Tara Haelle

CHICAGO — The nonhormonal investigational drug elinzanetant led to significant improvement in hot flashes as well as sleep disturbance and quality of life, according to data from three randomized controlled trials presented at The Menopause Society 2024 Annual Meeting in Chicago. Two phase 3 trials, OASIS 1 and 2, were also published in JAMA, and the longer-term OASIS 3 trial was presented as a poster at the conference.

Elinzanetant is a selective neurokinin (NK) receptor antagonist, similar to fezolinetant, the first drug in this class approved by the US Food and Drug Administration (FDA) for vasomotor symptoms in May 2023. This class of medications targets the estrogen-sensitive kisspeptin/NK B/dynorphin (KNDy) neurons thought to play a role in thermoregulation and hot flashes during menopause. While fezolinetant targets only the NK-3 receptor, elinzanetant is a dual NK receptor antagonist that targets both NK-1 and NK-3. Bayer submitted a New Drug Application for elinzanetant to the FDA on August 1.

For those in whom hormone therapy is contraindicated, “it’s always been difficult for women with really severe symptoms to have a safe and effective therapy,” lead author JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, told this news organization. “The nonhormonal therapies we’ve used mostly off-label — the antidepressants, gabapentin, clonidine, oxybutynin — do help the hot flashes, but they don’t work nearly as effectively as these new NK receptor antagonists, and having one that looks like it might have a broader use for hot flashes, night sweats, mood, and sleep is just really exciting.”

Dr. Pinkerton said approximately 80% of the women in the OASIS 1 and 2 studies had at least a 50% reduction in hot flashes. “It was a very strong, dramatic positive finding, but the improvements in sleep and mood have really encouraged us to go further,” she said.

Declining estrogen levels during and after menopause can cause hypertrophy and hyperactivity of the KNDy neurons, which has been linked to thermoregulation disruptions that may trigger hot flashes, James Simon, MD, a clinical professor of ob.gyn. at The George Washington University School of Medicine & Health Sciences and medical director of IntimMedicine in Washington, DC, told attendees. He presented pooled data from OASIS 1 and 2. The NK-1 receptor, targeted by elinzanetant but not fezolinetant, is also thought to play a role in insomnia and possibly in mood.

“Oftentimes the focus on a lot of these drugs is hot flashes, hot flashes, hot flashes, but we know hot flashes do not occur in isolation,” Chrisandra Shufelt, MD, professor and chair of general internal medicine and associate director of the Women’s Health Research Center at Mayo Clinic in Jacksonville, Florida, told this news organization. Elinzanetant is “an interesting compound because it actually works on sleep, and that was critical because sleep disturbance precedes” many other menopausal symptoms, said Dr. Shufelt, who was not involved in the study.

“I think it is an outstanding option for women who don’t have the opportunity to get hormones,” Dr. Shufelt said, and she was particularly pleased to see there were no safety concerns for the liver in the trial data. The FDA issued a warning on September 12 about the risk for rare liver injury with fezolinetant, but the early signals that had been seen in fezolinetant data were not seen in these elinzanetant data.

The OASIS 1 and 2 trials enrolled postmenopausal women, aged 40-65 years, who had at least 50 moderate to severe vasomotor occurrences per week.

“A moderate hot flash is a hot flash that is also associated with sweating, and a severe hot flash is a moderate hot flash that stops a woman in her tracks,” Dr. Simon said. “Namely, it’s severe enough with sweating and central nervous system effects that she is interrupted in whatever it is that she’s doing at the time.”

Exclusion criteria for the trials included a history of arrhythmias, heart block, or QT prolongation; abnormal lab results; history of malignancy within the past 5 years; uncontrolled or treatment-resistant hypertension, hypothyroidism, or hyperthyroidism; unexplained postmenopausal bleeding; clinically relevant abnormal mammogram findings; or disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer.

The predominantly White (80%) women were an average 54 years old, with an average body mass index (BMI) of 27.8, and were an average 3.5 years from their last period. For the first 12 weeks of the trials, 399 women were assigned to receive 120 mg once daily of oral elinzanetant and 397 were assigned to once daily placebo. Then the women taking placebo switched to elinzanetant for the final 14 weeks of the study.

The endpoints included mean change in frequency and severity of vasomotor symptoms at weeks 1, 4, and 12 as well as change in sleep disturbance and quality of life at week 12. Sleep was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form score, which ranges from 28.9 to 76.5, with a higher number denoting greater sleep disturbance. The Menopause-Specific Quality-of-Life score ranges from 1 to 8, with a higher score indicating poorer quality of life.

Daily frequency of vasomotor symptoms was 14 per day at baseline in the elinzanetant group, decreasing by 4.8 per day at week 1, 8 per day at week 4, and 9.4 per day at week 12. In the placebo group, women had an average 15.2 occurrences per day at baseline, which decreased by 3.2 at week 1, 5.2 at week 4, and 6.4 at week 12. Comparing the groups at 12 weeks, those receiving elinzanetant had 3.2 fewer daily vasomotor symptoms than those receiving placebo (P < .0001).

The severity of vasomotor symptoms also improved more in the elinzanetant group than in the placebo group over 12 weeks, after which severity improved further in those who switched from placebo to elinzanetant (P < .0001).

Sleep disturbance scores, starting at a mean 61.5 in the elinzanetant group and 60.5 in the placebo group, fell 10.7 points in the elinzanetant group and 5.3 points in the placebo group at 12 weeks, for a difference of 4.9 points (P < .0001). Sleep then further improved in those who switched from placebo to elinzanetant. Quality-of-life scores improved 1.37 points (from 4.52 at baseline) in the elinzanetant group and 0.96 points (from 4.49 at baseline) in the placebo group, for a mean difference at 12 weeks of 0.36 (P < .0001).

Though no head-to-head data exist comparing elinzanetant and fezolinetant, Dr. Simon told this news organization the side effects with fezolinetant “tend to be gastrointestinal, whereas the side effects for elinzanetant tend to be central nervous system,” such as drowsiness and lethargy.

The women who are the best candidates for elinzanetant, Dr. Pinkerton told this news organization, include those who have had an estrogen-sensitive cancer, such as breast or endometrial cancer, or who have fear of it, a family history, or are otherwise high risk. Other ideal candidates include those with a history of venous thromboembolism, people who have migraine with aura (due to concerns about increased risk for stroke), and those who have endometriosis or large fibroids.

“Then the last group might be women who took hormone therapy in their 50s and want to continue, but they’re trying to go off, and they have a recurrence of their hot flashes or night sweats or sleep issues,” Dr. Pinkerton said. “This might be a great group to switch over.”

OASIS 3 assessed the drug for 1 year and “supported the results of OASIS 1 and 2, demonstrating efficacy over a longer study duration and in a population with a vasomotor symptom profile representative of that seen in clinical practice,” Nick Panay, BSc, MBBS, director of the Menopause & PMS Centre at Queen Charlotte’s Hospital & Imperial College London, London, England, and his colleague reported.

Among 628 postmenopausal women aged 40-65, the predominantly White (78.5%) women were an average 54 years old, with an average BMI of 27.6, and were an average 5 years past their last period. Half received 120 mg elinzanetant and half received a placebo for 52 weeks.

At 12 weeks, the women receiving elinzanetant reported an average 1.6 moderate to severe vasomotor symptoms per day, down from 6.7 at baseline. Daily average symptoms in the placebo group fell from 6.8 at baseline to 3.4 at 12 weeks, for a difference of 1.6 fewer occurrences per day in the elinzanetant group (P < .0001).

Sleep disturbances also improved, falling 9.4 points from a baseline 57.4 in the elinzanetant group and 5.7 points from a baseline 58 in the placebo group. Quality-of-life scores improved from 4.1 to 2.8 (−1.3 change) in the elinzanetant group and from 4.4 to 3.3 (−1.1 change) in the placebo group.

In addition to looking at treatment-emergent adverse events, the safety assessments also included endometrial biopsies; bone mineral density in the femoral neck, hip, and lumbar spine; weight; and labs. Adverse events related to the study drug occurred in 30.4% of those in the elinzanetant group and 14.6% of those in the placebo group. The most commonly reported adverse events were headache (9.6% elinzanetant vs 7% placebo), fatigue (7% vs 10.2%), and sleepiness (5.1% vs 1.3%). A higher proportion of women taking elinzanetant (12.5%) than those taking placebo (4.1%) discontinued the study.

No serious adverse events deemed to be treatment-related occurred in either group, and no endometrial hyperplasia or malignant neoplasm occurred in either group. Bone mineral density changes in both groups were within the expected range for the women’s age, and their weight remained stable over the 52 weeks.

Six women taking elinzanetant and four taking placebo met predefined criteria for close liver observation, but none showed hepatotoxicity or evidence of possible drug-induced liver injury.

The research was funded by Bayer. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Dr. Shufelt had no disclosures. Dr. Simon had grant/research support, consulting/advisory board participation, and/or speaking disclosures with AbbVie, Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services, Covance, Daré Bioscience, DEKA M.E.L.A S.r.l., Femasys, Ipsen, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mayne Pharma, Mitsubishi Tanabe Pharma Development America, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Pfizer, Pharmavite, QUE Oncology, Scynexis, Sebela Pharmaceuticals, Sprout Pharmaceuticals, TherapeuticsMD, Vella Bioscience, and Viveve Medical, and he is a stockholder in Sermonix Pharmaceuticals.

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

CHICAGO — The nonhormonal investigational drug elinzanetant led to significant improvement in hot flashes as well as sleep disturbance and quality of life, according to data from three randomized controlled trials presented at The Menopause Society 2024 Annual Meeting in Chicago. Two phase 3 trials, OASIS 1 and 2, were also published in JAMA, and the longer-term OASIS 3 trial was presented as a poster at the conference.

Elinzanetant is a selective neurokinin (NK) receptor antagonist, similar to fezolinetant, the first drug in this class approved by the US Food and Drug Administration (FDA) for vasomotor symptoms in May 2023. This class of medications targets the estrogen-sensitive kisspeptin/NK B/dynorphin (KNDy) neurons thought to play a role in thermoregulation and hot flashes during menopause. While fezolinetant targets only the NK-3 receptor, elinzanetant is a dual NK receptor antagonist that targets both NK-1 and NK-3. Bayer submitted a New Drug Application for elinzanetant to the FDA on August 1.

For those in whom hormone therapy is contraindicated, “it’s always been difficult for women with really severe symptoms to have a safe and effective therapy,” lead author JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, told this news organization. “The nonhormonal therapies we’ve used mostly off-label — the antidepressants, gabapentin, clonidine, oxybutynin — do help the hot flashes, but they don’t work nearly as effectively as these new NK receptor antagonists, and having one that looks like it might have a broader use for hot flashes, night sweats, mood, and sleep is just really exciting.”

Dr. Pinkerton said approximately 80% of the women in the OASIS 1 and 2 studies had at least a 50% reduction in hot flashes. “It was a very strong, dramatic positive finding, but the improvements in sleep and mood have really encouraged us to go further,” she said.

Declining estrogen levels during and after menopause can cause hypertrophy and hyperactivity of the KNDy neurons, which has been linked to thermoregulation disruptions that may trigger hot flashes, James Simon, MD, a clinical professor of ob.gyn. at The George Washington University School of Medicine & Health Sciences and medical director of IntimMedicine in Washington, DC, told attendees. He presented pooled data from OASIS 1 and 2. The NK-1 receptor, targeted by elinzanetant but not fezolinetant, is also thought to play a role in insomnia and possibly in mood.

