Efficacy and Safety of Flibanserin in Women with Hypoactive Sexual Desire Disorder: A Systematic Review and Meta-Analysis

Abstract

Introduction Flibanserin, is a postsynaptic agonist of serotonin receptor 1A and an antagonist of serotonin receptor 2A, has been shown to increase sexual desire and reduce distress in women with hypoactive sexual desire disorder (HSDD). Aim We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug in women with HSDD. Methods A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of flibanserin for the treatment of HSDD. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. Main Outcome Measures Four publications involving a total of 3,414 patients were used in the analysis, including four randomized controlled trials that compared flibanserin with placebo. Results For the comparison of flibanserin with placebo, primary efficacy endpoints: satisfying sexual events (the standardized mean difference [SMD] = 0.59, 95% confidence interval [CI] = 0.37–0.80, P < 0.00001); sexual desire score (the SMD = 1.91, 95% CI = 0.21 to 3.60, P = 0.03) and Female Sexual Function Index (FSFI) desire domain score (the SMD = 0.32, 95% CI = 0.19–0.46, P < 0.00001) and key secondary efficacy endpoints: FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, FSDS-R Item 13 score, Patient's Global Impression of Improvement score and Patient Benefit Evaluation indicated that flibanserin was more effective than the placebo. Safety assessments included the proportion of women who experienced an adverse event (odds ratio = 1.54, 95% CI = 1.34 to 1.76, P < 0.00001), nervous system disorders and fatigue indicated that flibanserin was well tolerated. Conclusions This meta-analysis indicates that flibanserin to be an effective and safe treatment for HSDD in women.

Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology

“…223 Meta-analyses have shown that flibanserin resulted in approximately 1 additional satisfying sexual event every 2 months in premenopausal women. 224,225 This drug has not been studied in patients with cancer or survivors, but it is a reasonable option to discuss with premenopausal survivors with low or lack of desire, libido, or intimacy; other options for these survivors include bupropion and buspirone. 226 These drugs have been studied in a few trials involving noncancer populations.…”

Next-day residual effects of flibanserin on simulated driving performance in premenopausal women

“…In these trials, FLI 100 mg once daily significantly increased sexual desire and function while decreasing distress relative to placebo (PBO). These findings were further confirmed by a recent meta‐analysis (Gao, Yang, Yu, & Cui, ), and similar findings were reported in a phase III trial in naturally postmenopausal women with HSDD (Simon et al, ).…”

Statistical and Epistemological Issues in the Evaluation of Treatment Efficacy of Pharmaceutical, Psychological, and Combination Treatments for Women's Sexual Desire Difficulties

“…The meta-analyses by Gao, Yang, Yu, and Cui (2015) and Jaspers et al (2016), examining efficacy and risks associated with flibanserin treatment, are excellent examples of variability in the strengths and weaknesses of meta-analysis, specifically -the file-drawer effect‖ to which Balon and Seagraves were referring. Gao et al (2015) restricted their sample to four published RCTs and reported a standardized mean difference in SSEs of .59.…”

“…Gao et al (2015) restricted their sample to four published RCTs and reported a standardized mean difference in SSEs of .59. Jaspers et al (2016) replicated this effect using the same sample of published studies with an additional published study in which only women who showed improvement in an open-label phase were retained and randomized to treatment or placebo (Goldfischer et al, 2011 (2016) and Clayton and Pyke (2016) suggested that future research could focus on direct comparisons between pharmaceutical and psychological treatments, or combination treatments for low desire in women.…”