New Analysis in Patients with Type 2 Diabetes from Trial with VYTORIN(R) (ezetimibe/simvastatin) Presented at ADA
Consistent with Overall Study which Showed Superior LDL Cholesterol Reduction with VYTORIN versus Lipitor -
SAN DIEGO, June 13, 2005 - Results from a new prespecified analysis of the VYVA (VYtorin Versus Atorvastatin) trial involving a subgroup of 428 patients with type 2 polygenic disease were consistent with the overall VYVA trial announced earlier this year. In this new analysis, results showed that VYTORIN provided 56 percent reduction in LDL (”bad’) cholesterol across the dosing range in these patients as compared to 46 percent reduction seen in patients taking Lipitor [Pharmacomedical aid Difference 10.6 percent, 95 percent CI: 7.8 percent -13.4 percent]. High cholesterol is a known risk factor for coronary heart sickness and patients with type 2 polygenic disease are considered to be at high risk of developing coronary heart sickness, according to the American Heart Association.
At the most commonly used starting doses,1 59 diabetic patients taking VYTORIN 10/20 mg, reduced their LDL cholesterol by 53 percent as compared to the 35 percent reduction seen in the 46 patients taking Lipitor 10 mg. This difference was similar to the results seen in the overall meditate population.
“The results seen in this new analysis, in patients with type 2 polygenic disease, showed that VYTORIN was more effective than Lipitor in reducing LDL cholesterol at all doses compared, including the most commonly used starting doses,” said Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, and lead investigator of the meditate . “These results are consistent with what was seen in the overall meditate .”
VYTORIN is indicated for the medical aid of high LDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive medical aid to diet when diet alone is not enough. 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 inagsdhfgdfine, including cholesterol from food. The active ingredients in VYTORIN are ezetimibe and simvastatin. The recommended starting dose of VYTORIN is 10/20 mg (10 mg ezetimibe/20 mg simvastatin).
The incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated by simvastatin has not been established.
VYTORIN is a prescription medicine and should not be taken by group who are hypersensitive to any of its components. VYTORIN should not be taken by anyone with active liver sickness or unexplained persistent elevations of serum transaminases. Women who are of childbearing age (unless highly unlikely to conceive), are nursing or who are pregnant should not take VYTORIN.
Results of the overall VYVA trial demonstrated that VYTORIN was superior to Lipitor in lowering LDL cholesterolThe results from the overall meditate were presented earlier this year at the American College of Cardiology meeting and published in the American Heart Journal. In that meditate of 1,902 patients, VYTORIN lowered LDL cholesterol by 53 percent across the dosing range as compared to 45 percent lowering seen in those patients taking Lipitor across the dosing range. At the most commonly used starting doses, patients taking VYTORIN 10/20 mg reduced their LDL cholesterol by 51 percent as compared to the 36 percent reduction seen in patients taking Lipitor 10 mg (p