Men's Health

This transcript has been edited for clarity.

Incredibly, 25 years ago, Bob Dole, a senator from Kansas at the time and former presidential candidate, went on national television in a commercial and discussed the fact that he was sexually impotent. You might be thinking, “What was happening then? Was this an early Jerry Springer experience or reality TV gone haywire?” No. Viagra was approved as a treatment 25 years ago this year.

Bob Dole was recruited by Pfizer, the manufacturer of Viagra, to do commercials in which he discussed his sexual dysfunction. He was recruited for a very specific set of reasons. First, he was a distinguished, prominent, respected national figure. Second, he was conservative.

For those of you who don’t remember, when 25 years ago Viagra first appeared, Pfizer was terrified that they would get attacked for promoting promiscuity by introducing a sex pill onto the market. Bob Dole was basically saying, “I have a medical problem. It’s tough to talk about, but there is a treatment. I’m going to discuss the fact that I, among many other men, could use this to help that problem.”

He was used in a way to deflect conservative or religious critics worried about the promotion of sex outside of marriage. Bob Dole was also well known to be married to Elizabeth Dole. This wasn’t somebody who was out on the dating market. Bob Dole was a family man, and his selection was no accident. For all these reasons, Bob Dole was the first spokesperson for Viagra.

Now, as it happens, I had a role to play with this drug. Pfizer called me up and asked me to come and do a consult with them about the ethics of this brand-new treatment. I had never been asked by a drug company to do anything like this. I didn’t know what I was doing. I thought about it and said: “I’ll do it if you let me sit in on discussions and meetings at your New York headquarters about this drug. I want open access.”

I assume they gave me open access. I went to many meetings before the Food and Drug Administration approved Viagra, and many discussions took place about how to roll it out. Once I got there, the one thing I insisted upon was that they had to be treating a disease. If they didn’t want to get involved in criticisms about this new miracle solution to the age-old problem of sexual dysfunction, impotence wouldn’t do. It wasn’t a medical diagnosis, and it was kind of a very undefined situation.

Erectile dysfunction was the answer. They met with urologists, sex experts, and individuals within the company and came up with the idea that if you were unable to have an erection after trying for 6 months or more, you suffered from erectile dysfunction, and that was the group for whom they should market Viagra. I fully agreed with that.

What happened was that probably hundreds of millions of men worldwide came forward for the first time and said, “I’m ashamed and guilty. I feel stigmatized. Now, with something that might help me, I’m going to say to my doctor, I have this problem.”

It’s a very important lesson because 25 years later, it’s still difficult for people – men and women – to discuss sexual problems, sexual dysfunction, and unhappiness with their sex life. I know we’ve gotten better at asking about this, but it’s still difficult for patients to go into it, bring it up, and talk about it. It’s something that we have to think hard about how we bring forward, honest, frank conversation and make people comfortable so they can tell us.

One thing that Viagra proved to the world is that not only is there a large amount of sexual dysfunction – some numbers as high as 35% of men over age 65 – but that sexual dysfunction is related to diseases. It’s caused by hypertension, hardening of the arteries, and diabetes. It may be caused by psychological anxiety or even just a poor relationship where things are falling apart.

I think it’s important that, when Viagra first appeared, what Pfizer tried to do and with the marketing oriented around it was treating it as a disease, trying to treat erectile dysfunction as a symptom, and then trying to explore the underlying possible causes for that symptom.

Sadly, if we look today, we have come a long way – and not always a good way – from where Viagra started. Viagra is easily available online. Many companies say, just get online and a doctor will talk with you about a prescription. They do, but they don’t explore the underlying causes anymore online of what might be causing the erectile dysfunction. They certainly may have a checkbox and ask somebody about this or that, but I’ve gone and tested the sites, and you can get a prescription in about 30 seconds.

It’s not really gone with the old medical model that accompanied the appearance of Viagra. We now treat it as a recreational drug or an aphrodisiac, none of which is true. If your body is working properly, blood will flow where it’s going to go. Taking Viagra or any of the other treatments will not help improve that or enhance that.

The other problem I see today with where we are with these impotence and erectile dysfunction drugs is that we still have not developed a full array of interventions for women. It’s true that men have Viagra, and it’s true that that’s often reimbursed. We still have women complaining that they have sexual dysfunction or loss of interest or whatever the problem might be, and we haven’t been able to develop drugs that will help them.

Since Viagra’s approval 25 years ago until the patent ran out in 2019, $40 billion worth of the drug has been sold. Its advertising has shifted so that it’s now online and available almost on demand. I’m not sure that path has been good, but it is a reminder to us, in this 25th anniversary year, that people care about sexuality.

Doctors always need to be thinking about exploring that and trying to get a vision or a view of the health of their patients. It’s still hard for many people to speak up and say if they’re having problems in bed, and we want to make sure that we try our best to make that happen.

Overall, I think the approval of Viagra 25 years ago was a very good thing. It brought a terrible problem out into the open. It helped enhance the quality of life for many men. Despite where we are today, I think the introduction of that pill was actually a major achievement in pharmacology.

Dr. Kaplan is director, division of medical ethics, New York University Langone Medical Center, New York. He reported conflicts of interest with Johnson & Johnson, Medscape, and Pfizer.


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

This transcript has been edited for clarity.

Incredibly, 25 years ago, Bob Dole, a senator from Kansas at the time and former presidential candidate, went on national television in a commercial and discussed the fact that he was sexually impotent. You might be thinking, “What was happening then? Was this an early Jerry Springer experience or reality TV gone haywire?” No. Viagra was approved as a treatment 25 years ago this year.

Bob Dole was recruited by Pfizer, the manufacturer of Viagra, to do commercials in which he discussed his sexual dysfunction. He was recruited for a very specific set of reasons. First, he was a distinguished, prominent, respected national figure. Second, he was conservative.

For those of you who don’t remember, when 25 years ago Viagra first appeared, Pfizer was terrified that they would get attacked for promoting promiscuity by introducing a sex pill onto the market. Bob Dole was basically saying, “I have a medical problem. It’s tough to talk about, but there is a treatment. I’m going to discuss the fact that I, among many other men, could use this to help that problem.”

He was used in a way to deflect conservative or religious critics worried about the promotion of sex outside of marriage. Bob Dole was also well known to be married to Elizabeth Dole. This wasn’t somebody who was out on the dating market. Bob Dole was a family man, and his selection was no accident. For all these reasons, Bob Dole was the first spokesperson for Viagra.

Now, as it happens, I had a role to play with this drug. Pfizer called me up and asked me to come and do a consult with them about the ethics of this brand-new treatment. I had never been asked by a drug company to do anything like this. I didn’t know what I was doing. I thought about it and said: “I’ll do it if you let me sit in on discussions and meetings at your New York headquarters about this drug. I want open access.”

I assume they gave me open access. I went to many meetings before the Food and Drug Administration approved Viagra, and many discussions took place about how to roll it out. Once I got there, the one thing I insisted upon was that they had to be treating a disease. If they didn’t want to get involved in criticisms about this new miracle solution to the age-old problem of sexual dysfunction, impotence wouldn’t do. It wasn’t a medical diagnosis, and it was kind of a very undefined situation.

Erectile dysfunction was the answer. They met with urologists, sex experts, and individuals within the company and came up with the idea that if you were unable to have an erection after trying for 6 months or more, you suffered from erectile dysfunction, and that was the group for whom they should market Viagra. I fully agreed with that.

What happened was that probably hundreds of millions of men worldwide came forward for the first time and said, “I’m ashamed and guilty. I feel stigmatized. Now, with something that might help me, I’m going to say to my doctor, I have this problem.”

It’s a very important lesson because 25 years later, it’s still difficult for people – men and women – to discuss sexual problems, sexual dysfunction, and unhappiness with their sex life. I know we’ve gotten better at asking about this, but it’s still difficult for patients to go into it, bring it up, and talk about it. It’s something that we have to think hard about how we bring forward, honest, frank conversation and make people comfortable so they can tell us.

One thing that Viagra proved to the world is that not only is there a large amount of sexual dysfunction – some numbers as high as 35% of men over age 65 – but that sexual dysfunction is related to diseases. It’s caused by hypertension, hardening of the arteries, and diabetes. It may be caused by psychological anxiety or even just a poor relationship where things are falling apart.

