Statins and immune-mediated necrotizing myopathy: Variability in the risk
Thierry Trenque1, Jed Hadjoudj2, Agathe Trenque2
1Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France; University of Reims Champagne-Ardenne, Faculty of Medicine, EA 3797, 51095 Reims, France.
Therapie
|August 25, 2023
Summary
Atorvastatin is linked to the highest risk of immune-mediated necrotizing myopathy (IMNM), a statin-induced condition. This study suggests IMNM is a class effect of statins.
Area of Science:
- Pharmacovigilance
- Immunology
- Neurology
Background:
- Immune-mediated necrotizing myopathy (IMNM) is a severe adverse effect of statin therapy.
- IMNM is characterized by the presence of autoantibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti-HMGCR).
Purpose of the Study:
- To investigate the association between specific statin medications and the risk of developing IMNM.
- To analyze the global and national reporting of IMNM cases linked to statin use.
Main Methods:
- Descriptive analysis of the French national pharmacovigilance database (FNPV) from 1985 to 2020.
- Quantitative and qualitative review of individual case safety reports (ICSRs) using MedDRA terms for IMNM.
- Comparative analysis with the World Health Organization's Vigibase database.
- Calculation of reporting odds ratios (ROR) to assess the association between statins and IMNM.
Main Results:
- The FNPV identified 25 IMNM cases, with atorvastatin being the most frequently suspected statin (n=21).
- Vigibase recorded 567 IMNM notifications.
- Significant reporting odds ratios (ROR) were observed for atorvastatin, pitavastatin, simvastatin, pravastatin, and rosuvastatin.
Conclusions:
- Atorvastatin demonstrated the highest risk of inducing IMNM among the studied statins.
- The findings suggest that IMNM is a potential class effect associated with statin use.
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