimester, although a borderline significant association existed with gastrointestinal malformations. The authors also found no links between macrolides exposure and increased risk of cerebral palsy, epilepsy, ADHD, or autism spectrum disorder.

The findings did not change in several sensitivity analyses, including one that restricted analysis to antibiotics prescribed only for respiratory tract infections.

Dr. Fan and associates discussed several potential biological mechanisms for causation, including the arrhythmic effect of macrolides that may relate to cardiovascular malformations or contribute to fetal hypoxia. They noted that “macrolide prescribing during pregnancy warrants caution,” and recommend including on drug safety labels “that there is uncertainty about the safety of macrolides, including erythromycin” and alternative antibiotics should be used when possible.

Iris Krishna, MD, MPH, assistant professor of maternal-fetal medicine at Emory University, Atlanta, agreed with the study authors that use of macrolides in the first trimester warrants further investigation, and if an appropriate alternative antibiotic is available, then it should be preferentially considered when treating infections in the first trimester.

“However, if macrolides are the only treatment option, pregnant women can be reassured that the absolute risk of a birth defect is low, and this should not discourage them from taking a macrolide when needed as untreated infections pose a greater risk in pregnancy,” she said in an interview.

“This study does not establish that macrolide antibiotics cause birth defects, but it suggests a potential association. Previous studies examining the use of macrolides, such as erythromycin, have not demonstrated a consistent pattern of birth defects, and heart defects identified were classified as mostly mild. The authors suggest that the potential biologic mechanism based on rat models may be that macrolides might induce fetal cardiac arrhythmias and short-term fetal hypoxia. This study was underpowered to examine macrolide exposure for specific malformations. To avoid underpowered comparisons, the authors’ categorized malformations by organ systems, so the spectrum of cardiac defects is unclear,” commented Dr. Krishna, who also is a member of the Ob.Gyn. News editorial advisory board.

“Current recommendations for macrolide antibiotic use in pregnancy in the second and third trimester of pregnancy, and in particular when used for obstetric indications, such as prelabor rupture of membranes to prolong the latency period to delivery, should not be altered based on the findings of this study,” she concluded.

The research was funded by Child Health Research CIO Trust, the China Scholarship Council, Health Data Research UK, and the National Institute for Health Research. Dr. Fan and associates had no industry disclosures. Dr. Krishna had no relevant financial disclosures.

SOURCE: Fan H et al. BMJ. 2020;368:m331.

Women who had gestational diabetes mellitus had an increased risk for later type 2 diabetes if they carried certain genetic risk factors for the disease, according to a new analysis in BMJ Open Diabetes Research & Care of data from two independent populations.

A higher genetic risk score (GRS) had a modest association with developing type 2 diabetes, but a healthier diet may mitigate this risk, as Mengying Li, PhD, and her colleagues found for participants in the Nurses’ Health Study and members of the Danish National Birth Cohort who developed gestational diabetes mellitus (GDM).

Of 1,884 white women with a history of GDM in the Nurses’ Health Study II (NHSII), 446 (23.7%) went on to develop type 2 diabetes, and of the 550 women who had GDM in the Danish National Birth Cohort (DNBC), 155 (28.2%) developed the disease. The researchers calculated a GRS for type 2 diabetes for the full cohort. Genome-wide association studies completed in European populations were used to identify 59 single-nucleotide polymorphisms (SNPs) associated with the disease.

Dr. Li, an epidemiologist and postdoctoral researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md., and her coauthors found that women whose GRS was in the highest quartile had a relative risk of 1.19 for type 2 diabetes. The relative risks for the three lower quartiles were 1.25, 0.97, and 1.00, respectively (P value for trend = .02). For each increase of five risk alleles in the GRS, NHSII participants had a 7% increased risk for type 2 diabetes, and DNBC participants saw a 9% increased risk.

Comparing these findings with other studies looking at genetic risk and type 2 diabetes in the general population, Dr. Li and her coauthors noted that the increase in relative risk for type 2 disease with increase in GRS was actually slightly weaker in the GDM cohort they studied. “The smaller effect size among women with GDM likely reflects an already higher baseline genetic risk for [type 2 diabetes] than the general population, as we have demonstrated,” they explained.

Though 11 individual SNPs had a significant individual association with the risk for type 2 diabetes initially, that association disappeared after correction for a false-discovery rate. Dr. Li and her coinvestigators conducted a sensitivity analysis that included only 42 SNPs that were later definitively associated with type 2 disease and they saw essentially unchanged results.

The researchers also investigated how dietary quality affected the GRS–type 2 diabetes association by dichotomizing self-reported diet quality in both cohorts into healthier diet quality and less healthy diet quality. They found a tighter association between GRS and type 2 diabetes for women with diet quality below the median, whereas women with higher diet quality did not have such a strong association between GRS and type 2 disease. The researchers wrote that there was “suggestive evidence that a healthful diet might mitigate the excessive risk of T2D [type 2 diabetes] related to greater genetic susceptibility, which supports public health efforts of encouraging a healthful diet” for diabetes prevention in this high-risk population.

Patients in the NHSII were followed for a mean 21.3 years, and those in the DNBC were followed for a mean 12.7 years. Mean age at index pregnancy was 30.5 years for the NHSII cohort and 31.7 for the DNBC cohort. In the NHSII cohort, just 8.4% of participants reported smoking before pregnancy, compared with 26.4% of those in the DNBC cohort. The NHSII cohort participants, wrote Dr. Li and her coauthors, “were also less likely to have a family history of diabetes, less likely to smoke, and be leaner than women in the DNBC.”

Dr. Li and her coauthors noted that, “despite being the largest genetic study by far on [type 2 diabetes] among women with GDM, our study may not be sufficiently powered to examine the associations of individual T2D SNPs in relation to the risk of developing T2D.” Another limitation was that for the Danish cohort, information about diet was drawn from a one-time questionnaire administered between 9 and 16 years after the index pregnancy, so full data about dietary quality over time was not available. Also of note is that the study included only white participants, limiting generalizability to women of color. The authors called for expanding this research into more racially diverse populations.

The study was supported by the National Institutes of Health. The authors reported that they had no conflicts of interest.

SOURCE: Li M et al. BMJ Open Diab Res Care. 2020 Feb 13. doi: 10.1136/bmjdrc-2019-000850.

Women who had gestational diabetes mellitus had an increased risk for later type 2 diabetes if they carried certain genetic risk factors for the disease, according to a new analysis in BMJ Open Diabetes Research & Care of data from two independent populations.

A higher genetic risk score (GRS) had a modest association with developing type 2 diabetes, but a healthier diet may mitigate this risk, as Mengying Li, PhD, and her colleagues found for participants in the Nurses’ Health Study and members of the Danish National Birth Cohort who developed gestational diabetes mellitus (GDM).

Of 1,884 white women with a history of GDM in the Nurses’ Health Study II (NHSII), 446 (23.7%) went on to develop type 2 diabetes, and of the 550 women who had GDM in the Danish National Birth Cohort (DNBC), 155 (28.2%) developed the disease. The researchers calculated a GRS for type 2 diabetes for the full cohort. Genome-wide association studies completed in European populations were used to identify 59 single-nucleotide polymorphisms (SNPs) associated with the disease.

Dr. Li, an epidemiologist and postdoctoral researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md., and her coauthors found that women whose GRS was in the highest quartile had a relative risk of 1.19 for type 2 diabetes. The relative risks for the three lower quartiles were 1.25, 0.97, and 1.00, respectively (P value for trend = .02). For each increase of five risk alleles in the GRS, NHSII participants had a 7% increased risk for type 2 diabetes, and DNBC participants saw a 9% increased risk.

Comparing these findings with other studies looking at genetic risk and type 2 diabetes in the general population, Dr. Li and her coauthors noted that the increase in relative risk for type 2 disease with increase in GRS was actually slightly weaker in the GDM cohort they studied. “The smaller effect size among women with GDM likely reflects an already higher baseline genetic risk for [type 2 diabetes] than the general population, as we have demonstrated,” they explained.

Though 11 individual SNPs had a significant individual association with the risk for type 2 diabetes initially, that association disappeared after correction for a false-discovery rate. Dr. Li and her coinvestigators conducted a sensitivity analysis that included only 42 SNPs that were later definitively associated with type 2 disease and they saw essentially unchanged results.

