Essais de non-infériorité dans la maladie thromboembolique veineuse. Une lecture critique est nécessaire !

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• 作者：L. P&#xe9 ; rard ; A. Hot ; M. Cucherat ; M. Simon ; H. Desmurs ; B. Copp&#xe9 ; r&#xe9 ; M.-H. Girard-Madoux ; J.-P. Boissel ; J. Ninet
• 关键词：Clinical trials ; Venous thrombosis ; Therapeutic equivalency
• 刊名：La Revue de Medecine Interne
• 出版年：2007
• 期刊代码：237_02488663
• 类别：med
• 出版时间：November 2007
• 卷：28
• 期：11
• 页码：731-736
• 文件大小：263 K

摘要

Equivalence trials are actually frequently used to prove non-inferiority in anticoagulant therapy. Equivalence trials consist to demonstrate that two treatments are not too much different. This difference has to be under a margin previously determined. The margin corresponds to an efficacy loss that is defined to be acceptable, in accordance to the advantages due to the new treatment. The aim of this work is to explore the equivalence trial published in the thromboembolic disease by focus on the non-inferiority margin used.

Methods

We identified published equivalence trials in the venous thromboembolic disease, by a systematic search in Medline. We calculated the efficacy loss by reference with the value of the smallest effect size of the standard treatment compared to placebo.

Results

We found 9 equivalence trials used in venous thromboembolic disease. The mean value of the efficacy loss was 434%, and the median value was 357%. Eighty-five percent of the values of the efficacy loss were above 100%.

Discussion

Eighty-five percent of the equivalence trials conclude to equivalence despite a complete efficacy loss of the effect of the standard treatment compared to placebo. The results of equivalence trials should be interpreted warily. The corresponding non-inferiority margin should be chosen more rigorously and by reference with the value of the smallest effect size of the standard treatment compared to placebo.