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Gestational hypertension-diabetes combo signals CVD risk

Article Type
Changed
Thu, 12/15/2022 - 14:23

Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Dr. Natalie Bello


“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”

That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.

“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”

Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”

The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.

“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.

Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”

The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.

“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.

“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.

She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”

The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.



 

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Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Dr. Natalie Bello


“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”

That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.

“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”

Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”

The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.

“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.

Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”

The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.

“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.

“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.

She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”

The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.



 

Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Dr. Natalie Bello


“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”

That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.

“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”

Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”

The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.

“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.

Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”

The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.

“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.

“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.

She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”

The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.



 

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A new use for dating apps: Chasing STDs

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Wed, 12/07/2022 - 10:21

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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FDA requests more restrictions on ovarian cancer drugs

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Thu, 12/01/2022 - 15:22

The Food and Drug Administration is moving to further restrict the use of certain PARP inhibitors in patients with ovarian cancer, citing recent data showing an increased risk for death with the agents versus chemotherapy.

These restrictions could mean bankruptcy for one company.

Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.

Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.

The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.

On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.

The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.

The company noted, however, that its first-line indication remains unchanged.

The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.

According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.

In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”

Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.

Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.

However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”

The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”

The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”

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

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The Food and Drug Administration is moving to further restrict the use of certain PARP inhibitors in patients with ovarian cancer, citing recent data showing an increased risk for death with the agents versus chemotherapy.

These restrictions could mean bankruptcy for one company.

Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.

Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.

The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.

On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.

The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.

The company noted, however, that its first-line indication remains unchanged.

The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.

According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.

In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”

Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.

Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.

However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”

The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”

The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”

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

The Food and Drug Administration is moving to further restrict the use of certain PARP inhibitors in patients with ovarian cancer, citing recent data showing an increased risk for death with the agents versus chemotherapy.

These restrictions could mean bankruptcy for one company.

Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.

Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.

The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.

On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.

The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.

The company noted, however, that its first-line indication remains unchanged.

The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.

According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.

In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”

Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.

Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.

However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”

The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”

The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”

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

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Managing trastuzumab deruxtecan adverse events in the real world

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Fri, 12/16/2022 - 10:06

With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).

“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”

The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.

In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.

Expanding use of this drug has led to growing awareness among oncologists of T-DXd’s considerable toxicities, Dr. Yadav told this news organization.

Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.

There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.

It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.

His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.

One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.

A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.

Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.

As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.

Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.

In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazineondansetron, and lorazepam. If these don’t help, the team considers olanzapine.

They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.

Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.

Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.

These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.

The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.

Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.

Dr. Yadav reports no relevant conflicts of interest.

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

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With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).

“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”

The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.

In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.

Expanding use of this drug has led to growing awareness among oncologists of T-DXd’s considerable toxicities, Dr. Yadav told this news organization.

Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.

There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.

It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.

His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.

One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.

A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.

Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.

As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.

Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.

In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazineondansetron, and lorazepam. If these don’t help, the team considers olanzapine.

They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.

Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.

Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.

These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.

The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.

Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.

Dr. Yadav reports no relevant conflicts of interest.

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

With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).

“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”

The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.

In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.

Expanding use of this drug has led to growing awareness among oncologists of T-DXd’s considerable toxicities, Dr. Yadav told this news organization.

Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.

There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.

It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.

His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.

One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.

A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.

Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.

As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.

Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.

In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazineondansetron, and lorazepam. If these don’t help, the team considers olanzapine.

They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.

Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.

Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.

These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.

The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.

Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.

Dr. Yadav reports no relevant conflicts of interest.

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

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Whole breast radiation for breast cancer shown to be safe and effective

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Tue, 02/07/2023 - 12:07

Among high-risk early breast cancer patients, a radiation boost to the tumor bed during whole breast irradiation was just as safe and effective as delivering the boost sequentially after whole breast irradiation ended. The findings from a phase 3 clinical trial are a boon to patient convenience.

“These findings are indeed practice changing. This was a well-designed trial that looked at shortening treatment from 6 weeks down to 3 weeks. And, they showed equivalent local control and importantly, a good cosmetic outcome over time,” said Kathleen Horst, MD, who served as a discussant at a press conference held at the annual meeting of the American Society for Radiation Oncology where the findings were presented.

“This is substantially more convenient. It is cost effective, both for the health care system and for individual patients. Importantly, our patients come in for treatment every day. They’re taking time off of work, they have to arrange for childcare, and they have to arrange for transportation. So this makes a big difference for these patients,” said Dr. Horst, who is a professor of radiation oncology at Stanford (Calif.) Medicine and director of well-being in the radiation department at Stanford Medicine.

The study was presented by Frank A. Vicini, MD, FASTRO, a radiation oncologist with GenesisCare, Farmington Hills, Mich.

“One of the things I think that was surprising is I think all of us were thinking that this might be a more toxic regimen, but as Dr. Vincini showed, over time it was equally effective and with minimal toxicity, and cosmesis over time was stable, and that’s important. Importantly, that included patient-reported outcomes, not just the physician-reported outcomes. Broadly, I think these findings are applicable for many patients, all patients who are receiving whole breast radiotherapy with an added boost. I think over time this is going to improve the quality of life of our patients. It is an innovative change that everyone is going to be excited to embrace,” Dr. Horst said.

Previous randomized, controlled trials showed that an additional radiation dose to the tumor bed following lumpectomy and whole breast irradiation reduces the relative risk of local recurrence by about 35%. However, this increases treatment time for patients who have already endured an extensive regimen. For whole breast irradiation, hypofractionated radiation is in 15-16 fractions over 3 weeks has comparable recurrence rates as a 5-week regimen, but the relevant trials did not examine the effect hypofractionation may have on a radiation boost to the tumor bed of high-risk patients. Because of this lack of evidence, current practice is for the boost to remain sequential in five to eight fractions after completion of whole breast irradiation, which adds a week to a week and a half to treatment length.

The study included 2,262 patients who were randomized to receive a sequential boost or a concomitant boost. After a median follow-up of 7.4 years, there were 54 ipsilateral breast recurrence (IBR) events. The estimated 7-year risk of IBR was 2.2% in the sequential boost and 2.6% in the concurrent risk group (hazard ratio, 1.32; noninferiority test P = .039). Approximately 60% of patients received adjuvant chemotherapy.

Grade 3 or higher adverse events were similar, with a frequency of 3.3% in the sequential group and 3.5% in the concurrent group (P = .79). The researchers used the Global Cosmetic Score to assess outcomes from the perspective of both physicians and patients; 86% of physicians rated the outcome as excellent/good in the sequential group versus 82% in the concurrent group (P = .33).

“For high-risk early-stage breast cancer patients undergoing breast conservation, a concurrent boost with hypofractionated whole breast irradiation as compared to a sequential boost, results in noninferior local recurrence rates with no significant difference in toxicity, noninferior patient-rated cosmesis, no significant difference in physician rated cosmesis, and delivering the entire treatment even at high risk patients in 3 weeks. Just as critical, the use of target volume–based radiation planning for 3-D [three-dimensional] conformal or [intensity-modulated radiation therapy] whole breast irradiation assessed by dose volume analysis is feasible, and resulted in very low toxicity in the treatment arms, regardless of the fractionation schedule, or the boost delivery,” said Dr. Vincini during the press conference.

The study was grant funded. Neither Dr. Vincini nor Dr. Horst had relevant financial disclosures.

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Among high-risk early breast cancer patients, a radiation boost to the tumor bed during whole breast irradiation was just as safe and effective as delivering the boost sequentially after whole breast irradiation ended. The findings from a phase 3 clinical trial are a boon to patient convenience.

“These findings are indeed practice changing. This was a well-designed trial that looked at shortening treatment from 6 weeks down to 3 weeks. And, they showed equivalent local control and importantly, a good cosmetic outcome over time,” said Kathleen Horst, MD, who served as a discussant at a press conference held at the annual meeting of the American Society for Radiation Oncology where the findings were presented.

“This is substantially more convenient. It is cost effective, both for the health care system and for individual patients. Importantly, our patients come in for treatment every day. They’re taking time off of work, they have to arrange for childcare, and they have to arrange for transportation. So this makes a big difference for these patients,” said Dr. Horst, who is a professor of radiation oncology at Stanford (Calif.) Medicine and director of well-being in the radiation department at Stanford Medicine.

The study was presented by Frank A. Vicini, MD, FASTRO, a radiation oncologist with GenesisCare, Farmington Hills, Mich.

“One of the things I think that was surprising is I think all of us were thinking that this might be a more toxic regimen, but as Dr. Vincini showed, over time it was equally effective and with minimal toxicity, and cosmesis over time was stable, and that’s important. Importantly, that included patient-reported outcomes, not just the physician-reported outcomes. Broadly, I think these findings are applicable for many patients, all patients who are receiving whole breast radiotherapy with an added boost. I think over time this is going to improve the quality of life of our patients. It is an innovative change that everyone is going to be excited to embrace,” Dr. Horst said.