“Oftentimes the focus on a lot of these drugs is hot flashes, hot flashes, hot flashes, but we know hot flashes do not occur in isolation,” Chrisandra Shufelt, MD, professor and chair of general internal medicine and associate director of the Women’s Health Research Center at Mayo Clinic in Jacksonville, Florida, told this news organization. Elinzanetant is “an interesting compound because it actually works on sleep, and that was critical because sleep disturbance precedes” many other menopausal symptoms, said Dr. Shufelt, who was not involved in the study.

“I think it is an outstanding option for women who don’t have the opportunity to get hormones,” Dr. Shufelt said, and she was particularly pleased to see there were no safety concerns for the liver in the trial data. The FDA issued a warning on September 12 about the risk for rare liver injury with fezolinetant, but the early signals that had been seen in fezolinetant data were not seen in these elinzanetant data.

The OASIS 1 and 2 trials enrolled postmenopausal women, aged 40-65 years, who had at least 50 moderate to severe vasomotor occurrences per week.

“A moderate hot flash is a hot flash that is also associated with sweating, and a severe hot flash is a moderate hot flash that stops a woman in her tracks,” Dr. Simon said. “Namely, it’s severe enough with sweating and central nervous system effects that she is interrupted in whatever it is that she’s doing at the time.”

Exclusion criteria for the trials included a history of arrhythmias, heart block, or QT prolongation; abnormal lab results; history of malignancy within the past 5 years; uncontrolled or treatment-resistant hypertension, hypothyroidism, or hyperthyroidism; unexplained postmenopausal bleeding; clinically relevant abnormal mammogram findings; or disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer.

The predominantly White (80%) women were an average 54 years old, with an average body mass index (BMI) of 27.8, and were an average 3.5 years from their last period. For the first 12 weeks of the trials, 399 women were assigned to receive 120 mg once daily of oral elinzanetant and 397 were assigned to once daily placebo. Then the women taking placebo switched to elinzanetant for the final 14 weeks of the study.

The endpoints included mean change in frequency and severity of vasomotor symptoms at weeks 1, 4, and 12 as well as change in sleep disturbance and quality of life at week 12. Sleep was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form score, which ranges from 28.9 to 76.5, with a higher number denoting greater sleep disturbance. The Menopause-Specific Quality-of-Life score ranges from 1 to 8, with a higher score indicating poorer quality of life.

Daily frequency of vasomotor symptoms was 14 per day at baseline in the elinzanetant group, decreasing by 4.8 per day at week 1, 8 per day at week 4, and 9.4 per day at week 12. In the placebo group, women had an average 15.2 occurrences per day at baseline, which decreased by 3.2 at week 1, 5.2 at week 4, and 6.4 at week 12. Comparing the groups at 12 weeks, those receiving elinzanetant had 3.2 fewer daily vasomotor symptoms than those receiving placebo (P < .0001).

The severity of vasomotor symptoms also improved more in the elinzanetant group than in the placebo group over 12 weeks, after which severity improved further in those who switched from placebo to elinzanetant (P < .0001).

Sleep disturbance scores, starting at a mean 61.5 in the elinzanetant group and 60.5 in the placebo group, fell 10.7 points in the elinzanetant group and 5.3 points in the placebo group at 12 weeks, for a difference of 4.9 points (P < .0001). Sleep then further improved in those who switched from placebo to elinzanetant. Quality-of-life scores improved 1.37 points (from 4.52 at baseline) in the elinzanetant group and 0.96 points (from 4.49 at baseline) in the placebo group, for a mean difference at 12 weeks of 0.36 (P < .0001).

Though no head-to-head data exist comparing elinzanetant and fezolinetant, Dr. Simon told this news organization the side effects with fezolinetant “tend to be gastrointestinal, whereas the side effects for elinzanetant tend to be central nervous system,” such as drowsiness and lethargy.

The women who are the best candidates for elinzanetant, Dr. Pinkerton told this news organization, include those who have had an estrogen-sensitive cancer, such as breast or endometrial cancer, or who have fear of it, a family history, or are otherwise high risk. Other ideal candidates include those with a history of venous thromboembolism, people who have migraine with aura (due to concerns about increased risk for stroke), and those who have endometriosis or large fibroids.

“Then the last group might be women who took hormone therapy in their 50s and want to continue, but they’re trying to go off, and they have a recurrence of their hot flashes or night sweats or sleep issues,” Dr. Pinkerton said. “This might be a great group to switch over.”

OASIS 3 assessed the drug for 1 year and “supported the results of OASIS 1 and 2, demonstrating efficacy over a longer study duration and in a population with a vasomotor symptom profile representative of that seen in clinical practice,” Nick Panay, BSc, MBBS, director of the Menopause & PMS Centre at Queen Charlotte’s Hospital & Imperial College London, London, England, and his colleague reported.

Among 628 postmenopausal women aged 40-65, the predominantly White (78.5%) women were an average 54 years old, with an average BMI of 27.6, and were an average 5 years past their last period. Half received 120 mg elinzanetant and half received a placebo for 52 weeks.

At 12 weeks, the women receiving elinzanetant reported an average 1.6 moderate to severe vasomotor symptoms per day, down from 6.7 at baseline. Daily average symptoms in the placebo group fell from 6.8 at baseline to 3.4 at 12 weeks, for a difference of 1.6 fewer occurrences per day in the elinzanetant group (P < .0001).

Sleep disturbances also improved, falling 9.4 points from a baseline 57.4 in the elinzanetant group and 5.7 points from a baseline 58 in the placebo group. Quality-of-life scores improved from 4.1 to 2.8 (−1.3 change) in the elinzanetant group and from 4.4 to 3.3 (−1.1 change) in the placebo group.

In addition to looking at treatment-emergent adverse events, the safety assessments also included endometrial biopsies; bone mineral density in the femoral neck, hip, and lumbar spine; weight; and labs. Adverse events related to the study drug occurred in 30.4% of those in the elinzanetant group and 14.6% of those in the placebo group. The most commonly reported adverse events were headache (9.6% elinzanetant vs 7% placebo), fatigue (7% vs 10.2%), and sleepiness (5.1% vs 1.3%). A higher proportion of women taking elinzanetant (12.5%) than those taking placebo (4.1%) discontinued the study.

No serious adverse events deemed to be treatment-related occurred in either group, and no endometrial hyperplasia or malignant neoplasm occurred in either group. Bone mineral density changes in both groups were within the expected range for the women’s age, and their weight remained stable over the 52 weeks.

Six women taking elinzanetant and four taking placebo met predefined criteria for close liver observation, but none showed hepatotoxicity or evidence of possible drug-induced liver injury.

The research was funded by Bayer. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Dr. Shufelt had no disclosures. Dr. Simon had grant/research support, consulting/advisory board participation, and/or speaking disclosures with AbbVie, Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services, Covance, Daré Bioscience, DEKA M.E.L.A S.r.l., Femasys, Ipsen, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mayne Pharma, Mitsubishi Tanabe Pharma Development America, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Pfizer, Pharmavite, QUE Oncology, Scynexis, Sebela Pharmaceuticals, Sprout Pharmaceuticals, TherapeuticsMD, Vella Bioscience, and Viveve Medical, and he is a stockholder in Sermonix Pharmaceuticals.

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

CHICAGO — The nonhormonal investigational drug elinzanetant led to significant improvement in hot flashes as well as sleep disturbance and quality of life, according to data from three randomized controlled trials presented at The Menopause Society 2024 Annual Meeting in Chicago. Two phase 3 trials, OASIS 1 and 2, were also published in JAMA, and the longer-term OASIS 3 trial was presented as a poster at the conference.

Elinzanetant is a selective neurokinin (NK) receptor antagonist, similar to fezolinetant, the first drug in this class approved by the US Food and Drug Administration (FDA) for vasomotor symptoms in May 2023. This class of medications targets the estrogen-sensitive kisspeptin/NK B/dynorphin (KNDy) neurons thought to play a role in thermoregulation and hot flashes during menopause. While fezolinetant targets only the NK-3 receptor, elinzanetant is a dual NK receptor antagonist that targets both NK-1 and NK-3. Bayer submitted a New Drug Application for elinzanetant to the FDA on August 1.

For those in whom hormone therapy is contraindicated, “it’s always been difficult for women with really severe symptoms to have a safe and effective therapy,” lead author JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, told this news organization. “The nonhormonal therapies we’ve used mostly off-label — the antidepressants, gabapentin, clonidine, oxybutynin — do help the hot flashes, but they don’t work nearly as effectively as these new NK receptor antagonists, and having one that looks like it might have a broader use for hot flashes, night sweats, mood, and sleep is just really exciting.”

Dr. Pinkerton said approximately 80% of the women in the OASIS 1 and 2 studies had at least a 50% reduction in hot flashes. “It was a very strong, dramatic positive finding, but the improvements in sleep and mood have really encouraged us to go further,” she said.

Declining estrogen levels during and after menopause can cause hypertrophy and hyperactivity of the KNDy neurons, which has been linked to thermoregulation disruptions that may trigger hot flashes, James Simon, MD, a clinical professor of ob.gyn. at The George Washington University School of Medicine & Health Sciences and medical director of IntimMedicine in Washington, DC, told attendees. He presented pooled data from OASIS 1 and 2. The NK-1 receptor, targeted by elinzanetant but not fezolinetant, is also thought to play a role in insomnia and possibly in mood.

“Oftentimes the focus on a lot of these drugs is hot flashes, hot flashes, hot flashes, but we know hot flashes do not occur in isolation,” Chrisandra Shufelt, MD, professor and chair of general internal medicine and associate director of the Women’s Health Research Center at Mayo Clinic in Jacksonville, Florida, told this news organization. Elinzanetant is “an interesting compound because it actually works on sleep, and that was critical because sleep disturbance precedes” many other menopausal symptoms, said Dr. Shufelt, who was not involved in the study.

“I think it is an outstanding option for women who don’t have the opportunity to get hormones,” Dr. Shufelt said, and she was particularly pleased to see there were no safety concerns for the liver in the trial data. The FDA issued a warning on September 12 about the risk for rare liver injury with fezolinetant, but the early signals that had been seen in fezolinetant data were not seen in these elinzanetant data.

The OASIS 1 and 2 trials enrolled postmenopausal women, aged 40-65 years, who had at least 50 moderate to severe vasomotor occurrences per week.

“A moderate hot flash is a hot flash that is also associated with sweating, and a severe hot flash is a moderate hot flash that stops a woman in her tracks,” Dr. Simon said. “Namely, it’s severe enough with sweating and central nervous system effects that she is interrupted in whatever it is that she’s doing at the time.”

Exclusion criteria for the trials included a history of arrhythmias, heart block, or QT prolongation; abnormal lab results; history of malignancy within the past 5 years; uncontrolled or treatment-resistant hypertension, hypothyroidism, or hyperthyroidism; unexplained postmenopausal bleeding; clinically relevant abnormal mammogram findings; or disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer.

The predominantly White (80%) women were an average 54 years old, with an average body mass index (BMI) of 27.8, and were an average 3.5 years from their last period. For the first 12 weeks of the trials, 399 women were assigned to receive 120 mg once daily of oral elinzanetant and 397 were assigned to once daily placebo. Then the women taking placebo switched to elinzanetant for the final 14 weeks of the study.

The endpoints included mean change in frequency and severity of vasomotor symptoms at weeks 1, 4, and 12 as well as change in sleep disturbance and quality of life at week 12. Sleep was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form score, which ranges from 28.9 to 76.5, with a higher number denoting greater sleep disturbance. The Menopause-Specific Quality-of-Life score ranges from 1 to 8, with a higher score indicating poorer quality of life.

