Objective: The goal of this study was to evaluate the efficacy and safety of gastroretentive gabapentin (G-GR) for the treatment of moderate-to-severe menopausal hot flashes.
Methods: The primary endpoints of this randomized, placebo-controlled study of G-GR (600 mg am/1,200 mg pm) were the mean daily frequency and severity of hot flashes at weeks 4 and 12. Secondary endpoints included Patients’ Global Impression of Change, Clinicians’ Global Impression of Change, and daily sleep interference at week 24.
Results: Six hundred women with 7 or more moderate-to-severe hot flashes/day enrolled; 66.2% completed 24 weeks of treatment. At weeks 4 and 12, G-GR–treated women experienced significantly greater reductions in mean hot flash frequency and severity than placebo-treated women (frequency: week 4, −1.7, P < 0.0001; week 12, −1.14, P = 0.0007; severity: week 4, −0.21, P < 0.0001; week 12, −0.19, P = 0.012). Similar reductions were maintained up to week 24. On the Patient Global Impression of Change, more women receiving G-GR than placebo were “much” or ”very much” improved (week 12: 58% vs 44%, P = 0.0008; week 24: 76% vs 55%, P < 0.0001). G-GR significantly reduced sleep interference compared with placebo at week 12 (P = 0.0056) and week 24 (P = 0.0084). Approximately 5% more women taking G-GR withdrew because of adverse events (G-GR/placebo, 16.7%/11.5%). The most common adverse events were dizziness (12.7%/3.4%), headache (9.3%/8.1%), and somnolence (6.0%/2.7%); incidences dropped to sustained low levels after a few weeks.
Conclusions: G-GR is a modestly effective nonhormone therapy option for the treatment of moderate-to-severe hot flashes due to menopause and is well tolerated with titration.
From the 1Division of Midlife, Department of Obstetrics and Gynecology, University of Virginia Health Sciences Center, Charlottesville, VA; 2East Bay Physicians Medical Group, Sutter East Bay Medical Foundation, Berkeley, CA; 3Columbus Center for Women’s Health Research, Columbus, OH; and 4Depomed Inc, Newark, CA.
Received May 31, 2013; revised and accepted August 1, 2013.
Clinical trial registration: NCT01080300 (www.clinicaltrials.gov).
Funding/support: This study was funded by Depomed Inc.
Financial disclosure/conflicts of interest: J.V.P. has served as a consultant (fees to the University of Virginia) for Pfizer, Noven Pharmaceuticals, Depomed, and Shionogi; received grants/research support (fees to the University of Virginia) from Depomed, Bionova, and Endoceutics; and received travel funds from Pfizer, Noven Pharmaceuticals, Shionogi, and Depomed. R.K. has served as a consultant and advisory board member for Merck, Pfizer, Amgen, Noven, Novo Nordisk, Depomed, and Shionogi; has received research support and travel support from Depomed; has served on the speakers bureaus of Novo Nordisk, Noven, Novogyne, and Shionogi; is a member of the scientific advisory boards of the American Bone Health, The North American Menopause Society (through October 2012), and the American Orthopedics Association—Own the Bone; and has provided legal consulting for Merck and Warner Chilcott. D.P. has served as a consultant to Noven, Meda, and Teva; has received research grants from Noven, Depomed, Teva, Pfizer, and Bayer (paid to Columbus Center for Women’s Health Research); and has served on the speakers bureaus of Noven, Teva, and Warner Chilcott. M.S. and R.S. are employees of Depomed Inc and are shareholders in the company.
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Address correspondence to: JoAnn V. Pinkerton, MD, Box 801104, University of Virginia Health System, Charlottesville, VA 22908. E-mail: firstname.lastname@example.org