The researchers also investigated how dietary quality affected the GRS–type 2 diabetes association by dichotomizing self-reported diet quality in both cohorts into healthier diet quality and less healthy diet quality. They found a tighter association between GRS and type 2 diabetes for women with diet quality below the median, whereas women with higher diet quality did not have such a strong association between GRS and type 2 disease. The researchers wrote that there was “suggestive evidence that a healthful diet might mitigate the excessive risk of T2D [type 2 diabetes] related to greater genetic susceptibility, which supports public health efforts of encouraging a healthful diet” for diabetes prevention in this high-risk population.

Patients in the NHSII were followed for a mean 21.3 years, and those in the DNBC were followed for a mean 12.7 years. Mean age at index pregnancy was 30.5 years for the NHSII cohort and 31.7 for the DNBC cohort. In the NHSII cohort, just 8.4% of participants reported smoking before pregnancy, compared with 26.4% of those in the DNBC cohort. The NHSII cohort participants, wrote Dr. Li and her coauthors, “were also less likely to have a family history of diabetes, less likely to smoke, and be leaner than women in the DNBC.”

Dr. Li and her coauthors noted that, “despite being the largest genetic study by far on [type 2 diabetes] among women with GDM, our study may not be sufficiently powered to examine the associations of individual T2D SNPs in relation to the risk of developing T2D.” Another limitation was that for the Danish cohort, information about diet was drawn from a one-time questionnaire administered between 9 and 16 years after the index pregnancy, so full data about dietary quality over time was not available. Also of note is that the study included only white participants, limiting generalizability to women of color. The authors called for expanding this research into more racially diverse populations.

The study was supported by the National Institutes of Health. The authors reported that they had no conflicts of interest.

SOURCE: Li M et al. BMJ Open Diab Res Care. 2020 Feb 13. doi: 10.1136/bmjdrc-2019-000850.

Women who had gestational diabetes mellitus had an increased risk for later type 2 diabetes if they carried certain genetic risk factors for the disease, according to a new analysis in BMJ Open Diabetes Research & Care of data from two independent populations.

A higher genetic risk score (GRS) had a modest association with developing type 2 diabetes, but a healthier diet may mitigate this risk, as Mengying Li, PhD, and her colleagues found for participants in the Nurses’ Health Study and members of the Danish National Birth Cohort who developed gestational diabetes mellitus (GDM).

Of 1,884 white women with a history of GDM in the Nurses’ Health Study II (NHSII), 446 (23.7%) went on to develop type 2 diabetes, and of the 550 women who had GDM in the Danish National Birth Cohort (DNBC), 155 (28.2%) developed the disease. The researchers calculated a GRS for type 2 diabetes for the full cohort. Genome-wide association studies completed in European populations were used to identify 59 single-nucleotide polymorphisms (SNPs) associated with the disease.

Dr. Li, an epidemiologist and postdoctoral researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md., and her coauthors found that women whose GRS was in the highest quartile had a relative risk of 1.19 for type 2 diabetes. The relative risks for the three lower quartiles were 1.25, 0.97, and 1.00, respectively (P value for trend = .02). For each increase of five risk alleles in the GRS, NHSII participants had a 7% increased risk for type 2 diabetes, and DNBC participants saw a 9% increased risk.

Comparing these findings with other studies looking at genetic risk and type 2 diabetes in the general population, Dr. Li and her coauthors noted that the increase in relative risk for type 2 disease with increase in GRS was actually slightly weaker in the GDM cohort they studied. “The smaller effect size among women with GDM likely reflects an already higher baseline genetic risk for [type 2 diabetes] than the general population, as we have demonstrated,” they explained.

Though 11 individual SNPs had a significant individual association with the risk for type 2 diabetes initially, that association disappeared after correction for a false-discovery rate. Dr. Li and her coinvestigators conducted a sensitivity analysis that included only 42 SNPs that were later definitively associated with type 2 disease and they saw essentially unchanged results.

The researchers also investigated how dietary quality affected the GRS–type 2 diabetes association by dichotomizing self-reported diet quality in both cohorts into healthier diet quality and less healthy diet quality. They found a tighter association between GRS and type 2 diabetes for women with diet quality below the median, whereas women with higher diet quality did not have such a strong association between GRS and type 2 disease. The researchers wrote that there was “suggestive evidence that a healthful diet might mitigate the excessive risk of T2D [type 2 diabetes] related to greater genetic susceptibility, which supports public health efforts of encouraging a healthful diet” for diabetes prevention in this high-risk population.

Patients in the NHSII were followed for a mean 21.3 years, and those in the DNBC were followed for a mean 12.7 years. Mean age at index pregnancy was 30.5 years for the NHSII cohort and 31.7 for the DNBC cohort. In the NHSII cohort, just 8.4% of participants reported smoking before pregnancy, compared with 26.4% of those in the DNBC cohort. The NHSII cohort participants, wrote Dr. Li and her coauthors, “were also less likely to have a family history of diabetes, less likely to smoke, and be leaner than women in the DNBC.”

Dr. Li and her coauthors noted that, “despite being the largest genetic study by far on [type 2 diabetes] among women with GDM, our study may not be sufficiently powered to examine the associations of individual T2D SNPs in relation to the risk of developing T2D.” Another limitation was that for the Danish cohort, information about diet was drawn from a one-time questionnaire administered between 9 and 16 years after the index pregnancy, so full data about dietary quality over time was not available. Also of note is that the study included only white participants, limiting generalizability to women of color. The authors called for expanding this research into more racially diverse populations.

The study was supported by the National Institutes of Health. The authors reported that they had no conflicts of interest.

SOURCE: Li M et al. BMJ Open Diab Res Care. 2020 Feb 13. doi: 10.1136/bmjdrc-2019-000850.

Researchers have identified 24 common genetic variants that may be associated with a greater risk of developing endometrial cancer.

SilverV/Thinkstock

The 24 single-nucleotide polymorphisms (SNPs) were detected in genes that function in transcriptional regulation, cell survival, and estrogen metabolism.

“Understanding genetic predisposition to endometrial cancer could facilitate personalized risk assessment with a view to targeted prevention and screening interventions,” wrote Cemsel Bafligil, of the University of Manchester (England) and her coinvestigators. The group’s findings were published in the Journal of Medical Genetics.

The researchers searched major databases for primary studies that evaluated associations between endometrial cancer and SNPs. After applying the search criteria, 453 eligible records were found, and 149 of these were included in the study.

The majority of records were genome-wide association studies, case-control studies, and meta-analyses. Various data, including study type, ethnicity, and endometrial cancer type, were extracted and included in the qualitative synthesis.

After analysis, the researchers identified 24 independent genetic variants associated with a higher risk of developing endometrial cancer, and SNPs in 6 genes – CYP19A1, SOX4, HNF1B, MYC, KLF, and EIF2AK – showed a strong association.

The researchers also estimated the predictive value of the identified SNPs using a theoretical polygenic risk score model. They found that women with genome-wide significant SNPs had double the risk of developing endometrial cancer (relative risk, 2.09), and women with all 24 SNPs had a three-fold greater risk of developing the disease (RR, 3.16).

“The importance of these variants and relevance of the proximate genes in a functional or biological context is challenging to evaluate,” the researchers noted.

They also acknowledged that a key limitation of this study was the ethnic homogeneity of the cohort, with most patients being of European descent. As a result, the findings may not be fully representative of other ethnic groups.

“The multiplicative effects of these SNPs could be used in a PRS [polygenic risk score] to allow personalised risk prediction models to be developed for targeted screening and prevention interventions for women at greatest risk of endometrial cancer,” the researchers concluded.

The National Institute for Health Research Manchester Biomedical Research Centre funded the study. The authors reported having no conflicts of interest.

SOURCE: Bafligil C et al. J Med Genet. 2020 Feb 17. doi: 10.1136/jmedgenet-2019-106529.

Researchers have identified 24 common genetic variants that may be associated with a greater risk of developing endometrial cancer.

SilverV/Thinkstock

The 24 single-nucleotide polymorphisms (SNPs) were detected in genes that function in transcriptional regulation, cell survival, and estrogen metabolism.

