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Statin-Associated Autoimmune Myopathy: A Systematic Review of 100 Cases
Salik Nazir1, Saroj Lohani, Niranjan Tachamo
1From the *Reading Health System, Wyomissing, PA; and †Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA.
Background:
Statins are a group of drugs that reduce the levels of triglycerides and cholesterol in blood by inhibiting HMG-CoA reductase, an enzyme involved in rate limiting step in cholesterol synthesis. About 2-20% patients on statins develop toxic myopathies, which usually resolve on discontinuation of statin. More recently, an immune-mediated necrotizing myopathy has been found to be associated with statin use which in most cases requires treatment with immunosuppressants.
Objective:
To perform a systematic review on published case reports and case series of statin-associated autoimmune myopathy.
Methods:
A comprehensive search of PUBMED, EMBASE, Cochrane library and ClinicalTrials.gov databases was performed for relevant articles from inception until March 19, 2016 to identify cases of statin-associated necrotizing myopathy and characterize their symptoms, evaluation and response to treatment.
Results:
A total of 16 articles describing 100 patients with statin-associated autoimmune myopathy were identified. The mean age of presentation was 64.72 years, and 54.44% were males. The main presenting clinical feature was proximal muscle weakness, which was symmetric in 83.33% of patients. The mean creatine kinase (CK) was 6853 IU/l. Anti-HMG-CoA reductase antibody was positive in all cases tested (n = 57/57, 100%). In patients with no anti-HMG-CoA antibody results, diagnosis was established by findings of necrotizing myopathy on biopsy. Among the 83 cases where muscle biopsy information was available, 81.48% had necrosis, while 18.51% had combination of necrosis and inflammation. Most (83.82%) patients received two or more immunosuppressants to induce remission. Ninety-one percent had resolution of symptoms after treatment.
Conclusion:
Statin-associated necrotizing myopathy is a symmetric proximal muscle weakness associated with extreme elevations of CK. It is common in males and can occur after months of statin use. It is associated with necrosis on muscle biopsy and the presence of anti-HMG-CoA reductase antibodies. It usually requires discontinuation and immune suppression for resolution. Rechallenge with statin is unsuccessful in most cases.
Insights
Statin-associated autoimmune myopathy presents as muscle weakness and high creatine kinase (CK) levels, often requiring immunosuppression for resolution. This condition, linked to anti-HMG-CoA reductase antibodies, typically does not improve with statin rechallenge.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Statins inhibit HMG-CoA reductase, crucial for cholesterol synthesis, but can cause myopathies in 2-20% of patients.
- Immune-mediated necrotizing myopathy is a recognized, severe adverse effect of statin therapy.
- This condition often necessitates immunosuppressive treatment for management.
Purpose of the Study:
- To systematically review published case reports and series on statin-associated autoimmune myopathy.
- To characterize the clinical presentation, diagnostic findings, and treatment responses in affected patients.
Main Methods:
- Conducted a comprehensive literature search across major databases (PubMed, EMBASE, Cochrane, ClinicalTrials.gov) up to March 19, 2016.
- Identified and analyzed case reports and series detailing statin-associated necrotizing myopathy.
- Characterized patient demographics, symptoms, diagnostic markers (CK levels, antibodies), biopsy findings, and treatment outcomes.
Main Results:
- 100 patients from 16 articles were identified, with a mean age of 64.7 years; 54.4% were male.
- Symmetric proximal muscle weakness was the primary symptom, with mean creatine kinase (CK) levels of 6853 IU/l.
- Anti-HMG-CoA reductase antibodies were present in 100% of tested patients (n=57). Muscle biopsies showed necrosis (81.5%) or necrosis with inflammation (18.5%).
- Most patients (83.8%) required multiple immunosuppressants, achieving symptom resolution in 91%.
Conclusions:
- Statin-associated necrotizing myopathy is characterized by severe proximal muscle weakness, elevated CK, and anti-HMG-CoA reductase antibodies.
- Necrosis on muscle biopsy is a key diagnostic feature, often requiring immunosuppression for treatment.
- Statin rechallenge is generally unsuccessful, highlighting the need for alternative lipid-lowering strategies.
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