Efficacy and Safety of Evolocumab in Chinese Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia: 12-Week Primary Results of the HUA TUO Randomized Clinical Trial.

Abstract

Evolocumab, a fully human proprotein convertase/subtilisin kexin type9 inhibitor antibody, significantly lowers low-density lipoprotein cholesterol (LDL-C) in patients with type2 diabetes mellitus and hyperlipidemia and mixed dyslipidemia. This 12-week study evaluated the efficacy and safety of evolocumab in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia at different levels of cardiovascular disease risk. HUA TUO was a 12-week randomized, double-blind, placebo-controlled study. Chinese patients aged 18years or older on stable optimized statin therapy were randomized 2:2:1:1 to receive evolocumab 140mg every 2weeks (Q2W), evolocumab 420mg monthly (QM), or a matching placebo. The coprimary endpoints were percent change from baseline in LDL-C at the mean of weeks10 and 12 and at week12. Overall, 241 randomized patients (mean [standard deviation] age, 60.2 [10.3] years) received evolocumab 140mg Q2W (n = 79), evolocumab 420mg QM (n = 80), placebo Q2W (n = 41), or placebo QM (n = 41). At weeks10 and 12, the placebo-adjusted least-squares mean percent change from baseline in LDL-C for the evolocumab 140mg Q2W group was - 70.7% (95%CI - 78.0% to - 63.5%); - 69.7% (95%CI - 76.5% to - 63.0%) for the evolocumab 420mg QM group. Significant improvements in all other lipid parameters were observed with evolocumab. The patient incidence of treatment-emergent adverse events was similar between the treatment groups and across dosing regimens. In Chinese patients with primary hypercholesterolemia and mixed dyslipidemia, 12-week treatment with evolocumab significantly lowered LDL-C and other lipids, and was safe and well tolerated (NCT03433755).