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 – The IN‐CROSS study

Summary 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 ≤ 4.92 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.