Business Wire - New Trial Showed VYTORIN-TM- -ezetimibe/simvastatin- Superior Again to Lipitor at Lowering LDL -Bad- Cholesterol
WHITEHOUSE STATION and KENILWORTH, N.J. — Greater LDL Cholesterol Reduction with VYTORIN-TM- Compared to Lipitor Resulted in Greater Goal Attainment At Most Common Doses
Results from a new clinical trial conducted in 1,902 patients with high cholesterol showed that VYTORIN(TM) (ezetimibe/simvastatin) provided greater reduction in LDL (”bad”) cholesterol across the dosing ranges compared to Lipitor. At the most commonly used starting doses of these two therapies, VYTORIN 10/20 mg decreased LDL cholesterol by 51 percent compared with 36 percent for Lipitor 10 mg (p less than 0.001).
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In a subgroup of high risk patients (CHD or CHD risk equivalent), significant differences in LDL cholesterol reductions at these doses resulted in more patients achieving a goal of less than 100 mg/dL with VYTORIN as compared to Lipitor; specifically, 82 percent of high risk patients on VYTORIN 10/20 mg (n=106) achieved a cholesterol lowering goal of less than 100 mg/dL as compared to only 47 percent for patients on Lipitor 10 mg (n=106, p less than 0.001). High risk patients in the study with a goal of less than 100 mg/dL who were taking VYTORIN 10/20 mg had a baseline LDL cholesterol of 166 mg/dL as compared to patients taking Lipitor 10 mg who had a baseline of 169 mg/dL.
The results were presented this week at the 15th International Symposium on Drugs Affecting Lipid Metabolism (DALM), in Venice, Italy.
Additional results from the study showed that VYTORIN 10/40 mg decreased LDL cholesterol by 59 percent compared to 48 percent for Lipitor 40 mg in the subgroup of high risk patients. These patients had a baseline LDL cholesterol values of 169 mg/dL and 175 mg/dL respectively (p less than 0.001). In a post-hoc analysis of these data, significant differences in LDL cholesterol reductions, at all doses compared, resulted in more high risk patients achieving LDL cholesterol levels less than 70 mg/dL with VYTORIN as compared to Lipitor. In particular, 57 percent of high risk patients taking VYTORIN 10/40 mg (n=112) achieved a LDL cholesterol goal of less than 70 mg/dL as compared with 23 percent of the patients (n=115) taking Lipitor 40 mg (p less than 0.001).
“In this study, VYTORIN was significantly more effective than Lipitor in reducing LDL cholesterol at all doses compared and for attaining LDL cholesterol treatment goals pooled across the dosing range,” said Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, Texas, and lead investigator of the study. “This study gives further support to the new option that VYTORIN, which reduces both the production and the absorption of cholesterol, provides to physicians in the treatment of high LDL cholesterol.”
VYTORIN was approved by the FDA on July 23, 2004 for the treatment of high LDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy 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 intestine, 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).
VYTORIN is a prescription medicine and should not be taken by people who are hypersensitive to any of its components. VYTORIN should not be taken by anyone with active liver disease 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.
Study results also demonstrated VYTORIN increased HDL cholesterol by a greater degree than Lipitor
In other results observed in the six week study, VYTORIN 10/40 mg and 10/80 mg also provided significantly greater increases in HDL (”good”) cholesterol of nine percent and eight percent respectively as compared to the HDL cholesterol increase of four percent and 1.4 percent respectively seen in patients taking Lipitor 40 mg and 80 mg (p less than 0.001). Increased HDL cholesterol in patients treated with VYTORIN 10/10 mg (7.7 percent) and 10/20 mg (7.2 percent) was numerically higher compared to Lipitor 10 mg (6.9 percent) and 20 mg (5.1 percent). However, these differences did not reach statistical significance.
Study showed VYTORIN was well tolerated and had lower incidence of liver function elevations than Lipitor
Both VYTORIN and Lipitor were well tolerated in the study. The percentage of patients with clinical and laboratory adverse experiences was generally comparable between the two treatment groups. However, there was a significantly greater incidence of consecutive elevations in liver enzymes (ALT and/or AST) greater than or equal to three times the upper limit of normal in the pooled Lipitor group (1.2 percent, 11 out of 939 patients) compared with the pooled group of patients who took VYTORIN (0.1 percent, 1 out of 933 patients) (p less than 0.001). There were no clinically or statistically significant differences in the incidence of muscle enzyme elevations and no patients in the study were diagnosed with myopathy.
