Objective: The aim of this study was to assess the safety and efficacy of bazedoxifene (BZA)/conjugated estrogens (CE) treating moderate to severe vasomotor symptoms in the Selective Estrogen Menopause and Response to Therapy 2 trial.
Methods: This was an outpatient, multicenter, double-blind, randomized, placebo-controlled, phase 3 study conducted in the United States. Healthy postmenopausal women (N = 332; aged 40-65 y) with moderate to severe hot flushes (≥7/d or 50/wk) were randomized to BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo once daily for 12 weeks. Changes from baseline in the average daily number of moderate and severe hot flushes and daily severity score were assessed at weeks 4 and 12; adverse events were recorded.
Results: BZA/CE significantly reduced the number and severity of hot flushes at weeks 4 and 12 (P < 0.001). At week 12, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg reduced hot flushes from baseline by 74% (10.3 hot flushes [baseline] vs 2.8 [week 12]) and 80% (10.4 vs 2.4), respectively, compared with 51% (10.5 vs 5.4) for placebo. More participants at week 12 had at least a 75% decrease in hot flushes with BZA 20 mg/CE 0.45 mg (61%) and BZA 20 mg/CE 0.625 mg (73%) versus placebo (27%; P < 0.001). The safety profile was similar between BZA/CE and placebo, and no unexpected safety findings were reported.
Conclusions: BZA 20 mg paired with CE 0.45 or 0.625 mg is effective, with short-term safety, for treating vasomotor symptoms in postmenopausal women.
Postmenopausal women aged 40 to 65 years with 7 or more moderate to severe hot flashes per day or 50 per week enrolled in a 12-week placebo controlled, double-blind hot flash efficacy trial. Bazedoxifene 20 mg paired with conjugated estrogens 0.45 or 0.625 mg was found to be effective and safe in this trial for treating vasomotor symptoms.
From the 1University of Virginia, Midlife Health Center and Division, Charlottesville, VA; 2Rapid Medical Research, Inc., Cleveland, OH; and 3Wyeth Research, Collegeville, PA.
Received January 23, 2009; revised and accepted March 31, 2009.
Funding/support: This study and editorial support for this study were sponsored and funded by Wyeth Research, Collegeville, PA. Support was provided by Wyeth for manuscript preparation by Kathleen Ohleth, PhD, and Chastity Bradley, PhD.
Financial disclosure/conflicts of interest: The authors were not compensated; were all involved in the literature searches, planning, writing, and editing of this review; and retained full editorial control over the content of the article. Drs. Pinkerton and Utian have received research grants and are consultants to Wyeth. Drs. Constantine, Olivier and Pickar are employees of Wyeth Pharmaceuticals.
Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00675688
Address correspondence to: JoAnn V. Pinkerton, MD, Midlife Health Center and Division, University of Virginia, Box 801104, Charlottesville, VA 22903. E-mail: firstname.lastname@example.org