FRAN
Trial question
What is the effect of continuous transdermal nitroglycerin patches in patients with menopause-related hot flashes?
Study design
Single center
Double blinded
RCT
Population
134 female patients.
Inclusion criteria: perimenopausal or postmenopausal females reporting ≥ 7 hot flashes per day.
Key exclusion criteria: use of nitroglycerin or other nitrate-containing medications during the past 4 weeks; vaginal estrogen or progestins during the past 4 weeks or systemic estrogen during the past 12 weeks; other medications with potential efficacy for hot flashes during the past 4 weeks.
Interventions
N=65 nitroglycerin (transdermal nitroglycerin patient-directed dose titration from 0.2-0.6 mg/hr).
N=69 placebo (matching placebo patches).
Primary outcome
Reduction in hot flash frequency per day at week 5
4.5
3.6
4.5
3.4
2.3
1.1
0.0
Nitroglycerin
Placebo
No significant
difference ↔
No significant difference in reduction in hot flash frequency per day at week 5 (4.5 vs. 3.6; AD 0.9 , 95% CI -2.1 to 0.3).
Secondary outcomes
Borderline significantly greater reduction in moderate-to-severe hot flashes per day at week 5 (3.3 vs. 2.2; AD 1.1 , 95% CI 0 to 2.2).
No significant difference in reduction in total daily diary-based hot flash severity score at week 5 (8.3 points vs. 6.1 points; AD 2.2 points, 95% CI -0.4 to 4.7).
No significant difference in reduction in hot flash frequency per day at week 12 (4.6 vs. 4.7; AD -0.1 , 95% CI -1.2 to 1.4).
Safety outcomes
No significant differences in adverse event, headache.
Significant difference in headache at week 1 (65.7% vs. 5.6%).
Conclusion
In perimenopausal or postmenopausal females reporting ≥ 7 hot flashes per day, nitroglycerin was not superior to placebo with respect to reduction in hot flash frequency per day at week 5.
Reference
Alison J Huang, Steven R Cummings, Peter Ganz et al. Efficacy of Continuous Transdermal Nitroglycerin for Treating Hot Flashes by Inducing Nitrate Cross-tolerance in Perimenopausal and Postmenopausal Women: A Randomized Clinical Trial. JAMA Intern Med. 2023 Aug 1;183(8):776-783.
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