I think it’s important that, when Viagra first appeared, what Pfizer tried to do and with the marketing oriented around it was treating it as a disease, trying to treat erectile dysfunction as a symptom, and then trying to explore the underlying possible causes for that symptom.

Sadly, if we look today, we have come a long way – and not always a good way – from where Viagra started. Viagra is easily available online. Many companies say, just get online and a doctor will talk with you about a prescription. They do, but they don’t explore the underlying causes anymore online of what might be causing the erectile dysfunction. They certainly may have a checkbox and ask somebody about this or that, but I’ve gone and tested the sites, and you can get a prescription in about 30 seconds.

It’s not really gone with the old medical model that accompanied the appearance of Viagra. We now treat it as a recreational drug or an aphrodisiac, none of which is true. If your body is working properly, blood will flow where it’s going to go. Taking Viagra or any of the other treatments will not help improve that or enhance that.

The other problem I see today with where we are with these impotence and erectile dysfunction drugs is that we still have not developed a full array of interventions for women. It’s true that men have Viagra, and it’s true that that’s often reimbursed. We still have women complaining that they have sexual dysfunction or loss of interest or whatever the problem might be, and we haven’t been able to develop drugs that will help them.

Since Viagra’s approval 25 years ago until the patent ran out in 2019, $40 billion worth of the drug has been sold. Its advertising has shifted so that it’s now online and available almost on demand. I’m not sure that path has been good, but it is a reminder to us, in this 25th anniversary year, that people care about sexuality.

Doctors always need to be thinking about exploring that and trying to get a vision or a view of the health of their patients. It’s still hard for many people to speak up and say if they’re having problems in bed, and we want to make sure that we try our best to make that happen.

Overall, I think the approval of Viagra 25 years ago was a very good thing. It brought a terrible problem out into the open. It helped enhance the quality of life for many men. Despite where we are today, I think the introduction of that pill was actually a major achievement in pharmacology.

Dr. Kaplan is director, division of medical ethics, New York University Langone Medical Center, New York. He reported conflicts of interest with Johnson & Johnson, Medscape, and Pfizer.


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

This transcript has been edited for clarity.

Incredibly, 25 years ago, Bob Dole, a senator from Kansas at the time and former presidential candidate, went on national television in a commercial and discussed the fact that he was sexually impotent. You might be thinking, “What was happening then? Was this an early Jerry Springer experience or reality TV gone haywire?” No. Viagra was approved as a treatment 25 years ago this year.

Bob Dole was recruited by Pfizer, the manufacturer of Viagra, to do commercials in which he discussed his sexual dysfunction. He was recruited for a very specific set of reasons. First, he was a distinguished, prominent, respected national figure. Second, he was conservative.

For those of you who don’t remember, when 25 years ago Viagra first appeared, Pfizer was terrified that they would get attacked for promoting promiscuity by introducing a sex pill onto the market. Bob Dole was basically saying, “I have a medical problem. It’s tough to talk about, but there is a treatment. I’m going to discuss the fact that I, among many other men, could use this to help that problem.”

He was used in a way to deflect conservative or religious critics worried about the promotion of sex outside of marriage. Bob Dole was also well known to be married to Elizabeth Dole. This wasn’t somebody who was out on the dating market. Bob Dole was a family man, and his selection was no accident. For all these reasons, Bob Dole was the first spokesperson for Viagra.

Now, as it happens, I had a role to play with this drug. Pfizer called me up and asked me to come and do a consult with them about the ethics of this brand-new treatment. I had never been asked by a drug company to do anything like this. I didn’t know what I was doing. I thought about it and said: “I’ll do it if you let me sit in on discussions and meetings at your New York headquarters about this drug. I want open access.”

I assume they gave me open access. I went to many meetings before the Food and Drug Administration approved Viagra, and many discussions took place about how to roll it out. Once I got there, the one thing I insisted upon was that they had to be treating a disease. If they didn’t want to get involved in criticisms about this new miracle solution to the age-old problem of sexual dysfunction, impotence wouldn’t do. It wasn’t a medical diagnosis, and it was kind of a very undefined situation.

Erectile dysfunction was the answer. They met with urologists, sex experts, and individuals within the company and came up with the idea that if you were unable to have an erection after trying for 6 months or more, you suffered from erectile dysfunction, and that was the group for whom they should market Viagra. I fully agreed with that.

What happened was that probably hundreds of millions of men worldwide came forward for the first time and said, “I’m ashamed and guilty. I feel stigmatized. Now, with something that might help me, I’m going to say to my doctor, I have this problem.”

It’s a very important lesson because 25 years later, it’s still difficult for people – men and women – to discuss sexual problems, sexual dysfunction, and unhappiness with their sex life. I know we’ve gotten better at asking about this, but it’s still difficult for patients to go into it, bring it up, and talk about it. It’s something that we have to think hard about how we bring forward, honest, frank conversation and make people comfortable so they can tell us.

One thing that Viagra proved to the world is that not only is there a large amount of sexual dysfunction – some numbers as high as 35% of men over age 65 – but that sexual dysfunction is related to diseases. It’s caused by hypertension, hardening of the arteries, and diabetes. It may be caused by psychological anxiety or even just a poor relationship where things are falling apart.

I think it’s important that, when Viagra first appeared, what Pfizer tried to do and with the marketing oriented around it was treating it as a disease, trying to treat erectile dysfunction as a symptom, and then trying to explore the underlying possible causes for that symptom.

Sadly, if we look today, we have come a long way – and not always a good way – from where Viagra started. Viagra is easily available online. Many companies say, just get online and a doctor will talk with you about a prescription. They do, but they don’t explore the underlying causes anymore online of what might be causing the erectile dysfunction. They certainly may have a checkbox and ask somebody about this or that, but I’ve gone and tested the sites, and you can get a prescription in about 30 seconds.

It’s not really gone with the old medical model that accompanied the appearance of Viagra. We now treat it as a recreational drug or an aphrodisiac, none of which is true. If your body is working properly, blood will flow where it’s going to go. Taking Viagra or any of the other treatments will not help improve that or enhance that.

The other problem I see today with where we are with these impotence and erectile dysfunction drugs is that we still have not developed a full array of interventions for women. It’s true that men have Viagra, and it’s true that that’s often reimbursed. We still have women complaining that they have sexual dysfunction or loss of interest or whatever the problem might be, and we haven’t been able to develop drugs that will help them.

Since Viagra’s approval 25 years ago until the patent ran out in 2019, $40 billion worth of the drug has been sold. Its advertising has shifted so that it’s now online and available almost on demand. I’m not sure that path has been good, but it is a reminder to us, in this 25th anniversary year, that people care about sexuality.

Doctors always need to be thinking about exploring that and trying to get a vision or a view of the health of their patients. It’s still hard for many people to speak up and say if they’re having problems in bed, and we want to make sure that we try our best to make that happen.

Overall, I think the approval of Viagra 25 years ago was a very good thing. It brought a terrible problem out into the open. It helped enhance the quality of life for many men. Despite where we are today, I think the introduction of that pill was actually a major achievement in pharmacology.

Dr. Kaplan is director, division of medical ethics, New York University Langone Medical Center, New York. He reported conflicts of interest with Johnson & Johnson, Medscape, and Pfizer.


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

The Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH).

Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.

Olivier Le Moal/Getty Images

“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.

Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.

“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.

More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.

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

The Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH).

Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.

Olivier Le Moal/Getty Images

“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.

Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.

“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.

More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.

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

The Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH).

Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.

Olivier Le Moal/Getty Images

“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.

Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.

“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.

More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.

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

Topline

A new study provides early evidence of sex differences in rapid effects of stress systems on the cognitive control of negative emotions.

Methodology

• The study included 80 healthy participants, mean age 24 years.
• Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
• Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
• Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
• Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.

Takeaway

• In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
• In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
• Direct stress effects on ER were smaller than expected.

In practice

The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.

Source

The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.

Limitations

The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.

Disclosures

The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.

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

Topline

A new study provides early evidence of sex differences in rapid effects of stress systems on the cognitive control of negative emotions.

Methodology

• The study included 80 healthy participants, mean age 24 years.
• Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
• Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
• Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
• Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.

Takeaway

• In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
• In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
• Direct stress effects on ER were smaller than expected.

In practice

The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.

Source

The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.

Limitations

The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.

Disclosures

The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.

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

Topline

A new study provides early evidence of sex differences in rapid effects of stress systems on the cognitive control of negative emotions.

