Flibanserin

Levine, Stephen B.

doi:10.1007/s10508-015-0617-y

Cited by 4 publications

(1 citation statement)

References 2 publications

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“…Levine SB concluded from diverse controversies involving treatments for sexual difficulties that stakeholders interpret science for us in ways that support their political ideological views, economic interests, or skill sets. The worry about flibanserin is that physicians do not have the time, interest, or skills to elucidate the pathogenesis of women's loss of sexual desire [34]. This meta-analysis includes studies which are all findings from randomized double-blind, placebo-controlled trials.…”

Section: Discussionmentioning

confidence: 99%

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

Gao

Yang²,

et al. 2015

The Journal of Sexual Medicine

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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.

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Section: Discussionmentioning

confidence: 99%

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

Gao

Yang²,

et al. 2015

The Journal of Sexual Medicine

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A Little Deeper, Please

Levine

2017

Arch Sex Behav

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Ignorance Is Not Bliss: If We Don’t Understand Hypoactive Sexual Desire Disorder, How Can Flibanserin Treat It? Commentary

Anderson

Moffatt

2018

The Journal of Sexual Medicine

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Background Female sexual dysfunction (FSD) affects as many as 1 in every 3 women, with a significant portion of these with hypoactive sexual desire disorder (HSDD). These figures alone present significant psychological and pharmacologic challenges. Partly in response to this situation, in 2015 the US Food and Drug Administration approved flibanserin for the treatment of HSDD. This approval has drawn criticism on the grounds of efficacy and necessity. Aim To better inform potential consumers about FSD, flibanserin and other interventions for the treatment of HSDD, the importance of understanding the mechanism of FSD, and the efficacy of flibanserin and to review existing relevant knowledge. Methods A literature review of extant clinic studies and theoretical discussion articles was performed. Outcomes Efficacy of flibanserin for addressing symptoms associated with HSDD in premenopausal women. Results Extant literature and empirical evidence suggest that the efficacy of flibanserin for the treatment of HSDD in premenopausal women is at least questionable. Clinical Translation Clinicians considering the prescription of flibanserin would be well advised to appreciate some of the controversies concerning the efficacy of the drug. Strengths and Limitations The prohibitive usage guidelines, tenuous risk-benefit profile, and considerable cost of use of flibanserin are each worthy of consideration. Flibanserin thus far has been trialed in only a narrow patient range: premenopausal women in long-term relationships with acquired or generalized HSDD. Conclusions Although we acknowledge that the discovery and use of flibanserin constitute a compelling narrative, we conclude by questioning the specific efficacy and necessity of flibanserin in providing a treatment for HSDD in women.

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Flibanserin

Cited by 4 publications

References 2 publications

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

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

A Little Deeper, Please

Ignorance Is Not Bliss: If We Don’t Understand Hypoactive Sexual Desire Disorder, How Can Flibanserin Treat It? Commentary

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