Low-density lipoprotein cholesterol reduction and goal achievement with ezetimibe/simvastatin versus atorvastatin or rosuvastatin in patients with diabetes, metabolic syndrome, or neither disease, stratified by National Cholesterol Education Program risk category

Metab Syndr Relat Disord. 2009 Dec;7(6):601-10. doi: 10.1089/met.2009.0009.


Background: Patients with diabetes mellitus (DM) and metabolic syndrome are at increased risk of coronary heart disease (CHD). Studies have shown differential statin efficacy on low-density lipid cholesterol (LDL-C) by CHD risk strata.

Objective: The aim of this study was to evaluate the consistency of effect with ezetimibe/simvastatin (E/S) combination therapy, atorvastatin, or rosuvastatin in patients with DM, metabolic syndrome, or neither condition (No DM/metabolic syndrome), stratified by the National Cholesterol Education Panel Adult Treatment Panel III (NCEP ATP III) CHD risk group.

Methods: Post hoc analyses of 2 multicenter, double-blind, randomized, 6-week studies comparing E/S 10/10, 10/20, 10/40, or 10/80 mg with either atorvastatin 10, 20, 40, or 80 mg, or rosuvastatin 10, 20, or 40 mg. Treatments were compared by pooling across all doses for LDL-C reduction and NCEP LDL-C goal attainment in patients with DM, metabolic syndrome without DM, or No DM/metabolic syndrome across NCEP CHD risk strata.

Results: NCEP LDL-C goal attainment was lowest in the high-risk group with atherosclerotic vascular disease (12-64%) and greatest in the moderate and low-risk groups (84-100%). In contrast, LDL-C reduction was generally similar irrespective of disease or risk subgroup. All treatments were generally well tolerated, with overall similar safety regardless of disease and risk level.

Conclusions: In these studies, CHD risk strata were inversely related to the likelihood of attaining NCEP LDL-C goals, but did not appear to affect the percentage LDL-C change from baseline. This demonstrates the need for especially aggressive cholesterol lowering necessary to reach the lower LDL-C goal for high-risk patients.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anticholesteremic Agents / therapeutic use*
  • Atorvastatin
  • Azetidines / therapeutic use
  • Cholesterol, LDL / blood*
  • Coronary Disease / prevention & control
  • Diabetes Mellitus / blood*
  • Diabetes Mellitus / drug therapy*
  • Double-Blind Method
  • Drug Combinations
  • Ezetimibe, Simvastatin Drug Combination
  • Female
  • Fluorobenzenes / therapeutic use
  • Heptanoic Acids / therapeutic use
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Male
  • Metabolic Syndrome / blood*
  • Metabolic Syndrome / drug therapy*
  • Middle Aged
  • Pyrimidines / therapeutic use
  • Pyrroles / therapeutic use
  • Risk Factors
  • Rosuvastatin Calcium
  • Simvastatin / therapeutic use
  • Sulfonamides / therapeutic use


  • Anticholesteremic Agents
  • Azetidines
  • Cholesterol, LDL
  • Drug Combinations
  • Ezetimibe, Simvastatin Drug Combination
  • Fluorobenzenes
  • Heptanoic Acids
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrimidines
  • Pyrroles
  • Sulfonamides
  • Rosuvastatin Calcium
  • Atorvastatin
  • Simvastatin