Methodology

• The study included 80 healthy participants, mean age 24 years.
• Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
• Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
• Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
• Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.

Takeaway

• In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
• In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
• Direct stress effects on ER were smaller than expected.

In practice

The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.

Source

The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.

Limitations

The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.

Disclosures

The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.

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

TOPLINE:

Methotrexate (MTX) is not associated with testicular toxicity, so therapy can be safety started in men pursuing parenthood, a small study finds.

METHODOLOGY:

• Lack of evidence regarding MTX’s effect on sperm quality has resulted in inconsistent recommendations for men actively pursuing parenthood.
• Researchers enrolled 20 men aged 18 years or older with an immune-mediated inflammatory disease (IMID) who were about to begin MTX therapy and 25 healthy men as controls.
• Participants provided semen samples prior to beginning MTX therapy and 13 weeks after beginning therapy.
• Researchers tested samples in both groups for markers of testicular toxicity.
• Also evaluated whether MTX polyglutamates could be detected in sperm of seminal fluid, as a secondary outcome.

TAKEAWAY:

• Found no significant differences in conventional semen parameters, sperm DNA damage, or male reproductive endocrine axis between the MTX group and controls.
• The concentration of MTX polyglutamates is low in both sperm and seminal fluid and is particularly low in sperm.

IN PRACTICE:

“Therapy with MTX can be safely started or continued in men diagnosed with an IMID and with an active wish to become a father,” the authors write.

STUDY DETAILS:

Luis Fernando Perez-Garcia, MD, Erasmus Medical Center, Rotterdam, the Netherlands, led the research. The study was published online in Annals of the Rheumatic Diseases on June 1, 2023.

LIMITATIONS:

The small number of participants and that the study included only MTX starters and not those who have taken MTX longer term.

DISCLOSURES:

Grants from the Dutch Arthritis Foundation, The Netherlands Organization for Health Research and Development, and Consejo Nacional de Ciencia y Tecnologia funded the project. Researchers disclosed financial relationships with Galapagos NV and UCB.

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

TOPLINE:

Methotrexate (MTX) is not associated with testicular toxicity, so therapy can be safety started in men pursuing parenthood, a small study finds.

METHODOLOGY:

• Lack of evidence regarding MTX’s effect on sperm quality has resulted in inconsistent recommendations for men actively pursuing parenthood.
• Researchers enrolled 20 men aged 18 years or older with an immune-mediated inflammatory disease (IMID) who were about to begin MTX therapy and 25 healthy men as controls.
• Participants provided semen samples prior to beginning MTX therapy and 13 weeks after beginning therapy.
• Researchers tested samples in both groups for markers of testicular toxicity.
• Also evaluated whether MTX polyglutamates could be detected in sperm of seminal fluid, as a secondary outcome.

TAKEAWAY:

• Found no significant differences in conventional semen parameters, sperm DNA damage, or male reproductive endocrine axis between the MTX group and controls.
• The concentration of MTX polyglutamates is low in both sperm and seminal fluid and is particularly low in sperm.

IN PRACTICE:

“Therapy with MTX can be safely started or continued in men diagnosed with an IMID and with an active wish to become a father,” the authors write.

STUDY DETAILS:

Luis Fernando Perez-Garcia, MD, Erasmus Medical Center, Rotterdam, the Netherlands, led the research. The study was published online in Annals of the Rheumatic Diseases on June 1, 2023.

LIMITATIONS:

The small number of participants and that the study included only MTX starters and not those who have taken MTX longer term.

DISCLOSURES:

Grants from the Dutch Arthritis Foundation, The Netherlands Organization for Health Research and Development, and Consejo Nacional de Ciencia y Tecnologia funded the project. Researchers disclosed financial relationships with Galapagos NV and UCB.

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

TOPLINE:

Methotrexate (MTX) is not associated with testicular toxicity, so therapy can be safety started in men pursuing parenthood, a small study finds.

METHODOLOGY:

• Lack of evidence regarding MTX’s effect on sperm quality has resulted in inconsistent recommendations for men actively pursuing parenthood.
• Researchers enrolled 20 men aged 18 years or older with an immune-mediated inflammatory disease (IMID) who were about to begin MTX therapy and 25 healthy men as controls.
• Participants provided semen samples prior to beginning MTX therapy and 13 weeks after beginning therapy.
• Researchers tested samples in both groups for markers of testicular toxicity.
• Also evaluated whether MTX polyglutamates could be detected in sperm of seminal fluid, as a secondary outcome.

TAKEAWAY:

• Found no significant differences in conventional semen parameters, sperm DNA damage, or male reproductive endocrine axis between the MTX group and controls.
• The concentration of MTX polyglutamates is low in both sperm and seminal fluid and is particularly low in sperm.

IN PRACTICE:

“Therapy with MTX can be safely started or continued in men diagnosed with an IMID and with an active wish to become a father,” the authors write.

STUDY DETAILS:

Luis Fernando Perez-Garcia, MD, Erasmus Medical Center, Rotterdam, the Netherlands, led the research. The study was published online in Annals of the Rheumatic Diseases on June 1, 2023.

LIMITATIONS:

The small number of participants and that the study included only MTX starters and not those who have taken MTX longer term.

DISCLOSURES:

Grants from the Dutch Arthritis Foundation, The Netherlands Organization for Health Research and Development, and Consejo Nacional de Ciencia y Tecnologia funded the project. Researchers disclosed financial relationships with Galapagos NV and UCB.

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

Men who illicitly used anabolic-androgenic steroids to bulk up and then turned to illegal, web-based regimens for treating their steroid withdrawal complications have provided important clues for new approaches to treating a growing worldwide population of men who abuse steroids.

A retrospective, observational study at one steroid addiction center in Glasgow examined 641 men who had stopped using steroids within the prior 3 years in 2015-2022 and who had self-administered certain agents, collectively known as post-cycle therapy (PCT) – within 3 months of stopping steroids.

They had a significant 3.8-fold increased rate of normalization of their levels of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH), compared with men who either never used PCT or began it more than 3 months after stopping steroids, Channa N. Jayasena, PhD, MRCP, FRCPath, reported at the annual meeting of the Endocrine Society.

These testosterone, LH, and FSH levels served as a “surrogate marker of biochemical recovery from hypogonadism,” he explained. Normalization also occurred “slightly sooner” in men who began using PCT early after steroid cessation, added Dr. Jayasena, a reproductive endocrinologist at Imperial College, London.

When men recovered their endogenous testosterone-producing capacity, it occurred after an average of about 13 weeks on PCT and after an average of about 19 weeks without PCT, a significant difference.

“There is a vacuum of medical advice on what to do” when men stop taking steroids, said Dr. Jayasena during a press briefing at the meeting. “We can’t recommend anything yet because [our studies] have not proven causality” between the post-cycle therapy that many men start after stopping steroids and any symptom improvement they experience.”

The next step is to test the PCT agents in a prospective, controlled study, an investigation Dr. Jayasena and colleagues are eager to launch. The goal is to determine whether PCT is truly effective, the optimal doses, and whether the treatments are safe.
 

‘Incredibly sophisticated’ online community

The agents that constitute PCT include human chorionic gonadotropin (hCG, the “pregnancy hormone”), selective estrogen receptor modulators (SERMs), and aromatase inhibitors (AIs). SERMs and AIs are licensed only for use in women, the former for osteoporosis and breast cancer and the latter for breast cancer.

All of these agents, as well as others, are advertised by various illegal websites as treatments that can restore endogenous testosterone production in men whose native testosterone shut down during their steroid self-medication.

Restored testosterone resolves many of the adverse effects of steroid withdrawal such as diminished libido and erections, and depressed mood and energy.

Men buy PCT agents illegally from various websites. “There is an enormous, incredibly sophisticated community online that influences” PCT, and an “incredibly refined worldwide distribution network,” Dr. Jayasena explained.

His study included 410 men who turned to PCT after steroid cessation and 170 who did not.
 

Largest study of hormone recovery when men stop taking steroids

In a further multivariate analysis of the observational data, men who had used four or more different steroid treatments fared worse – with a significant 75% reduced rate of testosterone normalization with PCT – compared with men who had used a single steroid agent.

And men who had been on a steroid regimen for more than 6 months also fared badly – with a significant 66% reduced rate of testosterone normalization with PCT, compared with men on a steroid regimen for 3 months or less.

