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FDA backs Vytorin treatment claim

The FDA is to allow Merck & Co and Schering-Plough to add new data to the product label of their combination cholesterol drug Vytorin, saying it is more effective than AstraZeneca's Crestor at lowering LDL

The new data was from a study of patients with high cholesterol that showed Vytorin, along with diet, lowered LDL “bad” cholesterol more than Crestor. This response was observed across all study dose comparisons, with 52-61% for Vytorin, and 46-57% for Crestor. In addition, both Vytorin and Crestor raised HDL “good” cholesterol by 8%, averaged across all doses studied.

“Vytorin now has been shown in clinical studies to provide greater LDL cholesterol lowering efficacy versus Lipitor, Crestor and Zocor at all study dose comparisons,” said Deepak Khanna, vice president and general manager of Merck/Schering-Plough Pharmaceuticals.

Vytorin is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food.

Vytorin is marketed as Inegy in many countries outside the US.