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ATLANTA — In a new analysis presented today VYTORIN(R) (ezetimibe/simvastatin) significantly reduced LDL “bad” cholesterol by an average of 52.5 percent and C-reactive protein (CRP) by an average of 31.0 percent, compared to averages of 38.0 percent and 14.3 percent, respectively, achieved with Zocor(R) (simvastatin) (p

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C-reactive protein, a marker of inflammation, is considered an emerging risk factor for cardiovascular disease (CVD), according to the American Heart Association.(1) Studies of CRP have demonstrated that higher levels are associated with a higher risk for developing coronary events.(2) The specific relationship between reductions in CRP and reduction of CVD risk has not been established and no drugs are approved specifically for use in reducing CRP.
“In this analysis, while both treatments yielded LDL cholesterol and CRP reductions, we saw that VYTORIN lowered LDL cholesterol and CRP by a significantly greater amount in more patients than Zocor,” said Christie M. Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, TX.
About the Analysis
This post-hoc analysis pooled data from three similar randomized, placebo-controlled, double-blind studies that included a total of 3,083 patients with primary hypercholesterolemia. After a six to eight week washout period and a four week recommended cholesterol-lowering diet, investigators randomized patients with LDL cholesterol levels between 145-250 mg/dL equally into one of the following drug regimens for 12 weeks: ZETIA 10 mg; Zocor 10, 20, 40 or 80 mg, VYTORIN 10/10, 10/20, 10/40 or 10/80 mg; or placebo.
Overall, in a pooled analysis across all doses of VYTORIN and Zocor that included all patients with valid baseline and endpoint LDL cholesterol and CRP measurements, the geometric mean CRP level declined in patients taking VYTORIN (n=1007) by 31 percent as compared to a 14.3 percent reduction in the group of patients taking Zocor (n=1031; p3 X ULN) in serum transaminases was 1.8 percent overall and 3.6 percent for patients treated with VYTORIN 10/80 mg. These elevations in transaminases were generally asymptomatic, not associated with cholestasis and returned to baseline after discontinuation of therapy or with continued treatment. Doctors should perform blood tests before, and periodically during treatment with VYTORIN when clinically indicated to check for liver problems. People taking VYTORIN 10/80 mg should receive an additional liver function test prior to and three months after titration and periodically during the first year.
Due to the unknown effects of increased exposure to ezetimibe (an ingredient in VYTORIN) in patients with moderate or severe hepatic insufficiency, VYTORIN is not recommended in these patients. The safety and effectiveness of VYTORIN with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Caution should be exercised when initiating VYTORIN in patients treated with cyclosporine and in patients with severe renal insufficiency.