选择性血清素再摄取抑制剂,它们都是一样的吗?药物流行病学研究

E. Peron, J. Hardouin, Sébille, F. Feuillet, L. Wainstein, A. Chaslerie, J. Pivette, P. Jolliet, C. Victorri-Vigneau
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引用次数: 5

摘要

简介:根据法国卫生当局关于抑郁症和焦虑症治疗的指南,六种选择性5 -羟色胺再摄取抑制剂可作为一线治疗处方。该指南建议这些治疗方案之间是对等的,但关于疗效和安全性的研究存在分歧。此外,临床试验的条件受到严格控制,并不能真实反映现实生活中的使用情况。本研究的目的是评估这六种选择性血清素再摄取抑制剂在实际使用条件下的疗效和/或安全性差异。方法:使用法国国民健康保险区域数据库评估疗效和安全性。接受选择性5 -羟色胺再摄取抑制剂治疗新出现的抑郁症的患者,并且依从治疗至少6个月。在12个月的随访期间,在数据库中确定了表明缺乏疗效和/或安全性的事件(即,剂量增加,切换到另一种抗抑郁药物或与另一种抗抑郁药物相关)。采用Cox模型比较每种选择性5 -羟色胺再摄取抑制剂的每种指示性事件的发生频率和延迟时间。结果:在纳入的3542例患者中,1081例(30.5%)经历了指示性事件。Cox模型在疗效和安全性方面存在差异。用帕罗西汀、舍曲林或西酞普兰作为第一种抗抑郁药治疗的患者比用艾司西酞普兰或氟西汀治疗的患者更容易出现治疗失败。结论:Cox模型确定了选择性血清素再摄取抑制剂在疗效和/或安全性方面的差异。我们的研究将艾司西酞普兰定位为最有效和/或安全的治疗选择。该研究策略可用于评价其他药物的实际使用情况和效果,这是批准后评价的重要组成部分。
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Selective Serotonin Reuptake Inhibitors, are They All Equal? A Pharmacoepidemiological Study
Introduction: According to the French health authorities’ guidelines relative to depression and anxiety disorder treatments, six Selective Serotonin Reuptake Inhibitors are available for prescription as a first-line of treatment. The guidelines suggest equivalence between these treatment options, but studies diverge regarding efficacy and safety profiles. Moreover, conditions in clinical trials are strictly controlled and do not truly reflect real life utilization. The objective of this study was to evaluate differences in efficacy and/or safety between these six selective serotonin reuptake inhibitors in real conditions of use. Methods: Efficacy and safety were evaluated using a regional database of the French national health insurance. Patients who received a selective serotonin reuptake inhibitor for a new depressive disorder and who were compliant to the treatment for a period of at least 6 months were included. Events indicative of a lack of efficacy and/or safety during the 12-month follow-up period were identified in the database (i.e., a dose increase, a switch to another antidepressant drug or an association with another antidepressant drug). A Cox model was used to compare the frequency and the delay to onset of each type of indicative event for each selective serotonin reuptake inhibitor. Results: Out of 3542 patients included, 1081 (30.5%) experienced an indicative event. The Cox model showed differences in terms of efficacy and safety. Patients treated with paroxetine, sertraline or citalopram as a first antidepressant were more likely to present a therapeutic failure than those treated by escitalopram or fluoxetine. Conclusion: A Cox model identified differences between selective serotonin reuptake inhibitors in terms of efficacy and/or safety profile. Our study positioned Escitalopram as the most efficient and/or safe treatment option. This study strategy can viably be used to evaluate the real life usage and effects of other drugs, an essential part of post approval evaluation.
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