Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Division of Nephrology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Pharmacoepidemiol Drug Saf. 2013 Oct;22(10):1061-70. doi: 10.1002/pds.3500. Epub 2013 Aug 20.
Statins are widely used for preventing cardiovascular disease, yet recent reports suggest an increased risk of acute kidney injury (AKI). We estimated the one-year risk of AKI associated with statin initiation and determined the comparative safety of individual statin formulations.
We performed a cohort study in insurance billing data from commercial and Medicare insurance plans in the United States for the years 2000-2010. We identified statin initiators and non-users with histories of medication use and healthcare utilization. AKI diagnosis codes were identified in the one year following the index date. We estimated hazard ratios (HR) and 95% confidence intervals (CI) with adjusted and propensity score (PS)-matched Cox-proportional hazards models. Models were run separately in insurance groups and adjusted for cardiovascular and renal risk factors, markers of healthcare utilization, and other medication use.
We identified 3,905,155 statin initiators and 2,817,621 eligible non-users. The adjusted HR of AKI in statin initiators compared to non-users was: commercial, HR = 1.04 (95% CI: 0.99, 1.09); Medicare, HR = 0.72 (95% CI: 0.70, 0.75). PS-matching yielded: commercial, HR = 0.82 (95% CI: 0.78, 0.87); Medicare, HR = 0.66 (95% CI: 0.63, 0.69). As individual formulations, higher-potency simvastatin was associated with an increased risk of AKI over lower-potency simvastatin in adjusted models: commercial, HR = 1.42 (95% CI: 1.28, 1.58); Medicare, HR = 1.24 (95% CI: 1.15, 1.35).
As a class, statin initiation was not associated with an increase in AKI. However, higher-potency simvastatin did exhibit an increased AKI risk.
他汀类药物被广泛用于预防心血管疾病,但最近的报告表明其会增加急性肾损伤(AKI)的风险。我们评估了起始他汀类药物治疗与 AKI 风险的一年相关性,并确定了个体他汀类药物制剂的相对安全性。
我们在美国商业和医疗保险计划的保险计费数据中进行了一项队列研究,时间范围为 2000 年至 2010 年。我们确定了有药物使用和医疗保健利用史的起始他汀类药物治疗者和非使用者。在索引日期后的一年中,识别 AKI 诊断代码。我们使用调整后的和倾向评分(PS)匹配 Cox 比例风险模型估计风险比(HR)和 95%置信区间(CI)。在保险组中分别运行模型,并调整了心血管和肾脏危险因素、医疗保健利用标志物以及其他药物使用情况。
我们确定了 3905155 名起始他汀类药物治疗者和 2817621 名合格非使用者。与非使用者相比,起始他汀类药物治疗者 AKI 的调整 HR 为:商业保险,HR=1.04(95%CI:0.99,1.09);医疗保险,HR=0.72(95%CI:0.70,0.75)。PS 匹配后得到:商业保险,HR=0.82(95%CI:0.78,0.87);医疗保险,HR=0.66(95%CI:0.63,0.69)。就个别制剂而言,高剂量辛伐他汀与调整模型中低剂量辛伐他汀相比,AKI 风险增加:商业保险,HR=1.42(95%CI:1.28,1.58);医疗保险,HR=1.24(95%CI:1.15,1.35)。
作为一个类别,起始他汀类药物治疗与 AKI 增加无关。然而,高剂量辛伐他汀确实显示出 AKI 风险增加。