Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France; University of Reims Champagne-Ardenne, Faculty of Medicine, EA 3797, 51095 Reims, France.
Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France.
Therapie. 2024 May-Jun;79(3):365-370. doi: 10.1016/j.therap.2023.07.005. Epub 2023 Jul 30.
Immune-mediated necrotizing myopathy (IMNM) is a form of statin myopathy characterized by the presence of antibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti HMGCR).
The aim of this study was to investigate the relationship between the different statins and the risk of IMNM.
A two-time approach was used. First, we performed a descriptive analysis of the French national pharmacovigilance database (FNPV) for the period from 1985 to december2020. To identify relevant cases, we used Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) related to IMNM. We performed a quantitative and qualitative review of individual case safety reports (ICSRs) recorded in the french vigilance spontaneous reporting system. In a second time, we performed a comparative analysis with the World Health Organization global individual case safety reports database (Vigibase). The association between IMNM and statins exposure was assessed by calculating the reporting odds ratio (ROR) and its 95% confidence interval.
After analysis, a total of 25 ICSRs were related to IMNM in the FNPV. The suspected statins were atorvastatin (n=21), simvastatin (n=2), pravastatin (n=1) and rosuvastatin (n=1). In Vigibase, 567 notifications were identified. A significant ROR value was found for atorvastatin, pitavastatin, simvastatin, pravastatin and rosuvastatin.
Atorvastatin presents the highest risk of IMNM. Our data suggest that the occurrence of IMNM is a class effect.
免疫介导的坏死性肌病（IMNM）是他汀类药物肌病的一种形式，其特征是存在针对 3-羟基-3-甲基戊二酰基辅酶 A 还原酶（抗 HMGCR）的抗体。
本研究旨在探讨不同他汀类药物与 IMNM 风险之间的关系。
采用两阶段方法。首先，我们对 1985 年至 2020 年 12 月期间的法国国家药物警戒数据库（FNPV）进行了描述性分析。为了识别相关病例，我们使用了与 IMNM 相关的医学词典药物监管活动（MedDRA）首选术语（PT）。我们对法国警戒自发报告系统中记录的个别病例安全报告（ICSR）进行了定量和定性审查。在第二阶段，我们与世界卫生组织全球个别病例安全报告数据库（Vigibase）进行了比较分析。通过计算报告比值比（ROR）及其 95%置信区间来评估 IMNM 与他汀类药物暴露之间的关联。
经过分析，FNPV 中共有 25 份 ICSR 与 IMNM 相关。怀疑的他汀类药物有阿托伐他汀（n=21）、辛伐他汀（n=2）、普伐他汀（n=1）和罗苏伐他汀（n=1）。在 Vigibase 中，共发现 567 份通知。阿托伐他汀、匹伐他汀、辛伐他汀、普伐他汀和罗苏伐他汀的 ROR 值显著。
阿托伐他汀发生 IMNM 的风险最高。我们的数据表明，IMNM 的发生是一种类效应。
