Whitehouse Station/Kenilworth, NJ - The Food and Drug Administration has given its okay to a new indication for the cholesterol absorption inhibitor ezetimibe (Zetia, Merck/Schering-Plough Pharmaceuticals). The agency approved ezetimibe for use in combination with fenofibrate for the reduction of elevated total and LDL cholesterol levels in patients with mixed hyperlipidemia who fail to respond to dietary changes.

The approval is based on the results of a 12-week study, presented at the Drugs Affecting Lipid Metabolism meeting in 2004 and previously reported by heartwire, showing that the coadministration of ezetimibe and fenofibrate provided a complementary effect and improved the atherogenic profile in patients with mixed hyperlipidemia. These effects were durable for one year, and treatment with the ezetimibe/fenofibrate combination was safe and well tolerated, with a safety profile comparable to fenofibrate alone.

Ezetimibe is currently approved for use either alone or in combination with statins or fenofibrate to reduce LDL cholesterol and total cholesterol in patients with hyperlipidemia.