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Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial

Pinkerton, JoAnn V. MD1; Constantine, Ginger MD2; Hwang, Eunhee PhD3; Cheng, Ru-fong J. MD3for the Study 3353 Investigators

doi: 10.1097/gme.0b013e31826421a8
Original Articles

Objective The aim of this study was to assess the 12-week efficacy of desvenlafaxine in treating moderate to severe vasomotor symptoms and the clinical relevance of improvements in postmenopausal women experiencing 50 or more moderate to severe hot flashes per week.

Methods Participants were randomized to placebo or desvenlafaxine 100 mg/day in the 12-week efficacy substudy of a year-long, multicenter, parallel-group, double-blind study. Coprimary outcomes were changes from baseline in the daily number and severity of hot flashes on weeks 4 and 12. The percentage of women achieving the minimal clinically important difference (MCID) in the number of hot flashes on week 12 was determined.

Results The efficacy substudy modified intent-to-treat population included 365 women (desvenlafaxine, n = 184; placebo, n = 181). Desvenlafaxine 100 mg/day significantly reduced the number and severity of hot flashes versus placebo on week 4 (P < 0.001) and week 12 (P < 0.001). On week 12, desvenlafaxine reduced the number of moderate and severe hot flashes by 7.3 (62%) per day (placebo, −4.5 [38%] per day) and the severity score by 0.59 (25%) per day (placebo, −0.28 [12%] per day). MCID—a reduction of 5.35 moderate and severe hot flashes per day—was achieved by 64% of desvenlafaxine-treated women (placebo, 41%; P < 0.001). In all, 17.2% (67/390) of participants discontinued, 10.0% (20/200) of participants taking desvenlafaxine and 3.7% (7/190) of participants taking placebo discontinued because of adverse events (P = 0.016), and 2.5% (5/200) of participants taking desvenlafaxine and 8.4% (16/190) of participants taking placebo discontinued because of lack of efficacy (P = 0.012).

Conclusions Postmenopausal women with moderate to severe hot flashes who are treated with desvenlafaxine achieve rapid symptom reduction that is clinically relevant based on MCID.

From the 1University of Virginia Health System, Charlottesville, VA; 2EndoRheum Consultants LLC; and 3Pfizer Inc. (formerly Wyeth Research), Collegeville, PA.

Received March 26, 2012; revised and accepted June 5, 2012.

Data included in this manuscript have been presented at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, Washington, DC, April 30 to May 4, 2011; the 13th World Congress on Menopause, Rome, Italy, June 8 to 11, 2011; and the 67th Annual Clinical Meeting of the Society of Obstetricians and Gynecologists of Canada, Vancouver, BC, Canada, June 21 to 25, 2011.

Funding/support: This study was sponsored by Wyeth Research, which was acquired by Pfizer Inc. in October 2009.

Financial disclosure/conflicts of interest: Pfizer Inc. (formerly Wyeth Research) participated in study design, study conduct, data collection, and analysis, and assisted the authors in the preparation and review of the report. In the past 12 months, Dr. Pinkerton has served as a consultant (fees to the University of Virginia) for Pfizer Inc, Noven pharmaceuticals,and consultant for Novogyne pharmaceuticals; received grants/research support (fees to the University of Virginia) from DepoMed, Bionova, and Endoceutics; and received travel funds from Pfizer Inc, Noven Pharmaceuticals, and Novogyne pharmaceuticals. Dr. Constantine was a former full-time employee of Pfizer Inc. who held stock options. Drs. Cheng and Hwang are full-time employees of Pfizer Inc. with stock options.

All authors had access to data; were involved in planning, writing, and editing the manuscript; and approved the final submission. Dr. Pinkerton had access to all of the data in the study and had the final responsibility of deciding to submit the manuscript for publication.

This trial is registered with ClinicalTrials.gov, number NCT00683800.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.menopause.org).

Address correspondence to: JoAnn V. Pinkerton, MD, Women’s Midlife Health Center, University of Virginia Health System, Suite 104, 2955 Ivy Road, Charlottesville, VA 22903. E-mail: JVP9U@Virginia.edu

© 2013 by The North American Menopause Society.