Efficacy and safety of cerivastatin 0.8 mg in patients with hypercholesterolaemia: The pivotal placebo-controlled clinical trial

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

Research output: Contribution to journalArticle

Abstract

This pivotal, multicentre, double-blind, parallel-group study evaluated the efficacy and safety of cerivastatin 0.8 mg. Patients with primary hypercholesterolaemia were randomized, after 10 weeks' dietary stabilization on an American Heart Association (AHA) Step I diet, to treatment with cerivastatin 0.8 mg (n = 776), cerivastatin 0.4 mg (n = 195) or placebo (n = 199) once daily for 8 weeks. Cerivastatin 0.8 mg reduced mean low density lipoprotein-cholesterol (LDL-C) by 41.8% compared with cerivastatin 0.4 mg (-35.6%, P < 0.0001) or placebo. In 90% of patients receiving cerivastatin 0.8 mg LDL-C was reduced by 23.9-58.4% (6th-95th percentile). Overall attainment of the National Cholesterol Education Program (NCEP) goal was achieved by 84% of patients receiving cerivastatin 0.8 mg and by 59% of those with coronary heart disease (CHD). In the sub-population meeting the NCEP criteria for pharmacological therapy for LDL-C reduction, 74.6% of patients, including the 59% with CHD, reached the goal with cerivastatin 0.8 mg. Cerivastatin 0.8 mg also reduced mean total cholesterol by 29.9%, apolipoprotein B by 33.2% and median triglycerides by 22.9% (all P < 0.0001). Mean high density lipoprotein-cholesterol (HDL-C) and apolipoprotein A1 were elevated 8.7% (P < 0.0001) and 4.5% (P < 0.0001), respectively, by cerivastatin 0.8 mg. Reductions of triglyceride and elevation in HDL-C were dependent upon triglyceride baseline levels; in patients having baseline triglyceride levels 250-400 mg/dl, cerivastatin 0.8 mg reduced median triglycerides by 29.5% and elevated HDL-C by 13.2%. Cerivastatin 0.8 mg was well tolerated. The most commonly reported adverse events included headache, pharyngitis and rhinitis (4-6%). Symptomatic creatine kinase elevations > 10 times upper limit of normal occurred in 0%, 1% and 0.9% of patients receiving placebo, cerivastatin 0.4 mg or cerivastatin 0.8 mg respectively. Cerivastatin 0.8 mg is an effective and safe treatment for patients with primary hypercholesterolaemia who need aggressive LDL-C lowering in order to achieve NCEP-recommended levels.

Original languageEnglish (US)
Pages (from-to)47-68
Number of pages22
JournalJournal of International Medical Research
Volume28
Issue number2
DOIs
StatePublished - 2000

Keywords

  • Cerivastatin
  • HMG-CoA reductase inhibitors
  • Hypercholesterolaemia
  • Low density lipoprotein-cholesterol

ASJC Scopus subject areas

  • Biochemistry
  • Cell Biology
  • Biochemistry, medical

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    Insull, W., Isaacsohn, J., Kwiterovich, P., Ma, P., Brazg, R., Dujovne, C., Shan, M., Shugrue-Crowley, E., Ripa, S., & Tota, R. (2000). Efficacy and safety of cerivastatin 0.8 mg in patients with hypercholesterolaemia: The pivotal placebo-controlled clinical trial. Journal of International Medical Research, 28(2), 47-68. https://doi.org/10.1177/147323000002800201