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Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials.

Abstract

BACKGROUND

Flibanserin, a 5-hydroxytryptamine 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis assessed pooled efficacy and safety data for flibanserin in premenopausal women with HSDD.

MATERIALS AND METHODS

Data for flibanserin 100 mg once daily at bedtime (qhs) and placebo were pooled from three pivotal 24-week, randomized, placebo-controlled, multicenter studies (VIOLET, DAISY, and BEGONIA) of premenopausal women with HSDD. Pooled efficacy endpoints included the change from baseline to study end (i.e., 24 weeks) in the number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score.

RESULTS

The analysis included 2465 women (flibanserin, n = 1227; placebo, n = 1238) with a mean age of 36 years and a mean HSDD duration of 56.5 months. The mean ± standard error (SE) change from baseline to study end in SSEs over 28 days for flibanserin versus placebo was 2.1 ± 0.14 versus 1.2 ± 0.11, respectively (p < 0.0001). The least-squares mean ± SE changes from baseline to study end in FSFI desire domain score and FSDS-R-13 score were also significantly greater for flibanserin versus placebo (FSFI desire domain: 0.9 ± 0.04 vs. 0.6 ± 0.04, p < 0.0001; FSDS-R-13: -0.9 ± 0.04 vs. -0.6 ± 0.04, p < 0.0001). Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics. Adverse events occurring in ≥10% of patients included dizziness and somnolence.

CONCLUSIONS

This pooled analysis of three pivotal trials demonstrated that flibanserin 100 mg qhs was well tolerated, improved sexual desire, and reduced sexual distress associated with HSDD in premenopausal women, and these improvements were generally consistent across various subgroups based on demographic and baseline characteristics.

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  • Authors+Show Affiliations

    ,

    1 Department of Obstetrics and Gynecology, George Washington University School of Medicine, Washington, District of Columbia.

    ,

    2 Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.

    3 Sprout Pharmaceuticals, Inc., Raleigh, North Carolina.

    Source

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    30707049

    Citation

    Simon, James A., et al. "Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials." Journal of Women's Health (2002), 2019.
    Simon JA, Thorp J, Millheiser L. Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials. J Womens Health (Larchmt). 2019.
    Simon, J. A., Thorp, J., & Millheiser, L. (2019). Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials. Journal of Women's Health (2002), doi:10.1089/jwh.2018.7516.
    Simon JA, Thorp J, Millheiser L. Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials. J Womens Health (Larchmt). 2019 Feb 1; PubMed PMID: 30707049.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials. AU - Simon,James A, AU - Thorp,John, AU - Millheiser,Leah, Y1 - 2019/02/01/ PY - 2019/2/2/entrez KW - flibanserin KW - hypoactive sexual desire disorder KW - low libido KW - low sexual desire KW - premenopausal KW - sexual distress JF - Journal of women's health (2002) JO - J Womens Health (Larchmt) N2 - BACKGROUND: Flibanserin, a 5-hydroxytryptamine 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis assessed pooled efficacy and safety data for flibanserin in premenopausal women with HSDD. MATERIALS AND METHODS: Data for flibanserin 100 mg once daily at bedtime (qhs) and placebo were pooled from three pivotal 24-week, randomized, placebo-controlled, multicenter studies (VIOLET, DAISY, and BEGONIA) of premenopausal women with HSDD. Pooled efficacy endpoints included the change from baseline to study end (i.e., 24 weeks) in the number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score. RESULTS: The analysis included 2465 women (flibanserin, n = 1227; placebo, n = 1238) with a mean age of 36 years and a mean HSDD duration of 56.5 months. The mean ± standard error (SE) change from baseline to study end in SSEs over 28 days for flibanserin versus placebo was 2.1 ± 0.14 versus 1.2 ± 0.11, respectively (p < 0.0001). The least-squares mean ± SE changes from baseline to study end in FSFI desire domain score and FSDS-R-13 score were also significantly greater for flibanserin versus placebo (FSFI desire domain: 0.9 ± 0.04 vs. 0.6 ± 0.04, p < 0.0001; FSDS-R-13: -0.9 ± 0.04 vs. -0.6 ± 0.04, p < 0.0001). Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics. Adverse events occurring in ≥10% of patients included dizziness and somnolence. CONCLUSIONS: This pooled analysis of three pivotal trials demonstrated that flibanserin 100 mg qhs was well tolerated, improved sexual desire, and reduced sexual distress associated with HSDD in premenopausal women, and these improvements were generally consistent across various subgroups based on demographic and baseline characteristics. SN - 1931-843X UR - https://www.unboundmedicine.com/medline/citation/30707049/Flibanserin_for_Premenopausal_Hypoactive_Sexual_Desire_Disorder:_Pooled_Analysis_of_Clinical_Trials_ L2 - https://www.liebertpub.com/doi/full/10.1089/jwh.2018.7516?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -