抗体治疗患者的angiopoietin-Like 3 类抗体治疗 亚最佳控制的高脂血症: 一个第2期研究
Xiaojie Xie1, Xiaoxia Shi2, Yuming Zhang3
1Department of Cardiology, Second Affiliated Hospital, Zhejiang University School of Medicine, State Key Laboratory of Transvascular Implantation Devices, Heart Regeneration and Repair Key Laboratory of Zhejiang Province, Hangzhou, China.
Journal of the American College of Cardiology
|April 1, 2025
概括
SHR-1918是一种ANGPTL-3抑制剂,在患有高脂血症的患者中显著降低了LDL-C和甘油三. 这种抗体表现出剂量依赖的疗效,耐受性良好,为降低心血管疾病风险提供了新的选择.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
- 脂质代谢 脂质代谢是什么
背景情况:
- 血管类3 (ANGPTL-3) 通过抑制脂蛋白脂酶和内皮脂酶来调节脂质水平.
- 升高的ANGPTL-3活性有助于增加低密度脂蛋白胆固醇 (LDL-C) 和甘油三 (TG) 水平.
- SHR-1918是一种针对ANGPTL-3的新型单克隆抗体.
研究的目的:
- 评估SHR-1918的脂质改变功效和安全性.
- 评估SHR-1918在患有中度或较高风险的动脉样硬化心血管疾病 (ASCVD) 的高脂血症患者中.
- 为了确定SHR-1918在标准治疗中低于最佳控制的脂质水平的患者中的影响.
主要方法:
- 一个多中心,随机,双盲,安慰剂控制,剂量升级的第二阶段研究.
- 333名高胆固醇患者接受了SHR-1918 (150,300或600毫克每4周;或600毫克每8周) 或安慰剂.
- 治疗持续时间为16周,延长阶段进行安全性评估.
主要成果:
- 与安慰剂相比,SHR-1918显示LDL-C的剂量依赖性降低,从21.7%到29.9%不等.
- TG,非HDL-C,阿波利波蛋白B和阿波利波蛋白A1水平也显著降低.
- 该抗体在所有测试剂量和剂量频率中一般耐受良好.
结论:
- 用SHR-1918抑制ANGPTL-3可在患有高脂血症的患者中提供显著的额外LDL-C降低.
- 疗效取决于SHR-1918的剂量和剂量频率.
- SHR-1918代表了管理高脂血症和降低ASCVD风险的有前途的治疗策略.
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