Statins and immune-mediated necrotizing myopathy: Variability in the risk

IF 2.2 4区医学 Q3 PHARMACOLOGY & PHARMACY

Therapie Pub Date : 2024-05-01 DOI:10.1016/j.therap.2023.07.005

Thierry Trenque , Jed Hadjoudj , Agathe Trenque , Federica Tralongo , Salomé Martin , Brahim Azzouz

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引用次数: 0

Abstract

Introduction

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).

Objectives

The aim of this study was to investigate the relationship between the different statins and the risk of IMNM.

Methods

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.

Results

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.

Conclusion

Atorvastatin presents the highest risk of IMNM. Our data suggest that the occurrence of IMNM is a class effect.

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他汀类药物与免疫介导的坏死性肌病：风险的变异性。

简介免疫介导的坏死性肌病（IMNM）是他汀类药物肌病的一种形式，其特点是存在针对3-羟基-3-甲基戊二酰辅酶A还原酶（抗HMGCR）的抗体：本研究旨在调查不同他汀类药物与 IMNM 风险之间的关系：方法：我们采用了两种时间方法。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 相关的监管活动医学字典 (MedDRA) 首选术语 (PT)。我们对法国警戒自发报告系统中记录的个案安全报告（ICSR）进行了定量和定性审查。第二次，我们与世界卫生组织全球个体病例安全报告数据库（Vigibase）进行了对比分析。通过计算报告几率比（ROR）及其95%置信区间，评估了IMNM与他汀类药物暴露之间的关联：结果：经过分析，共有 25 例 ICSR 与 FNPV 中的 IMNM 有关。可疑的他汀类药物为阿托伐他汀（21 例）、辛伐他汀（2 例）、普伐他汀（1 例）和罗苏伐他汀（1 例）。在 Vigibase 中，确定了 567 份通知。结论：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值都很高：结论：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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapie 医学-药学

CiteScore

3.50

自引率

7.70%

发文量

132

审稿时长

57 days

期刊介绍： Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject. The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.