论文标题

评估与他汀类药物相关的II型糖尿病的最脆弱的子组:电子健康记录数据的证据

Assessing the Most Vulnerable Subgroup to Type II Diabetes Associated with Statin Usage: Evidence from Electronic Health Record Data

论文作者

Guo, Xinzhou, Wei, Waverly, Liu, Molei, Cai, Tianxi, Wu, Chong, Wang, Jingshen

论文摘要

人们一直担心他汀类药物是治疗冠状动脉疾病的最常见药物之一,可能与新发出的II型糖尿病(T2D)的风险增加有关。然而,迄今为止,尚无强有力的证据,表明在服用他汀类药物后是否以及哪种种群确实很容易发生T2D。在本案例研究中,利用合作伙伴卫生系统中的生物库和电子健康记录数据,我们引入了一个新的数据分析管道和一种新的统计方法,通过(i)设计一个严格的因果框架来解决现有的限制,该框架系统地设计了statin使用对观察数据的静脉内静脉内静脉内的静态效果的因果关系,(ii通过自举校准程序评估最脆弱的亚组的可复制性和统计意义。我们提出的方法在存在高维协变量的情况下提供了最脆弱的亚组的治疗效果的渐近置信区间和依据估计。采用我们提出的方法,我们发现,由于他汀类药物的使用,具有高T2D遗传风险的女性患T2D的风险最高。

There have been increased concerns that the use of statins, one of the most commonly prescribed drugs for treating coronary artery disease, is potentially associated with the increased risk of new-onset type II diabetes (T2D). Nevertheless, to date, there is no robust evidence supporting as to whether and what kind of populations are indeed vulnerable for developing T2D after taking statins. In this case study, leveraging the biobank and electronic health record data in the Partner Health System, we introduce a new data analysis pipeline and a novel statistical methodology that address existing limitations by (i) designing a rigorous causal framework that systematically examines the causal effects of statin usage on T2D risk in observational data, (ii) uncovering which patient subgroup is most vulnerable for developing T2D after taking statins, and (iii) assessing the replicability and statistical significance of the most vulnerable subgroup via a bootstrap calibration procedure. Our proposed approach delivers asymptotically sharp confidence intervals and debiased estimate for the treatment effect of the most vulnerable subgroup in the presence of high-dimensional covariates. With our proposed approach, we find that females with high T2D genetic risk are at the highest risk of developing T2D due to statin usage.

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