title: Efficacy and Safety of Flibanserin in Women with Hypoactive Sexual Desire Disorder: A Systematic Review and Meta-Analysis.
abstract: BACKGROUND
  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).
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.
authors.forename: Zhenli
authors.initials: Z
authors.lastname: Gao
authors.affiliation: Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.
authors.forename: Diandong
authors.initials: D
authors.lastname: Yang
authors.affiliation: Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.
authors.forename: Luxin
authors.initials: L
authors.lastname: Yu
authors.affiliation: Department of Urology, Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao University, Yantai, China.
authors.forename: Yuanshan
authors.initials: Y
authors.lastname: Cui
mesh_terms: D001562:Benzimidazoles / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007989:Libido / Q000187:drug effects*; D016032:Randomized Controlled Trials as Topic; D058825:Serotonin 5-HT1 Receptor Agonists / Q000627:therapeutic use*; D058830:Serotonin 5-HT2 Receptor Antagonists / Q000627:therapeutic use*; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D001562:Benzimidazoles; D058825:Serotonin 5-HT1 Receptor Agonists; D058830:Serotonin 5-HT2 Receptor Antagonists; C098107:flibanserin
keywords: Flibanserin; Hypoactive Sexual Desire Disorder; Meta-Analysis; Randomized Controlled Trial