Fibrate Fails to Reduce Heart Disease Deaths in Diabetics
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TriCor (fenofibrate) has not panned out as a substitute for statin therapy in patients with type 2 diabetes.
Patients randomized to TriCor at 200 mg daily plus standard therapy in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study had a slight increase in coronary heart disease mortality (P=0.22) and a significant 24% decrease in non-fatal MI (P=0.010) compared with placebo.
Taken together TriCor was associated with a non-significant 11% decrease in the primary endpoint of nonfatal MI and coronary heart disease death (P=0.16), according to results reported today at the American Heart Association meeting here and simultaneously published online by The Lancet.
“Based on these results, we cannot recommend substituting fenofibrate for statin therapy,” said Anthony Keech, M.D. of the University of Sydney. But he suggested that TriCor may be a good addition to statin therapy because it decreased non-fatal events.
Moreover, patients randomized to TriCor had “significantly less need for laser surgery suggesting that this drug may reduce microvascular events such as diabetic retinopathy,” he said. “Statins, which have a significant effect on macrovascular events, do not impact the microvasculature.”
Additionally, Dr. Keech said the real benefit of TriCor may have been masked by the study design. Patients were permitted to take statins during the trial, and 17% of the placebo patients started on statins during the study versus 8% of the patients in the TriCor arm.
He speculated that the statin benefit in the placebo arm might have masked the “true benefit of [TriCor], which was probably closer to 17% than 11%,” he said.
The trial randomized 4,900 patients to placebo and 4,895 to TriCor. The analysis was based on 4,852 placebo patients and 4,852 patients in the active therapy arm.
Thirty-seven percent of the patients were women, 40% were ages 65 or older, and 22% had a history of cardiovascular disease.
There had been concern that combining fibrate therapy with statin therapy could increase the risk of rhabdomylysis, but Dr. Keech said there was no increase in rhabdomylysis in either arm of the trial.
Gordon Tomaselli, M.D., of Johns Hopkins said the FIELD study results may not influence clinical practice because the drug “did not reduce mortality.” Nonetheless, said Dr. Tomaselli, who is co-chair of the AHA program committee, the safety findings were encouraging.
In a Lancet commentary, Helen Calhoun M.D., of Conway Institute at University College in Dublin wrote that “the results from this well-executed trial do not warrant a recommendation for increased fenofibrate use in patients with diabetes, nor do they provide convincing evidence of the benefit of fenofibrate therapy in patients already at target serum LDL cholesterol.”
Primary source: American Heart Association meeting 2005
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