Randomized comparison of the efficacy and safety of cerivastatin and pravastatin in 1030 hypercholesterolemic patients

Objective: To determine the relative efficacy and safety of cerivastatin and pravastatin in patients with type II hypercholesterolemia. Patients and Methods: In this prospective, double-blind, parallel-group study, hypercholesterolemic patients were randomized to treatment with cerivastatin, 0.3 mg (n=250) or 0.4 mg (n=258), or pravastatin, 20 mg (n=266) or 40 mg (n=256), for 8 weeks. Results: Cerivastatin, 0.3 mg, was significantly more effective than pravastatin, 20 mg, in reducing low-density lipoprotein (LDL) cholesterol from baseline (-29.6% vs -26.8%; P=.008), Cerivastatin,0.4 mg, was significantly more effective than pravastatin, 40 mg, in reducing LDL cholesterol (34.2% vs -30.3%; P<.001), A larger proportion of cerivastatin-treated patients had greater than 40% reductions in LDL cholesterol than those receiving pravastatin (11.1% vs 6.0%). The percentage of patients who achieved the National Cholesterol Education Program (NCEP) target was 71.3% with cerivastatin, 0.3 mg, compared with 67.5% with pravastatin, 20 mg, and 74.0% with cerivastatin, 0.4 mg, compared with 71.1% with pravastatin, 40 mg (no significant difference), Cerivastatin, 0.3 mg, reduced total cholesterol to a greater extent than did pravastatin, 20 mg (P<.03). Both agents reduced triglycerides and increased high-density lipoprotein cholesterol to a similar degree (no significant differences). Cerivastatin and pravastatin were well tolerated. Conclusions: Cerivastatin, 0.3 mg and 0.4 mg, showed greater efficacy than pravastatin, 20 mi: and 40 mg, respectively, in lowering LDL cholesterol, Cerivastatin is safe and effective for patients with hypercholesterolemia who require aggressive LDL cholesterol lowering to achieve NCEP-recommended targets.