Previous randomized, controlled trials showed that an additional radiation dose to the tumor bed following lumpectomy and whole breast irradiation reduces the relative risk of local recurrence by about 35%. However, this increases treatment time for patients who have already endured an extensive regimen. For whole breast irradiation, hypofractionated radiation is in 15-16 fractions over 3 weeks has comparable recurrence rates as a 5-week regimen, but the relevant trials did not examine the effect hypofractionation may have on a radiation boost to the tumor bed of high-risk patients. Because of this lack of evidence, current practice is for the boost to remain sequential in five to eight fractions after completion of whole breast irradiation, which adds a week to a week and a half to treatment length.

The study included 2,262 patients who were randomized to receive a sequential boost or a concomitant boost. After a median follow-up of 7.4 years, there were 54 ipsilateral breast recurrence (IBR) events. The estimated 7-year risk of IBR was 2.2% in the sequential boost and 2.6% in the concurrent risk group (hazard ratio, 1.32; noninferiority test P = .039). Approximately 60% of patients received adjuvant chemotherapy.

Grade 3 or higher adverse events were similar, with a frequency of 3.3% in the sequential group and 3.5% in the concurrent group (P = .79). The researchers used the Global Cosmetic Score to assess outcomes from the perspective of both physicians and patients; 86% of physicians rated the outcome as excellent/good in the sequential group versus 82% in the concurrent group (P = .33).

“For high-risk early-stage breast cancer patients undergoing breast conservation, a concurrent boost with hypofractionated whole breast irradiation as compared to a sequential boost, results in noninferior local recurrence rates with no significant difference in toxicity, noninferior patient-rated cosmesis, no significant difference in physician rated cosmesis, and delivering the entire treatment even at high risk patients in 3 weeks. Just as critical, the use of target volume–based radiation planning for 3-D [three-dimensional] conformal or [intensity-modulated radiation therapy] whole breast irradiation assessed by dose volume analysis is feasible, and resulted in very low toxicity in the treatment arms, regardless of the fractionation schedule, or the boost delivery,” said Dr. Vincini during the press conference.

The study was grant funded. Neither Dr. Vincini nor Dr. Horst had relevant financial disclosures.

Among high-risk early breast cancer patients, a radiation boost to the tumor bed during whole breast irradiation was just as safe and effective as delivering the boost sequentially after whole breast irradiation ended. The findings from a phase 3 clinical trial are a boon to patient convenience.

“These findings are indeed practice changing. This was a well-designed trial that looked at shortening treatment from 6 weeks down to 3 weeks. And, they showed equivalent local control and importantly, a good cosmetic outcome over time,” said Kathleen Horst, MD, who served as a discussant at a press conference held at the annual meeting of the American Society for Radiation Oncology where the findings were presented.

“This is substantially more convenient. It is cost effective, both for the health care system and for individual patients. Importantly, our patients come in for treatment every day. They’re taking time off of work, they have to arrange for childcare, and they have to arrange for transportation. So this makes a big difference for these patients,” said Dr. Horst, who is a professor of radiation oncology at Stanford (Calif.) Medicine and director of well-being in the radiation department at Stanford Medicine.

The study was presented by Frank A. Vicini, MD, FASTRO, a radiation oncologist with GenesisCare, Farmington Hills, Mich.

“One of the things I think that was surprising is I think all of us were thinking that this might be a more toxic regimen, but as Dr. Vincini showed, over time it was equally effective and with minimal toxicity, and cosmesis over time was stable, and that’s important. Importantly, that included patient-reported outcomes, not just the physician-reported outcomes. Broadly, I think these findings are applicable for many patients, all patients who are receiving whole breast radiotherapy with an added boost. I think over time this is going to improve the quality of life of our patients. It is an innovative change that everyone is going to be excited to embrace,” Dr. Horst said.

Previous randomized, controlled trials showed that an additional radiation dose to the tumor bed following lumpectomy and whole breast irradiation reduces the relative risk of local recurrence by about 35%. However, this increases treatment time for patients who have already endured an extensive regimen. For whole breast irradiation, hypofractionated radiation is in 15-16 fractions over 3 weeks has comparable recurrence rates as a 5-week regimen, but the relevant trials did not examine the effect hypofractionation may have on a radiation boost to the tumor bed of high-risk patients. Because of this lack of evidence, current practice is for the boost to remain sequential in five to eight fractions after completion of whole breast irradiation, which adds a week to a week and a half to treatment length.

The study included 2,262 patients who were randomized to receive a sequential boost or a concomitant boost. After a median follow-up of 7.4 years, there were 54 ipsilateral breast recurrence (IBR) events. The estimated 7-year risk of IBR was 2.2% in the sequential boost and 2.6% in the concurrent risk group (hazard ratio, 1.32; noninferiority test P = .039). Approximately 60% of patients received adjuvant chemotherapy.

Grade 3 or higher adverse events were similar, with a frequency of 3.3% in the sequential group and 3.5% in the concurrent group (P = .79). The researchers used the Global Cosmetic Score to assess outcomes from the perspective of both physicians and patients; 86% of physicians rated the outcome as excellent/good in the sequential group versus 82% in the concurrent group (P = .33).

“For high-risk early-stage breast cancer patients undergoing breast conservation, a concurrent boost with hypofractionated whole breast irradiation as compared to a sequential boost, results in noninferior local recurrence rates with no significant difference in toxicity, noninferior patient-rated cosmesis, no significant difference in physician rated cosmesis, and delivering the entire treatment even at high risk patients in 3 weeks. Just as critical, the use of target volume–based radiation planning for 3-D [three-dimensional] conformal or [intensity-modulated radiation therapy] whole breast irradiation assessed by dose volume analysis is feasible, and resulted in very low toxicity in the treatment arms, regardless of the fractionation schedule, or the boost delivery,” said Dr. Vincini during the press conference.

The study was grant funded. Neither Dr. Vincini nor Dr. Horst had relevant financial disclosures.

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Looking for a healthy meat substitute? Consider the potato

Article Type
Changed
Thu, 12/01/2022 - 09:51

 

Boil ‘em, mash ‘em, include ‘em in a balanced diet

It’s kind of funny that, even though potatoes are vegetables and vegetables are generally considered to be healthy foods, not many people think of potatoes as being particularly good for you. And that’s hardly surprising since we usually either consume them in the form of French fries or potato chips, neither of which are known for their healthiness.

PxHere

In fact, some previous research shows that potatoes are a food to avoid, particularly for people with insulin resistance. However, a new study from England goes against the grain and asserts that the potato is perfectly fine for insulin-resistant individuals and filled with valuable nutrients and health benefits. Which is great news for the state of Idaho and the potato organization funding the research. Of course there’s a potato organization.

For the study, a group of obese, overweight, or insulin-resistant individuals received a diet of either beans, peas, and meat or fish or white potatoes with meat or fish for 8 weeks; both diets were heavy in fruits and vegetables and both diets replaced about 40% of typical meat consumption with either beans and peas or potatoes. By the end of the study, those on the potato diet experienced health benefits equivalent to those on the bean and pea diet, including losing roughly equivalent amounts of weight and similarly reducing the body’s insulin response.

The researchers noted that, because people tend to eat the same amount of food no matter what, replacing something like meat with dense, low-calorie potatoes meant study participants could eat normally yet consume much fewer calories. So you could make a delicious, healthy stew without the brace of conies and the nice fish, which would make Smeagol very happy.
 

You won’t have ‘monkeypox’ to kick around anymore

It’s true. No more monkeypox. It’s gone. It’s history. Adios. The World Health Organization said that the disease formerly known as monkeypox will now be called mpox. What? You didn’t think it had been cured, did you? You did? Really? Silly readers.

NIAID

“Mpox will become a preferred term, replacing monkeypox, after a transition period of 1 year. This serves to mitigate the concerns raised by experts about confusion caused by a name change in the midst of a global outbreak,” WHO said in a statement announcing the change.

The stigma attached to the name was the main problem. New York City Health Commissioner Dr. Ashwin Vasan had sent a letter to WHO earlier this year, according to CNN, saying that there was “growing concern for the potentially devastating and stigmatizing effects that the messaging around the ‘monkeypox’ virus can have on … vulnerable communities.”

We here at LOTME applaud the fight against stigmas of any sort, but we sensed there was more to this name change business, so our dedicated team of investigative journalists went into action. Sure enough, while rooting through WHO Director-General Tedros Adhanom Ghebreyesus’s garbage, we found a list of the names that had been rejected in favor of mpox:

  • K-pop (already taken)
  • Keeping up with the Kardashi-pox
  • Trumpox
  • Pox the magic dragon
  • Monkey plague (didn’t really solve the problem)
  • Hockey pox
  • Mission mpoxible
  • Jurassic Pox
  • The pox that refreshes
  • Debbie

Feet catch what the ears miss

The spectrum of frequencies that can be heard by human ears varies from person to person. Then there’s the matter of personal taste in music and volume level. But what really gets people moving? A new study shows that it’s more about the frequency of the sound than the volume.

