USA-based firms Merck & Co and Schering-Plough say that new combined post-hoc analysis of three trials of the co-developed cholesterol-reducing agent Vytorin (ezetimibe/simvastatin) has revealed that the drug significantly-reduced low-density lipoprotein cholesterol an average of 52.5% when compared with Merck & Co's Zocor (simvastatin), which only achieved a 38% reduction. In addition, the analysis, which was presented at the 55th Annual Scientific Session of the American College of Cardiology, suggested that the product also reduced the concentration of the inflammation marker C-reactive protein an average of 31%.
The analysis examined pooled data from three randomized, placebo-controlled, double-blind studies of the drug used in the treatment of 3,083 patients with primary hypercholesterolemia. The original trial investigators grouped patients with LDL cholesterol levels between 145-250mg/dL into one of the following 12-week treatment regimens: Zetia (ezetimibe) 10mg; Zocor (simvastatin)10mg, 20mg, 40mg or 80mg, Vytorin 10/10, 10/20, 10/40, 10/80mr; or placebo.
The data analysis included all patients with valid baseline and endpoint LDL cholesterol and CRP levels, and showed that, in addition to the LDL-cholesterol reduction already reported, Vytorin brought about two times the reduction of CRP that Zocor produced. The researchers also noted that some members of the Vytorin study group did experience elevated levels of serum transaminases, but that these were generally asymptomatic, not associated with cholestasis and returned to baseline in due course.
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