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

Background: Flibanserin, a 5-HT(1A) agonist and 5-HT(2A) 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/m(2) in the flibanserin group (n = 1227) and 26.8 kg/m(2) 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/m(2) in the flibanserin group (n = 467) and 27.3 kg/m(2) 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.