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

Cardiovascular Therapeutics, 05/02/2012

Switching to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg versus ROSUVA 10 mg provided superior lipid reductions in patients with/without type 2 diabetes mellitus (T2DM).

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.

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