Congress requests Merck and Schering to hand over Vytorin data

By Margarita Snegireva. Congress today sent letters requesting that Food and Drug Administration commissioner Andrew von Eschenbach and executives of the drug companies Merck and Schering-Plough hand over documents detailing the marketing campaign for the cholesterol drug Vytorin.

The results of a clinical trial released Monday found that Vytorin did not reduce the buildup of harmful plaque in arteries any better than a much cheaper generic drug.

Ezetimibe/simvastatin is a drug combination used for the treatment of dyslipidemia. It is a combination of ezetimibe (best known as Zetia in the United States) and the statin drug simvastatin (best known as Zocor in the U.S.). The combination preparation is marketed by Merck & Co./Schering-Plough Pharmaceuticals (joint venture) under the trade names Vytorin and Inegy.

Ezetimibe is prescribed to reduce the amount of cholesterol that the body absorbs from the food ingested. But a recent study by the drug's manufacturers revealed that it did not reduce the buildup of plaque in the coronary arteries -- a key indicator of progression toward heart disease.

Simvastatin is an HMG-CoA reductase inhibitor or statin. It works by blocking an enzyme that is necessary for the body to make cholesterol.

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