Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia

Autor: Xiaozeng Wang, Miaohan Qiu, Zhifeng Cheng, Xianyou Ji, Jiyan Chen, Hong Zhu, Yida Tang, Zhouqing Huang, Guohai Su, Gaopin Wang, Zhijun Huang, Zhuhua Yao, Jinxiu Lin, Yihong Sun, Shunhui Li, Cong Shao, Yi Zhao, Xuelian Bai, Yaling Han
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 13, Iss 11 (2024)
Druh dokumentu: article
ISSN: 2047-9980
DOI: 10.1161/JAHA.123.033669
Popis: Background A phase 3 trial was conducted to evaluate the efficacy and safety of ongericimab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, as an add‐on treatment to optimized lipid‐lowering therapy in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia. Methods and Results A total of 806 patients who were receiving stable and optimized lipid‐lowering therapy but did not achieve their low‐density lipoprotein cholesterol (LDL‐C) targets were enrolled and randomly assigned in a 2:1:2:1 ratio to receive either ongericimab 150 mg or matching placebo every 2 weeks, or ongericimab 300 mg or matching placebo every 4 weeks for 52 weeks. Efficacy and safety were evaluated in 802 patients who received at least 1 dose of ongericimab or placebo. The primary end point was the percentage change in LDL‐C from baseline to week 24. Our findings demonstrated that the least‐squares mean difference of percentage change in LDL‐C from baseline to week 24 was −67.7% (95% CI, −72.5% to −63.0%; P
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