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Updated: Jul 15, 2025

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In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
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在现实世界的环境中,第一次使用inclisiran的临床经验
Janneke W C M Mulder1, Annette M H Galema-Boers1, Jeanine E Roeters van Lennep1
1Department of Internal Medicine, Erasmus University Medical Center, PO Box 2040, Rotterdam, CA 3000, the Netherlands.
Journal of clinical lipidology
|September 29, 2023
概括
新型siRNA PCSK9抑制剂Inclisiran在临床试验中显示出有效的LDL-C降低. 现实数据显示,有效性较低,但安全性相似,在从PCSK9单克隆抗体转换时,潜在的LDL-C增加.
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.
- 在RNA疗法方面.
背景情况:
- 英克利西兰是第一类的小干扰RNA (siRNA),准PCSK9.
- 临床试验表明,英克利西兰可以减少大约50%的LDL-C.
- 有限的现实世界数据存在于inclisiran的临床实用性.
研究的目的:
- 评估inclisiran在临床环境中的疗效和安全性.
- 将inclisiran的性能与临床试验数据进行比较.
- 评估开始使用inclisiran的患者和从PCSK9单克隆抗体转换的患者的结局.
主要方法:
- 在大学脂质诊所开始使用inclisiran的连续患者的注册研究.
- 患者被分为新发起者 (组1) 或从PCSK9 mAbs切换者 (组2).
- 低密度脂蛋白胆固醇 (LDL-C) 水平在开始后的3个月和9个月被测量.
主要成果:
- 启动Inclisiran导致新用户的LDL-C降低了38%.
- 同时服用他类药物与较高的LDL-C降低有关.
- 从PCSK9 mAbs转换的患者经历了38%的LDL-C增加.
- 副作用是轻微的,主要是注射部位反应.
结论:
- 与试验相比,Inclisiran在临床实践中显示LDL-C降低效率降低.
- 在临床实践中inclisiran的安全性概况与试验数据相比较.
- 从PCSK9单克隆抗体转换为inclisiran可能会导致LDL-C水平升高.
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