Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the food and drug administration adverse event reporting system (FAERS) database

The FDA Adverse Event Reporting System (FAERS) was used to evaluate the associations between oral anticoagulants (OACs) and acute kidney injury (AKI). Disproportionality analysis were applied to data in the FAERS database from January 2004 to December 2023 to detect adverse events (AEs) for various OACs. The adjusted reporting odds ratios (RORs) calculated using multiple logistic regression were used to explore the risk factors for OACs-associated AKI. The median age of patients with reported OACs-associated AKI was 76 years (interquartile range = 68–83 years), with 53.82% of the reports being for males. The crude RORs for the associations of AKI with warfarin, rivaroxaban, dabigatran, apixaban and edoxaban were 1.35, 2.14, 2.98, 1.33 and 3.56, respectively. The risk of OACs-associated AKI was affected by age and sex, being higher in those aged 65 years and males. The adjusted RORs for rivaroxaban, dabigatran, apixaban and edoxaban were 1.26, 1.67, 0.65 and 2.06, respectively. After adjusting for factors confounding the interactions between age, sex and the administered medication, all five OACs had different risk factors for AKI. Nearly 50% of AKI cases occurred within the first 2 months, and each OAC was of the early-failure type. Hospitalization and mortality rates for AKI patients after OACs were 45.53% and 22.98%, respectively. The study highlights the strong association between AKI and OACs, emphasizing the need for regular renal function monitoring from the initial stages of OACs, especially in elderly male patients. Further in-depth research is needed to confirm these findings.

本研究采用美国食品药品监督管理局不良事件报告系统（FDA Adverse Event Reporting System, FAERS），评估口服抗凝药（oral anticoagulants, OACs）与急性肾损伤（acute kidney injury, AKI）之间的关联。针对2004年1月至2023年12月FAERS数据库中的数据，采用不成比例分析法检测各类口服抗凝药相关的不良事件。通过多元logistic回归计算校正后的报告比值比（adjusted reporting odds ratios, ROR），以探究口服抗凝药相关性急性肾损伤的危险因素。报告的口服抗凝药相关性急性肾损伤患者的中位年龄为76岁（四分位间距为68~83岁），其中53.82%的报告为男性患者。华法林、利伐沙班、达比加群酯、阿哌沙班及艾多沙班与急性肾损伤关联的粗报告比值比分别为1.35、2.14、2.98、1.33及3.56。口服抗凝药相关性急性肾损伤的风险受年龄与性别影响，65岁及以上人群及男性患者的风险更高。利伐沙班、达比加群酯、阿哌沙班及艾多沙班的校正后报告比值比分别为1.26、1.67、0.65及2.06。在校正年龄、性别与给药药物之间的交互混杂因素后，五种口服抗凝药各自对应不同的急性肾损伤危险因素。近50%的急性肾损伤病例发生在用药最初2个月内，各类口服抗凝药对应的急性肾损伤均为早发型。口服抗凝药使用者并发急性肾损伤后的住院率及死亡率分别为45.53%及22.98%。本研究证实急性肾损伤与口服抗凝药之间存在显著关联，强调需在口服抗凝药治疗初期即开展规律肾功能监测，尤其针对老年男性患者，未来仍需开展进一步深入研究以验证本研究结论。