Long-term fenofibrate therapy did not reduce major coronary events but may reduce total CVD events in type 2 diabetes mellitus.

M e t h o d s Design: Randomized placebo-controlled trial (Fenofibrate Intervention and Event Lowering in Diabetes [FIELD]). Allocation: Concealed.* Blinding: Blinded (clinicians, patients, and outcome assessors).* Follow-up period: Median 5 years. Setting: 63 centers in Australia, New Zealand, and Finland. Patients: 9795 patients 50 to 75 years of age (mean age 62 y, 63% men) who had a World Health Organization diagnosis of type 2 diabetes, total cholesterol level 3 to 6.5 mmol/L, and a total cholesterol/high-density lipoprotein (HDL) cholesterol ratio ≥ 4 or a triglyceride level of 1 to 5 mmol/L, with no clear indication for lipid-modifying therapy. Exclusion criteria were renal impairment, chronic liver disease, symptomatic gallbladder disease, or occurrence of a cardiovascular disease (CVD) event within 3 months before study entry. Intervention: Micronized fenofibrate, 200 mg/d (n = 4895), or matching placebo (n = 4900). Outcomes: A composite endpoint of nonfatal myocardial infarction (MI) or CHD mortality. Secondary outcomes included a composite endpoint of major CVD events (CHD events, CVD death, and stroke), total CVD events (major CVD events, and revascularization), individual events of the composite endpoint, and all-cause mortality. The study had 80% power to detect a 22% reduction in the primary outcome. Patient follow-up: 99% (intention-to-treat analysis).