Efficacy of Ezetimibe/Simvastatin 10/20 mg Versus Rosuvastatin 10 mg in High-Risk Patients With or Without Obesity

Abstract

Introduction: This post-hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) or rosuvastatin 10 mg (ROSUVA) in high-risk hypercholesterolemic patients with/without obesity. Methods: Patients (n=618) at high-risk for coronary heart disease with elevated low-density lipoprotein cholesterol (LDL-C) >2.59 and <4.92 mmol/L, while on a statin, entered a 6-week open-label stabilization/screening period during which they continued on the same statin. Patients were then randomized 1:1 to double-blind EZE/SIMVA 10/20 mg or ROSUVA 10 mg for 6 weeks. Patients were classified as non-obese (n=437) or obese (n=180) based on body mass index <30 or >30 kg/m 2, respectively. Results: EZE/SIMVA was more effective than ROSUVA at lowering LDL-C, total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein (apo) B in the overall population (P<0.001 for all). These results were consistent for obese and non-obese patients as demonstrated by the lack of significant treatment-by-subgroup interaction terms for LDL-C, TC, non-HDL-C, and apo B (P>0. 050 for all). Conclusions: In this post-hoc analysis of high-risk patients with elevated LDL-C, despite prior use of statin therapy, switching to EZE/SIMVA 10/20 mg versus ROSUVA 10 mg provided superior reductions in LDL-C, TC, and non-HDL-C in obese and non-obese patients. 2011 Springer Healthcare.