Diabetes primary prevention of cardiovascular events

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Primary Prevention with Aspirin

The safety and efficacy of low-dose aspirin in the primary prevention of cardiovascular events in patients with type 2 diabetes is controversial.

In one prospective, randomized, multicenter, blinded trial, 2539 type 2 diabetes patients with no history of atherosclerotic events were followed for a median of 4.4 years were randomized to either low-dose aspirin (81 or 100 mg per day) or placebo control. There was no difference in the risk of fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke, and peripheral arterial disease: 13.6 events per 1000 person-years in the aspirin group vs 17.0 per 1000 person-years in the non-aspirin group, hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.58-1.10; log-rank test, P = .16). Thus, among patients with type 2 diabetes, the use of low-dose aspirin was not effective in primary prevention of atherosclerotic events.

The combined end point of fatal coronary events and fatal cerebrovascular events occurred in 1 patient (stroke) in the aspirin group and 10 patients (5 fatal myocardial infarctions and 5 fatal strokes) in the nonaspirin group (HR, 0.10; 95% CI, 0.01-0.79; P = .0037). A total of 34 patients in the aspirin group and 38 patients in the nonaspirin group died from any cause (HR, 0.90; 95% CI, 0.57-1.14; log-rank test, P = .67). The composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between the aspirin and nonaspirin groups. Secondary end points included each primary end point and combinations of primary end points as well as death from any cause.