Qi Litong, Liu Dexue, Qu Yanling, Chen Beijian, Meng Haiyan, Zhu Lei, Li Lipeng, Wang Shuqing, Liu Changyi, Zheng Guanzhong, Lian Qiufang, Yin Guotian, Lv Lingchun, Lu Di, Chen Xiaoshu, Xue Fengtai, An Pei, Li Haoyu, Deng Huan, Li Li, Qian Lei, Huo Yong
Department of Cardiology, Peking University First Hospital, Beijing, China.
Department of Endocrinology, The First Affiliated Hospital of Nanyang Medical College, Nanyang, China.
JACC Asia. 2023 Jul 11;3(4):636-645. doi: 10.1016/j.jacasi.2023.04.011. eCollection 2023 Aug.
Tafolecimab is a novel fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody, developed for the treatment of hypercholesterolemia.
The purpose of this study was to assess the efficacy and safety of tafolecimab in Chinese patients at high or very high cardiovascular risk with hypercholesterolemia.
Patients with diagnoses of heterozygous familial hypercholesterolemia (HeFH) by the Simon Broome criteria or at high or very high cardiovascular risk with nonfamilial hypercholesterolemia, with screening low-density lipoprotein cholesterol (LDL-C) level ≥1.8 mmol/L, were randomized 2:1 to receive tafolecimab or placebo 450 mg every 4 weeks (Q4W) in the 12-week double-blind treatment period. The primary endpoint was the percent change from baseline to week 12 in LDL-C levels.
A total of 303 patients were enrolled and received at least 1 dose of tafolecimab (n = 205) or placebo (n = 98). The least squares mean percent change in LDL-C level from baseline to week 12 was -68.9% (SE 1.4%) in the tafolecimab group and -5.8% (1.8%) in the placebo group (difference: -63.0%; [95% CI: -66.5% to -59.6%]; < 0.0001). More patients treated with tafolecimab achieved ≥50% LDL-C reductions, LDL-C <1.8 mmol/L, and LDL-C <1.4 mmol/L at week 12 than did those in the placebo group (all < 0.0001). Furthermore, tafolecimab markedly reduced non-HDL-C, apolipoprotein B, and lipoprotein(a) levels. During the double-blind treatment period, the most commonly reported adverse events included urinary tract infection (5.9% with tafolecimab vs 4.1% with placebo) and hyperuricemia (3.4% vs 4.1%).
Tafolecimab was safe and showed robust lipid-lowering efficacy in Chinese patients at high or very high cardiovascular risk with hypercholesterolemia. (A Study of IBI306 in Participants With Hypercholesterolemia; NCT04709536).
塔伏西单抗是一种新型的全人源前蛋白转化酶枯草溶菌素/kexin 9型（PCSK9）单克隆抗体，用于治疗高胆固醇血症。
本研究旨在评估塔伏西单抗在患有高胆固醇血症且心血管风险高或极高的中国患者中的疗效和安全性。
根据西蒙·布鲁姆标准诊断为杂合子家族性高胆固醇血症（HeFH）或患有非家族性高胆固醇血症且心血管风险高或极高的患者，筛选时低密度脂蛋白胆固醇（LDL-C）水平≥1.8 mmol/L，在为期12周的双盲治疗期内按2:1随机分组，每4周接受450 mg塔伏西单抗或安慰剂治疗。主要终点是从基线到第12周LDL-C水平的变化百分比。
共纳入303例患者，至少接受1剂塔伏西单抗（n = 205）或安慰剂（n = 98）治疗。塔伏西单抗组从基线到第12周LDL-C水平的最小二乘均值变化百分比为-68.9%（标准误1.4%），安慰剂组为-5.8%（1.8%）（差值：-63.0%；[95%置信区间：-66.5%至-59.6%]；P < 0.0001）。与安慰剂组相比，接受塔伏西单抗治疗的患者在第12周时实现LDL-C降低≥50%、LDL-C < 1.8 mmol/L和LDL-C < 1.4 mmol/L的人数更多（均P < 0.0001）。此外，塔伏西单抗显著降低了非HDL-C、载脂蛋白B和脂蛋白(a)水平。在双盲治疗期间，最常报告的不良事件包括尿路感染（塔伏西单抗组为5.9%，安慰剂组为4.1%）和高尿酸血症（3.4%对4.1%）。
塔伏西单抗在患有高胆固醇血症且心血管风险高或极高的中国患者中安全且显示出强大的降脂疗效。（一项关于IBI306在高胆固醇血症患者中的研究；NCT04709536）