“This is the largest study of hormone recovery when men stop taking steroids,” Dr. Jayasena noted.

And the data “require corroboration within an interventional study to determine causality.”

“We need further studies to help doctors and other health care professionals advise men about the risks of anabolic steroid use and support those who are motivated to stop,” Dr. Jayasena said.

He cautioned that the study has several limitations: biases were potentially introduced based on recruitment and on recall by participants; clinicians drew blood specimens used to measure hormone levels at random times; and participants may have engaged in concealed drug use and used steroid and PCT agents that did not contain the substances advertised.

Nevertheless, “Our data provide primary evidence that self-administered PCT drugs may be associated with improved biochemical recovery” from steroid-induced hypogonadism, and they “may have important therapeutic implications for the future treatment of men who are motivated to stop” steroids.

The study received no commercial funding. Dr. Jayasena has received research funding from Logixx Pharma.

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

Men who illicitly used anabolic-androgenic steroids to bulk up and then turned to illegal, web-based regimens for treating their steroid withdrawal complications have provided important clues for new approaches to treating a growing worldwide population of men who abuse steroids.

A retrospective, observational study at one steroid addiction center in Glasgow examined 641 men who had stopped using steroids within the prior 3 years in 2015-2022 and who had self-administered certain agents, collectively known as post-cycle therapy (PCT) – within 3 months of stopping steroids.

They had a significant 3.8-fold increased rate of normalization of their levels of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH), compared with men who either never used PCT or began it more than 3 months after stopping steroids, Channa N. Jayasena, PhD, MRCP, FRCPath, reported at the annual meeting of the Endocrine Society.

These testosterone, LH, and FSH levels served as a “surrogate marker of biochemical recovery from hypogonadism,” he explained. Normalization also occurred “slightly sooner” in men who began using PCT early after steroid cessation, added Dr. Jayasena, a reproductive endocrinologist at Imperial College, London.

When men recovered their endogenous testosterone-producing capacity, it occurred after an average of about 13 weeks on PCT and after an average of about 19 weeks without PCT, a significant difference.

“There is a vacuum of medical advice on what to do” when men stop taking steroids, said Dr. Jayasena during a press briefing at the meeting. “We can’t recommend anything yet because [our studies] have not proven causality” between the post-cycle therapy that many men start after stopping steroids and any symptom improvement they experience.”

The next step is to test the PCT agents in a prospective, controlled study, an investigation Dr. Jayasena and colleagues are eager to launch. The goal is to determine whether PCT is truly effective, the optimal doses, and whether the treatments are safe.
 

‘Incredibly sophisticated’ online community

The agents that constitute PCT include human chorionic gonadotropin (hCG, the “pregnancy hormone”), selective estrogen receptor modulators (SERMs), and aromatase inhibitors (AIs). SERMs and AIs are licensed only for use in women, the former for osteoporosis and breast cancer and the latter for breast cancer.

All of these agents, as well as others, are advertised by various illegal websites as treatments that can restore endogenous testosterone production in men whose native testosterone shut down during their steroid self-medication.

Restored testosterone resolves many of the adverse effects of steroid withdrawal such as diminished libido and erections, and depressed mood and energy.

Men buy PCT agents illegally from various websites. “There is an enormous, incredibly sophisticated community online that influences” PCT, and an “incredibly refined worldwide distribution network,” Dr. Jayasena explained.

His study included 410 men who turned to PCT after steroid cessation and 170 who did not.
 

Largest study of hormone recovery when men stop taking steroids

In a further multivariate analysis of the observational data, men who had used four or more different steroid treatments fared worse – with a significant 75% reduced rate of testosterone normalization with PCT – compared with men who had used a single steroid agent.

And men who had been on a steroid regimen for more than 6 months also fared badly – with a significant 66% reduced rate of testosterone normalization with PCT, compared with men on a steroid regimen for 3 months or less.

“This is the largest study of hormone recovery when men stop taking steroids,” Dr. Jayasena noted.

And the data “require corroboration within an interventional study to determine causality.”

“We need further studies to help doctors and other health care professionals advise men about the risks of anabolic steroid use and support those who are motivated to stop,” Dr. Jayasena said.

He cautioned that the study has several limitations: biases were potentially introduced based on recruitment and on recall by participants; clinicians drew blood specimens used to measure hormone levels at random times; and participants may have engaged in concealed drug use and used steroid and PCT agents that did not contain the substances advertised.

Nevertheless, “Our data provide primary evidence that self-administered PCT drugs may be associated with improved biochemical recovery” from steroid-induced hypogonadism, and they “may have important therapeutic implications for the future treatment of men who are motivated to stop” steroids.

The study received no commercial funding. Dr. Jayasena has received research funding from Logixx Pharma.

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

Men who illicitly used anabolic-androgenic steroids to bulk up and then turned to illegal, web-based regimens for treating their steroid withdrawal complications have provided important clues for new approaches to treating a growing worldwide population of men who abuse steroids.

A retrospective, observational study at one steroid addiction center in Glasgow examined 641 men who had stopped using steroids within the prior 3 years in 2015-2022 and who had self-administered certain agents, collectively known as post-cycle therapy (PCT) – within 3 months of stopping steroids.

They had a significant 3.8-fold increased rate of normalization of their levels of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH), compared with men who either never used PCT or began it more than 3 months after stopping steroids, Channa N. Jayasena, PhD, MRCP, FRCPath, reported at the annual meeting of the Endocrine Society.

These testosterone, LH, and FSH levels served as a “surrogate marker of biochemical recovery from hypogonadism,” he explained. Normalization also occurred “slightly sooner” in men who began using PCT early after steroid cessation, added Dr. Jayasena, a reproductive endocrinologist at Imperial College, London.

When men recovered their endogenous testosterone-producing capacity, it occurred after an average of about 13 weeks on PCT and after an average of about 19 weeks without PCT, a significant difference.

“There is a vacuum of medical advice on what to do” when men stop taking steroids, said Dr. Jayasena during a press briefing at the meeting. “We can’t recommend anything yet because [our studies] have not proven causality” between the post-cycle therapy that many men start after stopping steroids and any symptom improvement they experience.”

The next step is to test the PCT agents in a prospective, controlled study, an investigation Dr. Jayasena and colleagues are eager to launch. The goal is to determine whether PCT is truly effective, the optimal doses, and whether the treatments are safe.
 

‘Incredibly sophisticated’ online community

The agents that constitute PCT include human chorionic gonadotropin (hCG, the “pregnancy hormone”), selective estrogen receptor modulators (SERMs), and aromatase inhibitors (AIs). SERMs and AIs are licensed only for use in women, the former for osteoporosis and breast cancer and the latter for breast cancer.

All of these agents, as well as others, are advertised by various illegal websites as treatments that can restore endogenous testosterone production in men whose native testosterone shut down during their steroid self-medication.

Restored testosterone resolves many of the adverse effects of steroid withdrawal such as diminished libido and erections, and depressed mood and energy.

Men buy PCT agents illegally from various websites. “There is an enormous, incredibly sophisticated community online that influences” PCT, and an “incredibly refined worldwide distribution network,” Dr. Jayasena explained.

His study included 410 men who turned to PCT after steroid cessation and 170 who did not.
 

Largest study of hormone recovery when men stop taking steroids

In a further multivariate analysis of the observational data, men who had used four or more different steroid treatments fared worse – with a significant 75% reduced rate of testosterone normalization with PCT – compared with men who had used a single steroid agent.

And men who had been on a steroid regimen for more than 6 months also fared badly – with a significant 66% reduced rate of testosterone normalization with PCT, compared with men on a steroid regimen for 3 months or less.

“This is the largest study of hormone recovery when men stop taking steroids,” Dr. Jayasena noted.

And the data “require corroboration within an interventional study to determine causality.”

“We need further studies to help doctors and other health care professionals advise men about the risks of anabolic steroid use and support those who are motivated to stop,” Dr. Jayasena said.

He cautioned that the study has several limitations: biases were potentially introduced based on recruitment and on recall by participants; clinicians drew blood specimens used to measure hormone levels at random times; and participants may have engaged in concealed drug use and used steroid and PCT agents that did not contain the substances advertised.

Nevertheless, “Our data provide primary evidence that self-administered PCT drugs may be associated with improved biochemical recovery” from steroid-induced hypogonadism, and they “may have important therapeutic implications for the future treatment of men who are motivated to stop” steroids.

