Efficacy and Safety of Evolocumab in Chinese Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia: Primary Results of the Hua Tuo _ Clinical Trial

Background and Aims : The prevalence of dyslipidemia in China is approximately 40%, and many patients treated with lipid-lowering therapies fail to achieve LDL-C goals. This study evaluated the effect of evolocumab on LDL-C levels in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia with baseline LDL-C levels of ≥80 mg/dL or ≥130 mg/dL despite optimal stable statin therapy.Methods: This was a Phase 3, multicenter, double-blind, randomized, placebo-controlled study conducted in China. The full analysis set used for analyses included 241 patients. Patients received evolocumab 140 mg SC Q2W (N=79), evolocumab 420 mg SC QM (N=80), placebo SC Q2W (N=41), or placebo SC QM (N=41) for 12 weeks. Co-primary endpoints were mean percent change in LDL-C from baseline to weeks 10 and 12, and percent change from baseline to week 12. Subjects’ treatment-emergent adverse events (TEAEs) were assessed.Conclusions: Evolocumab 140 mg Q2W or 420 mg QM in combination with statins significantly lowered LDL-C levels in Chinese patients and was well-tolerated. Background and Aims : The prevalence of dyslipidemia in China is approximately 40%, and many patients treated with lipid-lowering therapies fail to achieve LDL-C goals. This study evaluated the effect of evolocumab on LDL-C levels in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia with baseline LDL-C levels of ≥80 mg/dL or ≥130 mg/dL despite optimal stable statin therapy. Methods: This was a Phase 3, multicenter, double-blind, randomized, placebo-controlled study conducted in China. The full analysis set used for analyses included 241 patients. Patients received evolocumab 140 mg SC Q2W (N=79), evolocumab 420 mg SC QM (N=80), placebo SC Q2W (N=41), or placebo SC QM (N=41) for 12 weeks. Co-primary endpoints were mean percent change in LDL-C from baseline to weeks 10 and 12, and percent change from baseline to week 12. Subjects’ treatment-emergent adverse events (TEAEs) were assessed. Conclusions: Evolocumab 140 mg Q2W or 420 mg QM in combination with statins significantly lowered LDL-C levels in Chinese patients and was well-tolerated.