Daily frequency of vasomotor symptoms was 14 per day at baseline in the elinzanetant group, decreasing by 4.8 per day at week 1, 8 per day at week 4, and 9.4 per day at week 12. In the placebo group, women had an average 15.2 occurrences per day at baseline, which decreased by 3.2 at week 1, 5.2 at week 4, and 6.4 at week 12. Comparing the groups at 12 weeks, those receiving elinzanetant had 3.2 fewer daily vasomotor symptoms than those receiving placebo (P < .0001).

The severity of vasomotor symptoms also improved more in the elinzanetant group than in the placebo group over 12 weeks, after which severity improved further in those who switched from placebo to elinzanetant (P < .0001).

Sleep disturbance scores, starting at a mean 61.5 in the elinzanetant group and 60.5 in the placebo group, fell 10.7 points in the elinzanetant group and 5.3 points in the placebo group at 12 weeks, for a difference of 4.9 points (P < .0001). Sleep then further improved in those who switched from placebo to elinzanetant. Quality-of-life scores improved 1.37 points (from 4.52 at baseline) in the elinzanetant group and 0.96 points (from 4.49 at baseline) in the placebo group, for a mean difference at 12 weeks of 0.36 (P < .0001).

Though no head-to-head data exist comparing elinzanetant and fezolinetant, Dr. Simon told this news organization the side effects with fezolinetant “tend to be gastrointestinal, whereas the side effects for elinzanetant tend to be central nervous system,” such as drowsiness and lethargy.

The women who are the best candidates for elinzanetant, Dr. Pinkerton told this news organization, include those who have had an estrogen-sensitive cancer, such as breast or endometrial cancer, or who have fear of it, a family history, or are otherwise high risk. Other ideal candidates include those with a history of venous thromboembolism, people who have migraine with aura (due to concerns about increased risk for stroke), and those who have endometriosis or large fibroids.

“Then the last group might be women who took hormone therapy in their 50s and want to continue, but they’re trying to go off, and they have a recurrence of their hot flashes or night sweats or sleep issues,” Dr. Pinkerton said. “This might be a great group to switch over.”

OASIS 3 assessed the drug for 1 year and “supported the results of OASIS 1 and 2, demonstrating efficacy over a longer study duration and in a population with a vasomotor symptom profile representative of that seen in clinical practice,” Nick Panay, BSc, MBBS, director of the Menopause & PMS Centre at Queen Charlotte’s Hospital & Imperial College London, London, England, and his colleague reported.

Among 628 postmenopausal women aged 40-65, the predominantly White (78.5%) women were an average 54 years old, with an average BMI of 27.6, and were an average 5 years past their last period. Half received 120 mg elinzanetant and half received a placebo for 52 weeks.

At 12 weeks, the women receiving elinzanetant reported an average 1.6 moderate to severe vasomotor symptoms per day, down from 6.7 at baseline. Daily average symptoms in the placebo group fell from 6.8 at baseline to 3.4 at 12 weeks, for a difference of 1.6 fewer occurrences per day in the elinzanetant group (P < .0001).

Sleep disturbances also improved, falling 9.4 points from a baseline 57.4 in the elinzanetant group and 5.7 points from a baseline 58 in the placebo group. Quality-of-life scores improved from 4.1 to 2.8 (−1.3 change) in the elinzanetant group and from 4.4 to 3.3 (−1.1 change) in the placebo group.

In addition to looking at treatment-emergent adverse events, the safety assessments also included endometrial biopsies; bone mineral density in the femoral neck, hip, and lumbar spine; weight; and labs. Adverse events related to the study drug occurred in 30.4% of those in the elinzanetant group and 14.6% of those in the placebo group. The most commonly reported adverse events were headache (9.6% elinzanetant vs 7% placebo), fatigue (7% vs 10.2%), and sleepiness (5.1% vs 1.3%). A higher proportion of women taking elinzanetant (12.5%) than those taking placebo (4.1%) discontinued the study.

No serious adverse events deemed to be treatment-related occurred in either group, and no endometrial hyperplasia or malignant neoplasm occurred in either group. Bone mineral density changes in both groups were within the expected range for the women’s age, and their weight remained stable over the 52 weeks.

Six women taking elinzanetant and four taking placebo met predefined criteria for close liver observation, but none showed hepatotoxicity or evidence of possible drug-induced liver injury.

The research was funded by Bayer. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Dr. Shufelt had no disclosures. Dr. Simon had grant/research support, consulting/advisory board participation, and/or speaking disclosures with AbbVie, Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services, Covance, Daré Bioscience, DEKA M.E.L.A S.r.l., Femasys, Ipsen, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mayne Pharma, Mitsubishi Tanabe Pharma Development America, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Pfizer, Pharmavite, QUE Oncology, Scynexis, Sebela Pharmaceuticals, Sprout Pharmaceuticals, TherapeuticsMD, Vella Bioscience, and Viveve Medical, and he is a stockholder in Sermonix Pharmaceuticals.

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

CHICAGO — The vast majority of women experiencing genitourinary syndrome of menopause (GSM) symptoms did not receive a prescription for hormonal vaginal therapies prior to seeking care at a specialized menopause clinic, according to research presented at the annual meeting of The Menopause Society.

“GSM symptoms are very common and affect women’s health and quality of life, often worsening without effective therapy,” Leticia Hernández Galán, PhD, of the Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada, and colleagues reported. “We have demonstrated that most women seeking specialty care in an urban center with GSM symptoms have not been given a trial of local vaginal therapies by referring providers despite guidelines about safety and lack of contraindications. Given very long wait times for menopause providers in Canada, improved education for both women and their providers is needed to reduce needless suffering and improve care.”

Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, was not involved with the study but agreed with the authors’ assessment of the findings.

“This study highlights the treatment gap for women with genitourinary syndrome of menopause,” Dr. Faubion told this news organization. “Clearly, there is underutilization of low-dose vaginal hormonal therapies, which are known to be safe and effective. We still have work to do in terms of educating both women and providers on established treatment options for this common concern in menopausal women.” 

The findings match previous ones that found a majority of women with GSM do not receive treatment. A 2017 study, which was cited in the 2020 Menopause Society position statement on the condition, found that half of women with GSM had never used any treatment.

GSM is the current term that replaces previously used “vulvovaginal atrophy” and “atrophic vaginitis” because it encompasses all the menopause symptoms and signs associated with menopause that affect the vagina, vulva, and urinary tract. Anywhere from 50% to 84% of postmenopausal women experience GSM, the authors noted, with symptoms that include “burning, itching, or irritation of the vulva” and “lack of lubrication and discomfort or pain with sexual activity as well as dysuria, increased frequency or urgency of urination, and increased risk for urinary tract infections.”

First-line treatment of mild GSM often includes nonhormonal vaginal lubricants and moisturizers, but vaginal estrogen is considered the most effective treatment for more severe or bothersome cases. Other treatments include systematic hormone therapy and ospemifene or other selective estrogen receptor modulators.
 

Increased Risk for Urinary Tract Infections (UTIs)

Untreated GSM is not simply a quality of life issue; it increases the risk of developing serious UTIs, explained JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, Charlottesville, who was not involved in the study.

“Estrogen depletion alters the vaginal epithelium, with distinct impairments in lubrication, elasticity, pH, and blood flow,” Dr. Pinkerton said. “The vaginal microbiome changes, with increasing pH following menopause and loss of lactobacillus predominance. These alterations allow a more hospitable environment for bacterial growth and increase the risk of UTI.”

Vaginal estrogen, meanwhile, reduces UTI risk because it “increases the presence of lactobacillus in the vagina due to improvements in vaginal pH, rebuilding superficial cells, elasticity, and connectivity,” she said.

The study assessed the incidence of GSM among patients at a single specialized Canadian institution, St. Joseph’s Healthcare Menopause Clinic in Hamilton, Ontario, between January 2021 and August 2024. Patients completed a Menopause Rating Scale that quantified two sets of GSM symptoms relating to “dryness of the vagina” and “bladder problems.” Patients also answered questions about the provider they had seen before coming to the specialized clinic and whether they had been prescribed local vaginal products before their visit.

Among 529 patients, the average age was 51, and the vast majority (88%) had some amount of tertiary education beyond high school. Only 21.5% were still menstruating, whereas the other respondents had stopped menstruating. The patient population was mostly White (85.6%), with Black, Hispanic, Asian, Middle Eastern, and Indigenous patients making up most of the other patient groups.

Among the 521 patients who answered the question on vaginal dryness, answers were similarly split between none (26%), mild (23%), moderate (21%), severe (15%), and very severe (15%). One third of the 526 women (34%) who answered the question on bladder problems said they had none, whereas the remainder reported their problems as mild (24%), moderate (24%), severe (11%), or very severe (7%).

Despite about half the participants reporting moderate to very severe vaginal dryness, 85% of them had not been prescribed local vaginal hormone therapies before their visit to the menopause clinic. Women were more likely to have been prescribed a localized therapy if they were older, were postmenopausal instead of perimenopausal, or had a female healthcare provider prior to this visit.

The survey also asked about the specialty and years in practice for the providers women had seen before visiting the clinic, but neither of these were predictors for receiving a hormone prescription. The patient’s education, partner status, and ethnicity were also not associated with the likelihood of a prescription.

Among 62 women who had been prescribed a vaginal hormone treatment, most were prescribed Vagifem (29%) or Premarin Vaginal cream (26%), followed by Intrarosa (19%), Estragyn cream (16%), Estring (3%), or something else (18%).
 

Serious Complications of GSM

Dr. Pinkerton described how GSM, particularly in older women, can run the risk of becoming life-threatening if untreated and unrecognized.

“For some women, UTIs can lead to urosepsis, as both the vaginal tissues and bladder tissues are thin with blood vessels close to the surface,” Dr. Pinkerton said. “What may have started as a UTI, can ascend to the kidneys or get into the bloodstream, which, in some, can develop into urosepsis, which can be life-threatening. The bacterial pathogen initiates the disease process, but host immune responses drive whether sepsis develops and its severity.”

The research by Dr. Hernández Galán was funded by the Canadian Institutes of Health Research, the Canadian Menopause Society, and Pfizer. Dr. Faubion had no disclosures, and Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer.

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

CHICAGO — The vast majority of women experiencing genitourinary syndrome of menopause (GSM) symptoms did not receive a prescription for hormonal vaginal therapies prior to seeking care at a specialized menopause clinic, according to research presented at the annual meeting of The Menopause Society.

“GSM symptoms are very common and affect women’s health and quality of life, often worsening without effective therapy,” Leticia Hernández Galán, PhD, of the Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada, and colleagues reported. “We have demonstrated that most women seeking specialty care in an urban center with GSM symptoms have not been given a trial of local vaginal therapies by referring providers despite guidelines about safety and lack of contraindications. Given very long wait times for menopause providers in Canada, improved education for both women and their providers is needed to reduce needless suffering and improve care.”

Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, was not involved with the study but agreed with the authors’ assessment of the findings.

“This study highlights the treatment gap for women with genitourinary syndrome of menopause,” Dr. Faubion told this news organization. “Clearly, there is underutilization of low-dose vaginal hormonal therapies, which are known to be safe and effective. We still have work to do in terms of educating both women and providers on established treatment options for this common concern in menopausal women.” 

The findings match previous ones that found a majority of women with GSM do not receive treatment. A 2017 study, which was cited in the 2020 Menopause Society position statement on the condition, found that half of women with GSM had never used any treatment.

GSM is the current term that replaces previously used “vulvovaginal atrophy” and “atrophic vaginitis” because it encompasses all the menopause symptoms and signs associated with menopause that affect the vagina, vulva, and urinary tract. Anywhere from 50% to 84% of postmenopausal women experience GSM, the authors noted, with symptoms that include “burning, itching, or irritation of the vulva” and “lack of lubrication and discomfort or pain with sexual activity as well as dysuria, increased frequency or urgency of urination, and increased risk for urinary tract infections.”