The study received no commercial funding. Dr. Jayasena has received research funding from Logixx Pharma.

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

CHICAGO – Testosterone replacement therapy does not appear to raise the risk for adverse cardiac events among middle-aged and older men with hypogonadism at high risk for heart disease, long-awaited results from a major clinical trial show.

Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.

And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.

The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.

The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.

Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.

“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.

These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
 

Findings apply only to men with bona fide testosterone deficiency

Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.

Safety reassuring, but some concerns will require more investigation

TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.

The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.

Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.

Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).

There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).

“These adverse events were not expected,” the authors wrote.

Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.

Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
 

Finally, ‘real data on something we’ve been prescribing for decades’

Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”

He added that even among the few previous randomized clinical trials, only one, the TTrials series,  had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.

Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”

At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.

“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.

Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
 

‘Big surprise’ and a mystery: Testosterone increased fracture risk

The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.

“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.

The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.

Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.

“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.

Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”

Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.

“This begs the question should we reorient the way we’re thinking about these men.”

The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.

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

This article was updated 6/19/23.

CHICAGO – Testosterone replacement therapy does not appear to raise the risk for adverse cardiac events among middle-aged and older men with hypogonadism at high risk for heart disease, long-awaited results from a major clinical trial show.

Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.

And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.

The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.

The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.

Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.

“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.

These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
 

Findings apply only to men with bona fide testosterone deficiency

Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.

Safety reassuring, but some concerns will require more investigation

TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.

The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.

Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.

Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).

There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).

“These adverse events were not expected,” the authors wrote.

Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.

Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
 

Finally, ‘real data on something we’ve been prescribing for decades’

Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”

He added that even among the few previous randomized clinical trials, only one, the TTrials series,  had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.

Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”

At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.

“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.

Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
 

‘Big surprise’ and a mystery: Testosterone increased fracture risk

The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.

“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.

The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.

Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.

“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.

Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”

Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.

“This begs the question should we reorient the way we’re thinking about these men.”

The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.

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

This article was updated 6/19/23.

CHICAGO – Testosterone replacement therapy does not appear to raise the risk for adverse cardiac events among middle-aged and older men with hypogonadism at high risk for heart disease, long-awaited results from a major clinical trial show.

Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.

And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.

The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.

The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.

Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.

“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.

These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
 

Findings apply only to men with bona fide testosterone deficiency

Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.

Safety reassuring, but some concerns will require more investigation

TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.

The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.

Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.

Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).

There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).

“These adverse events were not expected,” the authors wrote.

Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.

Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
 

Finally, ‘real data on something we’ve been prescribing for decades’

Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”

He added that even among the few previous randomized clinical trials, only one, the TTrials series,  had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.

Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”

At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.

“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.

Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
 

‘Big surprise’ and a mystery: Testosterone increased fracture risk

The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.

“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.

The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.

Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.

“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.

Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”

Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.

“This begs the question should we reorient the way we’re thinking about these men.”

The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.

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

This article was updated 6/19/23.

A topical gel that may work faster than erectile dysfunction pills has been approved for over-the-counter use in the United States. The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.

The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.

According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex. 

A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.

Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.

Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.

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

A topical gel that may work faster than erectile dysfunction pills has been approved for over-the-counter use in the United States. The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.

The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.

According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex. 

A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.

Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.

Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.

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

A topical gel that may work faster than erectile dysfunction pills has been approved for over-the-counter use in the United States. The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.

The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.

According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex. 

A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.

Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.

Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.

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

A new study finds that racial disparities in male breast cancer are persisting in the United States.

From 2000 to 2019, Black men were diagnosed at later ages than White males (median ages, 69 and 63 years, respectively) and were more likely to die from the disease (22.4% vs. 16.8%, respectively). Male breast cancer (MBC) was more likely to kill Black men in rural vs. urban areas (hazard ratio = 1.4; 95% confidence interval, 1.0-2.1; P less than .05). Among White males, in contrast, there was no difference on that front, according to the research, which was presented in a poster (Abstract No. 87P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

It’s not clear why the disparities exist, said lead author Lekha Yadukumar, MBBS, an internal medicine resident at the Wright Center for Graduate Medical Education in Scranton, Penn., in an interview.

“Several potential factors may contribute to the higher rate of breast cancer diagnosis in older [Black] men, including the pathology of the disease, limited awareness about breast cancer, and potential barriers to accessibility,” she said. “The increased mortality among [Black men] may be linked to variations in tumor pathology and molecular biology. Social factors may also potentially impact survival rates, including [having] limited access to health care in rural areas and inadequate social support.”

Male breast cancer is rare, accounting for less than 1% of all breast cancer cases in the United States, according to the Breast Cancer Research Foundation. An estimated 2,700 men are diagnosed each year, and about 530 will die. Previous research has suggested Black men have worse outcomes than White men, but the data covered earlier years than the new study.
 

Methods and results

Dr. Yadukumar and colleagues retrospectively analyzed statistics from the Surveillance, Epidemiology, and End Results database for patients diagnosed with primary male breast cancer from 2000 to 2019 (n = 8,373; Black men, 1,111 [13.26%]; White men, 6,817 [81.41%]).

Median income didn’t affect mortality, whereas men in both racial groups were less likely to die if they were married vs. single/divorced (hazard ratio = 0.6; P less than .05).

Other studies have shown that “[Black American] men diagnosed with breast cancer experience longer time intervals before receiving treatment, encounter more severe disease manifestations, and exhibit lower rates of survivorship,” Dr. Yadukumar said. “Despite these findings, there remains a scarcity of genetic studies aimed at comprehending the underlying causes of these disparities. Moreover, there is a dearth of research investigating other factors that may influence survival outcomes among men with breast cancer.”
 

Findings reflect the disparities in female breast cancer

In an interview, Duke University, Durham, N.C., oncologist Arif Kamal, MD, MBA, MHS, the chief patient officer at the American Cancer Society, said the study is impressive since the number of patients is large for a rare cancer and the population is diverse. Plus, the findings reflect the disparities in female breast cancer, he noted.

“We know that Black women’s mortality is worse vs. White women in breast cancer, and we believe that most of that has nothing to do with cancer screening,” said Dr. Kamal, who was not involved in the new study. “When the clock starts from diagnosis onwards, you start to see less introduction to clinical trials and standard care medications and more time to treatment, surgery, and radiation,” he said.

“You see similar disparities as related to mortality in Black vs. White men,” he noted.

The new findings about higher death rates for Black men, especially in rural areas, suggest that “distance matters, and race matters,” he said. In rural areas, it can be hard to access pathologists, radiologists, and surgeons with more experience with breast cancer, he said.

But, he noted, the study finds that income doesn’t appear to be a factor.

In the big picture, he said, the results suggest that when it comes to barriers to better outcomes, “things that are systemic don’t make exceptions because you are a man vs. a woman.”

No study funding was reported. The study authors and Dr. Kamal have no relevant financial disclosures.
 

A new study finds that racial disparities in male breast cancer are persisting in the United States.

From 2000 to 2019, Black men were diagnosed at later ages than White males (median ages, 69 and 63 years, respectively) and were more likely to die from the disease (22.4% vs. 16.8%, respectively). Male breast cancer (MBC) was more likely to kill Black men in rural vs. urban areas (hazard ratio = 1.4; 95% confidence interval, 1.0-2.1; P less than .05). Among White males, in contrast, there was no difference on that front, according to the research, which was presented in a poster (Abstract No. 87P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

It’s not clear why the disparities exist, said lead author Lekha Yadukumar, MBBS, an internal medicine resident at the Wright Center for Graduate Medical Education in Scranton, Penn., in an interview.

“Several potential factors may contribute to the higher rate of breast cancer diagnosis in older [Black] men, including the pathology of the disease, limited awareness about breast cancer, and potential barriers to accessibility,” she said. “The increased mortality among [Black men] may be linked to variations in tumor pathology and molecular biology. Social factors may also potentially impact survival rates, including [having] limited access to health care in rural areas and inadequate social support.”

Male breast cancer is rare, accounting for less than 1% of all breast cancer cases in the United States, according to the Breast Cancer Research Foundation. An estimated 2,700 men are diagnosed each year, and about 530 will die. Previous research has suggested Black men have worse outcomes than White men, but the data covered earlier years than the new study.
 

Methods and results

Dr. Yadukumar and colleagues retrospectively analyzed statistics from the Surveillance, Epidemiology, and End Results database for patients diagnosed with primary male breast cancer from 2000 to 2019 (n = 8,373; Black men, 1,111 [13.26%]; White men, 6,817 [81.41%]).

Median income didn’t affect mortality, whereas men in both racial groups were less likely to die if they were married vs. single/divorced (hazard ratio = 0.6; P less than .05).

Other studies have shown that “[Black American] men diagnosed with breast cancer experience longer time intervals before receiving treatment, encounter more severe disease manifestations, and exhibit lower rates of survivorship,” Dr. Yadukumar said. “Despite these findings, there remains a scarcity of genetic studies aimed at comprehending the underlying causes of these disparities. Moreover, there is a dearth of research investigating other factors that may influence survival outcomes among men with breast cancer.”
 

Findings reflect the disparities in female breast cancer

In an interview, Duke University, Durham, N.C., oncologist Arif Kamal, MD, MBA, MHS, the chief patient officer at the American Cancer Society, said the study is impressive since the number of patients is large for a rare cancer and the population is diverse. Plus, the findings reflect the disparities in female breast cancer, he noted.

“We know that Black women’s mortality is worse vs. White women in breast cancer, and we believe that most of that has nothing to do with cancer screening,” said Dr. Kamal, who was not involved in the new study. “When the clock starts from diagnosis onwards, you start to see less introduction to clinical trials and standard care medications and more time to treatment, surgery, and radiation,” he said.

“You see similar disparities as related to mortality in Black vs. White men,” he noted.

The new findings about higher death rates for Black men, especially in rural areas, suggest that “distance matters, and race matters,” he said. In rural areas, it can be hard to access pathologists, radiologists, and surgeons with more experience with breast cancer, he said.

But, he noted, the study finds that income doesn’t appear to be a factor.

In the big picture, he said, the results suggest that when it comes to barriers to better outcomes, “things that are systemic don’t make exceptions because you are a man vs. a woman.”

No study funding was reported. The study authors and Dr. Kamal have no relevant financial disclosures.
 

A new study finds that racial disparities in male breast cancer are persisting in the United States.

From 2000 to 2019, Black men were diagnosed at later ages than White males (median ages, 69 and 63 years, respectively) and were more likely to die from the disease (22.4% vs. 16.8%, respectively). Male breast cancer (MBC) was more likely to kill Black men in rural vs. urban areas (hazard ratio = 1.4; 95% confidence interval, 1.0-2.1; P less than .05). Among White males, in contrast, there was no difference on that front, according to the research, which was presented in a poster (Abstract No. 87P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

It’s not clear why the disparities exist, said lead author Lekha Yadukumar, MBBS, an internal medicine resident at the Wright Center for Graduate Medical Education in Scranton, Penn., in an interview.

“Several potential factors may contribute to the higher rate of breast cancer diagnosis in older [Black] men, including the pathology of the disease, limited awareness about breast cancer, and potential barriers to accessibility,” she said. “The increased mortality among [Black men] may be linked to variations in tumor pathology and molecular biology. Social factors may also potentially impact survival rates, including [having] limited access to health care in rural areas and inadequate social support.”

Male breast cancer is rare, accounting for less than 1% of all breast cancer cases in the United States, according to the Breast Cancer Research Foundation. An estimated 2,700 men are diagnosed each year, and about 530 will die. Previous research has suggested Black men have worse outcomes than White men, but the data covered earlier years than the new study.
 

Methods and results

Dr. Yadukumar and colleagues retrospectively analyzed statistics from the Surveillance, Epidemiology, and End Results database for patients diagnosed with primary male breast cancer from 2000 to 2019 (n = 8,373; Black men, 1,111 [13.26%]; White men, 6,817 [81.41%]).

Median income didn’t affect mortality, whereas men in both racial groups were less likely to die if they were married vs. single/divorced (hazard ratio = 0.6; P less than .05).

Other studies have shown that “[Black American] men diagnosed with breast cancer experience longer time intervals before receiving treatment, encounter more severe disease manifestations, and exhibit lower rates of survivorship,” Dr. Yadukumar said. “Despite these findings, there remains a scarcity of genetic studies aimed at comprehending the underlying causes of these disparities. Moreover, there is a dearth of research investigating other factors that may influence survival outcomes among men with breast cancer.”
 

Findings reflect the disparities in female breast cancer

In an interview, Duke University, Durham, N.C., oncologist Arif Kamal, MD, MBA, MHS, the chief patient officer at the American Cancer Society, said the study is impressive since the number of patients is large for a rare cancer and the population is diverse. Plus, the findings reflect the disparities in female breast cancer, he noted.

“We know that Black women’s mortality is worse vs. White women in breast cancer, and we believe that most of that has nothing to do with cancer screening,” said Dr. Kamal, who was not involved in the new study. “When the clock starts from diagnosis onwards, you start to see less introduction to clinical trials and standard care medications and more time to treatment, surgery, and radiation,” he said.

“You see similar disparities as related to mortality in Black vs. White men,” he noted.

The new findings about higher death rates for Black men, especially in rural areas, suggest that “distance matters, and race matters,” he said. In rural areas, it can be hard to access pathologists, radiologists, and surgeons with more experience with breast cancer, he said.

But, he noted, the study finds that income doesn’t appear to be a factor.

In the big picture, he said, the results suggest that when it comes to barriers to better outcomes, “things that are systemic don’t make exceptions because you are a man vs. a woman.”

No study funding was reported. The study authors and Dr. Kamal have no relevant financial disclosures.
 

A new strategy proposed by an international team of experts would limit the use of the prostate-specific antigen (PSA) test for screening tor prostate cancer to men who are younger than 70 years and who are at high risk or symptomatic.

This would reduce potential harms from overdiagnosis and overtreatment, the risk for which is high with the on-demand screening that is the current standard of care in most wealthy nations.

In a paper published online in The BMJ, the panel recommends instead a comprehensive nationwide program that would base PSA testing on individual patient risk and direct those with abnormal results to a managed system of imaging, targeted biopsy only if indicated, and subsequent active monitoring or treatment for those with more aggressive disease features.

Alternatively, government health programs could actively discourage widespread PSA testing and implement policies that would effectively limit PSA-based screening only to men with urologic symptoms warranting further exploration, said the authors, led by Andrew Vickers, PhD, a research epidemiologist at Memorial Sloan Kettering Cancer Center in New York.

“Although we believe that early detection of prostate cancer should involve shared decision making, the current approach of determining testing by shared decision making has resulted in the worst possible practical outcome of high levels of PSA testing and medical harm, with minimal benefit and inequity,” they wrote.

“To make better use of PSA testing, policy makers should choose between a comprehensive, risk adapted approach that is specifically designed to reduce overdiagnosis and overtreatment, or restricting PSA testing to people referred to urologists with symptoms. That choice will need to take into account wider patient and public perspective, as well as health economic concerns,” they continued.
 

Inappropriate testing

Since the Food and Drug Administration approved the first PSA screen in 1986 as a means for monitoring disease progression in patients being treated for prostate cancer, the test has remained controversial, embraced by some for its presumed ability to spot early prostate cancer but scorned by others for its equivocal results in patients with benign prostate pathology and for its potential to lead to overdiagnosis and overtreatment of low-grade disease in men who would otherwise be likely to die of other causes.

Currently, only Lithuania and Kazakhstan have government-supported population-based screening programs for prostate cancer. In contrast, the United States, United Kingdom, and other high-income countries have opted not to implement nationwide prostate cancer screening but allow so-called “informed choice testing,” in which men can receiving PSA screening after discussion with a primary care physician, urologist, or other specialist.

The U.S. Preventive Services Task Force recommends that for men aged 55-69 years, the decision to undergo PSA testing should be an individual one, based on an understanding of the risks and benefits. For men aged 70 or older, the task force flatly states, “Do not screen for prostate cancer.”

But as Dr. Vickers and colleagues noted, “high income countries that have made PSA testing available to men who request it after shared decision making with their physician now have a high prevalence of PSA testing with an inappropriate age distribution.”

For example, they pointed out that in the United Kingdom, men in their 80s are twice as likely as are men in their 50s to get a PSA test, even though men in the older age group are far less likely to have benefit and far more likely to experience harm from treatment. Similarly, in France, nearly one-third of men over 40 get an annual PSA test, with the highest incidence of PSA testing in men over age 70. There are also high rates of PSA testing in men over 70 in Italy, Germany, and Ireland.

