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Blood Studies for Cardiovascular System I: Cardiac Biomarkers01:20

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Genetic Biomarkers for Statin-Induced Myopathy.

Diana Prieto-Peña1,2, Juan David Urriago-Gil1, Gonzalo Ocejo-Vinyals2,3

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International Journal of Molecular Sciences
|November 27, 2025
PubMed
Summary

Genetic analysis reveals the HLA-DRB1*11 allele is strongly linked to immune-mediated necrotizing myopathy (IMNM) caused by statin use. This finding may help differentiate statin-induced muscle damage types.

Keywords:
HLA-DRB1*11SLCO1B1geneticsmyopathymyopathy necrotizing myopathystatins

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Area of Science:

  • Pharmacogenomics
  • Immunology
  • Neurology

Background:

  • Statin medications can cause muscle toxicity, ranging from mild symptoms to severe immune-mediated necrotizing myopathy (IMNM) associated with anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibodies.
  • The precise mechanisms behind statin-induced myopathy are not fully understood, and genetic factors are suspected to influence susceptibility.
  • Distinguishing between immune-mediated and non-immune forms of statin myopathy is crucial for appropriate patient management.

Purpose of the Study:

  • To investigate the association of specific genetic variants, namely HLA-DRB1*11 and SLCO1B1 rs4149056, with statin-induced muscle toxicity.
  • To determine if these genetic markers can help differentiate between immune-mediated and non-immune forms of statin-related myopathy.

Main Methods:

  • An observational study was conducted with 62 patients exposed to statins at a single tertiary center.
  • Patients were categorized into three groups: anti-HMGCR antibody-positive IMNM (n=11), non-immune myotoxicity (n=20), and statin-exposed controls without myopathy (n=31).
  • Genotyping for HLA-DRB1*11 and SLCO1B1 rs4149056 variants was performed, and their frequencies were compared across the patient groups.

Main Results:

  • The frequency of the HLA-DRB1*11 allele was significantly higher in patients with anti-HMGCR IMNM (81.0%) compared to both non-immune myotoxicity (25.0%) and control groups (17.2%).
  • The odds ratio for HLA-DRB1*11 in anti-HMGCR IMNM was 13.5 versus non-immune myotoxicity and 21.6 versus controls, with p-values < 0.01.
  • No significant association was found between the SLCO1B1 rs4149056 variant and either IMNM or non-immune myotoxicity, nor between non-immune myotoxicity and controls.

Conclusions:

  • The study confirms a strong genetic association between the HLA-DRB1*11 allele and the development of anti-HMGCR antibody-positive IMNM in statin-exposed individuals.
  • HLA-DRB1*11 serves as a potential genetic marker for identifying patients at higher risk for immune-mediated statin myopathy.
  • This genetic insight may aid in distinguishing immune-mediated from non-immune forms of statin-related muscle toxicity, guiding clinical decisions.