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Introduction: 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.
Patients And 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.
Conclusion: 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.
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