Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus
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DOI:
10.1056/nejmoa1307684
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发表时间:
2013-10-03
影响因子:
158.5
通讯作者:
Simmons, D.
Simmons, D.
中科院分区:
医学1区
文献类型:
--
作者:
Scirica, Benjamin M.;Bhatt, Deepak L.;Simmons, D.

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BackgroundThe心血管的安全性和有效性,目前许多抗高血糖药物,包括沙格列汀,二肽基肽酶4(DPP-4)抑制剂,是unclear.MethodsWe随机分配16,492例2型糖尿病患者的历史,或有风险,心血管事件接受沙格列汀或安慰剂,并遵循他们的中位数为2.1年。允许医生调整其他药物,包括降糖药。主要终点是心血管死亡、心肌梗死或缺血性strok.ResultsA主要终点事件发生在613例沙格列汀组和609例安慰剂组患者中(根据2年Kaplan-Meier估计,分别为7.3%和7.2%;沙格列汀的风险比为1.00; 95%置信区间[CI],0.89至1.12;优效性P=0.99; P
BackgroundThe cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear.MethodsWe randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke.ResultsA primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P