“Understanding genetic predisposition to endometrial cancer could facilitate personalized risk assessment with a view to targeted prevention and screening interventions,” wrote Cemsel Bafligil, of the University of Manchester (England) and her coinvestigators. The group’s findings were published in the Journal of Medical Genetics.

The researchers searched major databases for primary studies that evaluated associations between endometrial cancer and SNPs. After applying the search criteria, 453 eligible records were found, and 149 of these were included in the study.

The majority of records were genome-wide association studies, case-control studies, and meta-analyses. Various data, including study type, ethnicity, and endometrial cancer type, were extracted and included in the qualitative synthesis.

After analysis, the researchers identified 24 independent genetic variants associated with a higher risk of developing endometrial cancer, and SNPs in 6 genes – CYP19A1, SOX4, HNF1B, MYC, KLF, and EIF2AK – showed a strong association.

The researchers also estimated the predictive value of the identified SNPs using a theoretical polygenic risk score model. They found that women with genome-wide significant SNPs had double the risk of developing endometrial cancer (relative risk, 2.09), and women with all 24 SNPs had a three-fold greater risk of developing the disease (RR, 3.16).

“The importance of these variants and relevance of the proximate genes in a functional or biological context is challenging to evaluate,” the researchers noted.

They also acknowledged that a key limitation of this study was the ethnic homogeneity of the cohort, with most patients being of European descent. As a result, the findings may not be fully representative of other ethnic groups.

“The multiplicative effects of these SNPs could be used in a PRS [polygenic risk score] to allow personalised risk prediction models to be developed for targeted screening and prevention interventions for women at greatest risk of endometrial cancer,” the researchers concluded.

The National Institute for Health Research Manchester Biomedical Research Centre funded the study. The authors reported having no conflicts of interest.

SOURCE: Bafligil C et al. J Med Genet. 2020 Feb 17. doi: 10.1136/jmedgenet-2019-106529.

Researchers have identified 24 common genetic variants that may be associated with a greater risk of developing endometrial cancer.

SilverV/Thinkstock

The 24 single-nucleotide polymorphisms (SNPs) were detected in genes that function in transcriptional regulation, cell survival, and estrogen metabolism.

“Understanding genetic predisposition to endometrial cancer could facilitate personalized risk assessment with a view to targeted prevention and screening interventions,” wrote Cemsel Bafligil, of the University of Manchester (England) and her coinvestigators. The group’s findings were published in the Journal of Medical Genetics.

The researchers searched major databases for primary studies that evaluated associations between endometrial cancer and SNPs. After applying the search criteria, 453 eligible records were found, and 149 of these were included in the study.

The majority of records were genome-wide association studies, case-control studies, and meta-analyses. Various data, including study type, ethnicity, and endometrial cancer type, were extracted and included in the qualitative synthesis.

After analysis, the researchers identified 24 independent genetic variants associated with a higher risk of developing endometrial cancer, and SNPs in 6 genes – CYP19A1, SOX4, HNF1B, MYC, KLF, and EIF2AK – showed a strong association.

The researchers also estimated the predictive value of the identified SNPs using a theoretical polygenic risk score model. They found that women with genome-wide significant SNPs had double the risk of developing endometrial cancer (relative risk, 2.09), and women with all 24 SNPs had a three-fold greater risk of developing the disease (RR, 3.16).

“The importance of these variants and relevance of the proximate genes in a functional or biological context is challenging to evaluate,” the researchers noted.

They also acknowledged that a key limitation of this study was the ethnic homogeneity of the cohort, with most patients being of European descent. As a result, the findings may not be fully representative of other ethnic groups.

“The multiplicative effects of these SNPs could be used in a PRS [polygenic risk score] to allow personalised risk prediction models to be developed for targeted screening and prevention interventions for women at greatest risk of endometrial cancer,” the researchers concluded.

The National Institute for Health Research Manchester Biomedical Research Centre funded the study. The authors reported having no conflicts of interest.

SOURCE: Bafligil C et al. J Med Genet. 2020 Feb 17. doi: 10.1136/jmedgenet-2019-106529.

The total number of hysterectomies performed during residency training has declined significantly since 2008, despite an increase in laparoscopic hysterectomies performed, according to a new analysis of data from graduating ob.gyn. residents that has implications for the structure of resident education.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The investigators abstracted case log data from the Accreditation Council for Graduate Medical Education (ACGME) database to assess trends in residents’ operative experience and found decreases in abdominal and vaginal cases but an increase in experience with laparoscopic hysterectomy.

The median number of abdominal hysterectomies performed per resident over 4 years of training decreased by 57% between 2002-2003 and 2017-2018 (from 85 cases to 37), and the median number of vaginal hysterectomies decreased by 36% (from 31 to 20 cases).

Laparoscopic hysterectomy increased by 115% from a median of 20 procedures in 2008-2009 to 43 in 2017-2018. Even so, the median total number of hysterectomies per resident decreased by 6%, from 112 to 105 procedures during those two time periods. (Data on total hysterectomy and laparoscopic hysterectomy were not collected by ACGME until 2008.)

While the absolute decrease in the total number of hysterectomies is “relatively small,” the trend “raises questions about what the appropriate number of hysterectomies per graduating resident should be,” Gregory M. Gressel, MD, MSc, of the Montefiore Medical Center, New York, and coauthors wrote in Obstetrics & Gynecology.

“These data point,” they wrote, “to the necessity of maximizing surgical exposure in the face of a declining availability of procedures and the importance of reflecting on which (and how many) procedures an obstetrics and gynecology resident needs to complete before entering clinical practice.”

The training numbers parallel an increased use of laparoscopic hysterectomy in the United States and other countries, as well as a well-documented decline in the total number of hysterectomies performed in the United States, the latter of which is driven largely by the availability and increasing use of alternatives to the procedure (such as hormone therapy, endometrial ablation, and uterine artery embolization).

Hysterectomy still is a “core procedure of gynecologic surgery,” however, and is “at the heart of surgical training in obstetrics and gynecology,” as surgical techniques developed from learning hysterectomy “are applied broadly in the pelvis,” Saketh R. Guntupalli, MD, wrote in an accompanying editorial.

Dr. Guntupalli, of the University of Colorado at Aurora, Denver, was involved in a survey of fellowship program directors, published in 2015, that found only 20% of first-year fellows were able to independently perform a vaginal hysterectomy and 46% to independently perform an abdominal hysterectomy (Obstet Gynecol. 2015;126:559-68).

This and other research suggest that fellowship training is “used to address deficiencies in residency training rather than to develop new, specialized surgical skills,” he wrote. Given a dearth of fellowship positions in ob.gyn., “it is impossible to adequately use those avenues to train the number of competent surgeons necessary to address the surgical needs of women’s health in the United States.”

To address such concerns, some residency programs have instituted resident tracking to direct more hysterectomy cases toward those residents who plan to pursue surgical subspecialties. The Cleveland Clinic, Dr. Guntupalli noted, has tried the latter approach “with success.”

An increase in the number of accredited training programs and a decrease in the number of residents per program also might help to improve surgical exposure for residents, Dr. Gressel and associates wrote. Over the 16-year study period, the number of graduating residents increased significantly (by 12 per year) and the number of residency programs decreased significantly (0.52 fewer programs per year).

Additionally, Dr. Guntupalli wrote, regulatory bodies may need to reevaluate how competencies are assessed, and whether minimal numbers of cases “continue to carry the same weight as they did in previous generations.”

In the study, one coauthor is a full-time employee of ACGME, and another receives funds as a director for the American Board of Obstetrics and Gynecology. The remaining authors had no relevant financial disclosures. There was no outside funding for the study. Dr. Guntupalli said he had no conflicts of interest.

SOURCES: Gressel GM et al. Obstet Gynecol. 2020 Feb;135(2):268-73; Guntupalli SR. Obstet Gynecol 2020 Feb;135(2):266-7.

The total number of hysterectomies performed during residency training has declined significantly since 2008, despite an increase in laparoscopic hysterectomies performed, according to a new analysis of data from graduating ob.gyn. residents that has implications for the structure of resident education.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The investigators abstracted case log data from the Accreditation Council for Graduate Medical Education (ACGME) database to assess trends in residents’ operative experience and found decreases in abdominal and vaginal cases but an increase in experience with laparoscopic hysterectomy.

