作者
Jennifer B Green, M Angelyn Bethel, Paul W Armstrong, John B Buse, Samuel S Engel, Jyotsna Garg, Robert Josse, Keith D Kaufman, Joerg Koglin, Scott Korn, John M Lachin, Darren K McGuire, Michael J Pencina, Eberhard Standl, Peter P Stein, Shailaja Suryawanshi, Frans Van de Werf, Eric D Peterson, Rury R Holman
发表日期
2015/7/16
期刊
New England Journal of Medicine
卷号
373
期号
3
页码范围
232-242
出版商
Massachusetts Medical Society
简介
Background
Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease.
Methods
In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Results
During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference …
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JB Green, MA Bethel, PW Armstrong, JB Buse… - New England Journal of Medicine, 2015