FIELD: Mixed results found with fenofibrate therapy among patients with diabetes

Reduction in nonfatal MI but a trend toward higher rate of coronary mortality, total mortality found in the group assigned fenofibrate

Issue: January 2006

DALLAS – Fenofibrate therapy for diabetes-specific lipid disorders produced mixed results, with a reduction in nonfatal myocardial infarction but no effect on coronary heart disease.

Anthony Keech, MD, professor of medicine at the University of Sydney in Australia, presented results from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study at the American Heart Association Scientific Sessions 2005.

Keech said that patients with diabetes tend to have lipid disorders that are unaddressed by statin treatment, and fibrates may have properties that correct these diabetic-specific lipid disorders.

“Diabetics usually have total cholesterol and LDL levels similar to the general population, but their lipid patterns differ with smaller, denser LDL particles than in nondiabetic populations. Because of that, the equal amount of LDL might mask a higher number of LDL particles in diabetics,” he said.

FIELD researchers enrolled 9,795 patients from 63 centers in Australia, New Zealand and Finland. All patients had type 2 diabetes. Mean age of the cohort was 63 years and the duration of diabetes was about five years. Patients could not be taking statin therapy at baseline.

Participants were randomized to either 200 mg per day of fenofibrate or placebo and followed for about five years.

During the study duration, more patients in the placebo group (17%) than the fenofibrate group (8%) began other lipid-lowering therapies, which were often statins.

The event rate of the primary composite outcome was 5.9% in the placebo group and 5.2% in the treatment group (P=.16).

When the total composite outcome was observed as two separate outcomes, there was a reduction in nonfatal myocardial infarction of 24% in favor of the treatment group (P=.01) and a 19% increase in coronary heart disease mortality (P=.22).

A subgroup analysis was performed on the 2,131 patients who had previous CVD at baseline compared with the 7,664 patients who did not. Patients who did not have prior CVD had a 19% reduction in the primary outcome of coronary events, but there was no difference among those patients who had prior coronary disease. Total mortality was 6.6% in the placebo group and 7.3% in the fenofibrate group (P=.18).

In an interview, Udho Thadani, MD, professor of medicine at the University of Oklahoma Health Sciences Center said a previous meta-analysis had shown that fibrate treatment decreased major coronary events and had positive effects on cholesterol measures.

The VA HIT (Veterans Affairs High Density Lipoprotein Cholesterol Intervention Trial) reported that fibrate therapy reduced cardiovascular mortality and nonfatal MI.

“The results of the FIELD study are disappointing. The authors emphasize a significant reduction on nonfatal MI rates; however, this finding should be taken in context as the study showed a trend toward a higher rate of coronary mortality and total mortality in the treatment group,” Thadani said.

“One cannot recommend the routine use of fenofibrate to treat patients with type 2 diabetes mellitus with dyslipidemias either for primary or secondary prevention for coronary heart disease.” – by Jeremy Moore

This article was originally published in Today in Cardiology, a SLACK Incorporated publication.

For more information:

Keech A. The effect of fenofibrate on major coronary heart disease (CHD) events in people with type 2 diabetes: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Presented at the American Heart Association Scientific Sessions 2005. Nov. 13-16, 2005. Dallas.