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Development and Application of an Algorithm for Statin-Induced Myopathy Based on Electronic Health Record-Derived
Akinyemi Oni-Orisan1,2, Meng Lu3, Jonathan A Peng4,5
1Department of Clinical Pharmacy, University of California San Francisco, San Francisco, California, USA.
Pharmacoepidemiology and Drug Safety
|October 22, 2025
Summary
This study developed a new algorithm to accurately identify statin-induced myopathy (SIM) in electronic health records. The algorithm demonstrated good performance and can improve future SIM research.
Area of Science:
- Pharmacovigilance
- Clinical Informatics
- Drug Safety Research
Background:
- Statin-induced myopathy (SIM) presents non-specific symptoms, complicating identification in electronic health records (EHRs).
- Previous algorithms for SIM detection lacked broad applicability due to study population limitations.
Purpose of the Study:
- To develop and validate an accurate, efficient, and broadly applicable algorithm for identifying statin-induced myopathy (SIM) using structured EHR data.
- To improve the reliability of SIM case identification in large-scale EHR studies.
Main Methods:
- A two-step algorithm was created using structured EHR data: Step 1 excluded secondary causes, and Step 2 required statin discontinuation.
- Algorithm performance was validated against manual chart review (gold standard) using sensitivity, specificity, and positive predictive value.
- The validated algorithm was applied to identify SIM cases and analyze predictors.
Main Results:
- The algorithm achieved 76% sensitivity, 77% specificity, and 48% positive predictive value for detecting SIM.
- 1257 SIM cases were identified from 5430 potential cases.
- Pravastatin use increased SIM odds (OR 2.18), while hypothyroidism significantly elevated risk (OR 15.65).
Conclusions:
- An efficient and user-friendly algorithm for identifying statin-induced myopathy (SIM) in EHRs has been developed.
- This methodological tool enhances the quality and accuracy of future research on statin-induced myopathy.
