The effects of fenofibrate treatment on cardiovascular disease risk in 9795 people with type 2 diabetes and various components of the metabolic syndrome: the FIELD study

Abstract

Objective: We explored whether cardiovascular disease (CVD) risk and the effects of fenofibrate differed in subjects with and without metabolic syndrome (MS) and according to various features of MS defined by ATP III in subjects with type 2 diabetes in the FIELD study.

Research design and methods: The prevalence of MS and its features were calculated. Cox proportional models adjusted for age, gender, CVD status and baseline HbA1c levels were used to determine the independent contributions of MS features to total CVD event rates and the effects of fenofibrate.

Results: Over 80% of FIELD participants met the ATPIII criteria for MS. Each ATPIII feature of MS, apart from increased waist circumference, increased the absolute risk of CVD events over 5 years by at least 3%. Those with marked dyslipidemia (elevated triglycerides ≥2.3 mmol/L and low HDLc) were at the highest risk of CVD (17.8% over 5 years). Fenofibrate significantly reduced CVD events in those with low HDLc or hypertension. The largest effect of fenofibrate to reduce CVD risk was observed in subjects with marked dyslipidaemia where a 27% relative risk reduction (95%CI 9-42, p=0.005; number needed to treat [NNT]=23) was observed. Subjects with no prior CVD had greater risk reductions than the entire group.

Conclusions: MS components identify higher CVD risk in people with type 2 diabetes, so the absolute benefits of fenofibrate is likely to be greater when MS features are present. The highest risk and greatest benefits of fenofibrate are seen among those with marked hypertriglyceridemia.