Abstract 17189: Indications and Adverse Effects of Statin Therapy in Children: A Retrospective Electronic Medical Record Review

Introduction: Statins are the most commonly prescribed medications for primary and secondary prevention of coronary artery disease and stroke. Adverse drug reactions (ADRs) ranging from common myalgia to rhabdomyolysis with renal failure can occur. The indications for statin therapy and prevalence of statin ADRs in pediatrics have not been well described. Hypothesis: Statin ADRs occur less commonly in pediatric patients than in adults. Methods: Using electronic medical record (EMR) data, we abstracted charts of young subjects for whom statins were prescribed at Vanderbilt University Medical Center. We included 276 subjects with statin therapy initiated ≤21 years. Each record was reviewed manually for therapy indication, age at initiation, drug, dose(s), and reports of ADRs. Results: The most common indication for statin prescription in children was hypercholesterolemia, followed by renal disease, type 1 diabetes, and heart transplant. Only 10/276 (3.6%) subjects reported ADR to statins leading to a therapeutic change, lower than the 10-25% estimates from observational studies in adults. No pediatric patients were identified with rhabdomyolysis. Conclusions: ADRs during statin therapy in young patients are infrequent, mostly characterized by mild skeletal muscle symptoms, and rarely result in a change to statin therapy. The risk-to-benefit evaluation of using statin therapy in pediatrics with diverse indications appears favorable with regard to the incidence of skeletal muscle symptoms. However, our analysis does not address other concerns such as hormonal signaling in adolescent patients during times of rapid growth and pubertal development.