Abstract
OBJECTIVE: There is increasing evidence of an association between statin use and type 2 diabetes mellitus (T2DM) in adults, yet this relationship has never been studied in children or adolescents and may have important implications for assessing risks and benefits of treatment in this population. We estimated the association between statin use and the risk of T2DM in children with and without a dyslipidemia diagnosis. METHODS: Propensity scores were used to match new users of statins with a minimum 50 percent of days covered (PDC) in the first year of use to up to 10 nonusers. Analyses were stratified by a dyslipidemia diagnosis based on recent evidence suggesting a potentially protective effect of familial hypercholesterolemia on T2DM. In sensitivity analyses, we varied this period of exclusion and PDC. Cox proportional hazard models compared the hazard of the outcome between the exposed and unexposed patients. RESULTS: A total of 21,243,305 patients met the eligibility criteria, 2085 (0.01%) of whom met the exposure definition and 1046 (50%) of whom had a dyslipidemia diagnosis. Statin use was associated with an increased risk of T2DM in children without dyslipidemia (hazard ratio 1.96, 95% confidence interval 1.20-3.22), but not in children with dyslipidemia (hazard ratio 1.11, 95% confidence interval 0.65-1.90). The results were consistent across variations in the exclusion period and PDC. CONCLUSIONS: Statin use was associated with an increased likelihood of developing T2DM in children without dyslipidemia. Physicians and patients need to weigh the possible risk of T2DM against the long-term benefits of statin therapy at a young age.