英克利西兰的安全性:来自EudraVigilance数据库的不成比例分析
Giuseppe Cicala1, Michelangelo Rottura1, Viviana Maria Gianguzzo2
1Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy.
Pharmaceuticals (Basel, Switzerland)
|October 26, 2024
概括
这项研究评估了新型PCSK9抑制剂inclisiran的真实安全性,将其与PCSK9抗剂进行比较. 英克利西兰表现出类似的安全性,但增加了肌痛和LDL升高的报道,需要进一步调查.
科学领域:
- 药物监督 药物监督 药物监督
- 心血管药理学心血管药理学
- 药物安全评估 药物安全评估
背景情况:
- 蛋白转化酶亚素-素9型 (PCSK9) 抑制剂已经改变了降脂疗法.
- 作为一种向PCSK9mRNA的siRNA,Inclisiran代表了一种用于抑制PCSK9的新方法.
- 有限的现实世界安全数据存在于inclisiran.
研究的目的:
- 为了对inclisiran进行现实世界的安全评估.
- 为了比较inclisiran与PCSK9抗体 (evolocumab和alirocumab) 的安全性概况.
主要方法:
- 使用EudraVigilance数据进行回顾性药监测研究.
- 对inclisiran和PCSK9抗剂的个体病例安全报告 (ICSR) 的分析.
- 使用了描述性和不成比例性分析 (报告几率比率).
主要成果:
- 与PCSK9抗剂相比,Inclisiran与肌痛 (ROR: 2.43) 和低密度脂蛋白 (ROR: 11.95) 的报告增加有关.
- 对于英克利西兰,最常见的不良反应是注射部位条件和调查.
- 对"药物无效"的显著不成比例也被观察到inclisiran (ROR:6.37).
结论:
- 在现实世界中,inclisiran的安全性概况通常与商业化前的数据一致.
- 报告中观察到的差异,特别是肌痛和LDL升高的情况,需要进一步调查.
- 持续的现实世界监测对于充分阐明inclisiran在不同患者群体中的安全性至关重要.
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