Long-Term Efficacy and Safety of Cerivastatin 0.8 mg in Patients with Primary Hypercholesterolemia

Abstract

<p id="d7658779e303"> <i>Background</i>: Statins are the agents of choice in reducing elevated plasma low‐density lipoprotein cholesterol (LDL‐C). </p><p id="d7658779e308"> <i>Hypothesis</i>: Cerivastatin 0.8 mg has greater long‐term efficacy in reducing LDL‐C than pravastatin 40 mg in primary hypercholesterolemia. </p><p id="d7658779e313"> <i>Methods</i>: 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. </p><p id="d7658779e318"> <i>Results</i>: Cerivastatin 0.8 mg reduced LDL‐C versus cerivastatin 0.4 mg (40.8 vs. 33.6%, p&lt;0.0001) or pravastatin 40 mg (31.5%, p&lt;0.0001), and brought 81.8% of all patients, and 54.1% of patients with atherosclerotic disease, to National Cholesterol Education Program (NCEP) goals. Cerivastatin 0.8 mg improved mean total C (‐29.0%), triglycerides (‐18.3%), and high‐density lipoprotein cholesterol (HDL‐C) (+9.7%) (all ≤ 0.013 vs. pravastatin 40 mg). Higher baseline triglycerides were associated with greater reductions in triglycerides and elevations in HDL‐C with cerivastatin. Cerivastatin was well tolerated; the most commonly reported adverse events were arthralgia, headache, pharyngitis, and rhinitis. Symptomatic creatine kinase &gt; 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 &gt;3 × ULN occurred in 0.3–0.5,0.5, and 0% of patients, respectively. </p><p id="d7658779e323"> <i>Conclusion</i>: In long‐term use, cerivastatin 0.8 mg effectively and safely brings the majority of patients to NCEP goal. </p>