Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease

Vivencio Barrios, N. Amabile, F. Paganelli, J. W. Chen, C. Allen, A. O. Johnson-Levonas, R. Massaad, K. Vandormael

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42 Citations (Scopus)

Abstract

This randomised, double-blind study evaluated the efficacy and safety of ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg tablet compared to doubling the atorvastatin (ATV) dose in hypercholesterolaemic patients with atherosclerotic or coronary heart disease (CHD). The study group included 435 male and female CHD patients (aged ≥18 years) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal of <2.50 mmol/l while on a stable dose of ATV 10 mg for ≥6 weeks. After a 1-week diet/stabilisation period, patients with LDL-C ≥2.50 mmol/l and ≤4.20 mmol/l were randomised (1:1) to EZE/ SIMVA 10/20 mg/day (n = 221) or ATV 20 mg/day (n = 214) for 6 weeks. The primary efficacy objective was to determine the per cent reduction from baseline in LDL-C at week 6. EZE/SIMVA 10/20 mg produced significantly greater mean per cent changes from baseline in LDL-C compared with ATV 20 mg (-32.8 vs. -20.3%; p ≤ 0.001). A significantly greater proportion of patients achieved an LDL-C goal <2.50 mmol/l with EZE/SIMVA than ATV (77.9 vs. 51.9%; p ≤ 0.001). Significant improvements in total cholesterol (-20.3 vs. - 13.0%), non-high-density lipoprotein cholesterol (non-HDL-C) (-27.9 vs. -17.0%), apolipoprotein B (-23.4 vs. -14.7%) and HDL-C (1.8 vs. -0.4%) were observed after switching to EZE/SIMVA 10/20 mg for 6 weeks (p < 0.05 for all parameters). EZE/SIMVA 10/20 mg was generally well tolerated, with an overall safety profile similar to that of ATV 20 mg. EZE/SIMVA 10/;20 mg produced superior lipid-altering efficacy by dual inhibition of cholesterol synthesis and intestinal absorption compared with doubling the dose of ATV from 10 to 20 mg.

Original languageEnglish
Pages (from-to)1377-1386
Number of pages10
JournalInternational Journal of Clinical Practice
Volume59
Issue number12
DOIs
Publication statusPublished - Dec 2005
Externally publishedYes

Keywords

  • Atorvastatin
  • Coronary heart disease
  • Efficacy
  • Ezetimibe/simvastatin
  • Hypercholesterolaemia
  • Tablet

ASJC Scopus subject areas

  • General Medicine

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