Conjugated estrogens and bazedoxifene in minority populations: pooled analysis of four phase 3 trials

Menopause. 2016 Jun;23(6):611-20. doi: 10.1097/GME.0000000000000617.

Abstract

Objective: The aim of the study was to compare efficacy of conjugated estrogens (CE)/bazedoxifene (BZA) for treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in minorities (black/Hispanic) versus whites.

Methods: In a post hoc analysis, data were pooled from 3,424 white or minority nonhysterectomized postmenopausal women randomized to CE 0.45 or 0.625 mg/BZA 20 mg or placebo in four double-blind, phase 3 Selective Estrogens, Menopause, and Response to Therapy (SMART) trials. Outcomes included hot flush frequency/severity (daily diary) in women with at least seven moderate-to-severe hot flushes per day (SMART-1, -2), vaginal cytology in women with at most 5% superficial cells (SMART-1, -3), lumbar spine and total hip bone mineral density (BMD) (SMART-1, -5), and the Menopause-Specific Quality of Life (MENQOL) questionnaire (SMART-1, -2, -3, -5).

Results: The analysis included 2,907 white (84.9%), 315 black (9.2%), and 202 Hispanic (5.9%) women. The reduction in hot flush frequency/severity versus placebo (P < 0.05; week 12) was similar in white and minority women. In both populations, both doses significantly (P < 0.05 vs placebo) improved MENQOL vasomotor function, sexual function, and total scores at 3 months; decreased the percentage of parabasal cells at 2 years; and increased the percentage of BMD responders at 12 and 24 months. Significant differential treatment effects by race/ethnicity were observed only for effects on vaginal superficial cells at month 24 and vaginal pH at month 3.

Conclusions: Notwithstanding a limited sample size, CE/BZA had a similar and beneficial impact on hot flushes, MENQOL, and BMD in minorities and whites.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Black or African American
  • Bone Density / drug effects
  • Double-Blind Method
  • Dyspareunia / drug therapy
  • Dyspareunia / pathology
  • Estrogen Replacement Therapy / methods*
  • Estrogens, Conjugated (USP) / administration & dosage*
  • Female
  • Hispanic or Latino
  • Hot Flashes / drug therapy
  • Humans
  • Hydrogen-Ion Concentration
  • Indoles / administration & dosage*
  • Middle Aged
  • Minority Groups*
  • Placebos
  • Postmenopause*
  • Quality of Life
  • Selective Estrogen Receptor Modulators / administration & dosage
  • Vagina / chemistry
  • Vagina / drug effects
  • Vagina / pathology
  • White People

Substances

  • Estrogens, Conjugated (USP)
  • Indoles
  • Placebos
  • Selective Estrogen Receptor Modulators
  • bazedoxifene