title: Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women: A Systematic Review and Meta-analysis.
abstract: OBJECTIVE
  In August 2015, the US Food and Drug Administration (FDA) approved flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, despite concern about suboptimal risk-benefit trade-offs.
  
  
  OBJECTIVE
  To conduct a systematic review and meta-analysis of randomized clinical trials assessing efficacy and safety of flibanserin for the treatment of HSDD in women.
  
  
  METHODS
  Medical databases (among others, Embase, Medline, Psycinfo) and trial registries were searched from inception to June 17, 2015. Reference lists of retrieved studies were searched for additional publications.
  
  
  METHODS
  Randomized clinical trials assessing treatment effects of flibanserin in premenopausal and postmenopausal women were eligible. No age, language, or date restrictions were applied. Abstract and full-text selection was done by 2 independent reviewers.
  
  
  METHODS
  Data were extracted by one reviewer and checked by a second reviewer. Results were pooled using 2 approaches depending on the blinding risk of bias.
  
  
  METHODS
  Primary efficacy outcomes included number of satisfying sexual events (SSEs), eDiary sexual desire, and Female Sexual Function Index (FSFI) desire. Safety outcomes included, among others, 4 common adverse events (AEs): dizziness, somnolence, nausea, and fatigue.
  
  
  RESULTS
  Five published and 3 unpublished studies including 5914 women were included. Pooled mean differences for SSE change from baseline were 0.49 (95% CI, 0.32-0.67) between 100-mg flibanserin and placebo, 1.63 (95% CI, 0.45-2.82) for eDiary desire, and 0.27 (95% CI, 0.17-0.38) for FSFI desire. The risk ratio for study discontinuation due to AEs was 2.19 (95% CI, 1.50-3.20). The risk ratio for dizziness was 4.00 (95% CI, 2.56-6.27) in flibanserin vs placebo, 3.97 (95% CI, 3.01-5.24) for somnolence, 2.35 (95% CI, 1.85-2.98) for nausea, and 1.64 (95% CI, 1.27-2.13) for fatigue. Women's mean global impression of improvement scores indicated minimal improvement to no change.
  
  
  CONCLUSIONS
  Treatment with flibanserin, on average, resulted in one-half additional SSE per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue. Overall, the quality of the evidence was graded as very low. Before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause.
authors.affiliation: Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Loes
authors.initials: L
authors.lastname: Jaspers
authors.affiliation: Department of Family Medicine, Vrije Universiteit Brussel, Brussels, Belgium.
authors.forename: Frederik
authors.initials: F
authors.lastname: Feys
authors.affiliation: Medical Library, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Wichor M
authors.initials: WM
authors.lastname: Bramer
authors.affiliation: Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Oscar H
authors.initials: OH
authors.lastname: Franco
authors.affiliation: Department of Sexology, Groene Hart Hospital, Gouda, the Netherlands.
authors.forename: Peter
authors.initials: P
authors.lastname: Leusink
authors.affiliation: Department of Sexology and Psychosomatic Obstetrics and Gynecology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Ellen T M
authors.initials: ET
authors.lastname: Laan
mesh_terms: D001562:Benzimidazoles / Q000627:therapeutic use*; D004244:Dizziness / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007989:Libido; D009325:Nausea / Q000139:chemically induced; D017060:Patient Satisfaction; D017697:Premenopause; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D001562:Benzimidazoles; C098107:flibanserin