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Published on 6/12/2006 in the Prospect News Biotech Daily.

Merck/Schering-Plough: Vytorin superior to Lipitor in diabetic patients

By Elaine Rigoli

Tampa, Fla., June 12 - Results from a new clinical study conducted in 1,229 patients with type 2 diabetes mellitus and high cholesterol showed that Vytorin (ezetimibe/simvastatin) provided superior reduction in LDL "bad" cholesterol compared to Lipitor (atorvastatin) in comparisons of the recommended usual starting doses, according to data presented by Merck/Schering-Plough Pharmaceuticals.

The primary efficacy endpoint was the percent change from baseline to the end of the six-week treatment period in LDL cholesterol.

Vytorin, which contains ezetimibe and simvastatin, is the 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, according to a news release.

At the recommended usual starting doses of both agents, Vytorin 10/20 mg demonstrated a 53.6 mean percent reduction from baseline in LDL cholesterol as compared to a 38.3% reduction observed with Lipitor 10 mg and a 44.6% reduction with Lipitor 20 mg.

At the alternative starting dose for patients requiring greater LDL lowering for the two agents, Vytorin 10/40 mg decreased LDL cholesterol significantly more than Lipitor 40 mg - 57.6% compared to 50.9%.

Patients with diabetes and high cholesterol are considered to be in the high risk category for heart disease, the release said.

In this study, the greater LDL cholesterol reductions with Vytorin 10/20 mg helped more patients with type 2 diabetes (90.3%) achieve the LDL cholesterol treatment goal versus patients taking Lipitor 10 mg (70.0%) and Lipitor 20 mg (82.1%).

Merck/Schering-Plough Pharmaceuticals is a joint venture between Whitehouse Station, N.J.-based Merck & Co. and Kenilworth, N.J.-based Schering-Plough Corp.


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