Department of Pharmacy Practice and Science.
Clinical Trials Data Management Center, University of Iowa, Iowa City.
Clin Infect Dis. 2015 Jun 15;60(12):1760-6. doi: 10.1093/cid/civ190. Epub 2015 Mar 10.
Investigators have attributed protective effects of statins against pneumonia and other infections. However, these reports are based on observational data where treatments are not assigned randomly. We aimed to determine if the protective effects of statins against pneumonia are due to nonrandom treatment assignment.
We built a cohort consisting of 124 695 Medicare beneficiaries diagnosed with an acute myocardial infarction (AMI) for which we had complete claims data. We considered patients who survived at least 30 days post-AMI (full sample), or who survived for 1 year post-AMI (survivors). First, we used ordinary least squares (OLS) and logit models to determine if receiving a statin was protective against pneumonia. Second, to control for nonrandom treatment assignment, we performed an instrumental variables analysis using geographic treatment rates as an instrument. All models included patient demographics, medications, diagnoses, length of hospital stay, and out-of-pocket drug costs as covariates. Our outcome measure was a pneumonia diagnosis during the 1 year following AMI.
A total of 76 994 patients (61.9%) filled a statin prescription, and 19 078 (15.3%) were diagnosed with pneumonia. Using OLS, the statin coefficient was -0.016 (P < .001), indicating that statins are associated with a reduction in pneumonia. Using instrumental variables, we find that statin prescriptions are not associated with a reduction in pneumonia. For the full sample, statin coefficients ranged from -0.001 to -0.01 (P > .6).
For patients with AMI, the protective effect of statins against pneumonia is most likely the result of nonrandom treatment assignment (ie, a healthy-user bias).
研究人员认为他汀类药物对肺炎和其他感染具有保护作用。然而,这些报告是基于观察性数据,其中治疗并非随机分配。我们旨在确定他汀类药物预防肺炎的保护作用是否归因于非随机治疗分配。
我们构建了一个由 124695 名被诊断患有急性心肌梗死(AMI)的 Medicare 受益人的队列,我们有完整的索赔数据。我们考虑了至少在 AMI 后存活 30 天(全样本)或在 AMI 后存活 1 年(幸存者)的患者。首先,我们使用普通最小二乘法(OLS)和对数模型来确定是否接受他汀类药物对肺炎有保护作用。其次,为了控制非随机治疗分配,我们使用地理治疗率作为工具进行了工具变量分析。所有模型都包括患者的人口统计学、药物、诊断、住院时间和自付药物费用作为协变量。我们的结局测量是 AMI 后 1 年内肺炎的诊断。
共有 76994 名患者(61.9%)开了他汀类药物处方,19078 名患者(15.3%)被诊断患有肺炎。使用 OLS,他汀类药物的系数为-0.016(P<0.001),表明他汀类药物与肺炎的减少有关。使用工具变量,我们发现他汀类药物处方与肺炎的减少无关。对于全样本,他汀类药物的系数范围为-0.001 至-0.01(P>.6)。
对于 AMI 患者,他汀类药物预防肺炎的保护作用很可能是由于非随机治疗分配(即健康使用者偏倚)所致。