Objectives: Conjugated estrogens/bazedoxifene (CE/BZA) reduced menopause-related hot flashes (HFs) in the Selective estrogens, Menopause, And Response to Therapy (SMART) trials. This post hoc pooled analysis of SMART-1 and -2 further characterized effects of CE/BZA on HFs in the overall population and patient subgroups.
Methods: Data from two randomized, double-blind, placebo- and active-controlled, phase 3 studies were pooled for nonhysterectomized postmenopausal women with moderate/severe HFs given CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, or placebo for 12 weeks. HF frequency and severity were assessed by daily diary.
Results: The pooled analysis included 403 participants. At 12 weeks, CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg significantly (all p < 0.001) decreased moderate/severe HF frequency versus placebo (-7.9, -8.2, -4.1), reduced adjusted average daily HF severity score versus placebo (-1.0, -1.3, -0.3), increased the percentage of women who had a ≥50% (81.2%,87.1%, 50.6%) and ≥75% (62.4%, 74.8%, 26.4%) reduction from baseline in daily frequency of moderate/severe HFs, increased the percentage with ≥50% (38.3%, 58.1%, 11.0%) and ≥75% (24.2%, 38.1%, 5.5%) reductions in average daily HF severity score, and improved MENQOL vasomotor function versus placebo (adjusted mean change-3.08, -3.69, -1.37). CE/BZA was significantly more effective than placebo irrespective of time since menopause, with some evidence of a lower placebo response in women in later menopause (>5 years) versus early menopause (≤5 years).
Conclusions: CE/BZA effectively reduces moderate/severe HFs in postmenopausal women. NCT#'s: NCT00675688; NCT00234819.
Keywords: bazedoxifene; conjugated estrogens; hot flashes; menopause-specific quality of life; vasomotor.