The median number of abdominal hysterectomies performed per resident over 4 years of training decreased by 57% between 2002-2003 and 2017-2018 (from 85 cases to 37), and the median number of vaginal hysterectomies decreased by 36% (from 31 to 20 cases).

Laparoscopic hysterectomy increased by 115% from a median of 20 procedures in 2008-2009 to 43 in 2017-2018. Even so, the median total number of hysterectomies per resident decreased by 6%, from 112 to 105 procedures during those two time periods. (Data on total hysterectomy and laparoscopic hysterectomy were not collected by ACGME until 2008.)

While the absolute decrease in the total number of hysterectomies is “relatively small,” the trend “raises questions about what the appropriate number of hysterectomies per graduating resident should be,” Gregory M. Gressel, MD, MSc, of the Montefiore Medical Center, New York, and coauthors wrote in Obstetrics & Gynecology.

“These data point,” they wrote, “to the necessity of maximizing surgical exposure in the face of a declining availability of procedures and the importance of reflecting on which (and how many) procedures an obstetrics and gynecology resident needs to complete before entering clinical practice.”

The training numbers parallel an increased use of laparoscopic hysterectomy in the United States and other countries, as well as a well-documented decline in the total number of hysterectomies performed in the United States, the latter of which is driven largely by the availability and increasing use of alternatives to the procedure (such as hormone therapy, endometrial ablation, and uterine artery embolization).

Hysterectomy still is a “core procedure of gynecologic surgery,” however, and is “at the heart of surgical training in obstetrics and gynecology,” as surgical techniques developed from learning hysterectomy “are applied broadly in the pelvis,” Saketh R. Guntupalli, MD, wrote in an accompanying editorial.

Dr. Guntupalli, of the University of Colorado at Aurora, Denver, was involved in a survey of fellowship program directors, published in 2015, that found only 20% of first-year fellows were able to independently perform a vaginal hysterectomy and 46% to independently perform an abdominal hysterectomy (Obstet Gynecol. 2015;126:559-68).

This and other research suggest that fellowship training is “used to address deficiencies in residency training rather than to develop new, specialized surgical skills,” he wrote. Given a dearth of fellowship positions in ob.gyn., “it is impossible to adequately use those avenues to train the number of competent surgeons necessary to address the surgical needs of women’s health in the United States.”

To address such concerns, some residency programs have instituted resident tracking to direct more hysterectomy cases toward those residents who plan to pursue surgical subspecialties. The Cleveland Clinic, Dr. Guntupalli noted, has tried the latter approach “with success.”

An increase in the number of accredited training programs and a decrease in the number of residents per program also might help to improve surgical exposure for residents, Dr. Gressel and associates wrote. Over the 16-year study period, the number of graduating residents increased significantly (by 12 per year) and the number of residency programs decreased significantly (0.52 fewer programs per year).

Additionally, Dr. Guntupalli wrote, regulatory bodies may need to reevaluate how competencies are assessed, and whether minimal numbers of cases “continue to carry the same weight as they did in previous generations.”

In the study, one coauthor is a full-time employee of ACGME, and another receives funds as a director for the American Board of Obstetrics and Gynecology. The remaining authors had no relevant financial disclosures. There was no outside funding for the study. Dr. Guntupalli said he had no conflicts of interest.

SOURCES: Gressel GM et al. Obstet Gynecol. 2020 Feb;135(2):268-73; Guntupalli SR. Obstet Gynecol 2020 Feb;135(2):266-7.

The total number of hysterectomies performed during residency training has declined significantly since 2008, despite an increase in laparoscopic hysterectomies performed, according to a new analysis of data from graduating ob.gyn. residents that has implications for the structure of resident education.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The investigators abstracted case log data from the Accreditation Council for Graduate Medical Education (ACGME) database to assess trends in residents’ operative experience and found decreases in abdominal and vaginal cases but an increase in experience with laparoscopic hysterectomy.

The median number of abdominal hysterectomies performed per resident over 4 years of training decreased by 57% between 2002-2003 and 2017-2018 (from 85 cases to 37), and the median number of vaginal hysterectomies decreased by 36% (from 31 to 20 cases).

Laparoscopic hysterectomy increased by 115% from a median of 20 procedures in 2008-2009 to 43 in 2017-2018. Even so, the median total number of hysterectomies per resident decreased by 6%, from 112 to 105 procedures during those two time periods. (Data on total hysterectomy and laparoscopic hysterectomy were not collected by ACGME until 2008.)

While the absolute decrease in the total number of hysterectomies is “relatively small,” the trend “raises questions about what the appropriate number of hysterectomies per graduating resident should be,” Gregory M. Gressel, MD, MSc, of the Montefiore Medical Center, New York, and coauthors wrote in Obstetrics & Gynecology.

“These data point,” they wrote, “to the necessity of maximizing surgical exposure in the face of a declining availability of procedures and the importance of reflecting on which (and how many) procedures an obstetrics and gynecology resident needs to complete before entering clinical practice.”

The training numbers parallel an increased use of laparoscopic hysterectomy in the United States and other countries, as well as a well-documented decline in the total number of hysterectomies performed in the United States, the latter of which is driven largely by the availability and increasing use of alternatives to the procedure (such as hormone therapy, endometrial ablation, and uterine artery embolization).

Hysterectomy still is a “core procedure of gynecologic surgery,” however, and is “at the heart of surgical training in obstetrics and gynecology,” as surgical techniques developed from learning hysterectomy “are applied broadly in the pelvis,” Saketh R. Guntupalli, MD, wrote in an accompanying editorial.

Dr. Guntupalli, of the University of Colorado at Aurora, Denver, was involved in a survey of fellowship program directors, published in 2015, that found only 20% of first-year fellows were able to independently perform a vaginal hysterectomy and 46% to independently perform an abdominal hysterectomy (Obstet Gynecol. 2015;126:559-68).

This and other research suggest that fellowship training is “used to address deficiencies in residency training rather than to develop new, specialized surgical skills,” he wrote. Given a dearth of fellowship positions in ob.gyn., “it is impossible to adequately use those avenues to train the number of competent surgeons necessary to address the surgical needs of women’s health in the United States.”

To address such concerns, some residency programs have instituted resident tracking to direct more hysterectomy cases toward those residents who plan to pursue surgical subspecialties. The Cleveland Clinic, Dr. Guntupalli noted, has tried the latter approach “with success.”

An increase in the number of accredited training programs and a decrease in the number of residents per program also might help to improve surgical exposure for residents, Dr. Gressel and associates wrote. Over the 16-year study period, the number of graduating residents increased significantly (by 12 per year) and the number of residency programs decreased significantly (0.52 fewer programs per year).

Additionally, Dr. Guntupalli wrote, regulatory bodies may need to reevaluate how competencies are assessed, and whether minimal numbers of cases “continue to carry the same weight as they did in previous generations.”

In the study, one coauthor is a full-time employee of ACGME, and another receives funds as a director for the American Board of Obstetrics and Gynecology. The remaining authors had no relevant financial disclosures. There was no outside funding for the study. Dr. Guntupalli said he had no conflicts of interest.

SOURCES: Gressel GM et al. Obstet Gynecol. 2020 Feb;135(2):268-73; Guntupalli SR. Obstet Gynecol 2020 Feb;135(2):266-7.

The Food and Drug Administration has approved Agile Therapeutics’ levonorgestrel and ethinyl estradiol transdermal system (Twirla) for contraception in women whose body mass index is less than 30 kg/m² and for whom a combined hormonal contraceptive is appropriate.

Applied weekly to the abdomen, buttock, or upper torso (excluding the breasts), Twirla delivers a 30-mcg daily dose of ethinyl estradiol and 120-mcg daily dose of levonorgestrel.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives, David Portman, MD, an obstetrician/gynecologist in Columbus, Ohio, and a primary investigator of the SECURE trial, said in a news release issued by the company.

Twirla was evaluated in “a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle,” Dr. Portman added.

As part of approval, the FDA will require Agile Therapeutics to conduct a long-term, prospective, observational postmarketing study to assess risks for venous thromboembolism and arterial thromboembolism in new users of Twirla, compared with new users of other combined hormonal contraceptives.

Twirla is contraindicated in women at high risk for arterial or venous thrombotic disease, including women with a BMI equal to or greater than 30 kg/m²; women who have headaches with focal neurologic symptoms or migraine with aura; and women older than 35 years who have any migraine headache.

