TOPLINE: Vasomotor symptoms affect as many as 75% of menopausal women in the United States. Characterized by a sudden onset of flushing, sweating, and chills, symptoms of hot flashes can be managed with hormone therapy, but prolonged use of the treatment poses health risks. In a study published in JAMA Internal Medicine, researchers found that the use of nitroglycerin patches did not result in lasting improvements in the frequency and severity of hot flashes, but there was a short-term benefit.
The FRAN study was a randomized, double-blinded trial involving 134 California women aged 40 to 62 years.
Between July 2018 and December 2021, participants self-administered either a nitroglycerin patch at a dosage of 0.2 to 0.6 mg/h or a placebo patch every night.
Participants were in the late stages of menopause or had already undergone menopause. They reported having seven or more hot flashes per day; at least four were moderate to severe over a 1-week period.
The primary outcome was a change in the frequency of hot flashes over 5 and 12 weeks.
Over 5 weeks, the frequency of moderate to severe hot flashes decreased by 3.3 episodes per day in the nitroglycerine group, compared with 2.2 episodes per day in the placebo group (95% CI, −2.2 to 0; P = .05).
The reduction in overall frequency of hot flashes ― either mild, moderate, or severe ― over the 5-week period was not statistically significant.
Over the 12-week period, no statistically significant reductions in hot flashes occurred.
More than two thirds of participants assigned to the nitroglycerin patches reported having headaches, while three reported chest pain and one had a syncopal episode.
The findings do not support daily use of nitroglycerin patches to treat vasomotor symptoms, the researchers conclude.
"The bottom line is that our study doesn't allow us to recommend nitroglycerin skin patches as a strategy for consumers to suppress hot flashes in the long term," Alison Huang, MD, MAS, lead author of the study, said in a press release. "The menopause field is still lacking in effective treatment approaches that don't involve hormones."
The study was led by Alison Huang, MD, MAS, a professor of medicine at the University of California, San Francisco. Two of the authors reported grants from the National Institute on Aging.
Almost 20% of women who used the nitroglycerin patches discontinued treatment before the end of the trial because they could not tolerate the medication, experienced an adverse event, or their symptoms did not improve, according to the researchers. In addition, the 1-week period used to screen for severity and frequency of hot flashes may have been too short to confirm that symptoms were prolonged, which could explain the better-than-expected results in the placebo group.
One author served on the medical advisory board of SomaLogic. Another author is an unpaid consultant to Astellas Pharma. Another author reported grants from the National Institutes of Health.
Lead Image: iStock/Getty Images
Medscape Medical News © 2023
Cite this: Nitroglycerin Patches Do Not Improve Menopause Symptoms - Medscape - Jun 06, 2023.