A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age.

IF 3.6 3区医学 Q1 PSYCHIATRY

Annals of General Psychiatry Pub Date : 2024-11-07 DOI:10.1186/s12991-024-00519-9

Andrea Fagiolini, Melissa Paulita Mariano, Egbert Biesheuvel, Pradeep Purushottamahanti

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Abstract

Introduction: Gender- and age-specific research on medications is essential for personalizing treatment plans, optimizing dosing, minimizing adverse effects and improving outcomes. Women are twice as likely to be diagnosed with major depressive disorder (MDD), and it is commonly reported during their reproductive years. This post-hoc pooled analysis evaluated the efficacy of sertraline (one of the most studied medications in women) in women of reproductive age (18-44 years).

Methods: Data was pooled from nine clinical trials of sertraline that included 1832 subjects with MDD. The analysis set included 1097 women, 651 of those were of reproductive age. Sertraline was compared with placebo for changes in total HAM-D17 and CGI scores measured over time through MMRM analysis. The change from baseline to the end of study (-week 8) was assessed using ANCOVA.

Results: The changes from baseline in total HAM-D17 and CGI scores were significantly higher for sertraline than for placebo at the end of 8 weeks for all women (LS Mean difference, 95% CI: -1.81(-3.01,-0.62), P = 0.0029; -0.38(-0.55,-0.20), P < 0.0001, respectively). For women of reproductive age these changes (LS Mean difference, 95% CI: -2.08(-3.52,-0.64), P = 0.0047; -0.44(-0.66,-0.22), P < 0.0001, respectively), were significant from week 2 (HAM-D17) and week 1 (CGI) till the end of study.

Limitations: Only sertraline and placebo arms were included in the analysis. The dosing varied between studies, and the effect of dose was not addressed.

Conclusions: Sertraline is an effective option for treatment of MDD in women, including those in the childbearing age.

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关于舍曲林对妇女疗效的汇总分析，重点关注育龄妇女。

导言：针对不同性别和年龄的药物研究对于个性化治疗方案、优化剂量、减少不良反应和提高疗效至关重要。女性被诊断为重度抑郁障碍（MDD）的几率是男性的两倍，而且女性在生育期常会出现重度抑郁障碍。这项事后汇总分析评估了舍曲林（对女性研究最多的药物之一）对育龄女性（18-44 岁）的疗效：方法：汇总了9项舍曲林临床试验的数据，其中包括1832名患有多发性抑郁症的受试者。分析集包括 1097 名女性，其中 651 人为育龄妇女。通过MMRM分析，比较了舍曲林与安慰剂在HAM-D17和CGI总分上随时间的变化。使用方差分析评估了从基线到研究结束（第 8 周）的变化：所有女性的 HAM-D17 和 CGI 总分在 8 周结束时与基线相比的变化，舍曲林明显高于安慰剂（LS 平均差，95% CI：-1.81(-3.01,-0.62), P = 0.0029; -0.38(-0.55,-0.20), P 局限性：分析仅包括舍曲林和安慰剂组。不同研究的剂量各不相同，剂量的影响并未涉及：舍曲林是治疗女性（包括育龄期女性）多发性抑郁症的有效选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of General Psychiatry PSYCHIATRY-

CiteScore

6.60

自引率

2.70%

发文量

审稿时长

>12 weeks

期刊介绍： Annals of General Psychiatry considers manuscripts on all aspects of psychiatry, including neuroscience and psychological medicine. Both basic and clinical neuroscience contributions are encouraged. Annals of General Psychiatry emphasizes a biopsychosocial approach to illness and health and strongly supports and follows the principles of evidence-based medicine. As an open access journal, Annals of General Psychiatry facilitates the worldwide distribution of high quality psychiatry and mental health research. The journal considers submissions on a wide range of topics including, but not limited to, psychopharmacology, forensic psychiatry, psychotic disorders, psychiatric genetics, and mood and anxiety disorders.