Improving prospects for treating hypoactive sexual desire disorder (<scp>HSDD</scp>): development status of flibanserin

Thorp, Jr; Palacios, Santiago; Symons, James P.; Simon, James A.; Barbour, Krista A.

doi:10.1111/1471-0528.12878

Cited by 19 publications

(14 citation statements)

References 21 publications

(45 reference statements)

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“…3,24 This decision is not without controversy, as some researchers dispute whether there is sufficient evidence for the amalgamation 25 and others cite clinicians who find the new criteria excessively restrictive. 26 Nonetheless, 8-14% of women in the United States suffer from what the DSM-IV refers to as hypoactive sexual desire disorder (HSDD), characterized by distress due to decreased interest in sex, with effects on quality of life that continue to be underestimated. 26 While lab testing for low desire in women is rarely useful, physicians can look for key biological factors, including hypertension, diabetes mellitus and their treatments, and psychological factors, including past sexual trauma/abuse, personality disorders, anxiety, distraction, and body image issues.…”

Section: Womenmentioning

confidence: 99%

Assessment and management of sexual dysfunction in the context of depression

Chokka

Hankey

2017

Therapeutic Advances in Psychopharmacology

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Sexual dysfunction (SD) is pervasive and underreported, and its effects on quality of life are underestimated. Due in part to its bidirectional relationship with depression, SD can be difficult to diagnose; it is also a common side effect of many antidepressants, leading to treatment noncompliance. While physicians often count on patients to spontaneously report SD, treatment is optimized when the clinician instead performs a thorough assessment of sexual functioning before and during drug therapy using a standardized questionnaire such as the Arizona Sexual Experiences Scale (ASEX). Separating the effects of the disorder from those of medications is challenging; we present a concise, evidence-based schematic to assist physicians in minimizing treatment-emergent sexual dysfunction (TESD) while treating depression. Vascular, hormonal, neurogenic, and pharmacological factors should be considered when a patient presents with SD. We also recommend that physicians obtain patient information about baseline and historical sexual functioning before prescribing a drug that may lead to SD and follow up accordingly. When the goal is to treat depression while attenuating the risk of sexual symptoms, physicians may wish to consider agomelatine, bupropion, desvenlafaxine, moclobemide, trazodone, vilazodone, and vortioxetine.

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Section: Womenmentioning

confidence: 99%

Assessment and management of sexual dysfunction in the context of depression

Chokka

Hankey

2017

Therapeutic Advances in Psychopharmacology

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“…Flibanserin is thought to counteract the sexual effects of serotonin and increase dopamine and noradrenaline levels. Randomized controlled trials showed a significant improvement in Female Sexual Function Index (FSFI) score in women treated with flibanserin (Sprout Pharmaceuticals Inc., Raleigh, North Carolina, USA) when compared with placebo [34]. A total of 12% experienced side-effects including dizziness and fatigue, but no serious adverse reactions were reported.…”

Section: Pharmacological Treatment For Loss Of Sexual Desirementioning

confidence: 99%

Sex drive and sexual desire

Holloway

Wylie

2015

Current Opinion in Psychiatry

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“…The approval of flibanserin at the intersection of science, policy, and advocacy received considerable attention in the public domain and was accompanied by debates among health institutions and stakeholders. 7 Some observed significant benefits without safety concerns, 8 whereas others expressed concern about medicalization of women's sexuality, questioned whether benefits outweighed risks, and expressed concern about the pharmaceutical industry influencing FDA's decisions. 9 Several narrative reviews and commentaries have been published, providing a complete or partial overview of biomedical and integrative treatment options for HSDD.…”

mentioning

confidence: 99%

“…9 Several narrative reviews and commentaries have been published, providing a complete or partial overview of biomedical and integrative treatment options for HSDD. 8,[10][11][12][13][14][15][16][17] To our knowledge, no studies have comprehensively summarized the evidence regarding the beneficial and harmful treatment effects of flibanserin for women with HSDD. Therefore, in view of these controversies and the availability of this new prescription drug, we aimed to assess efficacy and safety of flibanserin for the treatment of HSDD in women by performing a systematic review and meta-analysis of randomized clinical trials.…”

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confidence: 99%

Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women

et al. 2016

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, 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. DATA SOURCES 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. STUDY SELECTION 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. DATA EXTRACTION AND SYNTHESIS 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. MAIN OUTCOMES AND MEASURES 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 AND RELEVANCE 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.

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Improving prospects for treating hypoactive sexual desire disorder (HSDD): development status of flibanserin

Cited by 19 publications

References 21 publications

Assessment and management of sexual dysfunction in the context of depression

Assessment and management of sexual dysfunction in the context of depression

Sex drive and sexual desire

Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women

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