“A key problem is that, in current routine care – and despite guidelines to the contrary – most men with an abnormal PSA result have prostate biopsy, even though only a minority will have aggressive prostate cancer,” Dr. Vickers and colleagues wrote. “Furthermore, most men with biopsy-detected cancers have either surgery or radiotherapy (with or without androgen deprivation therapy) even if they have low-risk tumors that are unlikely to cause cancer related morbidity or mortality.”

In addition, informed-choice PSA testing may lead to health inequities, the team noted, citing data from the United States, Canada, and Switzerland showing an inverse association between income and education and the likelihood of PSA testing. Also, in the United States and Canada, men from ethnic minority groups are less likely to have PSA testing.
 

Comprehensive risk-based program

Dr. Vickers and colleagues proposed that a “comprehensive, risk-based prostate cancer detection program based on best evidence on how to use PSA testing and manage subsequent diagnostic follow-up and treatment could reduce overdiagnosis and overtreatment.

“Such a program would restrict testing to men (and those not identifying as male but who have a prostate) aged 50-70, define testing intervals by PSA levels, stop testing early for those with lower PSA, offer biopsy only to those identified as at high risk of aggressive disease after a secondary test (such as magnetic resonance imaging [MRI] or blood markers), and limit treatment to those with high Gleason grade tumors,” they wrote.
 

‘Sound analysis’

Two experts who were not involved with the BMJ paper applaud the suggestions made in comments posted on the U.K. Science Media Centre.

Benjamin W. Lamb, MBBS, MA, PhD, a consultant urologist and surgeon at Barts Health NHS Trust in London, said the analysis conducted by the panel “is sound as there are known benefits from risk-adapted comprehensive screening trials in men aged 50-70, but discordance with current practice, meaning benefits and harms are not those seen in trials.”

However, he also said that the strategies proposed by the authors would be unlikely to prevent older, well-informed men from requesting and getting a PSA test.

“In my view, the emphasis should be on engaging younger and at-risk men rather than restricting access for older men,” he said, noting that the alternative proposal of restricting PSA testing “in my view, is not feasible.”

Nick James, MBBS, PhD, professor of prostate and bladder cancer research at the Institute of Cancer Research, London, and consultant oncologist at the Royal Marsden NHS Foundation Trust, said, “I agree with the authors and strongly support the implementation of a risk-based approach to PSA testing at a national level.

“There is an urgent need for a more equitable and targeted screening strategy, which could help address existing health disparities,” Dr. James said. “Currently, individuals from economically disadvantaged backgrounds are less likely to undergo PSA testing. Men in their 50s or younger, who may stand to benefit more from these tests, are also less likely to receive PSA tests compared to older men who benefit less. Linked to better diagnostic pathways with MRI, already standard in the UK, potential harms from overdiagnosis and overtreatment can be mitigated.”

The analysis was supported in part by the U.S. National Institutes of Health/National Cancer Institute with a Cancer Center Support Grant to Memorial Sloan Kettering Cancer Center, and NIH grants to coauthors. Dr. Vickers is a coinventor of the 4Kscore, a commercial test for predicting prostate biopsy outcome. He receives royalties from sales of the test and owns stock options in OPKO, which offers the test. Coauthor James W.F. Catto, PhD, disclosed ties to Astellas, AstraZeneca, BMS, Ferring, Gilead, Janssen, MSD, Nucleix, Photocure, QED Therapeutics, and Roche.

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

A new strategy proposed by an international team of experts would limit the use of the prostate-specific antigen (PSA) test for screening tor prostate cancer to men who are younger than 70 years and who are at high risk or symptomatic.

This would reduce potential harms from overdiagnosis and overtreatment, the risk for which is high with the on-demand screening that is the current standard of care in most wealthy nations.

In a paper published online in The BMJ, the panel recommends instead a comprehensive nationwide program that would base PSA testing on individual patient risk and direct those with abnormal results to a managed system of imaging, targeted biopsy only if indicated, and subsequent active monitoring or treatment for those with more aggressive disease features.

Alternatively, government health programs could actively discourage widespread PSA testing and implement policies that would effectively limit PSA-based screening only to men with urologic symptoms warranting further exploration, said the authors, led by Andrew Vickers, PhD, a research epidemiologist at Memorial Sloan Kettering Cancer Center in New York.

“Although we believe that early detection of prostate cancer should involve shared decision making, the current approach of determining testing by shared decision making has resulted in the worst possible practical outcome of high levels of PSA testing and medical harm, with minimal benefit and inequity,” they wrote.

“To make better use of PSA testing, policy makers should choose between a comprehensive, risk adapted approach that is specifically designed to reduce overdiagnosis and overtreatment, or restricting PSA testing to people referred to urologists with symptoms. That choice will need to take into account wider patient and public perspective, as well as health economic concerns,” they continued.
 

Inappropriate testing

Since the Food and Drug Administration approved the first PSA screen in 1986 as a means for monitoring disease progression in patients being treated for prostate cancer, the test has remained controversial, embraced by some for its presumed ability to spot early prostate cancer but scorned by others for its equivocal results in patients with benign prostate pathology and for its potential to lead to overdiagnosis and overtreatment of low-grade disease in men who would otherwise be likely to die of other causes.

Currently, only Lithuania and Kazakhstan have government-supported population-based screening programs for prostate cancer. In contrast, the United States, United Kingdom, and other high-income countries have opted not to implement nationwide prostate cancer screening but allow so-called “informed choice testing,” in which men can receiving PSA screening after discussion with a primary care physician, urologist, or other specialist.

The U.S. Preventive Services Task Force recommends that for men aged 55-69 years, the decision to undergo PSA testing should be an individual one, based on an understanding of the risks and benefits. For men aged 70 or older, the task force flatly states, “Do not screen for prostate cancer.”

But as Dr. Vickers and colleagues noted, “high income countries that have made PSA testing available to men who request it after shared decision making with their physician now have a high prevalence of PSA testing with an inappropriate age distribution.”

For example, they pointed out that in the United Kingdom, men in their 80s are twice as likely as are men in their 50s to get a PSA test, even though men in the older age group are far less likely to have benefit and far more likely to experience harm from treatment. Similarly, in France, nearly one-third of men over 40 get an annual PSA test, with the highest incidence of PSA testing in men over age 70. There are also high rates of PSA testing in men over 70 in Italy, Germany, and Ireland.

“A key problem is that, in current routine care – and despite guidelines to the contrary – most men with an abnormal PSA result have prostate biopsy, even though only a minority will have aggressive prostate cancer,” Dr. Vickers and colleagues wrote. “Furthermore, most men with biopsy-detected cancers have either surgery or radiotherapy (with or without androgen deprivation therapy) even if they have low-risk tumors that are unlikely to cause cancer related morbidity or mortality.”

In addition, informed-choice PSA testing may lead to health inequities, the team noted, citing data from the United States, Canada, and Switzerland showing an inverse association between income and education and the likelihood of PSA testing. Also, in the United States and Canada, men from ethnic minority groups are less likely to have PSA testing.
 

Comprehensive risk-based program

Dr. Vickers and colleagues proposed that a “comprehensive, risk-based prostate cancer detection program based on best evidence on how to use PSA testing and manage subsequent diagnostic follow-up and treatment could reduce overdiagnosis and overtreatment.

“Such a program would restrict testing to men (and those not identifying as male but who have a prostate) aged 50-70, define testing intervals by PSA levels, stop testing early for those with lower PSA, offer biopsy only to those identified as at high risk of aggressive disease after a secondary test (such as magnetic resonance imaging [MRI] or blood markers), and limit treatment to those with high Gleason grade tumors,” they wrote.
 

‘Sound analysis’

Two experts who were not involved with the BMJ paper applaud the suggestions made in comments posted on the U.K. Science Media Centre.

Benjamin W. Lamb, MBBS, MA, PhD, a consultant urologist and surgeon at Barts Health NHS Trust in London, said the analysis conducted by the panel “is sound as there are known benefits from risk-adapted comprehensive screening trials in men aged 50-70, but discordance with current practice, meaning benefits and harms are not those seen in trials.”

However, he also said that the strategies proposed by the authors would be unlikely to prevent older, well-informed men from requesting and getting a PSA test.

