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When major trials mean minor efficacy

机译：当重大试验意味着轻微的疗效时

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One of the drugs presented in the current issue has been evaluated in large-scale comparative clinical trials. Mirabegron, a beta-3 adrenoceptor agonist used to treat urge incontinence, was compared with an antimuscarin-ic drug or placebo in four trials, each including about 1000 to 2000 participants (p. 8-9). At first glance, trials conducted on such a large number of patients seem to indicate a robust evaluation, based on an impressive body of data concerning both efficacy and adverse effects. But this can be viewed in another light. When early data suggest that a drug is much more effective than the chosen comparator, there is no need to enrol a large number of patients to obtain a statistically significant result. On the other hand, when the difference in efficacy is expected to be minor, the trial is much less likely to demonstrate a statistically significant difference, unless a large number of patients are recruited. In fact, clinical trials showed that mirabegron is only slightly more effective than placebo, preventing about one incontinence episode every 2 days... Large trials can be useful for detecting adverse effects, clarifying the optimal treatment strategy, or demonstrating equivalent efficacy between drugs or efficacy against an uncommon event. But in practice, do not assume that "major" trials are necessarily a good thing: they can be a sign of minor efficacy. Prescrire
机译：在大规模的比较临床试验中评估了当前问题的药物之一。 Mirabegron，用于治疗冲动尿失禁的β-3肾上腺素受体激动剂，与四项试验中的抗血清素-IC药物或安慰剂进行比较，每次包括约1000至2000名参与者（第8-9页）。乍一看，在这种大量患者上进行的试验似乎表明了基于有关疗效和不利影响的令人印象深刻的数据体系的稳健评估。但这可以在另一个光线中观看。当早期数据表明，药物比所选比较者更有效时，没有必要注册大量患者以获得统计上显着的结果。另一方面，当有效的效果差异是未成年人的差异时，除非招募大量患者，否则试验的差异远不太可能表现出统计学意义。事实上，临床试验表明，米拉巴克仅比安慰剂略微有效，每2天预防一次失禁事件...大型试验可用于检测不利影响，阐明最佳治疗策略，或在药物之间阐明等效疗效针对罕见事件的功效。但在实践中，不要认为“主要”审判必然是一件好事：它们可以是轻微疗效的迹象。拘留所

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    《Prescrire international》 |2016年第167期|共1页
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  • 中图分类 药学;
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