First-line treatment of mild GSM often includes nonhormonal vaginal lubricants and moisturizers, but vaginal estrogen is considered the most effective treatment for more severe or bothersome cases. Other treatments include systematic hormone therapy and ospemifene or other selective estrogen receptor modulators.
 

Increased Risk for Urinary Tract Infections (UTIs)

Untreated GSM is not simply a quality of life issue; it increases the risk of developing serious UTIs, explained JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, Charlottesville, who was not involved in the study.

“Estrogen depletion alters the vaginal epithelium, with distinct impairments in lubrication, elasticity, pH, and blood flow,” Dr. Pinkerton said. “The vaginal microbiome changes, with increasing pH following menopause and loss of lactobacillus predominance. These alterations allow a more hospitable environment for bacterial growth and increase the risk of UTI.”

Vaginal estrogen, meanwhile, reduces UTI risk because it “increases the presence of lactobacillus in the vagina due to improvements in vaginal pH, rebuilding superficial cells, elasticity, and connectivity,” she said.

The study assessed the incidence of GSM among patients at a single specialized Canadian institution, St. Joseph’s Healthcare Menopause Clinic in Hamilton, Ontario, between January 2021 and August 2024. Patients completed a Menopause Rating Scale that quantified two sets of GSM symptoms relating to “dryness of the vagina” and “bladder problems.” Patients also answered questions about the provider they had seen before coming to the specialized clinic and whether they had been prescribed local vaginal products before their visit.

Among 529 patients, the average age was 51, and the vast majority (88%) had some amount of tertiary education beyond high school. Only 21.5% were still menstruating, whereas the other respondents had stopped menstruating. The patient population was mostly White (85.6%), with Black, Hispanic, Asian, Middle Eastern, and Indigenous patients making up most of the other patient groups.

Among the 521 patients who answered the question on vaginal dryness, answers were similarly split between none (26%), mild (23%), moderate (21%), severe (15%), and very severe (15%). One third of the 526 women (34%) who answered the question on bladder problems said they had none, whereas the remainder reported their problems as mild (24%), moderate (24%), severe (11%), or very severe (7%).

Despite about half the participants reporting moderate to very severe vaginal dryness, 85% of them had not been prescribed local vaginal hormone therapies before their visit to the menopause clinic. Women were more likely to have been prescribed a localized therapy if they were older, were postmenopausal instead of perimenopausal, or had a female healthcare provider prior to this visit.

The survey also asked about the specialty and years in practice for the providers women had seen before visiting the clinic, but neither of these were predictors for receiving a hormone prescription. The patient’s education, partner status, and ethnicity were also not associated with the likelihood of a prescription.

Among 62 women who had been prescribed a vaginal hormone treatment, most were prescribed Vagifem (29%) or Premarin Vaginal cream (26%), followed by Intrarosa (19%), Estragyn cream (16%), Estring (3%), or something else (18%).
 

Serious Complications of GSM

Dr. Pinkerton described how GSM, particularly in older women, can run the risk of becoming life-threatening if untreated and unrecognized.

“For some women, UTIs can lead to urosepsis, as both the vaginal tissues and bladder tissues are thin with blood vessels close to the surface,” Dr. Pinkerton said. “What may have started as a UTI, can ascend to the kidneys or get into the bloodstream, which, in some, can develop into urosepsis, which can be life-threatening. The bacterial pathogen initiates the disease process, but host immune responses drive whether sepsis develops and its severity.”

The research by Dr. Hernández Galán was funded by the Canadian Institutes of Health Research, the Canadian Menopause Society, and Pfizer. Dr. Faubion had no disclosures, and Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer.

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

CHICAGO — The vast majority of women experiencing genitourinary syndrome of menopause (GSM) symptoms did not receive a prescription for hormonal vaginal therapies prior to seeking care at a specialized menopause clinic, according to research presented at the annual meeting of The Menopause Society.

“GSM symptoms are very common and affect women’s health and quality of life, often worsening without effective therapy,” Leticia Hernández Galán, PhD, of the Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada, and colleagues reported. “We have demonstrated that most women seeking specialty care in an urban center with GSM symptoms have not been given a trial of local vaginal therapies by referring providers despite guidelines about safety and lack of contraindications. Given very long wait times for menopause providers in Canada, improved education for both women and their providers is needed to reduce needless suffering and improve care.”

Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, was not involved with the study but agreed with the authors’ assessment of the findings.

“This study highlights the treatment gap for women with genitourinary syndrome of menopause,” Dr. Faubion told this news organization. “Clearly, there is underutilization of low-dose vaginal hormonal therapies, which are known to be safe and effective. We still have work to do in terms of educating both women and providers on established treatment options for this common concern in menopausal women.” 

The findings match previous ones that found a majority of women with GSM do not receive treatment. A 2017 study, which was cited in the 2020 Menopause Society position statement on the condition, found that half of women with GSM had never used any treatment.

GSM is the current term that replaces previously used “vulvovaginal atrophy” and “atrophic vaginitis” because it encompasses all the menopause symptoms and signs associated with menopause that affect the vagina, vulva, and urinary tract. Anywhere from 50% to 84% of postmenopausal women experience GSM, the authors noted, with symptoms that include “burning, itching, or irritation of the vulva” and “lack of lubrication and discomfort or pain with sexual activity as well as dysuria, increased frequency or urgency of urination, and increased risk for urinary tract infections.”

First-line treatment of mild GSM often includes nonhormonal vaginal lubricants and moisturizers, but vaginal estrogen is considered the most effective treatment for more severe or bothersome cases. Other treatments include systematic hormone therapy and ospemifene or other selective estrogen receptor modulators.
 

Increased Risk for Urinary Tract Infections (UTIs)

Untreated GSM is not simply a quality of life issue; it increases the risk of developing serious UTIs, explained JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, Charlottesville, who was not involved in the study.

“Estrogen depletion alters the vaginal epithelium, with distinct impairments in lubrication, elasticity, pH, and blood flow,” Dr. Pinkerton said. “The vaginal microbiome changes, with increasing pH following menopause and loss of lactobacillus predominance. These alterations allow a more hospitable environment for bacterial growth and increase the risk of UTI.”

Vaginal estrogen, meanwhile, reduces UTI risk because it “increases the presence of lactobacillus in the vagina due to improvements in vaginal pH, rebuilding superficial cells, elasticity, and connectivity,” she said.

The study assessed the incidence of GSM among patients at a single specialized Canadian institution, St. Joseph’s Healthcare Menopause Clinic in Hamilton, Ontario, between January 2021 and August 2024. Patients completed a Menopause Rating Scale that quantified two sets of GSM symptoms relating to “dryness of the vagina” and “bladder problems.” Patients also answered questions about the provider they had seen before coming to the specialized clinic and whether they had been prescribed local vaginal products before their visit.

Among 529 patients, the average age was 51, and the vast majority (88%) had some amount of tertiary education beyond high school. Only 21.5% were still menstruating, whereas the other respondents had stopped menstruating. The patient population was mostly White (85.6%), with Black, Hispanic, Asian, Middle Eastern, and Indigenous patients making up most of the other patient groups.

Among the 521 patients who answered the question on vaginal dryness, answers were similarly split between none (26%), mild (23%), moderate (21%), severe (15%), and very severe (15%). One third of the 526 women (34%) who answered the question on bladder problems said they had none, whereas the remainder reported their problems as mild (24%), moderate (24%), severe (11%), or very severe (7%).

Despite about half the participants reporting moderate to very severe vaginal dryness, 85% of them had not been prescribed local vaginal hormone therapies before their visit to the menopause clinic. Women were more likely to have been prescribed a localized therapy if they were older, were postmenopausal instead of perimenopausal, or had a female healthcare provider prior to this visit.

The survey also asked about the specialty and years in practice for the providers women had seen before visiting the clinic, but neither of these were predictors for receiving a hormone prescription. The patient’s education, partner status, and ethnicity were also not associated with the likelihood of a prescription.

Among 62 women who had been prescribed a vaginal hormone treatment, most were prescribed Vagifem (29%) or Premarin Vaginal cream (26%), followed by Intrarosa (19%), Estragyn cream (16%), Estring (3%), or something else (18%).
 

Serious Complications of GSM

Dr. Pinkerton described how GSM, particularly in older women, can run the risk of becoming life-threatening if untreated and unrecognized.

“For some women, UTIs can lead to urosepsis, as both the vaginal tissues and bladder tissues are thin with blood vessels close to the surface,” Dr. Pinkerton said. “What may have started as a UTI, can ascend to the kidneys or get into the bloodstream, which, in some, can develop into urosepsis, which can be life-threatening. The bacterial pathogen initiates the disease process, but host immune responses drive whether sepsis develops and its severity.”

The research by Dr. Hernández Galán was funded by the Canadian Institutes of Health Research, the Canadian Menopause Society, and Pfizer. Dr. Faubion had no disclosures, and Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer.

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

CHICAGO — Less than 4% of American women aged 50-59 years use hormone therapy (HT) to treat menopausal symptoms today, approximately 10 times lower than the peak use of HT before the publication of the 2002 Women’s Health Initiative (WHI) study that misguidedly cast doubt on the safety of HT. Though subsequent research has addressed the flaws of the WHI study and supports the use of HT in most menopausal women younger than 60 years, use of this therapy has never recovered, according to research presented at the annual meeting of The Menopause Society (formerly The North American Menopause Society).

“Despite evidence supporting the efficacy and safety of HT, usage rates of US Food and Drug Administration–approved HT remain low,” Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, told attendees. “Improved education of clinicians and patients is critically needed.”

Today, “there is more clarity on the risk/benefit ratio of HT use with the benefits typically outweighing the risks in women who initiate therapy under the age of 60 years and within 10 years of menopause onset.”

Using medical and pharmacy claims data from OptumLabs, Dr. Faubion and her colleagues examined utilization rates from 2007 to 2023 of transdermal vs oral estrogen and of conjugated estrogen vs estradiol in women aged 40 years or older. The data included more than 200 million people throughout the United States covered by commercial insurance or Medicare Advantage. The researchers defined annual rate of HT use as the proportion of women who had at least 180 days of a filled prescription for a systemic HT preparation with estrogen.

The study population increased from an estimated 2 million women in 2007 to 4.5 million women in 2023, and the average age of enrollees increased from 53 in 2007 to 66 in 2023. Starting at 4.6% in 2007, HT use steadily declined to a low of 1.8% in 2023 for the whole cohort of women aged 40 years or older.

Though rates remained highest in women aged 50-64 years, it still declined within each age group: From 6% in 2007 to 3.6% in 2023 among women aged 50-54 years, from 7.3% to 3.8% among women aged 55-59 years, and from 7.5% to 2.9% among women aged 60-64 years. It also declined in younger women, from 3.2% in 2007 to 1.5% in 2023 in those aged 45-50 years. Estradiol was the most common formulation used, and oral administration was the most common route.

The researchers also saw a gradual decline during the study period in the use of high-dose oral HT and an increase in the use of low-dose oral HT, whereas standard dosages remained fairly consistent as the most common dose prescribed. Similarly, the use of high transdermal doses declined, whereas low transdermal doses increased and surpassed the use of standard doses. Conjugated estrogen use plummeted during the study period across all age groups, from 2%-5% in most age groups to < 1% in all age groups by 2023.

