Long-term efficacy and safety of cerivastatin 0.8 mg in patients with primary hypercholesterolemia

Background: Statins are the agents of choice in reducing elevated plasma low-density lipoprotein cholesterol (LDL-C). Hypothesis: Cerivastatin 0.8 mg has greater long-term efficacy in reducing LDL-C than pravastatin 40 mg in primary hypercholesterolemia. Methods: In this double-blind, parallel-group, 52-week study, patients (n = 1,170) were randomized (4:1:1) to cerivastatin 0.8 mg, cerivastatin 0.4 mg, or placebo daily. After 8 weeks, placebo was switched to pravastatin 40 mg. Patients with insufficient LDL-C lowering after 24 weeks were allowed open-labeled resin therapy. Results: Cerivastatin 0.8 mg reduced LDL-C versus cerivastatin 0.4 mg (40.8 vs. 33.6%, p 10 × the upper limit of normal (ULN) occurred in 1,1.5, and 0% of patients receiving cerivastatin 0.8 mg, cerivastatin 0.4 mg, and pravastatin 40 mg, respectively. Repeat hepatic transaminases >3 × ULN occurred in 0.3–0.5,0.5, and 0% of patients, respectively. Conclusion: In long-term use, cerivastatin 0.8 mg effectively and safely brings the majority of patients to NCEP goal.