Pooled Analysis of the Effects of Bazedoxifene/Conjugated Estrogens on Vasomotor Symptoms in the Selective Estrogens, Menopause, And Response to Therapy Trials

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 498-531-Female Repro Endocrinology & Case Reports
Clinical
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-514
Ellen W Freeman1, David F Archer2, JoAnn V Pinkerton3, Barry S Komm4, Kelly A Ryan4, Michael Messig5 and Sebastian Mirkin*4
1Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, 2Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, 3University of Virginia Health System, Charlottesville, VA, 4Pfizer Inc, Collegeville, PA, 5Pfizer Inc, New York, NY
Objective:Bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, reduced vasomotor symptoms (VMS) in symptomatic women in the Selective estrogens, Menopause, And Response to Therapy (SMART) trials. This study evaluated the effects of BZA/CE on VMS and health-related quality of life (HRQOL) in a pooled analysis of the SMART-1 and SMART-2 trials. 

Methods:The SMART-1 and SMART-2 trials were randomized, double-blind, placebo (PBO)- and active-controlled, phase 3 studies in non-hysterectomized postmenopausal women. Data were pooled for women (N=435) with moderate-to-severe hot flushes given BZA 20 mg/CE 0.45 and 0.625 mg and PBO over 12 weeks. Hot flushes were assessed by daily diary; HRQOL was evaluated using the Menopause-specific Quality of Life (MENQOL) questionnaire.

Results: At baseline, mean (standard deviation [SD]) age for the pooled population was 53.8 (4.9) y; mean (SD) body mass index was 26.0 (3.9) kg/m2. At 12 weeks, BZA 20 mg/CE 0.45 and 0.625 mg reduced the adjusted mean (standard error [SE]) change from baseline in average daily number of moderate and severe hot flushes (–7.9 [0.4] and –8.2 [0.4], respectively) versus PBO (–4.1 [0.5]; P <0.001 for both). BZA 20 mg/CE 0.45 and 0.625 mg also reduced the adjusted mean (SE) change from baseline in average daily severity score of hot flushes (–1.0 [0.1] and –1.3 [0.1], respectively) versus PBO (–0.3 [0.1]; P <0.001 for both). BZA 20 mg/CE 0.45 and 0.625 mg increased the percentage of women with ≥50% (81.2% and 87.1%, respectively) and ≥75% (62.4% and 74.8%, respectively) reduction from baseline in daily number of moderate and severe hot flushes versus PBO (50.6% and 26.4%, respectively; P <0.001 for all), as well as the percentage of women with ≥50% (38.3% and 58.1%, respectively) and ≥75% (24.2% and 38.1%, respectively) reduction from baseline in average daily severity score of hot flushes versus PBO (11.0% and 5.5%, respectively; P <0.001 for all) at 12 weeks. In addition, BZA 20 mg/CE 0.45 and 0.625 mg improved HRQOL by reducing the adjusted mean (SE) change in MENQOL vasomotor function (–3.1 [0.2] and –3.7 [0.2], respectively) and total (-1.5 [0.1] and -1.8 [0.1], respectively) scores versus PBO (–1.4 [0.2] and -0.9 [0.1], respectively; P<0.001 for both) at 12 weeks. 

Conclusion: In a pooled analysis of 12-week data from the SMART-1 and SMART-2 trials, BZA/CE provided clinically meaningful relief of VMS in a larger population of women with moderate-to-severe hot flushes.

Disclosure: EWF: Clinical Researcher, Forest Laboratories, Inc. DFA: Clinical Researcher, Pfizer, Inc., Clinical Researcher, Pfizer, Inc.. JVP: Clinical Researcher, Pfizer, Inc., Clinical Researcher, Endoceutics and Bionova with prior clinical trial support (fees to UVA) from Pfizer and DepoMed. BSK: Employee, Pfizer, Inc.. KAR: Employee, Pfizer, Inc.. MM: Employee, Pfizer, Inc.. SM: Employee, Pfizer, Inc..

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: This study was sponsored by Pfizer.