PxHere

For the study, participants at a concert by electronic music duo Orphx at LIVELab – a research performance center on the McMaster University campus in Hamilton, Ont., that was specifically designed to study music and dance – filled out questionnaires before and after the show. They also wore motion-capture headbands to detect their movement throughout the concert. During the show the researchers turned very-low-frequency (VLF) sounds (8-37 Hz) on and off every 2.5 minutes. Movement speed was calculated during on and off periods.

Although the effects of subliminal messaging aren’t new, past studies have shown that participants were mostly aware of the messaging. In this study, the researchers found that the subjects’ movements increased by 11.8% when the VLF sounds were on, but without their awareness. The researchers and the participants attributed movement to the bass, as lower pitches tend to elicit stronger neural responses and thus movement, compared with higher pitches.

“Our whole sense of the beat is mediated by the vestibular system but nobody’s really, I think, effectively confirmed that,” Jonathan Cannon, an assistant professor of psychology, neuroscience, and behavior at McMaster who not involved in the study, told Live Science.

Not to say this study didn’t have its limitations, such as the effect of the surrounding crowd or vibrations of the floor influencing the need to dance. But it definitely makes you wonder about what’s actually playing in your favorite song.
 

Uncle Leonid wants you

Do you like to travel? Are you a bit of a thrill seeker? Do you have any extra socks? If you’re a physician who answered yes to those three questions, then we’ve got an opportunity for you.

Bicanski/Pixnio

Leonid Slutsky, leader of Russia’s populist Liberal Democratic Party and chairman of the foreign relations committee in the lower house of Russia’s parliament – yes, that Leonid Slutsky – recently made a bit of a recruiting pitch, although that’s not how ABC News described it.

Mr. Slutsky, a strong supporter of his country’s war against Ukraine, recently told the mothers of Russian soldiers “that the whole world is watching us. We are the largest state and when we do not have socks, shorts, doctors, intelligence, communications, or simply care for our children, questions arise that will be very difficult to answer.”

It’s probably not what he meant, but the lack of intelligence is pretty clear.

Publications
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Sections

 

Boil ‘em, mash ‘em, include ‘em in a balanced diet

It’s kind of funny that, even though potatoes are vegetables and vegetables are generally considered to be healthy foods, not many people think of potatoes as being particularly good for you. And that’s hardly surprising since we usually either consume them in the form of French fries or potato chips, neither of which are known for their healthiness.

PxHere

In fact, some previous research shows that potatoes are a food to avoid, particularly for people with insulin resistance. However, a new study from England goes against the grain and asserts that the potato is perfectly fine for insulin-resistant individuals and filled with valuable nutrients and health benefits. Which is great news for the state of Idaho and the potato organization funding the research. Of course there’s a potato organization.

For the study, a group of obese, overweight, or insulin-resistant individuals received a diet of either beans, peas, and meat or fish or white potatoes with meat or fish for 8 weeks; both diets were heavy in fruits and vegetables and both diets replaced about 40% of typical meat consumption with either beans and peas or potatoes. By the end of the study, those on the potato diet experienced health benefits equivalent to those on the bean and pea diet, including losing roughly equivalent amounts of weight and similarly reducing the body’s insulin response.

The researchers noted that, because people tend to eat the same amount of food no matter what, replacing something like meat with dense, low-calorie potatoes meant study participants could eat normally yet consume much fewer calories. So you could make a delicious, healthy stew without the brace of conies and the nice fish, which would make Smeagol very happy.
 

You won’t have ‘monkeypox’ to kick around anymore

It’s true. No more monkeypox. It’s gone. It’s history. Adios. The World Health Organization said that the disease formerly known as monkeypox will now be called mpox. What? You didn’t think it had been cured, did you? You did? Really? Silly readers.

NIAID

“Mpox will become a preferred term, replacing monkeypox, after a transition period of 1 year. This serves to mitigate the concerns raised by experts about confusion caused by a name change in the midst of a global outbreak,” WHO said in a statement announcing the change.

The stigma attached to the name was the main problem. New York City Health Commissioner Dr. Ashwin Vasan had sent a letter to WHO earlier this year, according to CNN, saying that there was “growing concern for the potentially devastating and stigmatizing effects that the messaging around the ‘monkeypox’ virus can have on … vulnerable communities.”

We here at LOTME applaud the fight against stigmas of any sort, but we sensed there was more to this name change business, so our dedicated team of investigative journalists went into action. Sure enough, while rooting through WHO Director-General Tedros Adhanom Ghebreyesus’s garbage, we found a list of the names that had been rejected in favor of mpox:

  • K-pop (already taken)
  • Keeping up with the Kardashi-pox
  • Trumpox
  • Pox the magic dragon
  • Monkey plague (didn’t really solve the problem)
  • Hockey pox
  • Mission mpoxible
  • Jurassic Pox
  • The pox that refreshes
  • Debbie

Feet catch what the ears miss

The spectrum of frequencies that can be heard by human ears varies from person to person. Then there’s the matter of personal taste in music and volume level. But what really gets people moving? A new study shows that it’s more about the frequency of the sound than the volume.

PxHere

For the study, participants at a concert by electronic music duo Orphx at LIVELab – a research performance center on the McMaster University campus in Hamilton, Ont., that was specifically designed to study music and dance – filled out questionnaires before and after the show. They also wore motion-capture headbands to detect their movement throughout the concert. During the show the researchers turned very-low-frequency (VLF) sounds (8-37 Hz) on and off every 2.5 minutes. Movement speed was calculated during on and off periods.

Although the effects of subliminal messaging aren’t new, past studies have shown that participants were mostly aware of the messaging. In this study, the researchers found that the subjects’ movements increased by 11.8% when the VLF sounds were on, but without their awareness. The researchers and the participants attributed movement to the bass, as lower pitches tend to elicit stronger neural responses and thus movement, compared with higher pitches.

“Our whole sense of the beat is mediated by the vestibular system but nobody’s really, I think, effectively confirmed that,” Jonathan Cannon, an assistant professor of psychology, neuroscience, and behavior at McMaster who not involved in the study, told Live Science.

Not to say this study didn’t have its limitations, such as the effect of the surrounding crowd or vibrations of the floor influencing the need to dance. But it definitely makes you wonder about what’s actually playing in your favorite song.
 

Uncle Leonid wants you

Do you like to travel? Are you a bit of a thrill seeker? Do you have any extra socks? If you’re a physician who answered yes to those three questions, then we’ve got an opportunity for you.

Bicanski/Pixnio

Leonid Slutsky, leader of Russia’s populist Liberal Democratic Party and chairman of the foreign relations committee in the lower house of Russia’s parliament – yes, that Leonid Slutsky – recently made a bit of a recruiting pitch, although that’s not how ABC News described it.

Mr. Slutsky, a strong supporter of his country’s war against Ukraine, recently told the mothers of Russian soldiers “that the whole world is watching us. We are the largest state and when we do not have socks, shorts, doctors, intelligence, communications, or simply care for our children, questions arise that will be very difficult to answer.”

It’s probably not what he meant, but the lack of intelligence is pretty clear.

 

Boil ‘em, mash ‘em, include ‘em in a balanced diet

It’s kind of funny that, even though potatoes are vegetables and vegetables are generally considered to be healthy foods, not many people think of potatoes as being particularly good for you. And that’s hardly surprising since we usually either consume them in the form of French fries or potato chips, neither of which are known for their healthiness.

PxHere

In fact, some previous research shows that potatoes are a food to avoid, particularly for people with insulin resistance. However, a new study from England goes against the grain and asserts that the potato is perfectly fine for insulin-resistant individuals and filled with valuable nutrients and health benefits. Which is great news for the state of Idaho and the potato organization funding the research. Of course there’s a potato organization.

For the study, a group of obese, overweight, or insulin-resistant individuals received a diet of either beans, peas, and meat or fish or white potatoes with meat or fish for 8 weeks; both diets were heavy in fruits and vegetables and both diets replaced about 40% of typical meat consumption with either beans and peas or potatoes. By the end of the study, those on the potato diet experienced health benefits equivalent to those on the bean and pea diet, including losing roughly equivalent amounts of weight and similarly reducing the body’s insulin response.

The researchers noted that, because people tend to eat the same amount of food no matter what, replacing something like meat with dense, low-calorie potatoes meant study participants could eat normally yet consume much fewer calories. So you could make a delicious, healthy stew without the brace of conies and the nice fish, which would make Smeagol very happy.
 

You won’t have ‘monkeypox’ to kick around anymore

It’s true. No more monkeypox. It’s gone. It’s history. Adios. The World Health Organization said that the disease formerly known as monkeypox will now be called mpox. What? You didn’t think it had been cured, did you? You did? Really? Silly readers.

