Cerivastatin, a novel HMG-CoA reductase inhibitor: Efficacy and tolerability

Efficacy and tolerability of cerivastatin 0.1 to 0.3 mg in comparison to placebo were analysed across studies in order to characterise the effects of the compound on the basis of a large sample sire. 2400 patients (cerivastatin 1.749 placebo 651) with hyperlipidemia originating from 6 double-blind studies of at least 8-week duration were included in the analysis of efficacy and 2.614 (cerivastain 1898 placebo 716) in the analysis of safety and tolerability. The results after a treatment duration of 8 weeks are presented here. The individual studies had similar inclusion and exclusion criteria. LDL cholesterol was the primary efficacy parameter. With mean baseline values between 198.4 and 205.9 mg/dl mean percent reductions in LDL-C were 22% (cerivastatin 0.1 mg), 28% (0.2 mg) and 31% (0.3 mg). A negligible increase of 0.3% was seen on placebo. The differences between the dosages were statistically significant (p < 0.05). HDL-C was increased in a dose-dependent manner. The mean increase on 0.3 mg cerivastatin was 8.1%. 15.5% reduction in triglycerides was reached on cerivastatin 0.3 ma. Furthermore, a relation between baseline values of triglycerides and the extent of the treatment effect was observed. With a baseline value > 250 mg/dl cerivastatin lowered triglycerides by 22.5% as a mean and in an individual study where higher triglyceride values were present the mean reduction in triglycerides was 27.7% for baseline values > 350 mg/dl. Cerivastatin 0.1 to 0.3 mg was well tolerated. Elevations of transaminases and CK which are typical for statins were slightly mole frequent on cerivastatin than on placebo, however, more pronounced elevations occurred more frequently on placebo.