One limitation of the study was that it could not examine rates of compounded HT use because those would not be reflected in insurance claims, pointed out JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, who was not involved in the study. Dr. Pinkerton found it surprising that the numbers were so low, despite the fact that research estimates suggest less than 15% of menopausal women are receiving adequate treatment, she told this news organization. “You can see there’s a large unmet need to get treatment,” she said. “All major medical societies say the same thing: For healthy, symptomatic menopausal women, you can use hormone therapy safely and effectively.” 

The lack of education among providers is likely the biggest reason for the decline, Dr. Pinkerton says. “I think it’s because there’s a whole group of providers that did not receive any training, and that’s OB/GYNs, internal medicine, family practice, endocrinologists,” she said. “Now that people are starting to feel more confident that we can use it safely, we’re trying to get that training out to people about vasomotor symptoms, about hormone therapy, and now about new nonhormone therapies.”

Dr. Pinkerton noted that The Menopause Society has begun a new teaching program, Menopause Step-by-Step, aimed at providing short articles on the basics of menopause, HT, non-HT, and vaginal issues.

A separate poster presented at the conference provides insight into another potential factor contributing to low HT rates. A survey of 1050 American and Canadian women found that 90% discussed their symptoms with their healthcare providers, yet only 25% said their doctor identified the symptoms as likely due to perimenopause or menopause on their first visit — and only 10% of respondents said their doctor was the one to bring up perimenopause/menopause.

The respondents comprised a convenience sample of those who saw the survey on social media, in an email, or on the website of Morphus, a Toronto-based company aimed at providing support, information, and products related to menopause. Though the survey is ongoing, the analyzed responses are from March to May 2024.

Though 40% of the women said their provider attributed their symptoms to perimenopause or menopause on the second or third visit, 18% saw a provider four to five times, and 17% saw a provider more than five times before the provider considered menopause as a cause. About a third of the women (35%) brought it up to their doctor themselves and found their provider receptive, but 40% said the response was dismissive when they brought it up, and 15% said the topic was never broached at all.

Andrea Donsky, RHN, founder of Morphus who conducted the study, found these numbers surprising because she would have hoped that more doctors would have brought up perimenopause/menopause sooner. “We still have a lot of work to do to help educate women and healthcare providers,” Ms. Donsky told this news organization. “A lot of women spend years not knowing they’re in this phase of life, so they visit their doctors/HCPs [healthcare providers] many times because the connection isn’t made on the first visit.”

Danielle Meitiv, MS, a study co-author and health coach based in Silver Spring, Maryland, added, “Everyone wonders why we end up with Dr. Google; that’s the only doctor who’s talking to us about menopause.”

Dr. Pinkerton was less surprised by these survey findings. “As a menopause specialist, my most common new patient is a perimenopausal woman who feels like she hasn’t been listened to,” whether it’s her primary care doctor, her ob.gyn., or another clinician. “If the provider doesn’t ask or if the women doesn’t tell, then you don’t have the conversation,” Dr. Pinkerton said. “So many women in perimenopause are busy with work, families, partnerships, aging parents — all of the issues that they’re dealing with — that when they start to have sleep issues or mood issues or easy crying, they relate it to their life stressors, instead of recognizing that it’s fluctuating hormones.”

When Ms. Donsky examined the 1223 responses they had received through August 2024, the most common treatments advised for symptoms were antidepressants and HT, both recommended by 38% of providers. Other common recommendations were to “lose weight,” “eat less and exercise more,” supplements, or birth control pills.

Dr. Faubion had no disclosures, and her study used no external funding. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Ms. Donsky is the owner of Morphus. Ms. Meitiv had no disclosures. The poster on women’s experiences with providers was funded by Morphus Inc.

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

CHICAGO — Less than 4% of American women aged 50-59 years use hormone therapy (HT) to treat menopausal symptoms today, approximately 10 times lower than the peak use of HT before the publication of the 2002 Women’s Health Initiative (WHI) study that misguidedly cast doubt on the safety of HT. Though subsequent research has addressed the flaws of the WHI study and supports the use of HT in most menopausal women younger than 60 years, use of this therapy has never recovered, according to research presented at the annual meeting of The Menopause Society (formerly The North American Menopause Society).

“Despite evidence supporting the efficacy and safety of HT, usage rates of US Food and Drug Administration–approved HT remain low,” Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, told attendees. “Improved education of clinicians and patients is critically needed.”

Today, “there is more clarity on the risk/benefit ratio of HT use with the benefits typically outweighing the risks in women who initiate therapy under the age of 60 years and within 10 years of menopause onset.”

Using medical and pharmacy claims data from OptumLabs, Dr. Faubion and her colleagues examined utilization rates from 2007 to 2023 of transdermal vs oral estrogen and of conjugated estrogen vs estradiol in women aged 40 years or older. The data included more than 200 million people throughout the United States covered by commercial insurance or Medicare Advantage. The researchers defined annual rate of HT use as the proportion of women who had at least 180 days of a filled prescription for a systemic HT preparation with estrogen.

The study population increased from an estimated 2 million women in 2007 to 4.5 million women in 2023, and the average age of enrollees increased from 53 in 2007 to 66 in 2023. Starting at 4.6% in 2007, HT use steadily declined to a low of 1.8% in 2023 for the whole cohort of women aged 40 years or older.

Though rates remained highest in women aged 50-64 years, it still declined within each age group: From 6% in 2007 to 3.6% in 2023 among women aged 50-54 years, from 7.3% to 3.8% among women aged 55-59 years, and from 7.5% to 2.9% among women aged 60-64 years. It also declined in younger women, from 3.2% in 2007 to 1.5% in 2023 in those aged 45-50 years. Estradiol was the most common formulation used, and oral administration was the most common route.

The researchers also saw a gradual decline during the study period in the use of high-dose oral HT and an increase in the use of low-dose oral HT, whereas standard dosages remained fairly consistent as the most common dose prescribed. Similarly, the use of high transdermal doses declined, whereas low transdermal doses increased and surpassed the use of standard doses. Conjugated estrogen use plummeted during the study period across all age groups, from 2%-5% in most age groups to < 1% in all age groups by 2023.

One limitation of the study was that it could not examine rates of compounded HT use because those would not be reflected in insurance claims, pointed out JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, who was not involved in the study. Dr. Pinkerton found it surprising that the numbers were so low, despite the fact that research estimates suggest less than 15% of menopausal women are receiving adequate treatment, she told this news organization. “You can see there’s a large unmet need to get treatment,” she said. “All major medical societies say the same thing: For healthy, symptomatic menopausal women, you can use hormone therapy safely and effectively.” 

The lack of education among providers is likely the biggest reason for the decline, Dr. Pinkerton says. “I think it’s because there’s a whole group of providers that did not receive any training, and that’s OB/GYNs, internal medicine, family practice, endocrinologists,” she said. “Now that people are starting to feel more confident that we can use it safely, we’re trying to get that training out to people about vasomotor symptoms, about hormone therapy, and now about new nonhormone therapies.”

Dr. Pinkerton noted that The Menopause Society has begun a new teaching program, Menopause Step-by-Step, aimed at providing short articles on the basics of menopause, HT, non-HT, and vaginal issues.

A separate poster presented at the conference provides insight into another potential factor contributing to low HT rates. A survey of 1050 American and Canadian women found that 90% discussed their symptoms with their healthcare providers, yet only 25% said their doctor identified the symptoms as likely due to perimenopause or menopause on their first visit — and only 10% of respondents said their doctor was the one to bring up perimenopause/menopause.

The respondents comprised a convenience sample of those who saw the survey on social media, in an email, or on the website of Morphus, a Toronto-based company aimed at providing support, information, and products related to menopause. Though the survey is ongoing, the analyzed responses are from March to May 2024.

Though 40% of the women said their provider attributed their symptoms to perimenopause or menopause on the second or third visit, 18% saw a provider four to five times, and 17% saw a provider more than five times before the provider considered menopause as a cause. About a third of the women (35%) brought it up to their doctor themselves and found their provider receptive, but 40% said the response was dismissive when they brought it up, and 15% said the topic was never broached at all.

Andrea Donsky, RHN, founder of Morphus who conducted the study, found these numbers surprising because she would have hoped that more doctors would have brought up perimenopause/menopause sooner. “We still have a lot of work to do to help educate women and healthcare providers,” Ms. Donsky told this news organization. “A lot of women spend years not knowing they’re in this phase of life, so they visit their doctors/HCPs [healthcare providers] many times because the connection isn’t made on the first visit.”

Danielle Meitiv, MS, a study co-author and health coach based in Silver Spring, Maryland, added, “Everyone wonders why we end up with Dr. Google; that’s the only doctor who’s talking to us about menopause.”

Dr. Pinkerton was less surprised by these survey findings. “As a menopause specialist, my most common new patient is a perimenopausal woman who feels like she hasn’t been listened to,” whether it’s her primary care doctor, her ob.gyn., or another clinician. “If the provider doesn’t ask or if the women doesn’t tell, then you don’t have the conversation,” Dr. Pinkerton said. “So many women in perimenopause are busy with work, families, partnerships, aging parents — all of the issues that they’re dealing with — that when they start to have sleep issues or mood issues or easy crying, they relate it to their life stressors, instead of recognizing that it’s fluctuating hormones.”

When Ms. Donsky examined the 1223 responses they had received through August 2024, the most common treatments advised for symptoms were antidepressants and HT, both recommended by 38% of providers. Other common recommendations were to “lose weight,” “eat less and exercise more,” supplements, or birth control pills.

Dr. Faubion had no disclosures, and her study used no external funding. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Ms. Donsky is the owner of Morphus. Ms. Meitiv had no disclosures. The poster on women’s experiences with providers was funded by Morphus Inc.

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

CHICAGO — Less than 4% of American women aged 50-59 years use hormone therapy (HT) to treat menopausal symptoms today, approximately 10 times lower than the peak use of HT before the publication of the 2002 Women’s Health Initiative (WHI) study that misguidedly cast doubt on the safety of HT. Though subsequent research has addressed the flaws of the WHI study and supports the use of HT in most menopausal women younger than 60 years, use of this therapy has never recovered, according to research presented at the annual meeting of The Menopause Society (formerly The North American Menopause Society).

“Despite evidence supporting the efficacy and safety of HT, usage rates of US Food and Drug Administration–approved HT remain low,” Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, told attendees. “Improved education of clinicians and patients is critically needed.”

Today, “there is more clarity on the risk/benefit ratio of HT use with the benefits typically outweighing the risks in women who initiate therapy under the age of 60 years and within 10 years of menopause onset.”

Using medical and pharmacy claims data from OptumLabs, Dr. Faubion and her colleagues examined utilization rates from 2007 to 2023 of transdermal vs oral estrogen and of conjugated estrogen vs estradiol in women aged 40 years or older. The data included more than 200 million people throughout the United States covered by commercial insurance or Medicare Advantage. The researchers defined annual rate of HT use as the proportion of women who had at least 180 days of a filled prescription for a systemic HT preparation with estrogen.

The study population increased from an estimated 2 million women in 2007 to 4.5 million women in 2023, and the average age of enrollees increased from 53 in 2007 to 66 in 2023. Starting at 4.6% in 2007, HT use steadily declined to a low of 1.8% in 2023 for the whole cohort of women aged 40 years or older.

Though rates remained highest in women aged 50-64 years, it still declined within each age group: From 6% in 2007 to 3.6% in 2023 among women aged 50-54 years, from 7.3% to 3.8% among women aged 55-59 years, and from 7.5% to 2.9% among women aged 60-64 years. It also declined in younger women, from 3.2% in 2007 to 1.5% in 2023 in those aged 45-50 years. Estradiol was the most common formulation used, and oral administration was the most common route.

