title: Conjugated estrogens and bazedoxifene in minority populations: pooled analysis of four phase 3 trials.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  Notwithstanding a limited sample size, CE/BZA had a similar and beneficial impact on hot flushes, MENQOL, and BMD in minorities and whites.
authors.affiliation: 1University of Virginia Health System, Charlottesville, VA 2Department of Obstetrics and Gynecology, Columbia University, New York, NY 3Pfizer Inc, Collegeville, PA 4Pfizer Inc, New York, NY.
authors.forename: JoAnn V
authors.initials: JV
authors.lastname: Pinkerton
authors.forename: James H
authors.initials: JH
authors.lastname: Pickar
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Ryan
authors.forename: Ching-Ray
authors.initials: CR
authors.lastname: Yu
authors.forename: Sebastian
authors.initials: S
authors.lastname: Mirkin
authors.forename: Barry S
authors.initials: BS
authors.lastname: Komm
mesh_terms: D001741:Black or African American; D015519:Bone Density / Q000187:drug effects; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy / Q000473:pathology; D015914:Estrogen Replacement Therapy / Q000379:methods*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D006630:Hispanic or Latino; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007211:Indoles / Q000008:administration & dosage*; D008875:Middle Aged; D008913:Minority Groups; D010919:Placebos; D017698:Postmenopause; D011788:Quality of Life; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage; D014621:Vagina / Q000737:chemistry / Q000187:drug effects / Q000473:pathology; D044465:White People
chemical_list: D004966:Estrogens, Conjugated (USP); D007211:Indoles; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene