Efficacy and safety of cerivastatin, 0.2 mg and 0.4 mg, in patients with primary hypercholesterolaemia: a multinational, randomised, double-blind study

Elevated serum cholesterol la el is a key risk factor for cardiovascular mo rbidity and mortality Cerivastatin is a highly effective lipid-lowering age nt currently licensed at doses of 0.1, 0.2, 0.3 and 0.4 mg. This was a multicentre, radomised, double-blind, parallel-group study compa ring the efficacy and safety of cerivastatin 0.4 mg/day with that of ceriva statin 0.2 mg/day in patients with primary hypercholesterolaemia. There was a six-week placebo run-in phase followed by a 24-week active treatment pha se. A total of 494 patients were randomised to receive cerivastatin 0.4 mg (n = 332) or 0.2 mg (n = 162). Per-protocol (PP) analysis revealed that mea n low-density lipoprotein cholesterol (LDL-C) level decreased by 38.4 +/- 0 .7% from baseline in the 0.4 mg group, compared with a decrease of 31.5 +/- 0.9% in the 0.2 mg group (p < 0.0001). There was a significant gender diff erence in the 0.4 mg group: LDL-C decreased by 44.4 +/- 8.9% in women, comp ared with a decrease of 37.0 +/- 0.9% in men (p < 0.046). In the PP group a s a whole, total cholesterol decreased by 26.0 +/- 0.5% from baseline in th e 0.4 mg group, compared with a decrease of 21.6 +/- 0.7% in the 0.2 mg gro up (p < 0.0001). Both doses were were well tolerated; only eight (2.4%) pat ients in the 0.4 mg group and five (3.1%) patients in the 0.2 mg group with drew owing to adverse events. Cerivastatin 0.2 mg/day and 0.4 mg/day was found to lower low-density lipop rotein cholesterol and total cholesterol levels in a dose-dependent manurer , with bath doses exhibiting a good safety profile.