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Effects of bazedoxifene in nonflushing postmenopausal women: a randomized phase 2 trial

Bachmann, Gloria MD1; Crosby, Uel MD2; Feldman, Robert A. MD3; Ronkin, Sheila MD4; Constantine, Ginger D. MD4

Menopause:
doi: 10.1097/gme.0b013e3181fa358b
Original Articles
Abstract

Objective: Phase 3 studies of postmenopausal women with or at risk for osteoporosis reported that, compared with placebo, bazedoxifene increased the incidence of hot flushes. The current study evaluated the vasomotor effects of bazedoxifene in healthy nonflushing postmenopausal women.

Methods: In this phase 2 study, nonflushing postmenopausal women (n = 494) were randomized to daily treatment with bazedoxifene 5, 10, or 20 mg; raloxifene 60 mg; or placebo for 12 weeks. The primary endpoint was the percentage of women reporting hot flushes at any time during the study; secondary endpoints included the mean number and severity of hot flushes and the mean number of days with hot flushes. Effects on bone turnover markers and lipid parameters were also evaluated.

Results: Over the 12-week study, 25.5% of placebo-treated women reported hot flushes. The incidence of hot flushes with bazedoxifene 5, 10, and 20 mg and raloxifene 60 mg was 26.0%, 33.7%, 27.6%, and 21.4%, respectively, with no significant differences from that with placebo. The active treatment groups showed no significant differences from placebo in the mean number or severity of hot flushes during week 12 or any 4-week period. Bazedoxifene and raloxifene showed beneficial effects on lipid parameters and markers of bone turnover. All doses of bazedoxifene were generally well tolerated and did not increase endometrial thickness, vaginal bleeding, or breast pain compared with placebo over 12 weeks of therapy.

Conclusions: Data from this phase 2 clinical trial suggest that bazedoxifene does not increase the incidence of hot flushes relative to placebo in nonflushing postmenopausal women.

Author Information

From the 1University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ; 2University of Texas Southwestern Medical Center, Dallas, TX; 3Miami Research Associates, Miami, FL; and 4Pfizer Inc, Collegeville, PA.

Received June 14, 2010; revised and accepted August 30, 2010.

Portions of this work were presented at the 19th Annual Meeting of The North American Menopause Society (NAMS), September 24-27, 2008, Orlando, FL.

Funding/support: This study was sponsored by Wyeth Research, Collegeville, PA, which was acquired by Pfizer Inc in October 2009. Medical writing support for this manuscript was provided by Bo Choi, PhD, of MedErgy and was funded by Wyeth. Statistical analyses were provided by Robert Northington.

Financial disclosure/conflicts of interest: G.B. has served as a research consultant-principal investigator for Wyeth, Bayer, GlaxoSmithKline, Duramed, Novartis, Pfizer, Boehringer-Ingelheim, Johnson & Johnson, Roche, Boston Scientific, Novo Nordisk, Procter & Gamble, Merck, Xanodyne, Hormos, and Femme Pharma. U.C. and R.A.F. have no relevant conflicts of interest to report. S.R. and G.D.C. were employees of Wyeth, which was acquired by Pfizer Inc in October 2009.

Address correspondence to: Gloria Bachmann, MD, Clinical Academic Building, Suite 4200, 125 Paterson St., New Brunswick, NJ 08901. E-mail: bachmaga@umdnj.edu

©2011The North American Menopause Society