Twirla also should be avoided in women who have liver tumors, acute viral hepatitis, decompensated cirrhosis, liver disease, or undiagnosed abnormal uterine bleeding. It also should be avoided during pregnancy; in women who currently have or who have history of breast cancer or other estrogen- or progestin-sensitive cancer; in women who are hypersensitivity to any components of Twirla; and in women who use hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir, with or without dasabuvir.

Because cigarette smoking increases the risk for serious cardiovascular events from combined hormonal contraceptive use, Twirla also is contraindicated in women older than 35 who smoke.

Twirla will contain a boxed warning that will include these risks about cigarette smoking and the serious cardiovascular events, and it will stipulate that Twirla is contraindicated in women with a BMI greater than 30 kg/m².

This article first appeared on Medscape.com.

The Food and Drug Administration has approved Agile Therapeutics’ levonorgestrel and ethinyl estradiol transdermal system (Twirla) for contraception in women whose body mass index is less than 30 kg/m² and for whom a combined hormonal contraceptive is appropriate.

Applied weekly to the abdomen, buttock, or upper torso (excluding the breasts), Twirla delivers a 30-mcg daily dose of ethinyl estradiol and 120-mcg daily dose of levonorgestrel.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives, David Portman, MD, an obstetrician/gynecologist in Columbus, Ohio, and a primary investigator of the SECURE trial, said in a news release issued by the company.

Twirla was evaluated in “a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle,” Dr. Portman added.

As part of approval, the FDA will require Agile Therapeutics to conduct a long-term, prospective, observational postmarketing study to assess risks for venous thromboembolism and arterial thromboembolism in new users of Twirla, compared with new users of other combined hormonal contraceptives.

Twirla is contraindicated in women at high risk for arterial or venous thrombotic disease, including women with a BMI equal to or greater than 30 kg/m²; women who have headaches with focal neurologic symptoms or migraine with aura; and women older than 35 years who have any migraine headache.

Twirla also should be avoided in women who have liver tumors, acute viral hepatitis, decompensated cirrhosis, liver disease, or undiagnosed abnormal uterine bleeding. It also should be avoided during pregnancy; in women who currently have or who have history of breast cancer or other estrogen- or progestin-sensitive cancer; in women who are hypersensitivity to any components of Twirla; and in women who use hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir, with or without dasabuvir.

Because cigarette smoking increases the risk for serious cardiovascular events from combined hormonal contraceptive use, Twirla also is contraindicated in women older than 35 who smoke.

Twirla will contain a boxed warning that will include these risks about cigarette smoking and the serious cardiovascular events, and it will stipulate that Twirla is contraindicated in women with a BMI greater than 30 kg/m².

This article first appeared on Medscape.com.

The Food and Drug Administration has approved Agile Therapeutics’ levonorgestrel and ethinyl estradiol transdermal system (Twirla) for contraception in women whose body mass index is less than 30 kg/m² and for whom a combined hormonal contraceptive is appropriate.

Applied weekly to the abdomen, buttock, or upper torso (excluding the breasts), Twirla delivers a 30-mcg daily dose of ethinyl estradiol and 120-mcg daily dose of levonorgestrel.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives, David Portman, MD, an obstetrician/gynecologist in Columbus, Ohio, and a primary investigator of the SECURE trial, said in a news release issued by the company.

Twirla was evaluated in “a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle,” Dr. Portman added.

As part of approval, the FDA will require Agile Therapeutics to conduct a long-term, prospective, observational postmarketing study to assess risks for venous thromboembolism and arterial thromboembolism in new users of Twirla, compared with new users of other combined hormonal contraceptives.

Twirla is contraindicated in women at high risk for arterial or venous thrombotic disease, including women with a BMI equal to or greater than 30 kg/m²; women who have headaches with focal neurologic symptoms or migraine with aura; and women older than 35 years who have any migraine headache.

Twirla also should be avoided in women who have liver tumors, acute viral hepatitis, decompensated cirrhosis, liver disease, or undiagnosed abnormal uterine bleeding. It also should be avoided during pregnancy; in women who currently have or who have history of breast cancer or other estrogen- or progestin-sensitive cancer; in women who are hypersensitivity to any components of Twirla; and in women who use hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir, with or without dasabuvir.

Because cigarette smoking increases the risk for serious cardiovascular events from combined hormonal contraceptive use, Twirla also is contraindicated in women older than 35 who smoke.

Twirla will contain a boxed warning that will include these risks about cigarette smoking and the serious cardiovascular events, and it will stipulate that Twirla is contraindicated in women with a BMI greater than 30 kg/m².

This article first appeared on Medscape.com.

Among women with a history of gestational diabetes, a longer period of breastfeeding was associated with a lower probability of going on to develop type 2 diabetes, as well as a more favorable glucose metabolic biomarker profile. Women who breastfed for 2 years or longer had a 27% lower risk than that of those who did not breastfeed at all, even after adjustment for age, ethnicity, family history of diabetes, parity, age at first birth, smoking, diet quality, physical activity, and prepregnancy body mass index, according to findings published in Diabetes Care.

It remains to be seen if the association is causal, and if so, what mechanisms might connect breastfeeding duration to risk for type 2 diabetes, wrote study leaders Sylvia Ley, PhD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, and the Harvard T.H. Chan School of Public Health, Boston, and Cuilin Zhang, MD, PhD, of the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md., and colleagues.

“It’s really nice to see this consistency and the long-term association being borne out in a very large sample of women with gestational diabetes,” Erica P. Gunderson, PhD, said in an interview about the study. Dr. Gunderson has conducted similar studies of her own, including one published in 2018 that showed an independent association between lactation and reduced diabetes risk in women (JAMA Intern Med. 2018;178:328-37). That analysis showed no sign that the presence of gestational diabetes affected the reduction of diabetes risk associated with lactation.

Dr. Gunderson noted that pregnancy is a hyperlipidemic state, with triglyceride levels sometimes doubling, likely in response to the need to support the placenta and the growing fetus. Lactation may help restore lipid levels to the prepregnancy state by redirecting lipids to breast milk. She and others are working to produce more direct evidence of metabolic changes in the postpartum period associated with lactation. “That’s where we don’t have much mechanistic evidence right now,” said Dr. Gunderson, a senior research scientist and epidemiologist at Kaiser Permanente Northern California, Oakland.

Gestational diabetes occurs in an estimated 5%-9% of pregnancies in the United States, and women who experience this complication are at greater risk of developing type 2 diabetes in the future. Findings from other studies have shown that longer lactation periods are associated with lowered risk of future type 2 disease (JAMA. 2005;294:2601-10).

In the latest study, the researchers included 4,372 women with a history of gestational diabetes, identified through the Nurses’ Health Study II. Participants were excluded if they had a history of cancer, cardiovascular disease, or multiple-birth pregnancy before the pregnancy during which they were diagnosed with gestational diabetes. In all, 873 women developed type 2 diabetes over 87,411 person-years of follow-up. The median age at gestational diabetes diagnosis was 31.8 years, and 49.8 years for diagnoses of type 2 diabetes.

After adjustment, the researchers found a steadying decline of risk for type 2 diabetes with increasing length of lactation: for up to 6 months of lactation, the hazard ratio was 1.05 (95% confidence interval, 0.82-1.34); for 6-12 months, the HR was 0.91 (95% CI, 0.71-1.15); 12-24 months, 0.84 (95% CI, 0.67-1.06); more than 24 months, 0.73 (95% CI, 0.57-0.93; P for trend = .004). Age, parity, primipara, prepregnancy body mass index, and age had no statistically significant effect modification on the association.

At a follow-up blood collection taken at median age of 58.2 years and 26.3 years after the gestational-diabetes index pregnancy, the researchers found associations between longer breastfeeding (greater than 24 months vs. 0 months) and lower hemoglobin A_1c percentage (5.58 vs. 5.68; P for trend = .04), lower insulin levels (53.1 vs. 64.7 pmol/L; P for trend = .02), and lower C-peptide levels (3.42 vs. 3.88 ng/mL; P for trend = .02).

The study was supported by the National Institutes of Health. Dr. Ley was supported by a National Institute of General Medical Sciences grant from the NIH. None of the study authors reported any conflicts of interest, and neither did Dr. Gunderson.

