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J Womens Health (Larchmt). 2017 Nov;26(11):1161-1168. doi: 10.1089/jwh.2016.6230. Epub 2017 Aug 17.

Effect of Flibanserin Treatment on Body Weight in Premenopausal and Postmenopausal Women with Hypoactive Sexual Desire Disorder: A Post Hoc Analysis.

Author information

1
1 Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University , Richmond, Virginia.
2
2 Department of Obstetrics and Gynecology, George Washington University School of Medicine , Washington, District of Columbia.
3
3 The Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, Yeshiva University , New York, New York.
4
4 Valeant Pharmaceuticals North America, LLC , Bridgewater, New Jersey.

Abstract

BACKGROUND:

Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis evaluated the effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with HSDD.

MATERIALS AND METHODS:

This analysis included three 24-week, double-blind, placebo-controlled studies of flibanserin 100 mg each bedtime (qhs) in premenopausal women, a similarly designed study in postmenopausal women, and a 52-week, open-label extension study in premenopausal women.

RESULTS:

In a pooled analysis of premenopausal women, mean baseline body mass index (BMI) was 27.0 kg/m2 in the flibanserin group (n = 1227) and 26.8 kg/m2 in the placebo group (n = 1238). Among patients who completed 24 weeks of treatment, least squares (LS) mean weight change was -1.4 kg in the flibanserin group (n = 1010) and -0.1 kg in the placebo group (n = 1066; p < 0.0001). Weight loss ≥5% from baseline was reported in 21.0% of patients who received flibanserin and 7.8% of patients who received placebo; weight loss ≥10% was reported in 3.8% and 2.0% of patients, respectively. In postmenopausal women, mean baseline BMI was 27.7 kg/m2 in the flibanserin group (n = 467) and 27.3 kg/m2 in the placebo group (n = 480). LS mean weight change at week 24 was -1.8 kg in the flibanserin group (n = 385) and -0.1 kg in the placebo group (n = 425; p < 0.0001), with weight loss ≥5% reported in 24.7% and 7.3% of patients, respectively, and weight loss ≥10% reported in 5.2% and 1.7%, respectively. In HSDD patients with >12 months (n = 880) and >18 months (n = 637) of exposure to flibanserin, mean weight change was -1.0 and -1.2 kg, respectively; 25.4% and 26.9% of patients, respectively, experienced weight loss ≥5% from baseline, and 7.8% and 8.4%, respectively, experienced weight loss ≥10%.

CONCLUSIONS:

Women treated with flibanserin for HSDD may experience weight loss.

KEYWORDS:

body weight; flibanserin; reproductive health; sexuality; weight loss

PMID:
28817365
PMCID:
PMC5695746
DOI:
10.1089/jwh.2016.6230
[Indexed for MEDLINE]
Free PMC Article

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