NIAID

“Mpox will become a preferred term, replacing monkeypox, after a transition period of 1 year. This serves to mitigate the concerns raised by experts about confusion caused by a name change in the midst of a global outbreak,” WHO said in a statement announcing the change.

The stigma attached to the name was the main problem. New York City Health Commissioner Dr. Ashwin Vasan had sent a letter to WHO earlier this year, according to CNN, saying that there was “growing concern for the potentially devastating and stigmatizing effects that the messaging around the ‘monkeypox’ virus can have on … vulnerable communities.”

We here at LOTME applaud the fight against stigmas of any sort, but we sensed there was more to this name change business, so our dedicated team of investigative journalists went into action. Sure enough, while rooting through WHO Director-General Tedros Adhanom Ghebreyesus’s garbage, we found a list of the names that had been rejected in favor of mpox:

  • K-pop (already taken)
  • Keeping up with the Kardashi-pox
  • Trumpox
  • Pox the magic dragon
  • Monkey plague (didn’t really solve the problem)
  • Hockey pox
  • Mission mpoxible
  • Jurassic Pox
  • The pox that refreshes
  • Debbie

Feet catch what the ears miss

The spectrum of frequencies that can be heard by human ears varies from person to person. Then there’s the matter of personal taste in music and volume level. But what really gets people moving? A new study shows that it’s more about the frequency of the sound than the volume.

PxHere

For the study, participants at a concert by electronic music duo Orphx at LIVELab – a research performance center on the McMaster University campus in Hamilton, Ont., that was specifically designed to study music and dance – filled out questionnaires before and after the show. They also wore motion-capture headbands to detect their movement throughout the concert. During the show the researchers turned very-low-frequency (VLF) sounds (8-37 Hz) on and off every 2.5 minutes. Movement speed was calculated during on and off periods.

Although the effects of subliminal messaging aren’t new, past studies have shown that participants were mostly aware of the messaging. In this study, the researchers found that the subjects’ movements increased by 11.8% when the VLF sounds were on, but without their awareness. The researchers and the participants attributed movement to the bass, as lower pitches tend to elicit stronger neural responses and thus movement, compared with higher pitches.

“Our whole sense of the beat is mediated by the vestibular system but nobody’s really, I think, effectively confirmed that,” Jonathan Cannon, an assistant professor of psychology, neuroscience, and behavior at McMaster who not involved in the study, told Live Science.

Not to say this study didn’t have its limitations, such as the effect of the surrounding crowd or vibrations of the floor influencing the need to dance. But it definitely makes you wonder about what’s actually playing in your favorite song.
 

Uncle Leonid wants you

Do you like to travel? Are you a bit of a thrill seeker? Do you have any extra socks? If you’re a physician who answered yes to those three questions, then we’ve got an opportunity for you.

Bicanski/Pixnio

Leonid Slutsky, leader of Russia’s populist Liberal Democratic Party and chairman of the foreign relations committee in the lower house of Russia’s parliament – yes, that Leonid Slutsky – recently made a bit of a recruiting pitch, although that’s not how ABC News described it.

Mr. Slutsky, a strong supporter of his country’s war against Ukraine, recently told the mothers of Russian soldiers “that the whole world is watching us. We are the largest state and when we do not have socks, shorts, doctors, intelligence, communications, or simply care for our children, questions arise that will be very difficult to answer.”

It’s probably not what he meant, but the lack of intelligence is pretty clear.

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Buprenorphine linked with lower risk for neonatal harms than methadone

Article Type
Changed
Wed, 11/30/2022 - 12:13

Using buprenorphine for opioid use disorder in pregnancy was linked with a lower risk of neonatal side effects than using methadone, but the risk of adverse maternal outcomes was similar between the two treatments, according to new research.

Elizabeth A. Suarez, PhD, MPH, with Brigham and Women’s Hospital in Boston, led the study published online in the New England Journal of Medicine.

Opioid use disorder in pregnant women has increased steadily in the United States since 2000, the authors write. As of 2017, about 8.2 per 1,000 deliveries were estimated to be affected by the disorder. The numbers were particularly high in people insured by Medicaid. In that group, an estimated 14.6 per 1,000 deliveries were affected.

Researchers studied pregnant women enrolled in public insurance programs in the United States from 2000 through 2018 in a dataset of 2,548,372 pregnancies that ended in live births. They analyzed outcomes in those who received buprenorphine as compared with those who received methadone.

They looked at different periods of exposure to the two medications: early pregnancy (through gestational week 19); late pregnancy (week 20 through the day before delivery); and the 30 days before delivery.

Highlighted differences in infants included:

  • Neonatal abstinence syndrome in 52% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73).
  • Preterm birth in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (ARR, 0.58).
  • Small size for gestational age in 12.1% (buprenorphine) and 15.3% (methadone) (ARR, 0.72).
  • Low birth weight in 8.3% (buprenorphine) and 14.9% (methadone) (ARR, 0.56).
  • Delivery by cesarean section occurred in 33.6% of pregnant women exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (ARR, 1.02.).

Severe maternal complications developed in 3.3% of the women exposed to buprenorphine and 3.5% of those on methadone (ARR, 0.91.) Exposures in late pregnancy and early pregnancy yielded similar results, the authors say.

Dr. Michael Caucci

Michael Caucci, MD, of the department of psychiatry at Vanderbilt University Medical Center in Nashville, Tenn. who also runs the Women’s Mental Health Clinic at the university, said this paper supports preliminary findings from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study that suggested infants exposed to buprenorphine (compared with methadone) appeared to have lower rates of neonatal complications.

“It also supports buprenorphine as a relatively safe option for treatment of opioid use disorder during pregnancy,” said Dr. Caucci, who was not part of the study by Dr. Suarez and associates. “Reducing the fear of harming the fetus or neonate will help eliminate this barrier to perinatal substance use disorder treatment.”

But he cautions against concluding that, because buprenorphine has lower risks of fetal/neonatal complications, it is safer and therefore better than methadone in pregnancy. 

“Some women do not tolerate buprenorphine and do much better on methadone, Dr. Caucci said. “Current recommendations are that both buprenorphine and methadone are relatively safe options for treatment of OUD [opioid use disorder] in pregnancy.”

Among the differences between the treatments is that while methadone is administered daily during in-person visits to federally regulated opioid treatment programs, buprenorphine can be prescribed by approved providers, which allows patients to administer buprenorphine themselves.

Dr. Caucci said he was intrigued by the finding that there was no difference in pregnancy, neonatal, and maternal outcomes depending on the time of exposure to the agents.  

“I would have expected higher rates of neonatal abstinence syndrome (NAS) or poor fetal growth in those exposed later in pregnancy vs. those with early exposure,” he said. 

The work was supported by the National Institute on Drug Abuse. Dr. Caucci reports no relevant financial relationships. The authors’ disclosures are available with the full text.

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Using buprenorphine for opioid use disorder in pregnancy was linked with a lower risk of neonatal side effects than using methadone, but the risk of adverse maternal outcomes was similar between the two treatments, according to new research.

Elizabeth A. Suarez, PhD, MPH, with Brigham and Women’s Hospital in Boston, led the study published online in the New England Journal of Medicine.

Opioid use disorder in pregnant women has increased steadily in the United States since 2000, the authors write. As of 2017, about 8.2 per 1,000 deliveries were estimated to be affected by the disorder. The numbers were particularly high in people insured by Medicaid. In that group, an estimated 14.6 per 1,000 deliveries were affected.

Researchers studied pregnant women enrolled in public insurance programs in the United States from 2000 through 2018 in a dataset of 2,548,372 pregnancies that ended in live births. They analyzed outcomes in those who received buprenorphine as compared with those who received methadone.

They looked at different periods of exposure to the two medications: early pregnancy (through gestational week 19); late pregnancy (week 20 through the day before delivery); and the 30 days before delivery.

Highlighted differences in infants included:

  • Neonatal abstinence syndrome in 52% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73).
  • Preterm birth in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (ARR, 0.58).
  • Small size for gestational age in 12.1% (buprenorphine) and 15.3% (methadone) (ARR, 0.72).
  • Low birth weight in 8.3% (buprenorphine) and 14.9% (methadone) (ARR, 0.56).
  • Delivery by cesarean section occurred in 33.6% of pregnant women exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (ARR, 1.02.).

Severe maternal complications developed in 3.3% of the women exposed to buprenorphine and 3.5% of those on methadone (ARR, 0.91.) Exposures in late pregnancy and early pregnancy yielded similar results, the authors say.

Dr. Michael Caucci

Michael Caucci, MD, of the department of psychiatry at Vanderbilt University Medical Center in Nashville, Tenn. who also runs the Women’s Mental Health Clinic at the university, said this paper supports preliminary findings from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study that suggested infants exposed to buprenorphine (compared with methadone) appeared to have lower rates of neonatal complications.

