Objective: Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile. The impact of paroxetine 7.5 mg on body weight and sexual function was evaluated in a pooled analysis.
Methods: Postmenopausal women aged 40 years or older who had moderate to severe VMS were randomly assigned to receive paroxetine 7.5 mg or placebo once daily for 12 or 24 weeks. Assessments included changes in body mass index (BMI) and weight, Arizona Sexual Experiences Scale score, Hot Flash–Related Daily Interference Scale sexuality subscore, and adverse events related to weight or sexual dysfunction.
Results: Pooled efficacy and safety populations comprised 1,174 and 1,175 participants, respectively. Baseline values were similar for median weight (∼75 kg), median BMI (∼28 kg/m2), and the proportion of women with sexual dysfunction (∼58%). No clinically meaningful or statistically significant changes from baseline in weight or sexual function assessments occurred in the paroxetine 7.5 mg group. Small but statistically significant increases in weight and BMI were observed in the placebo group only on week 4. No significant difference between treatment groups was observed in the proportion of participants who had 7% or higher gain in body weight on week 4, 12, or 24. Rates of adverse events suggestive of sexual dysfunction were low and similar in both treatment groups.
Conclusions: Paroxetine 7.5 mg does not cause weight gain or negative changes in libido when used to treat menopause-associated VMS in postmenopausal women.
From the 1Columbus Center for Women’s Health Research, Columbus, OH; 2University of Florida College of Medicine, Jacksonville, FL; 3Amarex Clinical Research, Germantown, MD; and 4Noven Pharmaceuticals Inc, New York, NY.
Received August 14, 2013; revised and accepted December 18, 2013.
Funding/support: These studies (ClinicalTrials.gov identifiers NCT01361308 and NCT01101841) were funded by Noven Pharmaceuticals Inc (New York, NY).
Financial disclosure/conflicts of interest: D.J.P. is a member of the board of the International Society for the Study of Women’s Sexual Health and has served or serves as a consultant to Meda Pharmaceuticals Inc (Somerset, NJ), Noven Pharmaceuticals Inc, and Pfizer Pharmaceuticals Inc (New York, NY). The Columbus Center for Women’s Health Research has received fees for his participation in the speakers’ bureaus of Noven Pharmaceuticals Inc, Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), and Warner Chilcott (Rockaway, NJ). The Columbus Center for Women’s Health Research has received research/grant support from Bayer Corp (Perkasie, PA), Depomed Inc (Menlo Park, CA), Noven Pharmaceuticals Inc, Pfizer Pharmaceuticals Inc, and Teva Pharmaceutical Industries Ltd. D.J.P. has received fees from Noven Pharmaceuticals Inc for participating in review activities and for developing an educational presentation on hormone therapy. A.M.K. is a member of the board of The North American Menopause Society (Mayfield Heights, OH). He has received consultancy fees from Depomed Inc and receives consultancy fees from Merck (Whitehouse Station, NJ), Bayer AG (Leverkusen, Germany), Teva Pharmaceutical Industries Ltd, and Actavis Inc (Parsippany, NJ). The Department of Obstetrics and Gynecology at the University of Florida College of Medicine (Jacksonville, FL) is the recipient of grants from Bayer AG, EndoCeutics Inc (Quebec, Canada), Noven Pharmaceuticals Inc, Teva Pharmaceutical Industries Ltd, and Trimel Pharmaceuticals (Toronto, Canada). K.K. and H.M. have no conflicts of interest to disclose. S.B. and J.L. are employees of Noven Pharmaceuticals Inc.
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Address correspondence to: David J. Portman, MD, Columbus Center for Women’s Health Research, Suite 120, 99 North Brice Road, Columbus, OH 43213. E-mail: firstname.lastname@example.org
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