在接受贝佩多酸或阿托瓦斯塔丁的患者中报告的肌肉骨结果差异:使用EudraVigilance数据库进行不成比例分析
Gianluca Gazzaniga1,2, Antonio Romio1, Chiara Galuppi1
1Department of Medical Biotechnology and Translational Medicine, Postgraduate School of Clinical Pharmacology and Toxicology, University of Milano, Milano, Italy.
Frontiers in pharmacology
|February 9, 2026
概括
贝佩多酸 (BA) 与阿托瓦斯塔丁 (ATO) 相比,肌肉相关的药物不良反应 (ADR) 的几率更高,但这些通常不那么严重. 需要对BA的肌肉症状给予更多的注意,特别是与他类药物结合时.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 药品安全 药品安全
背景情况:
- 升高的低密度脂蛋白胆固醇 (LDL-C) 是动脉样硬化心血管疾病的关键危险因素.
- 类药物是主要的LDL-C降低药物,但可以导致肌肉骨系统疾病 (MSD),影响患者的坚持.
- 班佩多酸 (BA) 是一种具有有限肌肉激活的替代性降脂剂,尽管最近的数据表明可能存在与肌肉相关的不良药物反应 (ADR).
研究的目的:
- 为了比较bempedoic acid (BA) 和atorvastatin (ATO) 之间的与肌肉相关的ADRs.
- 在现实环境中评估BA关于肌肉相关不良事件的安全性.
主要方法:
- 来自欧洲自发报告系统到2024年6月的ADR报告的分析.
- 使用报告几率比率 (ROR) 进行不成比例分析,以比较BA和ATO之间的肌肉相关的ADR.
- 根据患者的人口统计和事件类型对副作用的分类.
主要成果:
- 总共分析了78,930份ADR报告 (仅为BA的2667,仅为ATO的76,137).
- 肌肉骨障碍与BA相比,与ATO相比,肌肉骨障碍的发生率明显高 (ROR 2.25).
- 肌肉不适与BA更为相关,而与ATO更频繁的严重事件,如拉布地质溶解;与BA相关的肌肉ADR通常不那么严重.
结论:
- 与阿托瓦斯塔丁 (ATO) 接受者相比,佩多酸 (BA) 接受者显示肌肉相关ADR报告的几率增加.
- 尽管报告几率更高,但BA相关的肌肉ADR的特点是更有利的临床结果和较低的严重程度.
- 临床医生在开药时应考虑药物诱导的肌肉症状,特别是在与他类药物联合治疗时.
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