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Posted on Nov 30, 2005, 5 a.m.
By Bill Freeman
DALLAS (Reuters Health) - In a large study of type 2 diabetic patients, treatment with fenofibrate did not markedly reduce the risk of major cardiac events. The drug, sold as Tricor by Abbott Laboratories, did, however, reduce the risk of total cardiac disease events, largely by preventing non-fatal heart attacks and the need for revascularization.
The findings of the study were announced this week during the American Heart Association's annual meeting in Dallas. They also appear in The Lancet.
Patients with type 2 diabetes are at increased risk of suffering cardiovascular events, particularly heart attacks, partly owing to the high concentrations of fatty substances (lipids) in their blood.
A class of drugs called fibrates can correct abnormal lipid levels in type 2 diabetes patients, however, their role in preventing heart attacks and similar events in this setting has been unclear until now.
To investigate, researchers randomly assigned 9,795 type 2 diabetics to fenofibrate 200 mg daily or placebo for five years. Most of the patients had no prior history of heart disease.
The study yielded "mixed results," said principal investigator Dr. Anthony Keech of the University of Sydney, Australia. Fenofibrate failed -- compared with placebo -- to meet the primary goal of reducing the combined occurrence of heart attacks and coronary deaths.
On the other hand, diabetic patients taking fenofibrate fared better on a number of secondary measures, including a reduction in the incidence of non-fatal heart attacks and the need for revascularization, a procedure used to clear clogged arteries, as well as the need for laser treatment for diabetic retinopathy -- an eye disease.
Dr. Helen Colhoun, from University College Dublin in Ireland and author of a commentary in The Lancet writes that these results "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."
SOURCE: The Lancet 2005.
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