{"title":"他汀类药物与免疫介导的坏死性肌病：风险的变异性。","authors":"Thierry Trenque , Jed Hadjoudj , Agathe Trenque , Federica Tralongo , Salomé Martin , Brahim Azzouz","doi":"10.1016/j.therap.2023.07.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Immune-mediated necrotizing myopathy<span> (IMNM) is a form of statin<span> myopathy characterized by the presence of antibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti HMGCR).</span></span></p></div><div><h3>Objectives</h3><p>The aim of this study was to investigate the relationship between the different statins and the risk of IMNM.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p><span>After analysis, a total of 25 ICSRs were related to IMNM in the FNPV. The suspected statins were atorvastatin (</span><em>n</em> <!-->=<!--> <span>21), simvastatin (</span><em>n</em> <!-->=<!--> <span>2), pravastatin (</span><em>n</em> <!-->=<!--> <span>1) and rosuvastatin (</span><em>n</em> <!-->=<!--> <span>1). In Vigibase, 567 notifications were identified. A significant ROR value was found for atorvastatin, pitavastatin, simvastatin, pravastatin and rosuvastatin.</span></p></div><div><h3>Conclusion</h3><p>Atorvastatin presents the highest risk of IMNM. Our data suggest that the occurrence of IMNM is a class effect.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.2000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Statins and immune-mediated necrotizing myopathy: Variability in the risk\",\"authors\":\"Thierry Trenque , Jed Hadjoudj , Agathe Trenque , Federica Tralongo , Salomé Martin , Brahim Azzouz\",\"doi\":\"10.1016/j.therap.2023.07.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Immune-mediated necrotizing myopathy<span> (IMNM) is a form of statin<span> myopathy characterized by the presence of antibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti HMGCR).</span></span></p></div><div><h3>Objectives</h3><p>The aim of this study was to investigate the relationship between the different statins and the risk of IMNM.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p><span>After analysis, a total of 25 ICSRs were related to IMNM in the FNPV. The suspected statins were atorvastatin (</span><em>n</em> <!-->=<!--> <span>21), simvastatin (</span><em>n</em> <!-->=<!--> <span>2), pravastatin (</span><em>n</em> <!-->=<!--> <span>1) and rosuvastatin (</span><em>n</em> <!-->=<!--> <span>1). In Vigibase, 567 notifications were identified. A significant ROR value was found for atorvastatin, pitavastatin, simvastatin, pravastatin and rosuvastatin.</span></p></div><div><h3>Conclusion</h3><p>Atorvastatin presents the highest risk of IMNM. Our data suggest that the occurrence of IMNM is a class effect.</p></div>\",\"PeriodicalId\":23147,\"journal\":{\"name\":\"Therapie\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapie\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0040595723001063\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapie","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0040595723001063","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Statins and immune-mediated necrotizing myopathy: Variability in the risk
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.
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.
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