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Merck/Schering-Plough Pharmaceuticals has received FDA approval for ezetimibe/simvastatin (Vytorin) for use in the reduction of elevated total cholesterol, low-density lipoprotein (LDL) cholesterol, apolipoprotein B (Apo B), triglycerides, and non-high-density lipoprotein (HDL) cholesterol. In addition, the FDA has approved its use to increase HDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia. Ezetimibe/simvastatin is also indicated for the reduction of elevated total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia, as an adjunct to another lipid-lowering treatment or if such treatments are not available.


The new medication is the first and only drug to treat two cholesterol sources by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the small intestine, including cholesterol from food. Vytorin should be used in conjunction with diet management.


A 12-week clinical trial of ezetimibe/simvastatin showed that it lowered cholesterol by 52% at the recommended starting dose (10 mg ezetimibe/20 mg simvastatin) and by 60% at the maximum recommended dose (10 mg ezetimibe/80 mg simvastatin).


Ezetimibe/simvastatin is generally well-tolerated.