Escitalopram: Superior to citalopram or a chiral chimera?
Escitalopram: Superior to citalopram or a chiral chimera?
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DOI：
10.1159/000074435
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发表时间：
2004-01-01
影响因子：
22.8
通讯作者：
Mansfield, PR
中科院分区：
文献类型：
--
作者：
Svensson, S;Mansfield, PR
背景：艾司西酞普兰是抗抑郁药西酞普兰的活性异构体。理论上，单异构体药物可能更优越，但很少发现有临床显著的优势。制造商声称艾司西酞普兰比西酞普兰更有效，起效更快。这项研究的目的是评估这些说法在多大程度上是合理的。方法：从H. Lundbeck A/S和瑞典药品监管局索取相关试验报告。这些试验包括对1321名患者的汇总分析，这些患者来自一项未发表、一项部分发表和一项已发表的8周试验，以及一项24周的试验，其中357名患者作为海报发表。这些研究比较了艾司西酞普兰与安慰剂和/或西酞普兰在大于或等于18岁且符合特定抑郁症标准的门诊患者中的疗效。采用Moncrieff等人的质量评估工具对试验的质量进行评估，并将结果与广告中的声称进行比较。结果：广告声称是不合理的，因为它们是基于次要结果，非意向治疗分析和任意定义的亚组。子组结果不一致。试验方法上的缺陷可以解释所发现的差异。即使声称的差异是真实的，它们似乎也太小，不足以证明价格上涨是合理的。结论：根据我们现有的证据，制造商声称艾司西酞普兰优于西酞普兰是没有根据的。瑞典和丹麦的药品监管当局也得出了类似的结论。这突出表明有必要向受欧洲联盟相互承认程序影响的其他国家更广泛地传播国家当局的声明。版权所有(C) 2004 S. Karger AG，巴塞尔。
Background: Escitalopram is the active isomer of the antidepressant citalopram. In theory single-isomer drugs may be superior but few have been found to have clinically significant advantages. The manufacturer claims that escitalopram has more efficacy and a faster onset of effect than citalopram. The purpose of this study was to assess how far these claims are justified. Methods: Relevant trial reports were requested from H. Lundbeck A/S and the Swedish drug regulatory authority. The trials consisted of a pooled analysis of 1,321 patients from one unpublished, one partly published and one published eight-week trial, as well as a 24-week trial with 357 patients published as a poster. The studies compared escitalopram with placebo and/or citalopram in outpatients aged greater than or equal to18 years who met specified criteria for depression. The trials' quality was assessed with Moncrieff et al.'s quality assessment instrument and the results compared with the claims from the advertisements. Results: The advertising claims are not justified because they are based on secondary outcomes, non-intention-to-treat analyses and arbitrarily defined subgroups. The sub-group results are inconsistent. Methodological flaws in the trials could account for the differences found. Even if the differences claimed were real they appear too small to justify higher prices. Conclusions: On the evidence available to us the manufacturer's claims of superiority for escitalopram over citalopram are unwarranted. The Swedish and Danish drug regulatory authorities reached similar conclusions. This highlights the need for wider dissemination of national authorities' statements to other countries affected by the European Union's mutual recognition procedure. Copyright (C) 2004 S. Karger AG, Basel.