Clinical Science, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA.
CNS Statistics, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA.
CNS Spectr. 2020 Feb;25(1):50-63. doi: 10.1017/S1092852919000750.
The objective of this work was to describe treatment-emergent sexual dysfunction (TESD) and tolerability following a switch from selective serotonin reuptake inhibitor (SSRI: citalopram, paroxetine, or sertraline) monotherapy to vortioxetine or escitalopram monotherapy in adults with well-treated major depressive disorder (MDD) and SSRI-induced sexual dysfunction.
Data were analyzed from the primary study, an 8-week, randomized, double-blind, head-to-head study in which participants with well-treated depressive symptoms but experiencing TESD with SSRIs were directly switched to flexible doses (10/20 mg) of vortioxetine or escitalopram. Sexual functioning was assessed by the Changes in Sexual Functioning Questionnaire-14 (CSFQ-14), efficacy by the Montgomery-Åsberg Depression Rating Scale scores (MADRS) and Clinicians Global Impression of Severity/Improvement (CGI-S/CGI-I), and tolerability by adverse events. Efficacy and tolerability were assessed by pre-switch SSRI therapy where possible, and by participant characteristics.
Greater improvements in TESD were seen in the vortioxetine compared with escitalopram groups based on: participant demographics (≤45 years, women; P = 0.045), prior SSRI treatment (P = 0.044), number of prior major depressive episodes (MDEs) (1-3; P = 0.001), and duration of prior SSRI therapy (>1 year; P = 0.001). Prior SSRI treatment did not appear to influence the incidence or severity of TEAEs, except for nausea. Regardless of prior SSRI, both treatments maintained antidepressant efficacy after 8 weeks.
Results suggest that vortioxetine is a safe and effective switch therapy for treating SSRI-induced sexual dysfunction in adults with well-treated MDD. Also, improvement in sexual dysfunction with vortioxetine or escitalopram may be influenced by prior SSRI usage, sex, age, and history of MDEs.
本研究旨在描述治疗有效的重度抑郁症（MDD）成人患者在停用选择性 5-羟色胺再摄取抑制剂（SSRI：西酞普兰、帕罗西汀或舍曲林）单药治疗后换用维拉唑汀或艾司西酞普兰单药治疗时出现的治疗中出现的性功能障碍（TESD）及其耐受性。
对主要研究的数据进行分析，该研究为 8 周、随机、双盲、头对头研究，在该研究中，接受 SSRI 充分治疗但出现与 SSRIs 相关的 TESD 的患者直接换用维拉唑汀或艾司西酞普兰的灵活剂量（10/20mg）。性功能通过性功能变化问卷-14（CSFQ-14）评估，疗效通过蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评分和临床医生总体印象严重程度/改善程度（CGI-S/CGI-I）评估，通过不良事件评估耐受性。根据可能的预切换 SSRI 治疗和患者特征评估疗效和耐受性。
与艾司西酞普兰组相比，维拉唑汀组在 TESD 方面有更大的改善，基于：患者人口统计学特征（≤45 岁，女性；P=0.045）、先前 SSRI 治疗（P=0.044）、先前 MDE 次数（1-3；P=0.001）和先前 SSRI 治疗持续时间（>1 年；P=0.001）。先前的 SSRI 治疗似乎不会影响 TEAEs 的发生率或严重程度，但会影响恶心的发生率。无论先前是否使用 SSRI，两种治疗方法在 8 周后均能维持抗抑郁疗效。
结果表明，维拉唑汀是治疗治疗有效的 MDD 成人患者 SSRI 诱导的性功能障碍的安全有效药物。此外，维拉唑汀或艾司西酞普兰治疗后性功能障碍的改善可能受先前 SSRI 用药、性别、年龄和 MDE 史的影响。