The researchers also saw a gradual decline during the study period in the use of high-dose oral HT and an increase in the use of low-dose oral HT, whereas standard dosages remained fairly consistent as the most common dose prescribed. Similarly, the use of high transdermal doses declined, whereas low transdermal doses increased and surpassed the use of standard doses. Conjugated estrogen use plummeted during the study period across all age groups, from 2%-5% in most age groups to < 1% in all age groups by 2023.

One limitation of the study was that it could not examine rates of compounded HT use because those would not be reflected in insurance claims, pointed out JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, who was not involved in the study. Dr. Pinkerton found it surprising that the numbers were so low, despite the fact that research estimates suggest less than 15% of menopausal women are receiving adequate treatment, she told this news organization. “You can see there’s a large unmet need to get treatment,” she said. “All major medical societies say the same thing: For healthy, symptomatic menopausal women, you can use hormone therapy safely and effectively.” 

The lack of education among providers is likely the biggest reason for the decline, Dr. Pinkerton says. “I think it’s because there’s a whole group of providers that did not receive any training, and that’s OB/GYNs, internal medicine, family practice, endocrinologists,” she said. “Now that people are starting to feel more confident that we can use it safely, we’re trying to get that training out to people about vasomotor symptoms, about hormone therapy, and now about new nonhormone therapies.”

Dr. Pinkerton noted that The Menopause Society has begun a new teaching program, Menopause Step-by-Step, aimed at providing short articles on the basics of menopause, HT, non-HT, and vaginal issues.

A separate poster presented at the conference provides insight into another potential factor contributing to low HT rates. A survey of 1050 American and Canadian women found that 90% discussed their symptoms with their healthcare providers, yet only 25% said their doctor identified the symptoms as likely due to perimenopause or menopause on their first visit — and only 10% of respondents said their doctor was the one to bring up perimenopause/menopause.

The respondents comprised a convenience sample of those who saw the survey on social media, in an email, or on the website of Morphus, a Toronto-based company aimed at providing support, information, and products related to menopause. Though the survey is ongoing, the analyzed responses are from March to May 2024.

Though 40% of the women said their provider attributed their symptoms to perimenopause or menopause on the second or third visit, 18% saw a provider four to five times, and 17% saw a provider more than five times before the provider considered menopause as a cause. About a third of the women (35%) brought it up to their doctor themselves and found their provider receptive, but 40% said the response was dismissive when they brought it up, and 15% said the topic was never broached at all.

Andrea Donsky, RHN, founder of Morphus who conducted the study, found these numbers surprising because she would have hoped that more doctors would have brought up perimenopause/menopause sooner. “We still have a lot of work to do to help educate women and healthcare providers,” Ms. Donsky told this news organization. “A lot of women spend years not knowing they’re in this phase of life, so they visit their doctors/HCPs [healthcare providers] many times because the connection isn’t made on the first visit.”

Danielle Meitiv, MS, a study co-author and health coach based in Silver Spring, Maryland, added, “Everyone wonders why we end up with Dr. Google; that’s the only doctor who’s talking to us about menopause.”

Dr. Pinkerton was less surprised by these survey findings. “As a menopause specialist, my most common new patient is a perimenopausal woman who feels like she hasn’t been listened to,” whether it’s her primary care doctor, her ob.gyn., or another clinician. “If the provider doesn’t ask or if the women doesn’t tell, then you don’t have the conversation,” Dr. Pinkerton said. “So many women in perimenopause are busy with work, families, partnerships, aging parents — all of the issues that they’re dealing with — that when they start to have sleep issues or mood issues or easy crying, they relate it to their life stressors, instead of recognizing that it’s fluctuating hormones.”

When Ms. Donsky examined the 1223 responses they had received through August 2024, the most common treatments advised for symptoms were antidepressants and HT, both recommended by 38% of providers. Other common recommendations were to “lose weight,” “eat less and exercise more,” supplements, or birth control pills.

Dr. Faubion had no disclosures, and her study used no external funding. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Ms. Donsky is the owner of Morphus. Ms. Meitiv had no disclosures. The poster on women’s experiences with providers was funded by Morphus Inc.

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.

“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”

Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.

In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.

The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.

The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.

Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.

“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”

The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.

Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.

Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.

The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.

Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.

Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.

“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”

Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.

Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”

Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.

“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.

“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”

The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.

*This story was corrected on July 25, 2024.

An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.

“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”

Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.

In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.

The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.

The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.

Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.

“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”

The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.

Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.

Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.

The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.

Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.

Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.

“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”

Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.

Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”

Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.

“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.

“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”

The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.

*This story was corrected on July 25, 2024.

An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.

“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”

Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.

In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.

The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.

The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.

Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.

“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”

The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.

Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.

Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.

The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.

Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.

Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.

“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”

Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.

Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”

Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.

“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.

“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”

The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.

*This story was corrected on July 25, 2024.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

Neuropsychiatric symptoms, including nightmares and hallucinatory “daymares,” may be a more important aspect of systemic lupus erythematosus (SLE) than formerly recognized, according to a qualitative mixed methods study published in The Lancet Discovery Science’s eClinicalMedicine. The findings suggested these neuropsychiatric symptoms can sometimes present as prodromal and other times act as an early warning system for a forthcoming flare.

“For clinicians, the key point is to be aware that neurological and psychiatric symptoms are much more common in patients with lupus and other autoimmune systemic rheumatic diseases than previously thought,” lead author Melanie Sloan, PhD, of the Department of Public Health and Primary Care at the University of Cambridge in England, told this news organization.

“If clinicians — and some do already — could all ask about and document these symptoms for each patient, the usual progression of symptoms in a flare can then be monitored, and patients could be supported and treated at an earlier stage,” Dr. Sloan said. “Another key point is to consider systemic autoimmune diseases at an early stage if a patient presents with multiple seemingly unconnected symptoms, which often include both physical and mental health symptoms.”

Alfred Kim, MD, PhD, associate professor of medicine in rheumatology at Washington University School of Medicine in St. Louis, Missouri, noted the difficulty of determining what neuropsychiatric symptoms may be linked to lupus vs those occurring independently or as part of a different condition.

Dr. Kim

Study Details

In planning for the study, the researchers first searched the existing literature for studies involving neuropsychiatric symptoms in patients with systemic autoimmune rheumatic diseases (SARDs). “The literature indicated frequent underreporting and misattributions of neuropsychiatric symptoms in SLE and other SARD patients, and clinician-patient discordance in neuropsychiatric symptom attribution,” the authors reported.

During 2022-2023, the researchers conducted two surveys, one with 676 adult patients with SLE and one with 400 clinicians, recruited through social media, online patient support groups, and professional networks. All patients self-reported an SLE diagnosis that the researchers did not independently confirm. The patients were predominantly White (80%) and female (94%), ranging in age from 18 to over 70, with most falling between ages 40 and 69. Most patients lived in the United Kingdom (76%) or Europe (15%).

The clinicians included 51% rheumatologists, 24% psychiatrists, 13% neurologists, 5% rheumatology nurses, 3% primary care physicians, and 7% other clinicians. Nearly half of the clinicians (45%) were from the United Kingdom, with others from the United States or Canada (16%), Europe (17%), Asia (9%), Latin America (8%), Australia or New Zealand (3%), or elsewhere (3%).

The patient surveys asked whether they had experienced any of the 29 neuropsychiatric symptoms. For the symptoms that patients had experienced at least three times in their lives, the survey asked when they first experienced the symptom in relation to their SLE onset or other SLE symptoms: Over a year before, within a year of (on either side), 1-4 years after, or more than 5 years after onset/other symptoms. “Other quantitative data included timings of disrupted dreaming sleep in relation to hallucinations for those patients reporting experiencing these,” the authors wrote.

The researchers also conducted video conference interviews with 50 clinicians, including 20 rheumatologists, and 69 interviews with patients who had a systemic autoimmune rheumatic disease, including 27 patients with SLE. Other conditions among those interviewed included inflammatory arthritis, vasculitis, Sjögren disease, systemic sclerosis, myositis, undifferentiated and mixed connective tissue diseases, and polymyalgia rheumatica. During interviews, the term “daymare” was used to discuss possible hallucinations.
 

Linking Neuropsychiatric Symptoms and Disease

Four themes emerged from the analysis of the surveys and interviews. First, despite many rheumatologists stating that it was an “established theory” that most neuropsychiatric symptoms related to SLE would initially present around the time of diagnosis or disease onset, the findings from patients and interviews with psychiatrists did not align with this theory. The first presentation of each neuropsychiatric symptom only occurred around the onset of other SLE symptoms, about one fifth to one third of the time. In fact, more than half of the patients with SLE who had experienced hallucinations or delusions/paranoia said they occurred more than a year after they first experienced their other SLE symptoms.

Patient experiences differed in terms of whether they believed their neuropsychiatric symptoms were directly related to their SLE or other rheumatic disease. Some did attribute the symptoms, such as hypomania, to their rheumatic illness, while others, such as a patient with major depression, did not see the two as linked.

A second theme focused on pattern recognition of neuropsychiatric symptoms and the onset of a disease flare. “For example, several patients described how they felt that some types of depressive symptoms were directly attributable to active inflammation due to its time of onset and differences in type and intensity compared to their more ‘reactive’ low mood that could be more attributable to a consequence of psychological distress,” the authors wrote. Another common report from patients was experiencing a sudden, intense fatigue that coincided with a flare and differed from other types of fatigue.

Some patients could recognize that a flare was coming because of familiar neuropsychiatric symptoms that acted like an “early warning system.” Often, however, these symptoms “were absent from current diagnostic guidelines and only rarely identified by clinician interviewees as related to SLE/NPSLE,” the authors found. “These neuropsychiatric prodromal symptoms were reported as sometimes preceding the more widely recognized SLE and other SARD symptoms such as joint pain, rashes, and other organ involvement.” These symptoms included sudden changes in mood (usually a lowering but sometimes mania), increased nightmares, a “feeling of unreality,” or increased sensory symptoms.

Other patients, on the other hand, had not considered a link between neuropsychiatric symptoms and their rheumatic disease until the interview, and many of the clinicians, aside from psychiatrists and nurses, said they had little time in clinic to gather information about symptom progression.
 

Nightmares and Daymares

A third theme centered on disrupted dreaming sleep, nightmares, and “daymares” as a prodromal symptom in particular. Some patients had already drawn a connection between an oncoming flare of their disease and these dreaming-related symptoms, while others had not considered a link until the interviews.

“Several SLE patients recounted flares consistently involving the segueing of increasingly vivid and distressing nightmares into distorted reality and daytime hallucinations,” the authors reported. Flare-related nightmares in particular “often involved being attacked, trapped, crushed, or falling.” Patients tended to be more forthcoming about hallucinatory experiences when the term “daymare” was used to describe them, and they often related to the idea of feeling “in-between asleep and awake.”

Only one of the rheumatologists interviewed had considered nightmares as potentially related to SLE flares, and several appeared skeptical about a link but planned to ask their patients about it. Most of the specialists interviewed, meanwhile, said they often discussed sleep disruption with patients.

“There was agreement that recognizing and eliciting these early flare symptoms may improve care and even reduce clinic times by averting flares at any earlier stage, although some rheumatologists were clear that limited appointment times meant that these symptoms would not be prioritized for discussion,” the authors wrote.

Though Dr. Kim acknowledged the possibility of nightmares as prodromal, he noted other ways in which nightmares may be indirectly linked to lupus. “Trauma is a major risk factor for lupus,” Dr. Kim said, with multiple studies showing childhood traumatic experiences and even posttraumatic stress disorder to be risk factors for lupus. “Whether nightmares represent a traumatic event or prior traumatic events is not clear to me, but one could hypothesize that this may be a manifestation of trauma,” Dr. Kim said.

