Boussageon R, Gueyffier F, Cornu C
Département de médecine générale, faculté de Poitiers, 11, route du Clos-Bardien, 86000 Poitiers, France.
UMR 5558, CNRS, 69622 Villeurbanne cedex, France; Clinical Pharmacology, Louis-Pradel Hospital, CHU de Lyon, 69677 Bron cedex, France.
Diabetes Metab. 2014 Jun;40(3):169-75. doi: 10.1016/j.diabet.2013.12.010. Epub 2014 Feb 3.
Antidiabetic drugs for type 2 diabetes receive marketing authorization if they show efficacy in reducing levels of HbA(1c). However, efficacy on this biological criterion does not necessarily reflect clinical benefit to patients. Several randomized clinical trials have shown that antidiabetic drugs reduce HbA(1c) without a corresponding reduction in clinical events. This suggests a need to focus on the clinical effectiveness (morbimortality criteria) of our available antidiabetic drugs. In this non-extensive review of the literature, it was found that none of the current antidiabetic drugs have clearly proven their superiority over placebo in the gold standard double-blind randomized clinical trials. Thus, in 2013, the level of evidence for the clinical efficacy of antidiabetic drugs is disappointing and does not support the millions of prescriptions being written for them.
2型糖尿病的抗糖尿病药物若能证明在降低糖化血红蛋白（HbA1c）水平方面有效，便可获得上市许可。然而，基于这一生物学指标的疗效并不一定反映对患者的临床益处。多项随机临床试验表明，抗糖尿病药物能降低糖化血红蛋白（HbA1c）水平，但临床事件并未相应减少。这表明有必要关注现有抗糖尿病药物的临床有效性（发病率和死亡率标准）。在本次非全面的文献综述中发现，在金标准双盲随机临床试验中，目前尚无一种抗糖尿病药物能明确证明其优于安慰剂。因此，2013年抗糖尿病药物临床疗效的证据水平令人失望，无法支持为其开出的数百万张处方。
