Fenofibrate effects on carotid artery intima-media thickness in adults with type 2 diabetes mellitus: A FIELD substudy

Dyslipidemia in type 2 diabetes contributes to an increased risk of cardiovascular disease. Fenofibrate, a lipid-regulating peroxisome proliferator-activated receptor-α (PPARα) agonist, has been shown to reduce vascular complications in adults with type 2 diabetes. The mechanisms for such benefit, however, are not yet well understood. We examined the effects of fenofibrate on carotid intima-media thickness (IMT), a marker of subclinical atherosclerosis, in adults with type 2 diabetes. In a prospectively designed substudy of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, we assessed carotid IMT in a subset of 422 representative adults. Traditional risk factors and IMT were assessed at 2 and 4 years after randomisation to fenofibrate (200 mg daily) or placebo. The prespecified primary study endpoint was the difference in IMT between treatment groups at 4 years. Post-hoc analyses were performed according to dyslipidemia and metabolic syndrome status. There was no difference in carotid IMT comparing those assigned to fenofibrate or placebo at 2 or 4 years, despite statistically significant improvement in lipid and lipoprotein parameters at 2 and 4 years, including TC, LDL-C and TG, and HDL-C at 4 months and 2 years. Similarly, there was no difference in carotid IMT on fenofibrate compared with placebo in those with dyslipidemia or metabolic syndrome. Fenofibrate was not associated with improved carotid IMT in adults with type 2 diabetes when compared with placebo, despite a statistically significant improvement in TC, LDL-C and TG at 2 and 4 years, and HDL-C at 4 months and 2 years.