NEW ORLEANS, November 8, 2004 Results from a new study showed that coadministration of ZETIA (ezetimibe) and fenofibrate significantly reduced LDL ("bad") cholesterol (LDL-C), non-high density lipoprotein cholesterol (non-HDL-C) and apo B in patients with mixed hyperlipidemia and high LDL cholesterol when compared to fenofibrate alone. The study, presented today at the 2004 American Heart Association Scientific Sessions, also showed that significant increases in HDL cholesterol and decreases in trigycerides (TG) similar to those seen with fenofibrate alone were seen in patients on ZETIA co-administered with fenofibrate. The treatment with ZETIA and fenofibrate for 12 weeks was also well-tolerated with a safety profile comparable to fenofibrate monotherapy. The label for ZETIA indicates that the safety and effectiveness of ZETIA with fibrates have not been established, therefore co-administration with fibrates is not recommended.
"This is the first large study to indicate that co-administration of ZETIA and fenofibrate significantly lowers LDL cholesterol and non-HDL cholesterol more than fenofibrate alone in a mixed hyperlipidemia population. This study revealed that when diet changes alone were not sufficient in mixed hyperlipidemia, the co-administration of ezetimibe and fenofibrate significantly lowered LDL cholesterol, compared to fenofibrate alone. ZETIA co-administered with fenofibrate also improved HDL cholesterol and triglyceride levels similar to fenofibrate alone," said Mason Wright Freeman, M.D., chief, Lipid Metabolism Unit, Massachusetts General Hospital. "Mixed hyperlipidemia is a metabolic disorder characterized by elevated LDL cholesterol, non HDL-C and TG and reduced levels of HDL cholesterol. Co-administration of ZETIA and fenofibrate is not indicated for use in the label for ZETIA, however further studies in these populations are certainly warranted to confirm these findings."
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Contact: Skip Irvine, Merck & Co., Inc.
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