Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study
| Autor: | Louise Brown, Harry A. Croft, James Yuan, Anita H. Clayton, Robert Kissling |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty Urology Endocrinology Diabetes and Metabolism Serotonin reuptake inhibitor Libido 030232 urology & nephrology Placebo-controlled study Placebo Dizziness 03 medical and health sciences 0302 clinical medicine Endocrinology Norepinephrine reuptake inhibitor Double-Blind Method Internal medicine Medicine Humans Sexual Dysfunctions Psychological 030219 obstetrics & reproductive medicine business.industry Depression Hypoactive sexual desire disorder Middle Aged medicine.disease Antidepressive Agents Discontinuation Psychiatry and Mental health Sexual Dysfunction Physiological Reproductive Medicine Premenopause Flibanserin Antidepressant Benzimidazoles Female business Selective Serotonin Reuptake Inhibitors medicine.drug |
| Zdroj: | The journal of sexual medicine. 15(1) |
| ISSN: | 1743-6109 |
| Popis: | Background Depression is often associated with sexual dysfunction, and pharmacologic treatment for hypoactive sexual desire disorder can be considered in women receiving treatment for depression. Aim To evaluate the safety of flibanserin in women treated for depression with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. Methods In this double-blinded, randomized, placebo-controlled trial, women with remitted or mild depression treated with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors who were not postmenopausal and were experiencing symptoms of hypoactive sexual desire disorder (ie, decreased sexual desire and related distress) received flibanserin 50 mg at bedtime (qhs) for 2 weeks and up-titrated to 100 mg qhs, flibanserin 100 mg qhs for the entire treatment period, or placebo for up to 12 weeks. Outcomes Safety assessment included adverse events and symptoms of depression and anxiety. Results 73 patients were randomly assigned to flibanserin (both dose groups combined) and 38 to placebo. The sponsor terminated the study early at discontinuation of the development of flibanserin. Treatment duration was at least 8 weeks for 84.9% and 94.7% of patients in the flibanserin and placebo groups, respectively. The most common adverse events (incidence ≥ 2% in the flibanserin group and higher than that in the placebo group) included dry mouth (5.5% for flibanserin vs 2.6% for placebo), insomnia (5.5% vs 2.6%), back pain (4.1% vs 2.6%), and dizziness (4.1% vs 0.0%). There were no serious adverse events and no instances of suicidal ideation or behavior. The proportions of patients with symptom worsening in the flibanserin and placebo groups, respectively, were 6.9% and 21.6% for depression and 1.4% and 2.7% for anxiety. Remission of depression at study end point, as measured by the Quick Inventory of Depressive Symptomatology–Self Report, was experienced by 19.4% of flibanserin-treated patients and 10.8% of patients receiving placebo; remission of anxiety based on the Beck Anxiety Inventory was noted in 16.4% and 2.7% of patients, respectively. Clinical Implications The results of this study support the safety of flibanserin in premenopausal women being treated with a serotonergic antidepressant. No increased risks were observed when adding flibanserin to a stable selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor treatment regimen. Strengths and Limitations This was a well-designed, randomized, placebo-controlled trial. The primary limitation was the early study discontinuation by the sponsor, which decreased the sample size and duration of treatment. Conclusion In this small trial, flibanserin 100 mg qhs was generally safe and well tolerated in premenopausal women with mild or remitted depression taking a serotonergic antidepressant. |
| Databáze: | OpenAIRE |
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