Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy Translation: Int. J. Clin. Pract. 2009 Apr; 63(4): 547-59.

Abstract

Aims: To evaluate the efficacy of switching from a previous statin monotherapy to ezetimibe⁄/simvastatin (EZE⁄SIMVA) 10/20 mg vs. rosuvastatin (ROSUVA) 10 mg.

Methods: In this randomised, double-blind study, 618 patients with documented hypercholesterolaemia (low-density lipoprotein cholesterol (LDL-C) ≥2,59 and ≤4,95 mmol/l) and with high cardiovascular risk who were taking a stable daily dose of one of several statin medications for 6 weeks prior to the study randomisation visit entered a 6-week open-label stabilisation⁄ screening period during which they continued to receive their prestudy statin dose. Following stratification by study site and statin dose/potency, patients were randomised to EZE/SIMVA 10/20 mg (n=314) or ROSUVA 10 mg (n=304) for 6 weeks.

Results: EZE/SIMVA produced greater reductions in LDL-C (-27,7% vs. -16,9%; p ≤0,001), total cholesterol (-17,5% vs. -10,3%; p ≤0,001), non-high-density lipoprotein cholesterol (HDL-C) (-23,4% vs. -14,0%; p ≤0,001) and apolipoprotein B (-17,9% vs. -9,8%; p ≤0,001) compared with ROSUVA, while both treatments were equally effective at increasing HDL-C (2,1% vs. 3,0%; p=0,433). More patients achieved LDL-C levels <2,59 mmol/l (73% vs. 56%), <2,00 mmol/l (38% vs. 19%) and <1,81 mmol/l (25% vs. 11%) with EZE ⁄ SIMVA than ROSUVA (p ≤0,001). A borderline significantly greater reduction in triglycerides (p=0,056) was observed for EZE⁄SIMVA (-11,0%) vs. ROSUVA (-5,3%). There were no between-group differences in the incidences of adverse events or liver transaminase and creatine kinase elevations.

Conclusion: EZE⁄SIMVA 10⁄20 mg produced greater improvements in LDL-C, total cholesterol, non-HDL-C and apoB with a similar safety profile as for ROSUVA 10 mg.