[Field, a randomized clinical trial of cardiovascular prevention with fenofibrate in type 2 diabetes]

Author(s): Radermecker RP, Scheen AJ

Affiliation(s): Departement de Medecine, CHU Sart Tilman, 4000 Liege. Regis.Radermecker@ulg.ac.be

Publication date & source: 2005-12, Rev Med Liege., 60(12):957-61.

Publication type: Multicenter Study; Randomized Controlled Trial

FIELD ("Fenofibrate Intervention and Events Lowering in Diabetes") study compared the incidence of coronary and cardiovascular events in 4895 patients with type 2 diabetes treated with fenofibrate (micronized fomulation, 200 mg/day) and in 4900 patients treated with placebo. After a mean 5-year follow-up, the fenofibrate group did not have less coronary events (primary endpoint), neither present a significant reduction in cardiovascular or total mortality as compared to the placebo group. However, it had significantly less non-fatal myocardial infarctions and cardiovascular events in general as well as less coronary and total revascularization procedures (secondary endpoints). The higher rate of starting statin therapy in patients allocated placebo might have masked a larger treatment benefit of fenofibrate on macrovascular complications. The tolerance of fenofibrate was good, even in combination with statins. More surprisingly, fenofibrate exerted a favourable effect on microangiopathy complications, with less albuminuria progression and less retinopathy needing laser treatment (tertiary endpoints).