SOURCE: Ley S et al. Diabetes Care. 2020 Feb 10. doi: 10.2337/dc19-2237.

Among women with a history of gestational diabetes, a longer period of breastfeeding was associated with a lower probability of going on to develop type 2 diabetes, as well as a more favorable glucose metabolic biomarker profile. Women who breastfed for 2 years or longer had a 27% lower risk than that of those who did not breastfeed at all, even after adjustment for age, ethnicity, family history of diabetes, parity, age at first birth, smoking, diet quality, physical activity, and prepregnancy body mass index, according to findings published in Diabetes Care.

It remains to be seen if the association is causal, and if so, what mechanisms might connect breastfeeding duration to risk for type 2 diabetes, wrote study leaders Sylvia Ley, PhD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, and the Harvard T.H. Chan School of Public Health, Boston, and Cuilin Zhang, MD, PhD, of the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md., and colleagues.

“It’s really nice to see this consistency and the long-term association being borne out in a very large sample of women with gestational diabetes,” Erica P. Gunderson, PhD, said in an interview about the study. Dr. Gunderson has conducted similar studies of her own, including one published in 2018 that showed an independent association between lactation and reduced diabetes risk in women (JAMA Intern Med. 2018;178:328-37). That analysis showed no sign that the presence of gestational diabetes affected the reduction of diabetes risk associated with lactation.

Dr. Gunderson noted that pregnancy is a hyperlipidemic state, with triglyceride levels sometimes doubling, likely in response to the need to support the placenta and the growing fetus. Lactation may help restore lipid levels to the prepregnancy state by redirecting lipids to breast milk. She and others are working to produce more direct evidence of metabolic changes in the postpartum period associated with lactation. “That’s where we don’t have much mechanistic evidence right now,” said Dr. Gunderson, a senior research scientist and epidemiologist at Kaiser Permanente Northern California, Oakland.

Gestational diabetes occurs in an estimated 5%-9% of pregnancies in the United States, and women who experience this complication are at greater risk of developing type 2 diabetes in the future. Findings from other studies have shown that longer lactation periods are associated with lowered risk of future type 2 disease (JAMA. 2005;294:2601-10).

In the latest study, the researchers included 4,372 women with a history of gestational diabetes, identified through the Nurses’ Health Study II. Participants were excluded if they had a history of cancer, cardiovascular disease, or multiple-birth pregnancy before the pregnancy during which they were diagnosed with gestational diabetes. In all, 873 women developed type 2 diabetes over 87,411 person-years of follow-up. The median age at gestational diabetes diagnosis was 31.8 years, and 49.8 years for diagnoses of type 2 diabetes.

After adjustment, the researchers found a steadying decline of risk for type 2 diabetes with increasing length of lactation: for up to 6 months of lactation, the hazard ratio was 1.05 (95% confidence interval, 0.82-1.34); for 6-12 months, the HR was 0.91 (95% CI, 0.71-1.15); 12-24 months, 0.84 (95% CI, 0.67-1.06); more than 24 months, 0.73 (95% CI, 0.57-0.93; P for trend = .004). Age, parity, primipara, prepregnancy body mass index, and age had no statistically significant effect modification on the association.

At a follow-up blood collection taken at median age of 58.2 years and 26.3 years after the gestational-diabetes index pregnancy, the researchers found associations between longer breastfeeding (greater than 24 months vs. 0 months) and lower hemoglobin A_1c percentage (5.58 vs. 5.68; P for trend = .04), lower insulin levels (53.1 vs. 64.7 pmol/L; P for trend = .02), and lower C-peptide levels (3.42 vs. 3.88 ng/mL; P for trend = .02).

The study was supported by the National Institutes of Health. Dr. Ley was supported by a National Institute of General Medical Sciences grant from the NIH. None of the study authors reported any conflicts of interest, and neither did Dr. Gunderson.

SOURCE: Ley S et al. Diabetes Care. 2020 Feb 10. doi: 10.2337/dc19-2237.

Among women with a history of gestational diabetes, a longer period of breastfeeding was associated with a lower probability of going on to develop type 2 diabetes, as well as a more favorable glucose metabolic biomarker profile. Women who breastfed for 2 years or longer had a 27% lower risk than that of those who did not breastfeed at all, even after adjustment for age, ethnicity, family history of diabetes, parity, age at first birth, smoking, diet quality, physical activity, and prepregnancy body mass index, according to findings published in Diabetes Care.

It remains to be seen if the association is causal, and if so, what mechanisms might connect breastfeeding duration to risk for type 2 diabetes, wrote study leaders Sylvia Ley, PhD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, and the Harvard T.H. Chan School of Public Health, Boston, and Cuilin Zhang, MD, PhD, of the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md., and colleagues.

“It’s really nice to see this consistency and the long-term association being borne out in a very large sample of women with gestational diabetes,” Erica P. Gunderson, PhD, said in an interview about the study. Dr. Gunderson has conducted similar studies of her own, including one published in 2018 that showed an independent association between lactation and reduced diabetes risk in women (JAMA Intern Med. 2018;178:328-37). That analysis showed no sign that the presence of gestational diabetes affected the reduction of diabetes risk associated with lactation.

Dr. Gunderson noted that pregnancy is a hyperlipidemic state, with triglyceride levels sometimes doubling, likely in response to the need to support the placenta and the growing fetus. Lactation may help restore lipid levels to the prepregnancy state by redirecting lipids to breast milk. She and others are working to produce more direct evidence of metabolic changes in the postpartum period associated with lactation. “That’s where we don’t have much mechanistic evidence right now,” said Dr. Gunderson, a senior research scientist and epidemiologist at Kaiser Permanente Northern California, Oakland.

Gestational diabetes occurs in an estimated 5%-9% of pregnancies in the United States, and women who experience this complication are at greater risk of developing type 2 diabetes in the future. Findings from other studies have shown that longer lactation periods are associated with lowered risk of future type 2 disease (JAMA. 2005;294:2601-10).

In the latest study, the researchers included 4,372 women with a history of gestational diabetes, identified through the Nurses’ Health Study II. Participants were excluded if they had a history of cancer, cardiovascular disease, or multiple-birth pregnancy before the pregnancy during which they were diagnosed with gestational diabetes. In all, 873 women developed type 2 diabetes over 87,411 person-years of follow-up. The median age at gestational diabetes diagnosis was 31.8 years, and 49.8 years for diagnoses of type 2 diabetes.

After adjustment, the researchers found a steadying decline of risk for type 2 diabetes with increasing length of lactation: for up to 6 months of lactation, the hazard ratio was 1.05 (95% confidence interval, 0.82-1.34); for 6-12 months, the HR was 0.91 (95% CI, 0.71-1.15); 12-24 months, 0.84 (95% CI, 0.67-1.06); more than 24 months, 0.73 (95% CI, 0.57-0.93; P for trend = .004). Age, parity, primipara, prepregnancy body mass index, and age had no statistically significant effect modification on the association.

At a follow-up blood collection taken at median age of 58.2 years and 26.3 years after the gestational-diabetes index pregnancy, the researchers found associations between longer breastfeeding (greater than 24 months vs. 0 months) and lower hemoglobin A_1c percentage (5.58 vs. 5.68; P for trend = .04), lower insulin levels (53.1 vs. 64.7 pmol/L; P for trend = .02), and lower C-peptide levels (3.42 vs. 3.88 ng/mL; P for trend = .02).

The study was supported by the National Institutes of Health. Dr. Ley was supported by a National Institute of General Medical Sciences grant from the NIH. None of the study authors reported any conflicts of interest, and neither did Dr. Gunderson.

SOURCE: Ley S et al. Diabetes Care. 2020 Feb 10. doi: 10.2337/dc19-2237.

LAS VEGAS – While it’s fading in popularity, ovary removal in hysterectomy is still far from uncommon. A gynecologic surgeon urged colleagues to give deeper consideration to whether the ovaries can stay in place.

“Gynecologists should truly familiarize themselves with the data on cardiovascular, endocrine, bone, and sexual health implications of removing the ovaries when there isn’t a medical indication to do so,” Amanda Nickles Fader, MD, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, said in an interview following her presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.