“In my view, the emphasis should be on engaging younger and at-risk men rather than restricting access for older men,” he said, noting that the alternative proposal of restricting PSA testing “in my view, is not feasible.”

Nick James, MBBS, PhD, professor of prostate and bladder cancer research at the Institute of Cancer Research, London, and consultant oncologist at the Royal Marsden NHS Foundation Trust, said, “I agree with the authors and strongly support the implementation of a risk-based approach to PSA testing at a national level.

“There is an urgent need for a more equitable and targeted screening strategy, which could help address existing health disparities,” Dr. James said. “Currently, individuals from economically disadvantaged backgrounds are less likely to undergo PSA testing. Men in their 50s or younger, who may stand to benefit more from these tests, are also less likely to receive PSA tests compared to older men who benefit less. Linked to better diagnostic pathways with MRI, already standard in the UK, potential harms from overdiagnosis and overtreatment can be mitigated.”

The analysis was supported in part by the U.S. National Institutes of Health/National Cancer Institute with a Cancer Center Support Grant to Memorial Sloan Kettering Cancer Center, and NIH grants to coauthors. Dr. Vickers is a coinventor of the 4Kscore, a commercial test for predicting prostate biopsy outcome. He receives royalties from sales of the test and owns stock options in OPKO, which offers the test. Coauthor James W.F. Catto, PhD, disclosed ties to Astellas, AstraZeneca, BMS, Ferring, Gilead, Janssen, MSD, Nucleix, Photocure, QED Therapeutics, and Roche.

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

A new strategy proposed by an international team of experts would limit the use of the prostate-specific antigen (PSA) test for screening tor prostate cancer to men who are younger than 70 years and who are at high risk or symptomatic.

This would reduce potential harms from overdiagnosis and overtreatment, the risk for which is high with the on-demand screening that is the current standard of care in most wealthy nations.

In a paper published online in The BMJ, the panel recommends instead a comprehensive nationwide program that would base PSA testing on individual patient risk and direct those with abnormal results to a managed system of imaging, targeted biopsy only if indicated, and subsequent active monitoring or treatment for those with more aggressive disease features.

Alternatively, government health programs could actively discourage widespread PSA testing and implement policies that would effectively limit PSA-based screening only to men with urologic symptoms warranting further exploration, said the authors, led by Andrew Vickers, PhD, a research epidemiologist at Memorial Sloan Kettering Cancer Center in New York.

“Although we believe that early detection of prostate cancer should involve shared decision making, the current approach of determining testing by shared decision making has resulted in the worst possible practical outcome of high levels of PSA testing and medical harm, with minimal benefit and inequity,” they wrote.

“To make better use of PSA testing, policy makers should choose between a comprehensive, risk adapted approach that is specifically designed to reduce overdiagnosis and overtreatment, or restricting PSA testing to people referred to urologists with symptoms. That choice will need to take into account wider patient and public perspective, as well as health economic concerns,” they continued.
 

Inappropriate testing

Since the Food and Drug Administration approved the first PSA screen in 1986 as a means for monitoring disease progression in patients being treated for prostate cancer, the test has remained controversial, embraced by some for its presumed ability to spot early prostate cancer but scorned by others for its equivocal results in patients with benign prostate pathology and for its potential to lead to overdiagnosis and overtreatment of low-grade disease in men who would otherwise be likely to die of other causes.

Currently, only Lithuania and Kazakhstan have government-supported population-based screening programs for prostate cancer. In contrast, the United States, United Kingdom, and other high-income countries have opted not to implement nationwide prostate cancer screening but allow so-called “informed choice testing,” in which men can receiving PSA screening after discussion with a primary care physician, urologist, or other specialist.

The U.S. Preventive Services Task Force recommends that for men aged 55-69 years, the decision to undergo PSA testing should be an individual one, based on an understanding of the risks and benefits. For men aged 70 or older, the task force flatly states, “Do not screen for prostate cancer.”

But as Dr. Vickers and colleagues noted, “high income countries that have made PSA testing available to men who request it after shared decision making with their physician now have a high prevalence of PSA testing with an inappropriate age distribution.”

For example, they pointed out that in the United Kingdom, men in their 80s are twice as likely as are men in their 50s to get a PSA test, even though men in the older age group are far less likely to have benefit and far more likely to experience harm from treatment. Similarly, in France, nearly one-third of men over 40 get an annual PSA test, with the highest incidence of PSA testing in men over age 70. There are also high rates of PSA testing in men over 70 in Italy, Germany, and Ireland.

“A key problem is that, in current routine care – and despite guidelines to the contrary – most men with an abnormal PSA result have prostate biopsy, even though only a minority will have aggressive prostate cancer,” Dr. Vickers and colleagues wrote. “Furthermore, most men with biopsy-detected cancers have either surgery or radiotherapy (with or without androgen deprivation therapy) even if they have low-risk tumors that are unlikely to cause cancer related morbidity or mortality.”

In addition, informed-choice PSA testing may lead to health inequities, the team noted, citing data from the United States, Canada, and Switzerland showing an inverse association between income and education and the likelihood of PSA testing. Also, in the United States and Canada, men from ethnic minority groups are less likely to have PSA testing.
 

Comprehensive risk-based program

Dr. Vickers and colleagues proposed that a “comprehensive, risk-based prostate cancer detection program based on best evidence on how to use PSA testing and manage subsequent diagnostic follow-up and treatment could reduce overdiagnosis and overtreatment.

“Such a program would restrict testing to men (and those not identifying as male but who have a prostate) aged 50-70, define testing intervals by PSA levels, stop testing early for those with lower PSA, offer biopsy only to those identified as at high risk of aggressive disease after a secondary test (such as magnetic resonance imaging [MRI] or blood markers), and limit treatment to those with high Gleason grade tumors,” they wrote.
 

‘Sound analysis’

Two experts who were not involved with the BMJ paper applaud the suggestions made in comments posted on the U.K. Science Media Centre.

Benjamin W. Lamb, MBBS, MA, PhD, a consultant urologist and surgeon at Barts Health NHS Trust in London, said the analysis conducted by the panel “is sound as there are known benefits from risk-adapted comprehensive screening trials in men aged 50-70, but discordance with current practice, meaning benefits and harms are not those seen in trials.”

However, he also said that the strategies proposed by the authors would be unlikely to prevent older, well-informed men from requesting and getting a PSA test.

“In my view, the emphasis should be on engaging younger and at-risk men rather than restricting access for older men,” he said, noting that the alternative proposal of restricting PSA testing “in my view, is not feasible.”

Nick James, MBBS, PhD, professor of prostate and bladder cancer research at the Institute of Cancer Research, London, and consultant oncologist at the Royal Marsden NHS Foundation Trust, said, “I agree with the authors and strongly support the implementation of a risk-based approach to PSA testing at a national level.

“There is an urgent need for a more equitable and targeted screening strategy, which could help address existing health disparities,” Dr. James said. “Currently, individuals from economically disadvantaged backgrounds are less likely to undergo PSA testing. Men in their 50s or younger, who may stand to benefit more from these tests, are also less likely to receive PSA tests compared to older men who benefit less. Linked to better diagnostic pathways with MRI, already standard in the UK, potential harms from overdiagnosis and overtreatment can be mitigated.”

The analysis was supported in part by the U.S. National Institutes of Health/National Cancer Institute with a Cancer Center Support Grant to Memorial Sloan Kettering Cancer Center, and NIH grants to coauthors. Dr. Vickers is a coinventor of the 4Kscore, a commercial test for predicting prostate biopsy outcome. He receives royalties from sales of the test and owns stock options in OPKO, which offers the test. Coauthor James W.F. Catto, PhD, disclosed ties to Astellas, AstraZeneca, BMS, Ferring, Gilead, Janssen, MSD, Nucleix, Photocure, QED Therapeutics, and Roche.

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

AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

• Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
• Advise. Make sure your patient knows many women struggle with the problem they have raised.
• Assess. Ask a set of standardized assessment questions.
• Assist. Tell your patient about treatment options.
• Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

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

AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

• Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
• Advise. Make sure your patient knows many women struggle with the problem they have raised.
• Assess. Ask a set of standardized assessment questions.
• Assist. Tell your patient about treatment options.
• Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

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

AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

• Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
• Advise. Make sure your patient knows many women struggle with the problem they have raised.
• Assess. Ask a set of standardized assessment questions.
• Assist. Tell your patient about treatment options.
• Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

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