Results from a new study showed that co-administration of Zetia (ezetimibe) and fenofibrate significantly reduced LDL cholesterol (LDL-C), non-high density lipoprotein cholesterol (non-HDL-C) and apo B1 in patients with mixed hyperlipidemia and high LDL cholesterol when compared to fenofibrate alone.
The study, presented recently 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, Merck said in a release.
"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, chief, Lipid Metabolism Unit, Massachusetts General Hospital.
Zetia, marketed by Merck/Schering-Plough Pharmaceuticals, is the first in a class of cholesterol-lowering agents that inhibits the intestinal absorption of cholesterol through a unique mechanism of action. Zetia is complementary to the class of cholesterol-lowering agents known as statins, which work in the liver to reduce the production of cholesterol.