“It also supports buprenorphine as a relatively safe option for treatment of opioid use disorder during pregnancy,” said Dr. Caucci, who was not part of the study by Dr. Suarez and associates. “Reducing the fear of harming the fetus or neonate will help eliminate this barrier to perinatal substance use disorder treatment.”

But he cautions against concluding that, because buprenorphine has lower risks of fetal/neonatal complications, it is safer and therefore better than methadone in pregnancy. 

“Some women do not tolerate buprenorphine and do much better on methadone, Dr. Caucci said. “Current recommendations are that both buprenorphine and methadone are relatively safe options for treatment of OUD [opioid use disorder] in pregnancy.”

Among the differences between the treatments is that while methadone is administered daily during in-person visits to federally regulated opioid treatment programs, buprenorphine can be prescribed by approved providers, which allows patients to administer buprenorphine themselves.

Dr. Caucci said he was intrigued by the finding that there was no difference in pregnancy, neonatal, and maternal outcomes depending on the time of exposure to the agents.  

“I would have expected higher rates of neonatal abstinence syndrome (NAS) or poor fetal growth in those exposed later in pregnancy vs. those with early exposure,” he said. 

The work was supported by the National Institute on Drug Abuse. Dr. Caucci reports no relevant financial relationships. The authors’ disclosures are available with the full text.

Using buprenorphine for opioid use disorder in pregnancy was linked with a lower risk of neonatal side effects than using methadone, but the risk of adverse maternal outcomes was similar between the two treatments, according to new research.

Elizabeth A. Suarez, PhD, MPH, with Brigham and Women’s Hospital in Boston, led the study published online in the New England Journal of Medicine.

Opioid use disorder in pregnant women has increased steadily in the United States since 2000, the authors write. As of 2017, about 8.2 per 1,000 deliveries were estimated to be affected by the disorder. The numbers were particularly high in people insured by Medicaid. In that group, an estimated 14.6 per 1,000 deliveries were affected.

Researchers studied pregnant women enrolled in public insurance programs in the United States from 2000 through 2018 in a dataset of 2,548,372 pregnancies that ended in live births. They analyzed outcomes in those who received buprenorphine as compared with those who received methadone.

They looked at different periods of exposure to the two medications: early pregnancy (through gestational week 19); late pregnancy (week 20 through the day before delivery); and the 30 days before delivery.

Highlighted differences in infants included:

  • Neonatal abstinence syndrome in 52% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73).
  • Preterm birth in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (ARR, 0.58).
  • Small size for gestational age in 12.1% (buprenorphine) and 15.3% (methadone) (ARR, 0.72).
  • Low birth weight in 8.3% (buprenorphine) and 14.9% (methadone) (ARR, 0.56).
  • Delivery by cesarean section occurred in 33.6% of pregnant women exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (ARR, 1.02.).

Severe maternal complications developed in 3.3% of the women exposed to buprenorphine and 3.5% of those on methadone (ARR, 0.91.) Exposures in late pregnancy and early pregnancy yielded similar results, the authors say.

Dr. Michael Caucci

Michael Caucci, MD, of the department of psychiatry at Vanderbilt University Medical Center in Nashville, Tenn. who also runs the Women’s Mental Health Clinic at the university, said this paper supports preliminary findings from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study that suggested infants exposed to buprenorphine (compared with methadone) appeared to have lower rates of neonatal complications.

“It also supports buprenorphine as a relatively safe option for treatment of opioid use disorder during pregnancy,” said Dr. Caucci, who was not part of the study by Dr. Suarez and associates. “Reducing the fear of harming the fetus or neonate will help eliminate this barrier to perinatal substance use disorder treatment.”

But he cautions against concluding that, because buprenorphine has lower risks of fetal/neonatal complications, it is safer and therefore better than methadone in pregnancy. 

“Some women do not tolerate buprenorphine and do much better on methadone, Dr. Caucci said. “Current recommendations are that both buprenorphine and methadone are relatively safe options for treatment of OUD [opioid use disorder] in pregnancy.”

Among the differences between the treatments is that while methadone is administered daily during in-person visits to federally regulated opioid treatment programs, buprenorphine can be prescribed by approved providers, which allows patients to administer buprenorphine themselves.

Dr. Caucci said he was intrigued by the finding that there was no difference in pregnancy, neonatal, and maternal outcomes depending on the time of exposure to the agents.  

“I would have expected higher rates of neonatal abstinence syndrome (NAS) or poor fetal growth in those exposed later in pregnancy vs. those with early exposure,” he said. 

The work was supported by the National Institute on Drug Abuse. Dr. Caucci reports no relevant financial relationships. The authors’ disclosures are available with the full text.

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FROM NEW ENGLAND JOURNAL OF MEDICINE

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Women need not wait to conceive after miscarriage, abortion

Article Type
Changed
Wed, 11/30/2022 - 09:49

Women who conceived within 6 months of having a miscarriage or an induced abortion did not appear to be at an increased risk of a problematic pregnancy, a new study of more than 70,000 live births in Norway has found.

The findings, published online in PLOS Medicine, should help women and clinicians navigate conflicting guidance over how soon it is safe to conceive again after a pregnancy loss, said Gizachew Tessema, PhD, senior research fellow at Curtin University, Perth, Australia, and the lead author of the research.

“Especially after a miscarriage, women want to conceive again,” Dr. Tessema told this news organization. “Why should they wait if there’s no increased risk?”

On the international front, the World Health Organization advises patients not to attempt to become pregnant until a minimum of 6 months after an abortion or miscarriage. Those 2007 recommendations spurred Dr. Tessema and his colleagues to take a deeper dive into risk factors associated with pregnancies following a shorter interval. 

Two-thirds of women in the study conceived again within 6 months of having a miscarriage. Only a quarter of women who had an induced abortion were pregnant again within that same timeframe.

Using Norway’s national health registries, the researchers examined the outcomes of 49,058 births following a miscarriage and 23,707 births after an induced abortion between 2008 and 2016. The birth registry includes information on livebirths, stillbirths, miscarriages, and induced abortions, with detailed descriptions provided around how a miscarriage or abortion is identified. The study included only miscarriages reported through the health care system.

Expanding on other studies that have shown no adverse outcomes with those pregnancy intervals, Dr. Tessema and colleagues found that women who became pregnant shortly after a miscarriage or abortion were not at a higher risk for delivering preterm, having newborns that were small for gestational age (SGA) or large for gestational age (LGA), or developing preeclampsia or gestational diabetes.

Dr. Tessema and his colleagues found a slightly smaller percentage of women who conceived within 3 months, compared with those who became pregnant within 6-11 months after a miscarriage (8.6% to 10.1%). Women who conceived within 3 months of an induced abortion had a slightly, but statistically nonsignificant (P = .07), increased risk for SGA, compared with those who conceived between 6 and 11 months (11.5% to 10%).

No greater risk was shown for the other adverse outcomes – preterm births, LGA, preeclampsia, and GDM – for women who became pregnant within 6 months of an abortion or miscarriage.

The results should reassure women who want to get pregnant again soon after abortions or miscarriage, according to Scott Sullivan, MD, the director of high-risk ob.gyn. at Inova Health, Fairfax, Va.

Often, patients hear conflicting advice from doctors, friends, or medical associations about the best time to try for a baby following a miscarriage or abortion, in part because there are differences in various guidelines. Adding to the confusion is a lack of robust research and data on pregnancy loss, especially in the United States, he said.

“The entire topic of pregnancy loss is underappreciated by the public at large – how painful this is for people, how common it is,” Dr. Sullivan said in an interview. “We need research and resources on it. It’s not even tracked routinely in the United States like it is in other countries.”

Dr. Sullivan said he typically tells patients they can try to get pregnant again right away, following recommendations from the American College of Obstetricians and Gynecologists, which say that patients can conceive as quickly as 2 weeks after an early pregnancy loss.

But he cautions that not all patients are mentally ready to make another attempt that soon, especially if they are still grieving their pregnancy loss.

“Even if you’re physically ready, a lot of people are not emotionally ready, because there’s a grieving process,” Dr. Sullivan said. “That’s very different for people.”
 

 

 

The WHO’s guidelines for developed countries

The WHO developed its guidelines based on research from lower income countries, including one study across Latin America that concluded pregnancy outcomes were worse for women who waited less than 6 months to conceive following an abortion or miscarriage.

Dr. Tessema noted his research is limited because it focused on Norway, a high-income country where women have guaranteed access to health care. Outcomes may be worse in developing countries where incomes are lower and health care inequality is greater, he said.

“The issue is when this international guideline was developed, most of the evidence is from low- and middle-income countries,” Dr. Tessema said. “No studies were conducted from high income cities. We said: ‘This is a different context.’ These recommendations may not be appropriate for this setting.”

The study was supported with funding by the Research Council of Norway through its Centres of Excellence funding program, the National Health and Medical Research Council, the Raine Medical Research Foundation, and the European Research Council under the European Union’s Horizon 2020 Research and Innovation Programme. None of the authors report relevant financial relationships.

