Ezetimibe/Simvastatin 10/20 mg versus Rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency

Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite prior statin treatment (n = 618) were randomized 1:1 to EZ/Simva 10/20 mg or Rosuva 10 mg for 6 weeks. Percent change from baseline in lipids and attainment of lipid targets were assessed within each subgroup (low potency n = 369, high potency n = 249). Consistency of the treatment effect across subgroups was evaluated by testing for treatment-by-subgroup interaction. No multiplicity adjustments were made.Significant treatment-by-subgroup interaction occurred for LDL-C (p = 0.013), total cholesterol (p = 0.025), non-HDL-C (p = 0.032), and apolipoprotein B (p = 0.016) with greater between-treatment differences in favor of EZ/Simva observed in patients from the high potency stratum vs low potency stratum. Individual and triple target attainment was higher for Eze/Simva compared with Rosuva in both strata.Compared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva.Registered at ClinicalTrials.gov: NCT00479713Low-density lipoprotein cholesterol (LDL-C) is the primary target of therapy in patients with hypercholesterolemia[1,2]. If therapeutic lifestyle changes do not lower LDL-C to recommended levels, interventions such as HMG-CoA reductase inhibitors (statins) are indicated for further LDL-C reductions. Rosuvastatin has demonstrated more effective LDL-C reductions across its dose range than other statins across their dose ranges and greater lipid-lowering effects compared with the other marketed statins[3-5]. However, despite the substantial lipid-lowering associated with the use of statins, LDL-C reductions beyond that achieved by currently used statin therapies--even those considered to b