8MG CERIVASTATIN VS 4MG CERIVASTATIN &PLACEBO &PRAVASTATIN IN HYPER

Wake Forest University, Winston Salem NC

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Abstract

Background Information: HMG-CoA reductase inhibitors have been increasingly used as first line pharmacologic therapy for primary hypercholesterolemia for those individuals where diet alone is insufficient. Studies have indicated that high serum cholesterol, specifically low density cholesterol (LDL-C), is one of the major risk factors for development of cardiovascular disease. It has been shown that reduction of LDL-C by dietary and cholesterol lowering treatment, particularly HMG-CoA reductase inhibitors, not only reduces this risk, but can also cause regression of pre-existing atherosclerotic lesions. HMG-CoA reductase inhibitors lower LDL-C by 20-50%, elevate high density cholesterol by 5-10%, lower triglycerides and have been shown to slow the progression of coronary atherosclerosis and reduce the incidence of death from coronary causes and death from all causes in men and women with documented coronary artery disease. BAYw6228 (Cerivastatin) is an extremely potent HMG-CoA reductase inhibitor. Purpose: Primary goal of this trial is to compare the safety and efficacy (how well it works) of once daily study drug (Cerivastatin) compared to placebo given once daily for eight weeks. Secondary goals are to compare the safety and efficacy of two dosages of study drug given once daily at 8 and 24 weeks, and both dosages of study drug with a comparator drug (Pravastatin) once daily at 24 weeks. In addition, the safety and efficacy of the two dosages of study drug will be compared to each other and to the comparator during the one-year double-blind extension phase of the trial.