Efficacy and Safety of Flibanserin for Hypoactive Sexual Desire Disorder in Premenopausal Women: A Meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 DENGTuo , CAIXiang , TIANYe , LIAOBang-hua , LUODe-yi , MENGYang , WANGKun-jie ,  LIHong

Department of Urology, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

LIHong, Email: wzwzlwww@qq.com

Keywords：

Flibanserin; Hypoactive sexual desire disorder in premenopausal women; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20150094

Video：

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Objective To systematically review the efficacy and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. Methods We searched PubMed, EMbase, MEDLINE, The Cochrane Library (Issue 7, 2014), CBM, CNKI, VIP and WanFang Data from their inception to August 2014, to collect randomized controlled trials (RCTs) on the effectiveness and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. And then, meta-analysis was performed using RevMan 5.3 software. Results A total of 4 RCTs involving 3 881 patients were included. The results of meta-analysis showed that:compared with the placebo group, the flibanserin group was superior in increasing the number of satisfying sexual events (SSE) (MD=0.72, 95%CI 0.51 to 0.92, P<0.000 01), improving the eDiary desire score (MD=2.21, 95%CI 1.45 to 2.97, P<0.000 01), FSFI domain score (MD=0.29, 95%CI 0.24 to 0.35, P<0.01) and FSFI total score (MD=1.82, 95%CI 1.47 to 2.17, P<0.000 01), and decreasing the FSDS-R item 13 score (MD=-0.24, 95%CI -0.31 to -0.17, P<0.000 01) and FSDS-R total score (MD=-2.70, 95%CI -3.43 to -1.96, P<0.000 01). However, the incidence of adverse events in the flibanserin group was higher than that of the placebo group (OR=1.31, 95%CI 1.11 to 1.54, P=0.001). Conclusion The current evidence suggests that, in premenopausal women with HSDD, flibanserin treatment is effective but may increase the incidence of adverse events.

Citation： DENGTuo, CAIXiang, TIANYe, LIAOBang-hua, LUODe-yi, MENGYang, WANGKun-jie, LIHong. Efficacy and Safety of Flibanserin for Hypoactive Sexual Desire Disorder in Premenopausal Women: A Meta-analysis. Chinese Journal of Evidence-Based Medicine, 2015, 15(5): 565-572. doi: 10.7507/1672-2531.20150094 Copy

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2.	Riley A, May K. Sexual desire disorders. In:Gabbord G, ed. Treatments of Psychiatric Disorders, 3rd edn. Washington, DC:American Psychiatric Press; 2001:1849-1872.
3.	Bachmann G. Female sexuality and sexual dysfunction:Are we stuck on the learning curve? J Sex Med, 2006, 3(4):639-645.
4.	Laumann E, Nicolsi A, Glasser D, et al. Sexual problems among women and men aged 40-80 years:prevalence and correlates identified in the global study of sexual attitudes and behavior. Int J Impot Res, 2005, 17(1):39-57.
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16.	Derogatis LR, Komer L, Katz M, et al. Treatment of hypoactive sexual desire disorder in premenopausal women:efficacy of flibanserin in the violet study. J Sex Med, 2012, 9(4):1074-1085.
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19.	Basson R, Leiblum S, Brotto L, et al. Revised definitions of women's sexual dysfunction. J Sex Med, 2004, 1(1):40-48.
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24.	Fabre LF, Brown CS, Smith LC, et al. Gepirone-ER Treatment of Hypoactive Sexual Desire Disorder (HSDD) Associated with Depression in Women. J Sex Med, 2011, 8(5):1411-1419.
25.	US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Draft guidance for industry:Female sexual dysfunction:Clinical development of drug products for treatment. Available at:http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm133202.htm.
26.	Tignol J, Clayton AH, van Lunsen R, et al. Using e-Diaries to measure sexual desire in women with HSDD. J Sex Med, 2008, 5(2):53.
27.	Revicki DA, Margolis MK, Bush EN, et al. Content validity of the female sexual function index (fsfi) in pre- and postmenopausal women with hypoactive sexual desire disorder. J Sex Med, 2011, 8(8):2237-2245.
28.	Meston CM.Validation of the Female Sexual Function Index (FSFI) in women with female orgasmic disorder and in women with hypoactive sexual desire disorder. J Sex Marital Ther, 2003, 29(1):39-46.
29.	DeRogatis L, Pyke R, McCormack J, et al. Does the female sexual distress scale-revised cover the feelings of women with hsdd? J Sex Med, 2011, 8(10):2810-2815.
30.	Simon JA, Kingsberg SA, Shumel B, et al. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder:results of the SNOWDROP trial. Menopause, 2014, 21(6):633-640.
31.	Guyatt G, Oxman A, Montori V, et al. GRADE指南:Ⅴ.证据质量评价-发表偏倚. 中国循证医学杂志, 2011, 11(12):1430-1434.

