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2 型糖尿病试验中的复合终点。

Composite endpoints in trials of type-2 diabetes.

机构信息

Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.

出版信息

Diabetes Obes Metab. 2014 Jun;16(6):492-9. doi: 10.1111/dom.12226. Epub 2013 Nov 8.

Abstract

Composite endpoints (CEPs) are being used more frequently as outcomes for trials of drugs in type-2 diabetes. We reviewed the literature to determine how CEPs have been used to date in trials of drugs for type-2 diabetes. A systematic search was undertaken on Medline, Embase and Cochrane databases and Clinicaltrials.gov for randomized controlled trials of currently marketed agents including SGLT-2 inhibitors (dapagliflozin), GLP-1 agonists (exenatide, liraglutide) and DPP-4 inhibitors (linagliptin, saxagliptin, sitagliptin and vildagliptin). CEPs used were identified as well as numbers and percentages of patients achieving each. Thirty-six studies were identified that reported results on ≥1 CEP; 15 different CEPs were reported (7 with 2 components, 8 with 3 components). All CEPs addressed goals recommended by the American Diabetes Association (ADA). All included HbA1c<7%; other endpoints measured weight, blood pressure and hypoglycaemic events. Results were obtained for CEPs from 6 months to 2 years. Rates of achieving CEPs decreased with increasing numbers of components and outcomes assessed. CEPs are becoming used as indicators of clinical outcomes in type-2 diabetes trials, but are still not common. More research is required to identify optimal CEPs. Standardization of outcomes and their reporting is needed.

摘要

复合终点(CEPs)在 2 型糖尿病药物试验中作为结局指标的应用越来越广泛。我们回顾了文献,以确定迄今为止 2 型糖尿病药物试验中 CEPs 的使用情况。在 Medline、Embase 和 Cochrane 数据库以及 Clinicaltrials.gov 上进行了系统性检索,以查找目前市售药物的随机对照试验,包括 SGLT-2 抑制剂(达格列净)、GLP-1 激动剂(艾塞那肽、利拉鲁肽)和 DPP-4 抑制剂(西格列汀、沙格列汀、维格列汀和利格列汀)。确定了使用的 CEPs 以及达到每个 CEPs 的患者数量和百分比。确定了 36 项报告了≥1 个 CEPs 结果的研究;报告了 15 种不同的 CEPs(7 种有 2 个组成部分,8 种有 3 个组成部分)。所有 CEPs 都涉及到美国糖尿病协会(ADA)推荐的目标。所有纳入的研究均将 HbA1c<7%作为终点;其他终点包括体重、血压和低血糖事件。CEPs 的结果从 6 个月到 2 年不等。随着评估的组成部分和结局数量的增加,达到 CEPs 的比例下降。CEPs 正在成为 2 型糖尿病试验中临床结局的指标,但仍不常见。需要进一步研究以确定最佳的 CEPs。需要对结局及其报告进行标准化。

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