In addition, nightmares represent a sleep disorder that can substantially reduce sleep quality, Dr. Kim said, and poor sleep is also associated with lupus. “One has to wonder whether disruptive dreaming sleep is one of several specific manifestations of poor sleep quality, which then increases the risk of lupus in those patients,” Dr. Kim said.
 

Misattribution of Neuropsychiatric Symptoms

The final theme to emerge from the findings was patients had been misdiagnosed with psychiatric or psychosomatic conditions shortly before getting their rheumatic disease diagnosis. One patient, for example, reported being diagnosed with borderline personality disorder just 6 months before the lupus diagnosis at age 19 and noticed that the symptoms of one “got under control” when the symptoms of the other did.

“Early misattributions of SARD symptoms to primary psychiatric or psychosomatic conditions were frequently reported to have delayed SARD diagnosis and led to future misattributions,” the authors reported. “Whilst some of these misdiagnoses likely reflect the widespread lack of knowledge and limited definitive tests for SLE, it is plausible that some early SLE neurological and/or psychiatric symptoms may represent a neuropsychiatric prodrome for SLE itself.”

Dr. Kim agreed that misattribution of symptoms to other diagnoses is common with lupus and a common reason for delays in diagnosis, even with symptoms that are not neuropsychiatric. The findings in this study broaden “the type of symptoms we need to put on our radar pre-diagnosis,” Dr. Kim said. “We just also have to be aware that these prodromal symptoms are not diagnostic for lupus, though.”

Dr. Sloan cited earlier work in recommending an “ABC” approach to improving clinician-patient relationships: “Availability is being accessible when patients need them, Belief is demonstrating belief and validating patient self-reports of symptoms, and Continuity is when the same clinician sees the same patient each clinic visit to build up a trusting relationship.” She noted the importance of asking about and normalizing the existence of these symptoms with rheumatic diseases.

The research was funded by The Lupus Trust. Three authors reported consultancy, speaker, or advisory fees from Alumis, Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Janssen, MGP, Novartis, Pfizer, Sanofi, UCB, Vifor, and/or Werfen Group. The other authors, including Dr. Sloan, had no industry-related disclosures. Dr. Kim reported research support from AstraZeneca, GlaxoSmithKline, and Novartis; speaking fees from Exagen Diagnostics and GlaxoSmithKline; and consulting fees from AbbVie, Amgen, ANI Pharmaceuticals, AstraZeneca, Atara Bio, Aurinia Pharmaceuticals, Cargo Therapeutics, Exagen Diagnostics, Hinge Bio, GlaxoSmithKline, Kypha, Miltenyi Biotec, Synthekine, and Tectonic Therapeutic.
 

A version of this article appeared on Medscape.com.

Neuropsychiatric symptoms, including nightmares and hallucinatory “daymares,” may be a more important aspect of systemic lupus erythematosus (SLE) than formerly recognized, according to a qualitative mixed methods study published in The Lancet Discovery Science’s eClinicalMedicine. The findings suggested these neuropsychiatric symptoms can sometimes present as prodromal and other times act as an early warning system for a forthcoming flare.

“For clinicians, the key point is to be aware that neurological and psychiatric symptoms are much more common in patients with lupus and other autoimmune systemic rheumatic diseases than previously thought,” lead author Melanie Sloan, PhD, of the Department of Public Health and Primary Care at the University of Cambridge in England, told this news organization.

“If clinicians — and some do already — could all ask about and document these symptoms for each patient, the usual progression of symptoms in a flare can then be monitored, and patients could be supported and treated at an earlier stage,” Dr. Sloan said. “Another key point is to consider systemic autoimmune diseases at an early stage if a patient presents with multiple seemingly unconnected symptoms, which often include both physical and mental health symptoms.”

Alfred Kim, MD, PhD, associate professor of medicine in rheumatology at Washington University School of Medicine in St. Louis, Missouri, noted the difficulty of determining what neuropsychiatric symptoms may be linked to lupus vs those occurring independently or as part of a different condition.

Dr. Kim

Study Details

In planning for the study, the researchers first searched the existing literature for studies involving neuropsychiatric symptoms in patients with systemic autoimmune rheumatic diseases (SARDs). “The literature indicated frequent underreporting and misattributions of neuropsychiatric symptoms in SLE and other SARD patients, and clinician-patient discordance in neuropsychiatric symptom attribution,” the authors reported.

During 2022-2023, the researchers conducted two surveys, one with 676 adult patients with SLE and one with 400 clinicians, recruited through social media, online patient support groups, and professional networks. All patients self-reported an SLE diagnosis that the researchers did not independently confirm. The patients were predominantly White (80%) and female (94%), ranging in age from 18 to over 70, with most falling between ages 40 and 69. Most patients lived in the United Kingdom (76%) or Europe (15%).

The clinicians included 51% rheumatologists, 24% psychiatrists, 13% neurologists, 5% rheumatology nurses, 3% primary care physicians, and 7% other clinicians. Nearly half of the clinicians (45%) were from the United Kingdom, with others from the United States or Canada (16%), Europe (17%), Asia (9%), Latin America (8%), Australia or New Zealand (3%), or elsewhere (3%).

The patient surveys asked whether they had experienced any of the 29 neuropsychiatric symptoms. For the symptoms that patients had experienced at least three times in their lives, the survey asked when they first experienced the symptom in relation to their SLE onset or other SLE symptoms: Over a year before, within a year of (on either side), 1-4 years after, or more than 5 years after onset/other symptoms. “Other quantitative data included timings of disrupted dreaming sleep in relation to hallucinations for those patients reporting experiencing these,” the authors wrote.

The researchers also conducted video conference interviews with 50 clinicians, including 20 rheumatologists, and 69 interviews with patients who had a systemic autoimmune rheumatic disease, including 27 patients with SLE. Other conditions among those interviewed included inflammatory arthritis, vasculitis, Sjögren disease, systemic sclerosis, myositis, undifferentiated and mixed connective tissue diseases, and polymyalgia rheumatica. During interviews, the term “daymare” was used to discuss possible hallucinations.
 

Linking Neuropsychiatric Symptoms and Disease

Four themes emerged from the analysis of the surveys and interviews. First, despite many rheumatologists stating that it was an “established theory” that most neuropsychiatric symptoms related to SLE would initially present around the time of diagnosis or disease onset, the findings from patients and interviews with psychiatrists did not align with this theory. The first presentation of each neuropsychiatric symptom only occurred around the onset of other SLE symptoms, about one fifth to one third of the time. In fact, more than half of the patients with SLE who had experienced hallucinations or delusions/paranoia said they occurred more than a year after they first experienced their other SLE symptoms.

Patient experiences differed in terms of whether they believed their neuropsychiatric symptoms were directly related to their SLE or other rheumatic disease. Some did attribute the symptoms, such as hypomania, to their rheumatic illness, while others, such as a patient with major depression, did not see the two as linked.

A second theme focused on pattern recognition of neuropsychiatric symptoms and the onset of a disease flare. “For example, several patients described how they felt that some types of depressive symptoms were directly attributable to active inflammation due to its time of onset and differences in type and intensity compared to their more ‘reactive’ low mood that could be more attributable to a consequence of psychological distress,” the authors wrote. Another common report from patients was experiencing a sudden, intense fatigue that coincided with a flare and differed from other types of fatigue.

Some patients could recognize that a flare was coming because of familiar neuropsychiatric symptoms that acted like an “early warning system.” Often, however, these symptoms “were absent from current diagnostic guidelines and only rarely identified by clinician interviewees as related to SLE/NPSLE,” the authors found. “These neuropsychiatric prodromal symptoms were reported as sometimes preceding the more widely recognized SLE and other SARD symptoms such as joint pain, rashes, and other organ involvement.” These symptoms included sudden changes in mood (usually a lowering but sometimes mania), increased nightmares, a “feeling of unreality,” or increased sensory symptoms.

Other patients, on the other hand, had not considered a link between neuropsychiatric symptoms and their rheumatic disease until the interview, and many of the clinicians, aside from psychiatrists and nurses, said they had little time in clinic to gather information about symptom progression.
 

Nightmares and Daymares

A third theme centered on disrupted dreaming sleep, nightmares, and “daymares” as a prodromal symptom in particular. Some patients had already drawn a connection between an oncoming flare of their disease and these dreaming-related symptoms, while others had not considered a link until the interviews.

“Several SLE patients recounted flares consistently involving the segueing of increasingly vivid and distressing nightmares into distorted reality and daytime hallucinations,” the authors reported. Flare-related nightmares in particular “often involved being attacked, trapped, crushed, or falling.” Patients tended to be more forthcoming about hallucinatory experiences when the term “daymare” was used to describe them, and they often related to the idea of feeling “in-between asleep and awake.”

Only one of the rheumatologists interviewed had considered nightmares as potentially related to SLE flares, and several appeared skeptical about a link but planned to ask their patients about it. Most of the specialists interviewed, meanwhile, said they often discussed sleep disruption with patients.

“There was agreement that recognizing and eliciting these early flare symptoms may improve care and even reduce clinic times by averting flares at any earlier stage, although some rheumatologists were clear that limited appointment times meant that these symptoms would not be prioritized for discussion,” the authors wrote.

Though Dr. Kim acknowledged the possibility of nightmares as prodromal, he noted other ways in which nightmares may be indirectly linked to lupus. “Trauma is a major risk factor for lupus,” Dr. Kim said, with multiple studies showing childhood traumatic experiences and even posttraumatic stress disorder to be risk factors for lupus. “Whether nightmares represent a traumatic event or prior traumatic events is not clear to me, but one could hypothesize that this may be a manifestation of trauma,” Dr. Kim said.

In addition, nightmares represent a sleep disorder that can substantially reduce sleep quality, Dr. Kim said, and poor sleep is also associated with lupus. “One has to wonder whether disruptive dreaming sleep is one of several specific manifestations of poor sleep quality, which then increases the risk of lupus in those patients,” Dr. Kim said.
 

Misattribution of Neuropsychiatric Symptoms

The final theme to emerge from the findings was patients had been misdiagnosed with psychiatric or psychosomatic conditions shortly before getting their rheumatic disease diagnosis. One patient, for example, reported being diagnosed with borderline personality disorder just 6 months before the lupus diagnosis at age 19 and noticed that the symptoms of one “got under control” when the symptoms of the other did.

“Early misattributions of SARD symptoms to primary psychiatric or psychosomatic conditions were frequently reported to have delayed SARD diagnosis and led to future misattributions,” the authors reported. “Whilst some of these misdiagnoses likely reflect the widespread lack of knowledge and limited definitive tests for SLE, it is plausible that some early SLE neurological and/or psychiatric symptoms may represent a neuropsychiatric prodrome for SLE itself.”

Dr. Kim agreed that misattribution of symptoms to other diagnoses is common with lupus and a common reason for delays in diagnosis, even with symptoms that are not neuropsychiatric. The findings in this study broaden “the type of symptoms we need to put on our radar pre-diagnosis,” Dr. Kim said. “We just also have to be aware that these prodromal symptoms are not diagnostic for lupus, though.”

Dr. Sloan cited earlier work in recommending an “ABC” approach to improving clinician-patient relationships: “Availability is being accessible when patients need them, Belief is demonstrating belief and validating patient self-reports of symptoms, and Continuity is when the same clinician sees the same patient each clinic visit to build up a trusting relationship.” She noted the importance of asking about and normalizing the existence of these symptoms with rheumatic diseases.

