A Fine-Gray competing-risks model was derived (CPRD Gold, n=1,785,207) and externally validated (CPRD Aurum, n=3,889,504) to predict 1-, 5-, and 10-year risk of serious muscle disorders (hospitalisation or death) in men ≥50 and women ≥60 years eligible for statin treatment in England, using data from 1998–2018.
The 22-predictor model showed good discrimination and calibration in external validation: C-index 0.782, D-statistic 2.176 (95% CI 2.139–2.212), E/O ratio 1.151, and calibration slope 1.063; 99.6% of the validation cohort had a predicted 10-year risk below 10%, and decision curve analysis indicated net clinical benefit.
Retrospective design using electronic health records limits causal inference. External validation was confined to a second UK primary care database (CPRD Aurum), so generalisability outside England is uncertain. Slight over-prediction is suggested by an E/O ratio of 1.151.
This model can quantify a patient's personalised risk of serious statin-related muscle harm, which—used alongside existing CVD risk tools—supports more informed shared decision-making about starting or continuing statin therapy. Clinicians should note that for most eligible patients the absolute 10-year risk of serious muscle disorders is very low (<10%).
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