[Efficacy and safety of flibanserin "new female Viagra®?": Literature review].
BACKGROUND
In August 2015, the US Food and Drug Administration (FDA) has approved Addyi®(flibanserin) for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in pre-menopausal women. We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug in women with HSDD.


METHODS
A systematic literature review from the PubMed database search was carried out until April 2016 using the following keywords: "HSDD", "flibanserin", "sexual desire" and "ransomised controlled trial".


RESULTS
We found four randomized double-blind control studies and two meta-analyzes and literature reviews. For the comparison of flibanserin with placebo, the results were reported in standardized mean difference (SMD). Regarding the main criterion "Satisfactory Sexual Event" (SSE), SMD was ranged from 0.49 to 1 (P<0.05); "Desire Sexual Score" SMD was ranged from 1.63 to 2.20 (P<0.05). For the Female Sexual Function Index (FSFI) desire domain score SMD was ranged from 0.03 to 0.4 (P<0.05). Adverse effects were mostly minor: dizziness and drowsiness.


CONCLUSIONS
Flibanserin showed a moderate benefit in terms of frequency of sex and patient satisfaction. The long-term safety of flibanserin is still poorly defined and scientific data concerning this drug are still few.
Department of gynecology, infirmerie protestante Lyon, chemin du Penthod, 69300 Caluire-et-Cuire, France.
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Terrier
Department of urology, centre hospitalo-universitaire Lyon-Sud, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France. Electronic address: jean-etienne.terrier01@chu-lyon.fr.
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Terrier
D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D016896:Treatment Outcome
D001562:Benzimidazoles; C098107:flibanserin
Baisse du désir; Distress; Dysfonction sexuelle féminine; Female sexual dysfunction; Flibanserin; Flibansérine; HSDD; Hypoactive sexual desire disorder; Libido; Low desire; Menopausal; Ménopause; Pre-menopausal women; Pré-ménopause; Trouble du désir sexuel hypoactif