There was a 24% MI. There was no effect on stroke with fenofibrate. A higher rate of statin therapy initiation occurred in patients allocated to placebo, which might have masked a treatment effect. The ACCORD trial randomized 5518 patients with type 2 diabetes mellitus who were being treated with open-label simvastatin to double-blind treatment with fenofibrate or placebo.177 There was no effect of added fenofibrate on the primary outcome (first occurrence of nonfatal MI, nonfatal stroke, or death from cardiovascular causes [HR, 0.92; 95% CI, 0.79 1.08; P=0.32]) and no effect on any secondary outcome, including stroke (HR, 1.05; 95% CI, 0.71 1.56; P=0.80). A recent meta-analysis examining the effects of fibrates on stroke in 37791 patients included some patients with diabetes Overall, fibrate therapy was not associated with a significant reduction on the risk of stroke (RR, 1.02; 95% CI, 0.90 1.16; P=0.78). However, a subgroup analysis suggested that fibrate therapy reduced fatal stroke (RR, 0.49; 95% CI, 0.26 0.93; P=0.03) in patients with diabetes mellitus, CVD, or stroke. Diabetes Mellitus, Aspirin, and Stroke The benefit of aspirin in the primary prevention of cardiovascu- lar events, including stroke in patients with diabetes mellitus, remains unclear. A recent study at 163 institutions throughout Japan enrolled 2539 patients with type 2 diabetes mellitus and no history of atherosclerotic vascular disease.321 Patients were assigned to receive low-dose aspirin (81 or 100 mg/d) or no aspirin. Over 4.37 years, a total of 154 atherosclerotic vascu- lar events occurred (68 in the aspirin group [13.6 per 1000 person-years] and 86 in the nonaspirin group [17.0 per 1000 single fatal stroke occurred in the aspirin group, but 5 strokes occurred in the nonaspirin group; thus, the study was insuf- ficiently powered to detect an effect on stroke. Severallargeprimarypreventiontrialshaveincludedsubgroup analyses of patients with diabetes mellitus. 