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Jun 18 2006, 12:00 PM EST

New Study Showed VYTORIN(R) (ezetimibe/simvastatin) Significantly More Effective than Crestor(R) (rosuvastatin) at Lowering LDL ''Bad'' Cholesterol At All Doses Compared

News source: Business Wire

Greater LDL Cholesterol Reduction with VYTORIN Compared to Crestor Resulted in Greater LDL Cholesterol Goal Attainment

Results from a new clinical study which included 2,855 patients with high cholesterol showed that VYTORIN(R) (ezetimibe/simvastatin) was significantly more effective than Crestor(R) (rosuvastatin) in reducing LDL "bad" cholesterol across all study dose comparisons, 52-61 percent for VYTORIN 10/20 mg to 10/80 mg and 46-57 percent for Crestor 10 mg to 40 mg. In addition, both VYTORIN and Crestor raised HDL "good" cholesterol by 8 percent, averaged across all doses studied. The primary endpoint of the study was LDL cholesterol reduction from baseline averaged across all doses. Key secondary endpoints included LDL cholesterol reductions from baseline at each dose comparison. With the results of this study, VYTORIN now has been shown in clinical studies to provide greater LDL cholesterol lowering efficacy versus Zocor (simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) at all study dose comparisons.

In a post-hoc subgroup analysis of 715 high risk patients included in the study, the results revealed that VYTORIN, as a result of greater LDL cholesterol reduction, helped significantly more high-risk patients achieve an LDL cholesterol of less than 70 mg/dL and less than 100 mg/dL compared to patients taking Crestor (50 percent vs. 29 percent; p <0.001 and 90 percent vs. 82 percent, p<0.05 respectively) averaged across the doses studied.

"In this study, VYTORIN was significantly more effective than Crestor in reducing LDL cholesterol and averaged across the doses in attaining an LDL cholesterol goal of less than 100 mg/dL and LDL cholesterol of less than 70 mg/dL in high-risk patients," said Michael Davidson, M.D., professor of medicine, director of Preventive Cardiology, Rush University Medical Center, Chicago. "These data provide further evidence that VYTORIN is an excellent option to help lower the LDL, or bad, cholesterol levels of patients with high cholesterol."

The results were presented today at the International Symposium on Atherosclerosis (ISA 2006) meeting in Rome.

VYTORIN, which contains ezetimibe and simvastatin, 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 outside the U.S.

"Recent data shows that many patients do not reach recommended LDL cholesterol treatment goals," added Dr. Davidson, who was the principal investigator of the study. "Now with the new recommendations from the American Heart Association and the American College of Cardiology calling for more aggressive treatment of high cholesterol in certain high risk patients, physicians should consider providing more patients with greater LDL cholesterol lowering right from the start to help more patients reach recommended LDL cholesterol treatment goals."

About the study

This double-blind, six-week, parallel-group study included 2,855 patients. Patients were randomized equally to one of six treatment groups.

VYTORIN provided significantly greater LDL cholesterol reduction, compared to Crestor, when averaged across all dose comparisons (56 percent vs. 52 percent; p<0.001), and at all individual dose comparisons. The LDL cholesterol reductions for VYTORIN compared to Crestor were 52 percent, VYTORIN 10/20 mg vs. 46 percent, Crestor 10 mg, 55 percent, VYTORIN 10/40 mg vs. 52 percent, Crestor 20 mg and 61 percent, VYTORIN 10/80 mg vs. 57 percent for Crestor 40 mg. In addition, VYTORIN provided greater reductions compared to Crestor in total cholesterol, apolipoprotein B, and non-HDL cholesterol when averaged across all doses studied and at each dose comparison. VYTORIN also lowered triglycerides by similar levels co

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