作者
Benjamin M Scirica, Deepak L Bhatt, Eugene Braunwald, P Gabriel Steg, Jaime Davidson, Boaz Hirshberg, Peter Ohman, Robert Frederich, Stephen D Wiviott, Elaine B Hoffman, Matthew A Cavender, Jacob A Udell, Nihar R Desai, Ofri Mosenzon, Darren K McGuire, Kausik K Ray, Lawrence A Leiter, Itamar Raz
发表日期
2013/10/3
期刊
New England Journal of Medicine
卷号
369
期号
14
页码范围
1317-1326
出版商
Massachusetts Medical Society
简介
Background
The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear.
Methods
We 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.
Results
A 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<0.001 for noninferiority); the results …
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