Efficacy and Safety of 300 μg and 400 μg Cerivastatin Once Daily in Patients with Primary Hypercholesterolemia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study

Abstract

This study examined the action of cerivastatin, a new statin, in subjects with primary hypercholesterolemia. The effects of two oral doses of cerivastatin (400 μg/day or 300 μg/day) were compared with placebo in 349 patients using a multicentre, randomized, double-blind, placebo-controlled study design. Cerivastatin treatment lasted 8 weeks and produced significant reductions in low density lipoproteincholesterol (LDL-C) levels from baseline compared with placebo. The reduction in LDL-C was significantly greater with 400 μg than with 300 μg cerivastatin. When responder rates were examined, the higher (400 μg/day) cerivastatin dose was found to be more effective in producing larger (> 40%) reductions in LDL-C levels. Cerivastatin treatment was well tolerated. Only two withdrawals due to adverse events during active treatment occurred, neither of which was considered to be due to the study medication. In addition, no clinically relevant increases in the levels of creatine Phosphokinase and hepatic transaminases (alanine transaminase and aspartate transaminase) compared with placebo were seen in this study. In conclusion, cerivastatin treatment produced a significant lowering of LDL-C levels, with the higher dose providing the greatest benefit.