“Until I started giving this talk, I thought I knew this data. However, once I took a deeper dive into the studies of how hormonally active the postmenopausal ovaries are, as well as the population-based studies demonstrating worse all-cause mortality outcomes in low-risk women who have their ovaries surgically removed prior to their 60s, I was stunned at how compelling this data is,” she said.

The conventional wisdom about ovary removal in hysterectomy has changed dramatically over the decades. As Dr. Nickles Fader explained in the interview, “in the ’80s and early ’90s, the mantra was ‘just take everything out’ at hysterectomy surgery – tubes and ovaries should be removed – without understanding the implications. Then in the late ’90s and early 2000s, it was a more selective strategy of ‘wait until menopause to remove the ovaries.’ ”

Now, “more contemporary data suggests that the ovaries appear to be hormonally active to some degree well into the seventh decade of life, and even women in their early 60s who have their ovaries removed without a medical indication may be harmed.”

Still, ovary removal occurs in about 50%-60% of the 450,000-500,000 hysterectomies performed each year in the United States, Dr. Nickles Fader said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

These findings seem to suggest that messages about the potential benefits of ovary preservation are not getting through to surgeons and patients.

Indeed, a 2017 study of 57,776 benign premenopausal hysterectomies with ovary removal in California from 2005 to 2011 found that 38% had no documented sign of an appropriate diagnosis signaling a need for oophorectomy. These included “ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses,” the study authors wrote (Menopause. 2017 Aug;24[8]:947-53).

Dr. Nickles Fader emphasized that ovary removal is appropriate in cases of gynecologic malignancy, while patients at high genetic risk of ovarian cancer may consider salpingo-oophorectomy or salpingectomy.

What about other situations? She offered these pearls in the presentation:

• Don’t remove ovaries before age 60 “without a good reason” because the procedure may lower lifespan and increase cardiovascular risk.
• Ovary removal is linked to cognitive decline, Parkinson’s disease, depression and anxiety, glaucoma, sexual dysfunction, and bone fractures.
• Ovary preservation, in contrast, is linked to improvement of menopausal symptoms, sleep quality, urogenital atrophy, skin conditions, and metabolism.
• Fallopian tubes may be the true trouble area. “The prevailing theory amongst scientists and clinicians is that ‘ovarian cancer’ is in most cases a misnomer, and most of these malignancies start in the fallopian tube,” Dr. Nickles Fader said in the interview.

“It’s a better time than ever to be thoughtful about removing a woman’s ovaries in someone who is at low risk for ovarian cancer. The new, universal guideline is that instead of removing ovaries in most women undergoing hysterectomy, it’s quite important to consider removing just the fallopian tubes to best optimize cancer risk reduction and general health outcomes.”

Dr. Nickles Fader disclosed consulting work for Ethicon and Merck.

LAS VEGAS – While it’s fading in popularity, ovary removal in hysterectomy is still far from uncommon. A gynecologic surgeon urged colleagues to give deeper consideration to whether the ovaries can stay in place.

“Gynecologists should truly familiarize themselves with the data on cardiovascular, endocrine, bone, and sexual health implications of removing the ovaries when there isn’t a medical indication to do so,” Amanda Nickles Fader, MD, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, said in an interview following her presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.

“Until I started giving this talk, I thought I knew this data. However, once I took a deeper dive into the studies of how hormonally active the postmenopausal ovaries are, as well as the population-based studies demonstrating worse all-cause mortality outcomes in low-risk women who have their ovaries surgically removed prior to their 60s, I was stunned at how compelling this data is,” she said.

The conventional wisdom about ovary removal in hysterectomy has changed dramatically over the decades. As Dr. Nickles Fader explained in the interview, “in the ’80s and early ’90s, the mantra was ‘just take everything out’ at hysterectomy surgery – tubes and ovaries should be removed – without understanding the implications. Then in the late ’90s and early 2000s, it was a more selective strategy of ‘wait until menopause to remove the ovaries.’ ”

Now, “more contemporary data suggests that the ovaries appear to be hormonally active to some degree well into the seventh decade of life, and even women in their early 60s who have their ovaries removed without a medical indication may be harmed.”

Still, ovary removal occurs in about 50%-60% of the 450,000-500,000 hysterectomies performed each year in the United States, Dr. Nickles Fader said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

These findings seem to suggest that messages about the potential benefits of ovary preservation are not getting through to surgeons and patients.

Indeed, a 2017 study of 57,776 benign premenopausal hysterectomies with ovary removal in California from 2005 to 2011 found that 38% had no documented sign of an appropriate diagnosis signaling a need for oophorectomy. These included “ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses,” the study authors wrote (Menopause. 2017 Aug;24[8]:947-53).

Dr. Nickles Fader emphasized that ovary removal is appropriate in cases of gynecologic malignancy, while patients at high genetic risk of ovarian cancer may consider salpingo-oophorectomy or salpingectomy.

What about other situations? She offered these pearls in the presentation:

• Don’t remove ovaries before age 60 “without a good reason” because the procedure may lower lifespan and increase cardiovascular risk.
• Ovary removal is linked to cognitive decline, Parkinson’s disease, depression and anxiety, glaucoma, sexual dysfunction, and bone fractures.
• Ovary preservation, in contrast, is linked to improvement of menopausal symptoms, sleep quality, urogenital atrophy, skin conditions, and metabolism.
• Fallopian tubes may be the true trouble area. “The prevailing theory amongst scientists and clinicians is that ‘ovarian cancer’ is in most cases a misnomer, and most of these malignancies start in the fallopian tube,” Dr. Nickles Fader said in the interview.

“It’s a better time than ever to be thoughtful about removing a woman’s ovaries in someone who is at low risk for ovarian cancer. The new, universal guideline is that instead of removing ovaries in most women undergoing hysterectomy, it’s quite important to consider removing just the fallopian tubes to best optimize cancer risk reduction and general health outcomes.”

Dr. Nickles Fader disclosed consulting work for Ethicon and Merck.

LAS VEGAS – While it’s fading in popularity, ovary removal in hysterectomy is still far from uncommon. A gynecologic surgeon urged colleagues to give deeper consideration to whether the ovaries can stay in place.

“Gynecologists should truly familiarize themselves with the data on cardiovascular, endocrine, bone, and sexual health implications of removing the ovaries when there isn’t a medical indication to do so,” Amanda Nickles Fader, MD, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, said in an interview following her presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.

“Until I started giving this talk, I thought I knew this data. However, once I took a deeper dive into the studies of how hormonally active the postmenopausal ovaries are, as well as the population-based studies demonstrating worse all-cause mortality outcomes in low-risk women who have their ovaries surgically removed prior to their 60s, I was stunned at how compelling this data is,” she said.

The conventional wisdom about ovary removal in hysterectomy has changed dramatically over the decades. As Dr. Nickles Fader explained in the interview, “in the ’80s and early ’90s, the mantra was ‘just take everything out’ at hysterectomy surgery – tubes and ovaries should be removed – without understanding the implications. Then in the late ’90s and early 2000s, it was a more selective strategy of ‘wait until menopause to remove the ovaries.’ ”

Now, “more contemporary data suggests that the ovaries appear to be hormonally active to some degree well into the seventh decade of life, and even women in their early 60s who have their ovaries removed without a medical indication may be harmed.”

Still, ovary removal occurs in about 50%-60% of the 450,000-500,000 hysterectomies performed each year in the United States, Dr. Nickles Fader said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

These findings seem to suggest that messages about the potential benefits of ovary preservation are not getting through to surgeons and patients.

Indeed, a 2017 study of 57,776 benign premenopausal hysterectomies with ovary removal in California from 2005 to 2011 found that 38% had no documented sign of an appropriate diagnosis signaling a need for oophorectomy. These included “ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses,” the study authors wrote (Menopause. 2017 Aug;24[8]:947-53).

Dr. Nickles Fader emphasized that ovary removal is appropriate in cases of gynecologic malignancy, while patients at high genetic risk of ovarian cancer may consider salpingo-oophorectomy or salpingectomy.