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

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Women who conceived within 6 months of having a miscarriage or an induced abortion did not appear to be at an increased risk of a problematic pregnancy, a new study of more than 70,000 live births in Norway has found.

The findings, published online in PLOS Medicine, should help women and clinicians navigate conflicting guidance over how soon it is safe to conceive again after a pregnancy loss, said Gizachew Tessema, PhD, senior research fellow at Curtin University, Perth, Australia, and the lead author of the research.

“Especially after a miscarriage, women want to conceive again,” Dr. Tessema told this news organization. “Why should they wait if there’s no increased risk?”

On the international front, the World Health Organization advises patients not to attempt to become pregnant until a minimum of 6 months after an abortion or miscarriage. Those 2007 recommendations spurred Dr. Tessema and his colleagues to take a deeper dive into risk factors associated with pregnancies following a shorter interval. 

Two-thirds of women in the study conceived again within 6 months of having a miscarriage. Only a quarter of women who had an induced abortion were pregnant again within that same timeframe.

Using Norway’s national health registries, the researchers examined the outcomes of 49,058 births following a miscarriage and 23,707 births after an induced abortion between 2008 and 2016. The birth registry includes information on livebirths, stillbirths, miscarriages, and induced abortions, with detailed descriptions provided around how a miscarriage or abortion is identified. The study included only miscarriages reported through the health care system.

Expanding on other studies that have shown no adverse outcomes with those pregnancy intervals, Dr. Tessema and colleagues found that women who became pregnant shortly after a miscarriage or abortion were not at a higher risk for delivering preterm, having newborns that were small for gestational age (SGA) or large for gestational age (LGA), or developing preeclampsia or gestational diabetes.

Dr. Tessema and his colleagues found a slightly smaller percentage of women who conceived within 3 months, compared with those who became pregnant within 6-11 months after a miscarriage (8.6% to 10.1%). Women who conceived within 3 months of an induced abortion had a slightly, but statistically nonsignificant (P = .07), increased risk for SGA, compared with those who conceived between 6 and 11 months (11.5% to 10%).

No greater risk was shown for the other adverse outcomes – preterm births, LGA, preeclampsia, and GDM – for women who became pregnant within 6 months of an abortion or miscarriage.

The results should reassure women who want to get pregnant again soon after abortions or miscarriage, according to Scott Sullivan, MD, the director of high-risk ob.gyn. at Inova Health, Fairfax, Va.

Often, patients hear conflicting advice from doctors, friends, or medical associations about the best time to try for a baby following a miscarriage or abortion, in part because there are differences in various guidelines. Adding to the confusion is a lack of robust research and data on pregnancy loss, especially in the United States, he said.

“The entire topic of pregnancy loss is underappreciated by the public at large – how painful this is for people, how common it is,” Dr. Sullivan said in an interview. “We need research and resources on it. It’s not even tracked routinely in the United States like it is in other countries.”

Dr. Sullivan said he typically tells patients they can try to get pregnant again right away, following recommendations from the American College of Obstetricians and Gynecologists, which say that patients can conceive as quickly as 2 weeks after an early pregnancy loss.

But he cautions that not all patients are mentally ready to make another attempt that soon, especially if they are still grieving their pregnancy loss.

“Even if you’re physically ready, a lot of people are not emotionally ready, because there’s a grieving process,” Dr. Sullivan said. “That’s very different for people.”
 

 

 

The WHO’s guidelines for developed countries

The WHO developed its guidelines based on research from lower income countries, including one study across Latin America that concluded pregnancy outcomes were worse for women who waited less than 6 months to conceive following an abortion or miscarriage.

Dr. Tessema noted his research is limited because it focused on Norway, a high-income country where women have guaranteed access to health care. Outcomes may be worse in developing countries where incomes are lower and health care inequality is greater, he said.

“The issue is when this international guideline was developed, most of the evidence is from low- and middle-income countries,” Dr. Tessema said. “No studies were conducted from high income cities. We said: ‘This is a different context.’ These recommendations may not be appropriate for this setting.”

The study was supported with funding by the Research Council of Norway through its Centres of Excellence funding program, the National Health and Medical Research Council, the Raine Medical Research Foundation, and the European Research Council under the European Union’s Horizon 2020 Research and Innovation Programme. None of the authors report relevant financial relationships.

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

Women who conceived within 6 months of having a miscarriage or an induced abortion did not appear to be at an increased risk of a problematic pregnancy, a new study of more than 70,000 live births in Norway has found.

The findings, published online in PLOS Medicine, should help women and clinicians navigate conflicting guidance over how soon it is safe to conceive again after a pregnancy loss, said Gizachew Tessema, PhD, senior research fellow at Curtin University, Perth, Australia, and the lead author of the research.

“Especially after a miscarriage, women want to conceive again,” Dr. Tessema told this news organization. “Why should they wait if there’s no increased risk?”

On the international front, the World Health Organization advises patients not to attempt to become pregnant until a minimum of 6 months after an abortion or miscarriage. Those 2007 recommendations spurred Dr. Tessema and his colleagues to take a deeper dive into risk factors associated with pregnancies following a shorter interval. 

Two-thirds of women in the study conceived again within 6 months of having a miscarriage. Only a quarter of women who had an induced abortion were pregnant again within that same timeframe.

Using Norway’s national health registries, the researchers examined the outcomes of 49,058 births following a miscarriage and 23,707 births after an induced abortion between 2008 and 2016. The birth registry includes information on livebirths, stillbirths, miscarriages, and induced abortions, with detailed descriptions provided around how a miscarriage or abortion is identified. The study included only miscarriages reported through the health care system.

Expanding on other studies that have shown no adverse outcomes with those pregnancy intervals, Dr. Tessema and colleagues found that women who became pregnant shortly after a miscarriage or abortion were not at a higher risk for delivering preterm, having newborns that were small for gestational age (SGA) or large for gestational age (LGA), or developing preeclampsia or gestational diabetes.

Dr. Tessema and his colleagues found a slightly smaller percentage of women who conceived within 3 months, compared with those who became pregnant within 6-11 months after a miscarriage (8.6% to 10.1%). Women who conceived within 3 months of an induced abortion had a slightly, but statistically nonsignificant (P = .07), increased risk for SGA, compared with those who conceived between 6 and 11 months (11.5% to 10%).

No greater risk was shown for the other adverse outcomes – preterm births, LGA, preeclampsia, and GDM – for women who became pregnant within 6 months of an abortion or miscarriage.

The results should reassure women who want to get pregnant again soon after abortions or miscarriage, according to Scott Sullivan, MD, the director of high-risk ob.gyn. at Inova Health, Fairfax, Va.

Often, patients hear conflicting advice from doctors, friends, or medical associations about the best time to try for a baby following a miscarriage or abortion, in part because there are differences in various guidelines. Adding to the confusion is a lack of robust research and data on pregnancy loss, especially in the United States, he said.

“The entire topic of pregnancy loss is underappreciated by the public at large – how painful this is for people, how common it is,” Dr. Sullivan said in an interview. “We need research and resources on it. It’s not even tracked routinely in the United States like it is in other countries.”

Dr. Sullivan said he typically tells patients they can try to get pregnant again right away, following recommendations from the American College of Obstetricians and Gynecologists, which say that patients can conceive as quickly as 2 weeks after an early pregnancy loss.

But he cautions that not all patients are mentally ready to make another attempt that soon, especially if they are still grieving their pregnancy loss.

“Even if you’re physically ready, a lot of people are not emotionally ready, because there’s a grieving process,” Dr. Sullivan said. “That’s very different for people.”
 

 

 

The WHO’s guidelines for developed countries

The WHO developed its guidelines based on research from lower income countries, including one study across Latin America that concluded pregnancy outcomes were worse for women who waited less than 6 months to conceive following an abortion or miscarriage.

Dr. Tessema noted his research is limited because it focused on Norway, a high-income country where women have guaranteed access to health care. Outcomes may be worse in developing countries where incomes are lower and health care inequality is greater, he said.

“The issue is when this international guideline was developed, most of the evidence is from low- and middle-income countries,” Dr. Tessema said. “No studies were conducted from high income cities. We said: ‘This is a different context.’ These recommendations may not be appropriate for this setting.”

The study was supported with funding by the Research Council of Norway through its Centres of Excellence funding program, the National Health and Medical Research Council, the Raine Medical Research Foundation, and the European Research Council under the European Union’s Horizon 2020 Research and Innovation Programme. None of the authors report relevant financial relationships.

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

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More work needed to optimize STI screening in primary care settings

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Changed
Tue, 11/29/2022 - 14:18

– Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

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

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– Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

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

– Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

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

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Transgender patients on hormone therapy require monitoring

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Tue, 11/29/2022 - 11:02

– Transgender patients on hormone therapy have an increased mortality risk and so must be closely monitored, especially in terms of cardiovascular health and oncology, reported Marie D’Assigny, MD, of the department of endocrinology, diabetes, and dietetics at Poitiers (France) University Hospital, at the Infogyn 2022 conference. Because transgender women (those assigned male at birth who have assumed a female gender identity) are at risk of breast cancer, they should also be recommended for breast cancer screening.

