دورية أكاديمية
Statins and immune-mediated necrotizing myopathy: Variability in the risk.
| العنوان: | Statins and immune-mediated necrotizing myopathy: Variability in the risk. |
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| المؤلفون: | Trenque T; 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. Electronic address: ttrenque@chu-reims.fr., Hadjoudj J; Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France., Trenque A; Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France., Tralongo F; Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France., Martin S; Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France., Azzouz B; 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. |
| المصدر: | Therapie [Therapie] 2024 May-Jun; Vol. 79 (3), pp. 365-370. Date of Electronic Publication: 2023 Jul 30. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Masson Country of Publication: France NLM ID: 0420544 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1958-5578 (Electronic) Linking ISSN: 00405957 NLM ISO Abbreviation: Therapie Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2016- : Paris : Elsevier Masson Original Publication: Paris : Doin |
| مواضيع طبية MeSH: | Hydroxymethylglutaryl-CoA Reductase Inhibitors*/adverse effects , Muscular Diseases*/chemically induced , Muscular Diseases*/epidemiology , Muscular Diseases*/pathology , Pharmacovigilance*, Humans ; Male ; Female ; Middle Aged ; Aged ; France/epidemiology ; Hydroxymethylglutaryl CoA Reductases/immunology ; Adult ; Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Necrosis/chemically induced ; Databases, Factual ; Atorvastatin/adverse effects ; Aged, 80 and over |
| مستخلص: | 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. (Copyright © 2023 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Antibodies; Myopathy; Pharmacovigilance; Risk; Statins |
| المشرفين على المادة: | 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) EC 1.1.1.- (Hydroxymethylglutaryl CoA Reductases) EC 1.1.1.- (HMGCR protein, human) A0JWA85V8F (Atorvastatin) |
| تواريخ الأحداث: | Date Created: 20230825 Date Completed: 20240602 Latest Revision: 20240602 |
| رمز التحديث: | 20240603 |
| DOI: | 10.1016/j.therap.2023.07.005 |
| PMID: | 37625939 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1958-5578 |
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| DOI: | 10.1016/j.therap.2023.07.005 |