Clinical Question

Is flibanserin (Addyi) a safe and effective treatment of hypoactive sexual desire disorder in premenopausal women?

Bottom Line

Flibanserin produces a minimal effect on sexual desire and minimally increases the number of satisfying sexual events in women (less than one-half an event per month increase). Many women will be unable to tolerate the adverse effects. (Level of Evidence = 1a)

Synopsis

To assemble studies for inclusion, these authors searched three trial registries and 13 electronic databases, including the Cochrane Library, with reference lists of retrieved articles to identify randomized studies. They included studies published in any language. Two researchers independently identified the studies for inclusion; data were extracted by one reviewer and checked by another. They included five published and three unpublished studies that enrolled a total of 5,914 premenopausal and postmenopausal women. The overall study quality was low: many women dropped out, some authors shifted end points mid-study, and some authors used the “last observation carried forward.” Benefit was statistically significant but clinically minimal for most outcomes. On average across the studies, treatment, compared with placebo, resulted in one additional satisfying sexual event every two months. Diary scores for sexual desire increased from 1.7 to 2.3 points on a scale of 0 to 84 (four studies), and scores on the female sexual function index increased an average of 0.2 to 0.4 on a scale of 1.2 to 6.0. There was minimal or no change in the women's mean global impression of improvement. Patients who received treatment were twice as likely to drop out because of adverse effects, including dizziness, which was four times more likely in that group.

Study design: Meta-analysis (randomized controlled trial)

Funding source: Self-funded or unfunded

Setting: Various (meta-analysis)

Reference: JaspersLFeysFBramerWMFrancoOHLeusinkPLaanETEfficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women: a systematic review and meta-analysis. JAMA Intern Med2016;176(4):453–462.