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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 =  .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.

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  • Authors+Show Affiliations

    ,

    Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.

    ,

    Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.

    ,

    Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.

    Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.

    Source

    The journal of sexual medicine 12:11 2015 Nov pg 2095-104

    MeSH

    Benzimidazoles
    Double-Blind Method
    Female
    Humans
    Libido
    Randomized Controlled Trials as Topic
    Serotonin 5-HT1 Receptor Agonists
    Serotonin 5-HT2 Receptor Antagonists
    Sexual Dysfunctions, Psychological
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Meta-Analysis
    Review
    Systematic Review

    Language

    eng

    PubMed ID

    26745616

    Citation

    Gao, Zhenli, et al. "Efficacy and Safety of Flibanserin in Women With Hypoactive Sexual Desire Disorder: a Systematic Review and Meta-Analysis." The Journal of Sexual Medicine, vol. 12, no. 11, 2015, pp. 2095-104.
    Gao Z, Yang D, Yu L, et al. Efficacy and Safety of Flibanserin in Women with Hypoactive Sexual Desire Disorder: A Systematic Review and Meta-Analysis. J Sex Med. 2015;12(11):2095-104.
    Gao, Z., Yang, D., Yu, L., & Cui, Y. (2015). Efficacy and Safety of Flibanserin in Women with Hypoactive Sexual Desire Disorder: A Systematic Review and Meta-Analysis. The Journal of Sexual Medicine, 12(11), pp. 2095-104. doi:10.1111/jsm.13037.
    Gao Z, et al. Efficacy and Safety of Flibanserin in Women With Hypoactive Sexual Desire Disorder: a Systematic Review and Meta-Analysis. J Sex Med. 2015;12(11):2095-104. PubMed PMID: 26745616.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and Safety of Flibanserin in Women with Hypoactive Sexual Desire Disorder: A Systematic Review and Meta-Analysis. AU - Gao,Zhenli, AU - Yang,Diandong, AU - Yu,Luxin, AU - Cui,Yuanshan, PY - 2016/1/9/entrez PY - 2016/1/9/pubmed PY - 2016/7/21/medline KW - Flibanserin KW - Hypoactive Sexual Desire Disorder KW - Meta-Analysis KW - Randomized Controlled Trial SP - 2095 EP - 104 JF - The journal of sexual medicine JO - J Sex Med VL - 12 IS - 11 N2 - 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 =  .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. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/26745616/Efficacy_and_Safety_of_Flibanserin_in_Women_with_Hypoactive_Sexual_Desire_Disorder:_A_Systematic_Review_and_Meta_Analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)34446-5 DB - PRIME DP - Unbound Medicine ER -