Transgender men and women, especially transgender women, “should be deemed high-risk cardiovascular patients, or even very high risk in some cases,” said Dr. D’Assigny. This means that they should be considered candidates for cholesterol-lowering medication earlier than their cisgender counterparts, and a target LDL cholesterol of less than 0.70 g/L (70 mg/dL) should be sought. Likewise, blood pressure must be strictly monitored, especially because it tends to rise when on hormone therapy.

Feminizing hormone therapy requires chemical castration with the use of anti-androgen drugs to achieve a blood testosterone level less than 0.5 ng/mL (1.73 nmol/L). Low-dose cyproterone acetate (< 25 to 50 mg/day) is usually used. Treatment is stopped if a patient undergoes an orchidectomy. For feminizing hormone therapy, administration of 17beta-estradiol transcutaneously (patch or gel) is recommended, because it is associated with a lower risk of thromboembolism than oral administration.

Masculinizing hormone therapy is based on administration of progestogens, then testosterone in the form of an injection (mostly testosterone enanthate via intramuscular injection every 10 days) or percutaneously (gel or patch). There are few contraindications, and treatment is generally well tolerated.
 

High mortality rate

A recent retrospective study highlighted the mortality and risk factors for death in transgender men and women receiving hormone therapy. More than 4,500 people, mostly male to female transgender women, were enrolled in this study, which was conducted over a 47-year period (1972-2018) at a specialist clinic at Amsterdam UMC.

Over the course of the study, the mortality rate in transgender men and women was twice that of the general population. The death rate was 10.8% in transgender women vs. 2.7% in transgender men, after a follow-up of 40,232 person-years and 17,285 person-years, respectively. In transgender women, mortality was nearly three times that of cisgender women in the general population.

Over the nearly 5 decades of study, there was no improvement in the mortality rate, even over the last 10 years when transgender issues started to be more recognized. The mortality trends are markedly distinct over the years from those observed in the cisgender population, and this is especially true for transgender women compared to transgender men. “Much is still to be done,” said Dr. D’Assigny.

According to the study, cause-specific mortality in transgender women was high for cardiovascular disease and lung cancer, possibly because of a higher smoking rate in this population. HIV-related disease and suicide remained very high in both transgender men and women.

People with gender dysphoria who do not receive treatment for gender reassignment have a suicide rate of 40%, reported François-Xavier Madec, MD, of Foch Hospital in Suresnes, France, at a previous presentation. For transgender men and women who receive care, this rate is lowered to 15%, which is still significantly higher than the rate of 1.6% observed in the general population.

“These causes of death don’t give any indication as to a specific effect of hormone treatment but show that monitoring and, if necessary, treatment of comorbidities and lifestyle-related factors are important in managing transgender patients,” said the study authors.

“Strengthening social acceptance and treating cardiovascular risk factors could also help to reduce mortality in transgender men and women,” they added.
 

 

 

Screening for osteoporosis

In addition to receiving cardiovascular risk factor assessment and monitoring, transgender men and women on hormone therapy should also undergo bone density testing “when risk factors for osteoporosis are present, especially in patients stopping hormone therapy after a gonadectomy,” said Dr. D’Assigny.

Calcium and vitamin D supplements are also recommended for all patients after a gonadectomy, especially in transgender men on testosterone. Osteoporosis screening is recommended for transgender men 10 years after starting treatment with testosterone, then every 10 years.

There is also the risk for breast cancer in transgender women, although the risk is lower than in cisgender women. This risk was highlighted in another study of more than 2,260 transgender women that was carried out by a team at Amsterdam UMC.

A total of 18 cases of breast cancer (15 invasive) were diagnosed after a median 18 years of hormone treatment. This represents an incidence of breast cancer that is 46 times higher than that expected in cisgender men of the same age but 3 times lower than in cisgender women.

The authors noted that “the risk of breast cancer in transgender women increases during a relatively short duration of hormone treatment,” going on to say that “these results suggest that breast cancer screening recommendations are relevant for transgender men and women on hormone therapy.”
 

Poorly attended screening

All of this means that transgender women older than age 50 years, as well as transgender men who have not had a mastectomy, should be offered a mammogram screening, taking into account the possible presence of implants in the former. Transgender women are also at risk for prostate cancer. Monitoring is personalized according to the individual risk of prostate disease, as it is for cisgender men.

There is no consensus on the monitoring of transgender men on hormone therapy for uterine cancer. Yet there is a risk. “Testosterone causes thinning of the endometrium, which may lead to dysplasia,” said Dr. D’Assigny. A physical examination once a year or a pelvic ultrasound scan every 2 years should form the basis of endometrial and ovarian appearance monitoring.

Transgender women are also at risk for prostate cancer. However, they are less likely to attend a prostate cancer screening test, said Dr. D’Assigny, which means “we need to raise awareness of their benefit in advance.” Vaginal swabs for transgender men and mammograms in transgender women “are resented, on both a physical and emotional level.” As a result, delays in diagnosis are common in transgender men and women.

Globally, access to care is still difficult for transgender patients because they don’t always receive appropriate gynecological monitoring, through fear of judgment or discrimination. Many transgender men and women are reluctant to see a gynecologist, even though they are at risk of gynecological cancers, as well as unwanted pregnancies in transgender men who have not undergone a hysterectomy.

In a demonstration of the collective desire to improve patient care for the transgender community, a literature review was recently published by a French team that analyzed gynecological monitoring methods in transgender patients. In September, the French National Authority for Health also issued a guidance memorandum on the transgender transition pathway, pending new recommendations scheduled for 2023.

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

This article was translated from the Medscape French edition.

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– Transgender patients on hormone therapy have an increased mortality risk and so must be closely monitored, especially in terms of cardiovascular health and oncology, reported Marie D’Assigny, MD, of the department of endocrinology, diabetes, and dietetics at Poitiers (France) University Hospital, at the Infogyn 2022 conference. Because transgender women (those assigned male at birth who have assumed a female gender identity) are at risk of breast cancer, they should also be recommended for breast cancer screening.

Transgender men and women, especially transgender women, “should be deemed high-risk cardiovascular patients, or even very high risk in some cases,” said Dr. D’Assigny. This means that they should be considered candidates for cholesterol-lowering medication earlier than their cisgender counterparts, and a target LDL cholesterol of less than 0.70 g/L (70 mg/dL) should be sought. Likewise, blood pressure must be strictly monitored, especially because it tends to rise when on hormone therapy.

Feminizing hormone therapy requires chemical castration with the use of anti-androgen drugs to achieve a blood testosterone level less than 0.5 ng/mL (1.73 nmol/L). Low-dose cyproterone acetate (< 25 to 50 mg/day) is usually used. Treatment is stopped if a patient undergoes an orchidectomy. For feminizing hormone therapy, administration of 17beta-estradiol transcutaneously (patch or gel) is recommended, because it is associated with a lower risk of thromboembolism than oral administration.

Masculinizing hormone therapy is based on administration of progestogens, then testosterone in the form of an injection (mostly testosterone enanthate via intramuscular injection every 10 days) or percutaneously (gel or patch). There are few contraindications, and treatment is generally well tolerated.
 

High mortality rate

A recent retrospective study highlighted the mortality and risk factors for death in transgender men and women receiving hormone therapy. More than 4,500 people, mostly male to female transgender women, were enrolled in this study, which was conducted over a 47-year period (1972-2018) at a specialist clinic at Amsterdam UMC.

Over the course of the study, the mortality rate in transgender men and women was twice that of the general population. The death rate was 10.8% in transgender women vs. 2.7% in transgender men, after a follow-up of 40,232 person-years and 17,285 person-years, respectively. In transgender women, mortality was nearly three times that of cisgender women in the general population.

Over the nearly 5 decades of study, there was no improvement in the mortality rate, even over the last 10 years when transgender issues started to be more recognized. The mortality trends are markedly distinct over the years from those observed in the cisgender population, and this is especially true for transgender women compared to transgender men. “Much is still to be done,” said Dr. D’Assigny.

According to the study, cause-specific mortality in transgender women was high for cardiovascular disease and lung cancer, possibly because of a higher smoking rate in this population. HIV-related disease and suicide remained very high in both transgender men and women.

People with gender dysphoria who do not receive treatment for gender reassignment have a suicide rate of 40%, reported François-Xavier Madec, MD, of Foch Hospital in Suresnes, France, at a previous presentation. For transgender men and women who receive care, this rate is lowered to 15%, which is still significantly higher than the rate of 1.6% observed in the general population.

“These causes of death don’t give any indication as to a specific effect of hormone treatment but show that monitoring and, if necessary, treatment of comorbidities and lifestyle-related factors are important in managing transgender patients,” said the study authors.

