Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared to rosuvastatin 10 mg in high-risk patients with and without type 2 diabetes mellitus inadequately controlled despite prior statin monotherapy

Cardiovasc Ther. 2012 Apr;30(2):61-74. doi: 10.1111/j.1755-5922.2010.00181.x. Epub 2010 Jul 7.

Abstract

Aims: This post hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) or rosuvastatin 10 mg (ROSUVA) in uncontrolled high-risk hypercholesterolemic patients with/without type 2 diabetes mellitus (T2DM) despite statin monotherapy.

Methods: Patients (n = 618) at high risk for coronary vascular disease with elevated LDL-C ≥100 and ≤190 mg/dL despite use of statins were randomized 1:1 to double-blind EZE/SIMVA 10/20 mg or ROSUVA 10 mg for 6 weeks. Patients were classified as having T2DM based on ≥1 of the following: diagnosis of T2DM, antidiabetic medication, or FPG ≥126 mg/dL. This analysis evaluated percent changes from baseline in lipids among patients with (n = 182) and without T2DM (n = 434).

Results: EZE/SIMVA was more effective than ROSUVA at lowering LDL-C, TC, non-HDL-C, and apo B in the overall study population and within both subgroups. Numerically, greater between-treatment reductions in LDL-C, TC, non-HDL-C, and apo B were seen in patients with T2DM versus those without T2DM. A significant interaction (P= 0.015) was seen for LDL-C indicating that patients with T2DM achieved larger between-group reductions versus those without T2DM.

Conclusions: Switching to EZE/SIMVA 10/20 mg versus ROSUVA 10 mg provided superior lipid reductions in patients with/without T2DM.

Publication types

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

MeSH terms

  • Anticholesteremic Agents / adverse effects
  • Anticholesteremic Agents / therapeutic use*
  • Apolipoproteins B / metabolism
  • Azetidines / adverse effects
  • Azetidines / therapeutic use*
  • C-Reactive Protein / metabolism
  • Cholesterol / blood
  • Cholesterol, LDL / blood
  • Diabetes Mellitus, Type 2 / blood*
  • Double-Blind Method
  • Drug Resistance
  • Drug Therapy, Combination
  • Ezetimibe
  • Fluorobenzenes / adverse effects
  • Fluorobenzenes / therapeutic use*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / drug therapy*
  • Lipids / blood
  • Odds Ratio
  • Pyrimidines / adverse effects
  • Pyrimidines / therapeutic use*
  • Rosuvastatin Calcium
  • Simvastatin / adverse effects
  • Simvastatin / therapeutic use*
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*

Substances

  • Anticholesteremic Agents
  • Apolipoproteins B
  • Azetidines
  • Cholesterol, LDL
  • Fluorobenzenes
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Lipids
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium
  • C-Reactive Protein
  • Cholesterol
  • Simvastatin
  • Ezetimibe