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RESEARCH PRODUCT

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

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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. What’s known • Optimal management of plasma LDL-C levels is the primary goal of therapeutic intervention in patients at risk of coronary events. • A substantial proportion of patients at risk of coronary events fail to achieve recommended LDL-C goals with statin monotherapy and are therefore at increased risk of future coronary events.