What about other situations? She offered these pearls in the presentation:

• Don’t remove ovaries before age 60 “without a good reason” because the procedure may lower lifespan and increase cardiovascular risk.
• Ovary removal is linked to cognitive decline, Parkinson’s disease, depression and anxiety, glaucoma, sexual dysfunction, and bone fractures.
• Ovary preservation, in contrast, is linked to improvement of menopausal symptoms, sleep quality, urogenital atrophy, skin conditions, and metabolism.
• Fallopian tubes may be the true trouble area. “The prevailing theory amongst scientists and clinicians is that ‘ovarian cancer’ is in most cases a misnomer, and most of these malignancies start in the fallopian tube,” Dr. Nickles Fader said in the interview.

“It’s a better time than ever to be thoughtful about removing a woman’s ovaries in someone who is at low risk for ovarian cancer. The new, universal guideline is that instead of removing ovaries in most women undergoing hysterectomy, it’s quite important to consider removing just the fallopian tubes to best optimize cancer risk reduction and general health outcomes.”

Dr. Nickles Fader disclosed consulting work for Ethicon and Merck.

Women with breast cancer may be receiving treatments that are discordant with guideline recommendations for genetic subtypes of disease, based on a retrospective analysis of more than 20,000 patients.

Radiotherapy and chemotherapy practices were particularly out of alignment with guidelines, reported lead author Allison W. Kurian, MD, of Stanford (Calif.) University, and colleagues.

“Integrating genetic testing into breast cancer care has been complex and challenging,” the investigators wrote in JAMA Oncology. “There is wide variability in which clinicians order testing and disclose results, in the clinical significance of results, and in how clinicians interpret results to patients.”

According to the investigators, while germline testing is on the rise, little is known about how these test results are translating to clinical care.

To learn more, the investigators evaluated data from 20,568 women with stage 0-III breast cancer who entered the Surveillance, Epidemiology, and End Results registries of Georgia and California between 2014 and 2016.

Three treatment types were evaluated: surgery (bilateral vs. unilateral mastectomy), radiotherapy after lumpectomy, and chemotherapy. Treatment selection was compared with test results for breast cancer–associated genes, such as BRCA1/2, TP53, PTEN, and others. Associations were then compared with guideline recommendations.

Data analysis suggested that many clinicians were correctly using genetic test results to guide surgical decisions. For example, almost two-thirds (61.7%) of women with a BRCA mutation underwent bilateral mastectomy, compared with one-quarter (24.3%) who were BRCA negative (odds ratio, 5.52). For other pathogenic variants, the rate of bilateral mastectomy was still elevated, albeit to a lesser degree (OR, 2.41).

Generally, these practices align with recommendations, the investigators wrote, noting that research supports bilateral mastectomy with BRCA1/2, TP53, and PTEN variants, while data are lacking for other genetic subtypes.

Radiotherapy and chemotherapy practices were more discordant with guidelines. For example, women with a BRCA mutation were 78% less likely to receive radiotherapy after lumpectomy (OR, 0.22) and 76% more likely to receive chemotherapy for early-stage, hormone-positive disease (OR, 1.76). According to investigators, these findings suggest possible trends in undertreatment and overtreatment, respectively.

“We believe more research is needed to confirm our results and to evaluate long-term outcomes of pathogenic variant carriers to understand treatment decision making and consequences,” the investigators concluded.

The study was funded by the National Institutes of Health and the California Department of Public Health. The investigators reported relationships with Myriad Genetics, Genomic Health, Roche, and other companies.

SOURCE: Kurian AW et al. JAMA Oncol. 2020 Feb 6. doi: 10.1001/jamaoncol.2019.6400.

Women with breast cancer may be receiving treatments that are discordant with guideline recommendations for genetic subtypes of disease, based on a retrospective analysis of more than 20,000 patients.

Radiotherapy and chemotherapy practices were particularly out of alignment with guidelines, reported lead author Allison W. Kurian, MD, of Stanford (Calif.) University, and colleagues.

“Integrating genetic testing into breast cancer care has been complex and challenging,” the investigators wrote in JAMA Oncology. “There is wide variability in which clinicians order testing and disclose results, in the clinical significance of results, and in how clinicians interpret results to patients.”

According to the investigators, while germline testing is on the rise, little is known about how these test results are translating to clinical care.

To learn more, the investigators evaluated data from 20,568 women with stage 0-III breast cancer who entered the Surveillance, Epidemiology, and End Results registries of Georgia and California between 2014 and 2016.

Three treatment types were evaluated: surgery (bilateral vs. unilateral mastectomy), radiotherapy after lumpectomy, and chemotherapy. Treatment selection was compared with test results for breast cancer–associated genes, such as BRCA1/2, TP53, PTEN, and others. Associations were then compared with guideline recommendations.

Data analysis suggested that many clinicians were correctly using genetic test results to guide surgical decisions. For example, almost two-thirds (61.7%) of women with a BRCA mutation underwent bilateral mastectomy, compared with one-quarter (24.3%) who were BRCA negative (odds ratio, 5.52). For other pathogenic variants, the rate of bilateral mastectomy was still elevated, albeit to a lesser degree (OR, 2.41).

Generally, these practices align with recommendations, the investigators wrote, noting that research supports bilateral mastectomy with BRCA1/2, TP53, and PTEN variants, while data are lacking for other genetic subtypes.

Radiotherapy and chemotherapy practices were more discordant with guidelines. For example, women with a BRCA mutation were 78% less likely to receive radiotherapy after lumpectomy (OR, 0.22) and 76% more likely to receive chemotherapy for early-stage, hormone-positive disease (OR, 1.76). According to investigators, these findings suggest possible trends in undertreatment and overtreatment, respectively.

“We believe more research is needed to confirm our results and to evaluate long-term outcomes of pathogenic variant carriers to understand treatment decision making and consequences,” the investigators concluded.

The study was funded by the National Institutes of Health and the California Department of Public Health. The investigators reported relationships with Myriad Genetics, Genomic Health, Roche, and other companies.

SOURCE: Kurian AW et al. JAMA Oncol. 2020 Feb 6. doi: 10.1001/jamaoncol.2019.6400.

Women with breast cancer may be receiving treatments that are discordant with guideline recommendations for genetic subtypes of disease, based on a retrospective analysis of more than 20,000 patients.

Radiotherapy and chemotherapy practices were particularly out of alignment with guidelines, reported lead author Allison W. Kurian, MD, of Stanford (Calif.) University, and colleagues.

“Integrating genetic testing into breast cancer care has been complex and challenging,” the investigators wrote in JAMA Oncology. “There is wide variability in which clinicians order testing and disclose results, in the clinical significance of results, and in how clinicians interpret results to patients.”

According to the investigators, while germline testing is on the rise, little is known about how these test results are translating to clinical care.

To learn more, the investigators evaluated data from 20,568 women with stage 0-III breast cancer who entered the Surveillance, Epidemiology, and End Results registries of Georgia and California between 2014 and 2016.

Three treatment types were evaluated: surgery (bilateral vs. unilateral mastectomy), radiotherapy after lumpectomy, and chemotherapy. Treatment selection was compared with test results for breast cancer–associated genes, such as BRCA1/2, TP53, PTEN, and others. Associations were then compared with guideline recommendations.

Data analysis suggested that many clinicians were correctly using genetic test results to guide surgical decisions. For example, almost two-thirds (61.7%) of women with a BRCA mutation underwent bilateral mastectomy, compared with one-quarter (24.3%) who were BRCA negative (odds ratio, 5.52). For other pathogenic variants, the rate of bilateral mastectomy was still elevated, albeit to a lesser degree (OR, 2.41).

Generally, these practices align with recommendations, the investigators wrote, noting that research supports bilateral mastectomy with BRCA1/2, TP53, and PTEN variants, while data are lacking for other genetic subtypes.

Radiotherapy and chemotherapy practices were more discordant with guidelines. For example, women with a BRCA mutation were 78% less likely to receive radiotherapy after lumpectomy (OR, 0.22) and 76% more likely to receive chemotherapy for early-stage, hormone-positive disease (OR, 1.76). According to investigators, these findings suggest possible trends in undertreatment and overtreatment, respectively.

“We believe more research is needed to confirm our results and to evaluate long-term outcomes of pathogenic variant carriers to understand treatment decision making and consequences,” the investigators concluded.

The study was funded by the National Institutes of Health and the California Department of Public Health. The investigators reported relationships with Myriad Genetics, Genomic Health, Roche, and other companies.

SOURCE: Kurian AW et al. JAMA Oncol. 2020 Feb 6. doi: 10.1001/jamaoncol.2019.6400.