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th edition. Text revision. Washington, DC:American Psychiatric Press, 2000.
2. Riley A, May K. Sexual desire disorders. In:Gabbord G, ed. Treatments of Psychiatric Disorders, 3rd edn. Washington, DC:American Psychiatric Press; 2001:1849-1872.
3. Bachmann G. Female sexuality and sexual dysfunction:Are we stuck on the learning curve? J Sex Med, 2006, 3(4):639-645.
4. Laumann E, Nicolsi A, Glasser D, et al. Sexual problems among women and men aged 40-80 years:prevalence and correlates identified in the global study of sexual attitudes and behavior. Int J Impot Res, 2005, 17(1):39-57.
5. Rosen RC, Shifren JL, Monz BU, et al. Correlates of sexually related personal distress in women with low sexual desire. J Sex Med, 2009, 6(6):1549-1560.
6. Fourcroy JL. Female sexual dysfunction:potential for pharmacotherapy. Drugs, 2003, 63(14):1445-1457.
7. Brotto LA, Bitzer J, Laan E, et al. Women's sexual desire and arousal disorders. J Sex Med, 2010, 7(1 Pt 2):586-614.
8. Bancroft J, Graham CA, Janssen E, et al. The dual control model:Current status and future directions. J Sex Res, 2009, 46(2-3):121-142.
9. Pfaus JG. Pathways of sexual desire. J Sex Med, 2009, 6(6):1506-1533.
10. Invernizzi RW, Sacchetti G, Parini S, et al. Flibanserin, a potential antidepressant drug, lowers 5-HT and raises dopamine and noradrenaline in the rat prefrontal cortex dialysate:role of 5-HT(1A) receptors. Br J Pharmacol, 2003, 139(7):1281-1288.
11. Newman-Tancredi A, Heusler P, Martel JC, et al. Agonist and antagonist properties of antipsychotics at human dopamine D4.4 receptors:G-protein activation and K+ channel modulation in transfected cells. Int J Neuropsychopharmacol, 2008, 11(3):293-307.
12. Soules MR, Sherman S, Parrott E, et al. Executive summary:Stages of Reproductive Aging Workshop (STRAW). Climacteric, 2001, 4(4):267-272.
13. DeRogatis L, Clayton A, Lewis-D'Agostino D, et al. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med, 2008, 5(2):357-364.
14. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[updated March 2011]. The Cochrane Collaboration, 2011, Available at:www.cochranehandbook.org.
15. Goldfischer ER, Breaux J, Katz M, et al. Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD):results from a randomized withdrawal trial. J Sex Med, 2011, 8(11):3160-3172.
16. Derogatis LR, Komer L, Katz M, et al. Treatment of hypoactive sexual desire disorder in premenopausal women:efficacy of flibanserin in the violet study. J Sex Med, 2012, 9(4):1074-1085.
17. Thorp J, Simon J, Dattani D, et al. Treatment of hypoactive sexual desire disorder in premenopausal women:efficacy of flibanserin in the daisy study. J Sex Med, 2012, 9(3):793-804.
18. Katz M, DeRogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder:results from the begonia trial. J Sex Med, 2013, 10(7):1807-1815.
19. Basson R, Leiblum S, Brotto L, et al. Revised definitions of women's sexual dysfunction. J Sex Med, 2004, 1(1):40-48.
20. Bancroft J, Loftus J, Long JS. Distress about sex:a national survey of women in heterosexual relationships. Arch Sex Behav, 2003, 32(3):193-208.
21. Moynihan R. The marketing of a disease:female sexual dysfunction. BMJ, 2005, 330(7484):192-194.
22. Tiefer L. Female sexual dysfunction:a case-study of disease mongering and activist resistance. PLoS Med, 2006, 3(4):436-444.
23. Biddle AK, West SL, D'Aloisio AA, et al. Hypoactive Sexual Desire Disorder in Postmenopausal Women:Quality of Life and Health Burden. Value Health, 2009, 12(5):763-772.
24. Fabre LF, Brown CS, Smith LC, et al. Gepirone-ER Treatment of Hypoactive Sexual Desire Disorder (HSDD) Associated with Depression in Women. J Sex Med, 2011, 8(5):1411-1419.
25. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Draft guidance for industry:Female sexual dysfunction:Clinical development of drug products for treatment. Available at:http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm133202.htm.
26. Tignol J, Clayton AH, van Lunsen R, et al. Using e-Diaries to measure sexual desire in women with HSDD. J Sex Med, 2008, 5(2):53.
27. Revicki DA, Margolis MK, Bush EN, et al. Content validity of the female sexual function index (fsfi) in pre- and postmenopausal women with hypoactive sexual desire disorder. J Sex Med, 2011, 8(8):2237-2245.
28. Meston CM.Validation of the Female Sexual Function Index (FSFI) in women with female orgasmic disorder and in women with hypoactive sexual desire disorder. J Sex Marital Ther, 2003, 29(1):39-46.
29. DeRogatis L, Pyke R, McCormack J, et al. Does the female sexual distress scale-revised cover the feelings of women with hsdd? J Sex Med, 2011, 8(10):2810-2815.
30. Simon JA, Kingsberg SA, Shumel B, et al. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder:results of the SNOWDROP trial. Menopause, 2014, 21(6):633-640.
31. Guyatt G, Oxman A, Montori V, et al. GRADE指南:Ⅴ.证据质量评价-发表偏倚. 中国循证医学杂志, 2011, 11(12):1430-1434.

Chinese Journal of Evidence-Based Medicine

Efficacy and Safety of Flibanserin for Hypoactive Sexual Desire Disorder in Premenopausal Women: A Meta-analysis

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