“Strengthening social acceptance and treating cardiovascular risk factors could also help to reduce mortality in transgender men and women,” they added.
 

 

 

Screening for osteoporosis

In addition to receiving cardiovascular risk factor assessment and monitoring, transgender men and women on hormone therapy should also undergo bone density testing “when risk factors for osteoporosis are present, especially in patients stopping hormone therapy after a gonadectomy,” said Dr. D’Assigny.

Calcium and vitamin D supplements are also recommended for all patients after a gonadectomy, especially in transgender men on testosterone. Osteoporosis screening is recommended for transgender men 10 years after starting treatment with testosterone, then every 10 years.

There is also the risk for breast cancer in transgender women, although the risk is lower than in cisgender women. This risk was highlighted in another study of more than 2,260 transgender women that was carried out by a team at Amsterdam UMC.

A total of 18 cases of breast cancer (15 invasive) were diagnosed after a median 18 years of hormone treatment. This represents an incidence of breast cancer that is 46 times higher than that expected in cisgender men of the same age but 3 times lower than in cisgender women.

The authors noted that “the risk of breast cancer in transgender women increases during a relatively short duration of hormone treatment,” going on to say that “these results suggest that breast cancer screening recommendations are relevant for transgender men and women on hormone therapy.”
 

Poorly attended screening

All of this means that transgender women older than age 50 years, as well as transgender men who have not had a mastectomy, should be offered a mammogram screening, taking into account the possible presence of implants in the former. Transgender women are also at risk for prostate cancer. Monitoring is personalized according to the individual risk of prostate disease, as it is for cisgender men.

There is no consensus on the monitoring of transgender men on hormone therapy for uterine cancer. Yet there is a risk. “Testosterone causes thinning of the endometrium, which may lead to dysplasia,” said Dr. D’Assigny. A physical examination once a year or a pelvic ultrasound scan every 2 years should form the basis of endometrial and ovarian appearance monitoring.

Transgender women are also at risk for prostate cancer. However, they are less likely to attend a prostate cancer screening test, said Dr. D’Assigny, which means “we need to raise awareness of their benefit in advance.” Vaginal swabs for transgender men and mammograms in transgender women “are resented, on both a physical and emotional level.” As a result, delays in diagnosis are common in transgender men and women.

Globally, access to care is still difficult for transgender patients because they don’t always receive appropriate gynecological monitoring, through fear of judgment or discrimination. Many transgender men and women are reluctant to see a gynecologist, even though they are at risk of gynecological cancers, as well as unwanted pregnancies in transgender men who have not undergone a hysterectomy.

In a demonstration of the collective desire to improve patient care for the transgender community, a literature review was recently published by a French team that analyzed gynecological monitoring methods in transgender patients. In September, the French National Authority for Health also issued a guidance memorandum on the transgender transition pathway, pending new recommendations scheduled for 2023.

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

This article was translated from the Medscape French edition.

– Transgender patients on hormone therapy have an increased mortality risk and so must be closely monitored, especially in terms of cardiovascular health and oncology, reported Marie D’Assigny, MD, of the department of endocrinology, diabetes, and dietetics at Poitiers (France) University Hospital, at the Infogyn 2022 conference. Because transgender women (those assigned male at birth who have assumed a female gender identity) are at risk of breast cancer, they should also be recommended for breast cancer screening.

Transgender men and women, especially transgender women, “should be deemed high-risk cardiovascular patients, or even very high risk in some cases,” said Dr. D’Assigny. This means that they should be considered candidates for cholesterol-lowering medication earlier than their cisgender counterparts, and a target LDL cholesterol of less than 0.70 g/L (70 mg/dL) should be sought. Likewise, blood pressure must be strictly monitored, especially because it tends to rise when on hormone therapy.

Feminizing hormone therapy requires chemical castration with the use of anti-androgen drugs to achieve a blood testosterone level less than 0.5 ng/mL (1.73 nmol/L). Low-dose cyproterone acetate (< 25 to 50 mg/day) is usually used. Treatment is stopped if a patient undergoes an orchidectomy. For feminizing hormone therapy, administration of 17beta-estradiol transcutaneously (patch or gel) is recommended, because it is associated with a lower risk of thromboembolism than oral administration.

Masculinizing hormone therapy is based on administration of progestogens, then testosterone in the form of an injection (mostly testosterone enanthate via intramuscular injection every 10 days) or percutaneously (gel or patch). There are few contraindications, and treatment is generally well tolerated.
 

High mortality rate

A recent retrospective study highlighted the mortality and risk factors for death in transgender men and women receiving hormone therapy. More than 4,500 people, mostly male to female transgender women, were enrolled in this study, which was conducted over a 47-year period (1972-2018) at a specialist clinic at Amsterdam UMC.

Over the course of the study, the mortality rate in transgender men and women was twice that of the general population. The death rate was 10.8% in transgender women vs. 2.7% in transgender men, after a follow-up of 40,232 person-years and 17,285 person-years, respectively. In transgender women, mortality was nearly three times that of cisgender women in the general population.

Over the nearly 5 decades of study, there was no improvement in the mortality rate, even over the last 10 years when transgender issues started to be more recognized. The mortality trends are markedly distinct over the years from those observed in the cisgender population, and this is especially true for transgender women compared to transgender men. “Much is still to be done,” said Dr. D’Assigny.

According to the study, cause-specific mortality in transgender women was high for cardiovascular disease and lung cancer, possibly because of a higher smoking rate in this population. HIV-related disease and suicide remained very high in both transgender men and women.

People with gender dysphoria who do not receive treatment for gender reassignment have a suicide rate of 40%, reported François-Xavier Madec, MD, of Foch Hospital in Suresnes, France, at a previous presentation. For transgender men and women who receive care, this rate is lowered to 15%, which is still significantly higher than the rate of 1.6% observed in the general population.

“These causes of death don’t give any indication as to a specific effect of hormone treatment but show that monitoring and, if necessary, treatment of comorbidities and lifestyle-related factors are important in managing transgender patients,” said the study authors.

“Strengthening social acceptance and treating cardiovascular risk factors could also help to reduce mortality in transgender men and women,” they added.
 

 

 

Screening for osteoporosis

In addition to receiving cardiovascular risk factor assessment and monitoring, transgender men and women on hormone therapy should also undergo bone density testing “when risk factors for osteoporosis are present, especially in patients stopping hormone therapy after a gonadectomy,” said Dr. D’Assigny.

Calcium and vitamin D supplements are also recommended for all patients after a gonadectomy, especially in transgender men on testosterone. Osteoporosis screening is recommended for transgender men 10 years after starting treatment with testosterone, then every 10 years.

There is also the risk for breast cancer in transgender women, although the risk is lower than in cisgender women. This risk was highlighted in another study of more than 2,260 transgender women that was carried out by a team at Amsterdam UMC.

A total of 18 cases of breast cancer (15 invasive) were diagnosed after a median 18 years of hormone treatment. This represents an incidence of breast cancer that is 46 times higher than that expected in cisgender men of the same age but 3 times lower than in cisgender women.

The authors noted that “the risk of breast cancer in transgender women increases during a relatively short duration of hormone treatment,” going on to say that “these results suggest that breast cancer screening recommendations are relevant for transgender men and women on hormone therapy.”
 

Poorly attended screening

All of this means that transgender women older than age 50 years, as well as transgender men who have not had a mastectomy, should be offered a mammogram screening, taking into account the possible presence of implants in the former. Transgender women are also at risk for prostate cancer. Monitoring is personalized according to the individual risk of prostate disease, as it is for cisgender men.

There is no consensus on the monitoring of transgender men on hormone therapy for uterine cancer. Yet there is a risk. “Testosterone causes thinning of the endometrium, which may lead to dysplasia,” said Dr. D’Assigny. A physical examination once a year or a pelvic ultrasound scan every 2 years should form the basis of endometrial and ovarian appearance monitoring.

Transgender women are also at risk for prostate cancer. However, they are less likely to attend a prostate cancer screening test, said Dr. D’Assigny, which means “we need to raise awareness of their benefit in advance.” Vaginal swabs for transgender men and mammograms in transgender women “are resented, on both a physical and emotional level.” As a result, delays in diagnosis are common in transgender men and women.

Globally, access to care is still difficult for transgender patients because they don’t always receive appropriate gynecological monitoring, through fear of judgment or discrimination. Many transgender men and women are reluctant to see a gynecologist, even though they are at risk of gynecological cancers, as well as unwanted pregnancies in transgender men who have not undergone a hysterectomy.

In a demonstration of the collective desire to improve patient care for the transgender community, a literature review was recently published by a French team that analyzed gynecological monitoring methods in transgender patients. In September, the French National Authority for Health also issued a guidance memorandum on the transgender transition pathway, pending new recommendations scheduled for 2023.

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

This article was translated from the Medscape French edition.

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