It is now well established that elevated plasma cholesterol levels, especially LDL-cholesterol (LDL-C), are associated with coronary atherosclerosis progression, and therefore with an enhanced risk for coronary heart disease. Primary and secondary prevention trials have clearly demonstrated that reductions in LDL-C concentrations in the range of 25% to 35% in patients with normal to high cholesterol levels, significantly decrease mortality due to cardiovascular causes as well as preventing coronary heart disease events. For this reason, different approaches are currently in use to decrease plasma LDL-C levels at least by this percentage. Saturable hepatic uptake of fluvastatin, rapid elimination and the absence of circulating active metabolites may limit its efficacy. Consequently, a slow release formulation adequately designed to deliver active drug in a more sustained fashion to the liver as compared to the conventional immediate release formulation, may prove to be more efficacious in further decreasing plasma LDL-C levels, achieving as a result 36 to 38 mean percent reduction in LDL-C. This study will assess the efficacy and safety of fluvastatin 80 mg slow release formulation compared to atorvastatin 10 mg, simvastatin 40 mg and pravastatin 40 mg in patients with primary hypercholesterolemia.
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