作者
William B White, Christopher P Cannon, Simon R Heller, Steven E Nissen, Richard M Bergenstal, George L Bakris, Alfonso T Perez, Penny R Fleck, Cyrus R Mehta, Stuart Kupfer, Craig Wilson, William C Cushman, Faiez Zannad
发表日期
2013/10/3
期刊
New England journal of medicine
卷号
369
期号
14
页码范围
1327-1335
出版商
Massachusetts Medical Society
简介
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 …
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