Aspirin for Cardiovascular Prevention in Patients With Diabetes

STUDY 1

Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, Jinnouchi H, Sugiyama S, Saito Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators: Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA 300:2134-2141, 2008

SUMMARY

Design. A multicenter, randomized trial.

Subjects. A total of 2,539 Japanese patients aged 30-85 years with type 2 diabetes and no previous history of atherosclerotic disease. Mean age was 65 years, and ~ 45% of participants were female.

Methods. Participants were randomized to receive low-dose aspirin or no aspirin in an open-label design. The primary outcome was any atherosclerotic event, defined as cardiovascular death, nonfatal myocardial infarction, unstable angina, new-onset stable angina, stroke (ischemic or hemorrhagic), transient ischemic attack, or new peripheral vascular disease. All outcomes were adjudicated by an independent committee blinded to intervention status. Median follow-up was 4.37 years (193 of 2,539 were lost to follow-up).

Results. Aspirin use was associated with a nonstatistically significant reduction in the incidence rate of the primary outcome (13.6/1,000 patient-years in the aspirin group …