Predictors of Frequency and Severity of Vasomotor Symptoms: Results from the REPLENISH Trial [19M

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INTRODUCTION: The objective of this analysis was to determine whether baseline characteristics can predict the frequency and severity of hot flushes (HF) in postmenopausal women. METHODS: REPLENISH was a phase 3, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of TX-001HR (17β-estradiol/progesterone oral capsule) in 767 postmenopausal women, who had ≥50 moderate to severe HF/week at baseline. Post hoc associations of baseline characteristics (age, race, BMI, smoking, time since last menstrual period [LMP], age at LMP, tubal ligation, parity, estradiol levels, and menopause-specific quality of life [MENQOL] total and vasomotor domain scores) with frequency and severity of hot flushes were evaluated. RESULTS: Baseline predictors for having ≥50 moderate to severe HF/week were BMI (P=.0299), MENQOL total score (P<.0001), and MENQOL Vasomotor domain score (P<.0001). For every unit increase in BMI, the odds of having ≥50 moderate to severe HF decreased by 12.6% while a one-point increase in MENQOL total and vasomotor scores increased the odds by 20.9% and 110.9%, respectively. Baseline predictors for HF severity were current smoking (P=.0042), and MENQOL overall (P<.0001) and vasomotor (P<.0001) scores. Multiple regression analyses showed that the MENQOL vasomotor score was the best predictor of severity (R2=0.1876; P<.0001), followed by MENQOL total score + smoking (R2=0.0325; P<.0001). Other baseline characteristics evaluated were not predictors of HF frequency and/or severity. CONCLUSION: In REPLENISH, baseline BMI, smoking, and MENQOL total and vasomotor scores were predictors for moderate to severe HF frequency and/or severity. These characteristics could potentially be used to predict women's HF frequency and severity at menopause.