Department of Epidemiology, Brown University School of Public Health, Providence, RI; Department of Health Care Policy, Harvard Medical School, Boston, Mass.
Lillie Frank Abercrombie Section of Pediatric Cardiology, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, Tex.
Acad Pediatr. 2017 Jul;17(5):515-522. doi: 10.1016/j.acap.2017.02.006. Epub 2017 Feb 21.
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.
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.
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.
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.
越来越多的证据表明,他汀类药物的使用与成年人 2 型糖尿病(T2DM)之间存在关联,但这一关系从未在儿童或青少年中进行过研究,而这可能对评估该人群治疗的风险和益处具有重要意义。我们评估了他汀类药物的使用与存在或不存在血脂异常诊断的儿童 T2DM 风险之间的关联。
采用倾向评分匹配新使用他汀类药物且第一年的用药覆盖天数(PDC)至少为 50%的患者与最多 10 名未使用者。根据最近的证据表明家族性高胆固醇血症可能对 T2DM 具有保护作用,分析按血脂异常诊断进行分层。在敏感性分析中,我们改变了排除期和 PDC。采用 Cox 比例风险模型比较暴露和未暴露患者的结局风险。
共有 21243305 名患者符合入选标准,其中 2085 名(0.01%)符合暴露定义,1046 名(50%)存在血脂异常。在没有血脂异常的儿童中,他汀类药物的使用与 T2DM 的风险增加相关(风险比 1.96,95%置信区间 1.20-3.22),但在存在血脂异常的儿童中则无相关性(风险比 1.11,95%置信区间 0.65-1.90)。在排除期和 PDC 的变化中,结果都是一致的。
在没有血脂异常的儿童中,他汀类药物的使用与 T2DM 的发生可能性增加相关。医生和患者需要权衡 T2DM 的潜在风险与他汀类药物在年轻时治疗的长期益处。