Simvastatin

Simvastatin (brand name Zocor) is a synthetic derivative of lovastatin, differing only in that it contains an additional methyl group. Simvastatin was developed in 1981 and patented by Merck & Co. Simvastatin was first approved for use in Sweden in 1988; it did not receive FDA approval until December of 1991. Merck & Co. and Schering-Plough partnered to create Vytorin, a combination of simvastatin and ezetimibe (Zetia), a non-statin cholesterol-lowering drug. Vytorin was approved by the FDA in 2004.

Simvastatin is available in 5, 10, 20 and 40 mg tablets. The daily dosing range is 5-80 mg with a recommended starting dose of 20 to 40 mgs daily, taken with meals. The patent for simvastatin expired in June 2006. As a result, total sales of Zocor in 2006 fell by 36% to $2.8 billion. However, sales of Vytorin for 2006 totaled $1.9 billion, a 90% increase from 2005. Recent clinical studies have failed to show that the Zetia has any signigicant effect in lowering cholesterol over simvastatin alone. There have also been suggestions of a link between Vytorin and an increased risk of cancer, but the FDA is still investigating that possibility.