Alogliptin after acute coronary syndrome in patients with type 2 diabetes.
Alogliptin after acute coronary syndrome in patients with type 2 diabetes.
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DOI：
10.1056/nejmoa1305889
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发表时间：
2013-10-03
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影响因子：
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通讯作者：
Zannad, Faiez
中科院分区：
文献类型：
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作者：
White, William B;Cannon, Christopher P;Zannad, Faiez
背景技术背景：为了评估2型糖尿病患者中与新型降糖药物相关的潜在心血管风险升高，监管机构要求对新型降糖治疗的心血管安全性特征进行全面评价。我们评估了近期有急性冠状动脉综合征的2型糖尿病患者使用新型二肽基肽酶4（DPP-4）抑制剂阿格列汀与安慰剂相比的心血管结局。我们随机分配了2型糖尿病患者和急性心肌梗死或不稳定型心绞痛患者，这些患者在过去15 - 90天内需要住院治疗，并接受阿格列汀或安慰剂治疗。现有的抗高血糖和心血管药物治疗。研究设计是一个双盲，非劣效性试验与预先规定的非劣效性界值为1.3的风险比为主要终点的复合心血管原因死亡，非致命性心肌梗死，或非致命性stroke.RESULTS：共5380例患者进行随机分组，并随访长达40个月（中位数，18个月）。阿罗格列酮组305例（11.3%）和安慰剂组316例（11.8%）发生主要终点事件（风险比，0.96;单侧重复置信区间上限，1.16; P
BACKGROUND: To assess potentially elevated cardiovascular risk related to new antihyperglycemic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new antidiabetic therapies. We assessed cardiovascular outcomes with alogliptin, a new inhibitor of dipeptidyl peptidase 4 (DPP-4), as compared with placebo in patients with type 2 diabetes who had had a recent acute coronary syndrome.METHODS: We randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy. The study design was a double-blind, noninferiority trial with a prespecified noninferiority margin of 1.3 for the hazard ratio for the primary end point of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.RESULTS: A total of 5380 patients underwent randomization and were followed for up to 40 months (median, 18 months). A primary end-point event occurred in 305 patients assigned to alogliptin (11.3%) and in 316 patients assigned to placebo (11.8%) (hazard ratio, 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; P