The research was funded by The Lupus Trust. Three authors reported consultancy, speaker, or advisory fees from Alumis, Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Janssen, MGP, Novartis, Pfizer, Sanofi, UCB, Vifor, and/or Werfen Group. The other authors, including Dr. Sloan, had no industry-related disclosures. Dr. Kim reported research support from AstraZeneca, GlaxoSmithKline, and Novartis; speaking fees from Exagen Diagnostics and GlaxoSmithKline; and consulting fees from AbbVie, Amgen, ANI Pharmaceuticals, AstraZeneca, Atara Bio, Aurinia Pharmaceuticals, Cargo Therapeutics, Exagen Diagnostics, Hinge Bio, GlaxoSmithKline, Kypha, Miltenyi Biotec, Synthekine, and Tectonic Therapeutic.
 

A version of this article appeared on Medscape.com.

Neuropsychiatric symptoms, including nightmares and hallucinatory “daymares,” may be a more important aspect of systemic lupus erythematosus (SLE) than formerly recognized, according to a qualitative mixed methods study published in The Lancet Discovery Science’s eClinicalMedicine. The findings suggested these neuropsychiatric symptoms can sometimes present as prodromal and other times act as an early warning system for a forthcoming flare.

“For clinicians, the key point is to be aware that neurological and psychiatric symptoms are much more common in patients with lupus and other autoimmune systemic rheumatic diseases than previously thought,” lead author Melanie Sloan, PhD, of the Department of Public Health and Primary Care at the University of Cambridge in England, told this news organization.

“If clinicians — and some do already — could all ask about and document these symptoms for each patient, the usual progression of symptoms in a flare can then be monitored, and patients could be supported and treated at an earlier stage,” Dr. Sloan said. “Another key point is to consider systemic autoimmune diseases at an early stage if a patient presents with multiple seemingly unconnected symptoms, which often include both physical and mental health symptoms.”

Alfred Kim, MD, PhD, associate professor of medicine in rheumatology at Washington University School of Medicine in St. Louis, Missouri, noted the difficulty of determining what neuropsychiatric symptoms may be linked to lupus vs those occurring independently or as part of a different condition.

Dr. Kim

Study Details

In planning for the study, the researchers first searched the existing literature for studies involving neuropsychiatric symptoms in patients with systemic autoimmune rheumatic diseases (SARDs). “The literature indicated frequent underreporting and misattributions of neuropsychiatric symptoms in SLE and other SARD patients, and clinician-patient discordance in neuropsychiatric symptom attribution,” the authors reported.

During 2022-2023, the researchers conducted two surveys, one with 676 adult patients with SLE and one with 400 clinicians, recruited through social media, online patient support groups, and professional networks. All patients self-reported an SLE diagnosis that the researchers did not independently confirm. The patients were predominantly White (80%) and female (94%), ranging in age from 18 to over 70, with most falling between ages 40 and 69. Most patients lived in the United Kingdom (76%) or Europe (15%).

The clinicians included 51% rheumatologists, 24% psychiatrists, 13% neurologists, 5% rheumatology nurses, 3% primary care physicians, and 7% other clinicians. Nearly half of the clinicians (45%) were from the United Kingdom, with others from the United States or Canada (16%), Europe (17%), Asia (9%), Latin America (8%), Australia or New Zealand (3%), or elsewhere (3%).

The patient surveys asked whether they had experienced any of the 29 neuropsychiatric symptoms. For the symptoms that patients had experienced at least three times in their lives, the survey asked when they first experienced the symptom in relation to their SLE onset or other SLE symptoms: Over a year before, within a year of (on either side), 1-4 years after, or more than 5 years after onset/other symptoms. “Other quantitative data included timings of disrupted dreaming sleep in relation to hallucinations for those patients reporting experiencing these,” the authors wrote.

The researchers also conducted video conference interviews with 50 clinicians, including 20 rheumatologists, and 69 interviews with patients who had a systemic autoimmune rheumatic disease, including 27 patients with SLE. Other conditions among those interviewed included inflammatory arthritis, vasculitis, Sjögren disease, systemic sclerosis, myositis, undifferentiated and mixed connective tissue diseases, and polymyalgia rheumatica. During interviews, the term “daymare” was used to discuss possible hallucinations.
 

Linking Neuropsychiatric Symptoms and Disease

Four themes emerged from the analysis of the surveys and interviews. First, despite many rheumatologists stating that it was an “established theory” that most neuropsychiatric symptoms related to SLE would initially present around the time of diagnosis or disease onset, the findings from patients and interviews with psychiatrists did not align with this theory. The first presentation of each neuropsychiatric symptom only occurred around the onset of other SLE symptoms, about one fifth to one third of the time. In fact, more than half of the patients with SLE who had experienced hallucinations or delusions/paranoia said they occurred more than a year after they first experienced their other SLE symptoms.

Patient experiences differed in terms of whether they believed their neuropsychiatric symptoms were directly related to their SLE or other rheumatic disease. Some did attribute the symptoms, such as hypomania, to their rheumatic illness, while others, such as a patient with major depression, did not see the two as linked.

A second theme focused on pattern recognition of neuropsychiatric symptoms and the onset of a disease flare. “For example, several patients described how they felt that some types of depressive symptoms were directly attributable to active inflammation due to its time of onset and differences in type and intensity compared to their more ‘reactive’ low mood that could be more attributable to a consequence of psychological distress,” the authors wrote. Another common report from patients was experiencing a sudden, intense fatigue that coincided with a flare and differed from other types of fatigue.

Some patients could recognize that a flare was coming because of familiar neuropsychiatric symptoms that acted like an “early warning system.” Often, however, these symptoms “were absent from current diagnostic guidelines and only rarely identified by clinician interviewees as related to SLE/NPSLE,” the authors found. “These neuropsychiatric prodromal symptoms were reported as sometimes preceding the more widely recognized SLE and other SARD symptoms such as joint pain, rashes, and other organ involvement.” These symptoms included sudden changes in mood (usually a lowering but sometimes mania), increased nightmares, a “feeling of unreality,” or increased sensory symptoms.

Other patients, on the other hand, had not considered a link between neuropsychiatric symptoms and their rheumatic disease until the interview, and many of the clinicians, aside from psychiatrists and nurses, said they had little time in clinic to gather information about symptom progression.
 

Nightmares and Daymares

A third theme centered on disrupted dreaming sleep, nightmares, and “daymares” as a prodromal symptom in particular. Some patients had already drawn a connection between an oncoming flare of their disease and these dreaming-related symptoms, while others had not considered a link until the interviews.

“Several SLE patients recounted flares consistently involving the segueing of increasingly vivid and distressing nightmares into distorted reality and daytime hallucinations,” the authors reported. Flare-related nightmares in particular “often involved being attacked, trapped, crushed, or falling.” Patients tended to be more forthcoming about hallucinatory experiences when the term “daymare” was used to describe them, and they often related to the idea of feeling “in-between asleep and awake.”

Only one of the rheumatologists interviewed had considered nightmares as potentially related to SLE flares, and several appeared skeptical about a link but planned to ask their patients about it. Most of the specialists interviewed, meanwhile, said they often discussed sleep disruption with patients.

“There was agreement that recognizing and eliciting these early flare symptoms may improve care and even reduce clinic times by averting flares at any earlier stage, although some rheumatologists were clear that limited appointment times meant that these symptoms would not be prioritized for discussion,” the authors wrote.

Though Dr. Kim acknowledged the possibility of nightmares as prodromal, he noted other ways in which nightmares may be indirectly linked to lupus. “Trauma is a major risk factor for lupus,” Dr. Kim said, with multiple studies showing childhood traumatic experiences and even posttraumatic stress disorder to be risk factors for lupus. “Whether nightmares represent a traumatic event or prior traumatic events is not clear to me, but one could hypothesize that this may be a manifestation of trauma,” Dr. Kim said.

In addition, nightmares represent a sleep disorder that can substantially reduce sleep quality, Dr. Kim said, and poor sleep is also associated with lupus. “One has to wonder whether disruptive dreaming sleep is one of several specific manifestations of poor sleep quality, which then increases the risk of lupus in those patients,” Dr. Kim said.
 

Misattribution of Neuropsychiatric Symptoms

The final theme to emerge from the findings was patients had been misdiagnosed with psychiatric or psychosomatic conditions shortly before getting their rheumatic disease diagnosis. One patient, for example, reported being diagnosed with borderline personality disorder just 6 months before the lupus diagnosis at age 19 and noticed that the symptoms of one “got under control” when the symptoms of the other did.

“Early misattributions of SARD symptoms to primary psychiatric or psychosomatic conditions were frequently reported to have delayed SARD diagnosis and led to future misattributions,” the authors reported. “Whilst some of these misdiagnoses likely reflect the widespread lack of knowledge and limited definitive tests for SLE, it is plausible that some early SLE neurological and/or psychiatric symptoms may represent a neuropsychiatric prodrome for SLE itself.”

Dr. Kim agreed that misattribution of symptoms to other diagnoses is common with lupus and a common reason for delays in diagnosis, even with symptoms that are not neuropsychiatric. The findings in this study broaden “the type of symptoms we need to put on our radar pre-diagnosis,” Dr. Kim said. “We just also have to be aware that these prodromal symptoms are not diagnostic for lupus, though.”

Dr. Sloan cited earlier work in recommending an “ABC” approach to improving clinician-patient relationships: “Availability is being accessible when patients need them, Belief is demonstrating belief and validating patient self-reports of symptoms, and Continuity is when the same clinician sees the same patient each clinic visit to build up a trusting relationship.” She noted the importance of asking about and normalizing the existence of these symptoms with rheumatic diseases.

The research was funded by The Lupus Trust. Three authors reported consultancy, speaker, or advisory fees from Alumis, Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Janssen, MGP, Novartis, Pfizer, Sanofi, UCB, Vifor, and/or Werfen Group. The other authors, including Dr. Sloan, had no industry-related disclosures. Dr. Kim reported research support from AstraZeneca, GlaxoSmithKline, and Novartis; speaking fees from Exagen Diagnostics and GlaxoSmithKline; and consulting fees from AbbVie, Amgen, ANI Pharmaceuticals, AstraZeneca, Atara Bio, Aurinia Pharmaceuticals, Cargo Therapeutics, Exagen Diagnostics, Hinge Bio, GlaxoSmithKline, Kypha, Miltenyi Biotec, Synthekine, and Tectonic Therapeutic.
 

A version of this article appeared on Medscape.com.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.

Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.

Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.

“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”

Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
 

Starting With the Basics

Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”

Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.

“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.

Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.

“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”

Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
 

Three Pharmacotherapy Categories

Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.

The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.

These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.

Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.

Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”

Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
 

The GLP-1 Receptor Agonists

Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.

“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”

The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.

• Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
• Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
• Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.

The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.

“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.

It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
 

Getting Patients Started

All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.

Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.

For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.

”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.

This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”

A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.

“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”

Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.

Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.

Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.

No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.

SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.

Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.

Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.

“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”

Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
 

Starting With the Basics

Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”

Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.

“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.

Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.

“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”

Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
 

Three Pharmacotherapy Categories

Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.

The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.

These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.

Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.

Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”

Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
 

The GLP-1 Receptor Agonists

Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.

“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”

The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.

• Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
• Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
• Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.

The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.

“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.

It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
 

Getting Patients Started

All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.

Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.

For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.

”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.

This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”

A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.

“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”

Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.

Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.

Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.

No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.

SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.

Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.

Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.

“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”

Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
 

Starting With the Basics

Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”

Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.

“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.

Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.

“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”

Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
 

Three Pharmacotherapy Categories

Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.

The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.

These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.

Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.

Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”

Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
 

The GLP-1 Receptor Agonists

Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.

“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”

The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.

• Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
• Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
• Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.

The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.

“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.

It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
 

Getting Patients Started

All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.

Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.

For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.

”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.

This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”

A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.

“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”

Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.

Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.

Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.

No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.