No proof fibrate drugs reduce heart risk in diabetes patients on statins

Type 2 diabetes patients, who face higher risk of cardiovascular disease, often take a combination of medications designed to lower their LDL or "bad" cholesterol and triglyceride levels while raising their HDL or "good" cholesterol because doctors long have thought that taken together, the drugs offer protection from heart attacks and improve survival.

But in a commentary in the current New England Journal of Medicine, a trio of doctors who served on a recent Food and Drug Administration panel that evaluated the drugs' effectiveness says the commonly prescribed medications have not been proven successful at preventing heart attacks in Type 2 diabetes patients with elevated cholesterol.

The drugs, called fibrates, seek to lower blood triglyceride levels and raise the amount of HDL cholesterol. They often are prescribed to diabetes patients as an add-on to statins, drugs that lower LDL cholesterol. Annual sales in the U.S. for the three fibrates now approved by the FDA — gemfibrozil (Lopid), fenofibrate (Tricor) and fenofibric acid (Trilipix) — amount to billions of dollars.

"There have been few studies regarding the clinical outcome efficacy of fibrates," said Sanjay Kaul, MD, a commentary author and director of the Cardiology Fellowship Training Program at the Cedars-Sinai Heart Institute. "Thousands and thousands of Americans take fibrates every day but so far, there are no long-term studies showing that fibrates lower cardiovascular risk or improve survival among diabetes patients who are also on statins."

The commentary calls for more studies. Meantime, the authors suggest that doctors prescribe the statin-fibrate combination only to diabetic patients at high risk for a heart attack and only after optimal control of LDL cholesterol has been achieved with statin treatment.