Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome

Diab Vasc Dis Res. 2011 Oct;8(4):262-70. doi: 10.1177/1479164111418136. Epub 2011 Aug 22.

Abstract

Metabolic syndrome (MetS) is a clustering of atherosclerotic coronary heart disease risk factors. This post-hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg or rosuvastatin 10 mg in a cohort of 618 high-risk hypercholesterolaemic patients with (n=368) and without (n=217) MetS who had previously been on statin monotherapy. Patients were randomised 1:1 to double-blind ezetimibe/simvastatin 10/20 mg or rosuvastatin 10 mg for 6 weeks. Least squares mean percent change from baseline and 95% confidence intervals in lipid efficacy parameters were calculated for the population and within subgroups. Treatment with ezetimibe/simvastatin was significantly more effective than rosuvastatin at lowering low-density lipoprotein cholesterol, total cholesterol, non- high-density lipoprotein cholesterol, and apolipoprotein B (all p<0.001). No significant differences in treatment effects were seen between the presence and absence of MetS. In this post-hoc analysis of high-risk hypercholesterolaemic patients the lipid-reducing effects of ezetimibe/simvastatin or rosuvastatin were not altered significantly by the presence of MetS.

Trial registration: ClinicalTrials.gov NCT00479713.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Analysis of Variance
  • Anticholesteremic Agents / administration & dosage*
  • Anticholesteremic Agents / adverse effects
  • Apolipoproteins B / blood
  • Azetidines / administration & dosage*
  • Azetidines / adverse effects
  • Biomarkers / blood
  • Cholesterol / blood
  • Cholesterol, LDL / blood
  • Coronary Disease / blood
  • Coronary Disease / etiology
  • Coronary Disease / prevention & control*
  • Double-Blind Method
  • Drug Combinations
  • Drug Substitution*
  • Europe
  • Ezetimibe, Simvastatin Drug Combination
  • Female
  • Fluorobenzenes / administration & dosage*
  • Fluorobenzenes / adverse effects
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / complications
  • Hypercholesterolemia / drug therapy*
  • Least-Squares Analysis
  • Lipids / blood*
  • Logistic Models
  • Male
  • Metabolic Syndrome / blood
  • Metabolic Syndrome / complications
  • Metabolic Syndrome / drug therapy*
  • Middle Aged
  • Odds Ratio
  • Pyrimidines / administration & dosage*
  • Pyrimidines / adverse effects
  • Risk Assessment
  • Risk Factors
  • Rosuvastatin Calcium
  • Simvastatin / administration & dosage*
  • Simvastatin / adverse effects
  • Sulfonamides / administration & dosage*
  • Sulfonamides / adverse effects
  • Treatment Outcome

Substances

  • Anticholesteremic Agents
  • Apolipoproteins B
  • Azetidines
  • Biomarkers
  • Cholesterol, LDL
  • Drug Combinations
  • Ezetimibe, Simvastatin Drug Combination
  • Fluorobenzenes
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Lipids
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium
  • Cholesterol
  • Simvastatin

Associated data

  • ClinicalTrials.gov/NCT00479713