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

作者：Tan Hong; Li Weimin; Huang Zhouqing; Han Yajun; Huang Xuecheng; Li Dongye; Xing Xiaochun; Monsalvo Maria Laura; Wu You; Mao Jackie; Xin Lily; Chen Jiyan

来源：Cardiology and Therapy, 2023, 12(2): 341-359.

DOI：10.1007/s40119-023-00304-x

• Evolocumab
• Hypercholesterolemia
• Hyperlipidemia
• LDL cholesterol
• Mixed dyslipidemia
• PCSK9

Introduction: Evolocumab, a fully human proprotein convertase/subtilisin kexin type?9 inhibitor antibody, significantly lowers low-density lipoprotein cholesterol (LDL-C) in patients with type?2 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. Methods: HUA TUO was a 12-week randomized, double-blind, placebo-controlled study. Chinese patients aged 18?years or older on stable optimized statin therapy were randomized 2:2:1:1 to receive evolocumab 140?mg every 2?weeks (Q2W), evolocumab 420?mg monthly (QM), or a matching placebo. The coprimary endpoints were percent change from baseline in LDL-C at the mean of weeks?10 and 12 and at week?12. Results: Overall, 241 randomized patients (mean [standard deviation] age, 60.2 [10.3] years) received evolocumab 140?mg Q2W (n = 79), evolocumab 420?mg QM (n = 80), placebo Q2W (n = 41), or placebo QM (n = 41). At weeks?10 and 12, the placebo-adjusted least-squares mean percent change from baseline in LDL-C for the evolocumab 140?mg Q2W group was ? 70.7% (95%?CI ? 78.0% to ? 63.5%); ? 69.7% (95%?CI ? 76.5% to ? 63.0%) for the evolocumab 420?mg 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. Conclusion: 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). Graphical Abstract: [Figure not available: see fulltext.] ? 2023, The Author(s).