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

J. Isaacsohn, Jr Insull W., E. Stein, P. Kwiterovich, P. Ma, R. Brazg, C. A. Dujovne, M. Shan, E. Shugrue-Crowley, S. Ripa, R. Tota

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

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<0.0001) or pravastatin 40 mg (31.5%, p<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 p≤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 >10 times; 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.

Original languageEnglish (US)
Pages (from-to)IV1-IV9
JournalClinical Cardiology
Volume24
Issue number10 SUPPL.
DOIs
StatePublished - 2001

Keywords

  • Cerivastatin
  • Hypercholesterolemia
  • Low-density lipoprotein
  • Safety
  • Statins

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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