The effects of fenofibrate in patients with type 2 diabetes were described by two recently published post hoc analyses of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial.
The FIELD trial included 9,795 patients with type 2 diabetes, ages 50 to 75 years, randomized to 200 mg of co-micronized fenofibrate per day or placebo and followed for a median of five years. Its initial results, which found no reduction in the primary outcome of coronary events with fenofibrate, were published in The Lancet on Nov. 14, 2005.
A post hoc analysis published by The Lancet Diabetes & Endocrinology on Feb. 26 looked at the effect of fenofibrate on uric acid levels and gout among FIELD participants. It found that taking fenofibrate lowered uric acid concentrations by 20%, both in a six-week run-in period prior to randomization and in a comparison of the active treatment and placebo groups. Patients taking fenofibrate had about half as much gout as those on placebo (81 vs. 151 first gout events; hazard ratio [HR], 0.54 [95% CI, 0.41 to 0.70; P<0.0001]; HR for all gout events, 0.48 [95% CI, 0.37 to 0.60; P<0.0001]). The risk reductions for gout were similar when patients were categorized by sex, dyslipidemia, diuretic use, and uric acid concentration. The authors noted that gout was not a prespecified endpoint of the FIELD trial, but based on the results, they concluded that fenofibrate could be a useful adjunct for treating gout in patients with type 2 diabetes.
Another study, published by Diabetes Care on Feb. 16, used data from FIELD and other trials to estimate the cardiovascular risk reduction benefit that patients could see from fenofibrate treatment based on their individual characteristics. The authors externally validated the FIELD risk model's ability to predict major cardiovascular events (MACE) within five years in 17,142 patients with type 2 diabetes and found good calibration and moderate discrimination. Then they calculated the absolute reduction in five-year MACE risk that patients would see with fenofibrate, finding it to be 2.15% in patients with dyslipidemia and 0.22% in patients without dyslipidemia, with numbers needed to treat of 47 and 455, respectively. However, the authors noted that treatment effects ranged widely, and although the effect was generally higher in patients with dyslipidemia, some patients without dyslipidemia would also benefit from fenofibrate. The study provided an algorithm that could be used to calculate individual patients' potential benefit from fenofibrate, based on factors including age, gender, diabetes control, blood pressure, and renal function.