Risk of kidney injury due to oral anticoagulants: a study based on FDA Adverse Event Reporting System database
10.3760/cma.j.cn114015-20240430-00296
- VernacularTitle:口服抗凝药致肾损伤风险：基于美国FDA不良事件报告系统数据库的研究
- Author:
Wenxing PENG
1
;
Guoquan CHEN
;
Zheng DING
Author Information
1. 首都医科大学附属北京安贞医院药事部，北京 100029
- Publication Type:Journal Article
- Keywords:
Factor Xa inhibitors;
Acute kidney injury;
Data mining;
Adverse events reporting system database;
Anticoagulant-related nephropathy;
Oral anticoagulants;
Di
- From:
Adverse Drug Reactions Journal
2025;27(1):11-16
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the risk signal of acute kidney injury (AKI) induced by different oral anticoagulant drugs (OACs) in various populations and provide a reference for clinical use of OACs.Methods:Reports of AKI induced by OACs and non-OACs in the US Food and Drug Administration Adverse Event Reporting System database from the 1st quarter of 2004 to the 3rd quarter of 2023 were collected. The relationship between the drugs mentioned above and the AKI in patients were analyzed by methods of reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN). When the number of reports of the target adverse event (AE) for the target drug was ≥3, and the lower limit of the 95% confidence interval ( CI) of ROR was >1 or the lower limit of the 95% CI of the information component ( IC025) was >0, it indicated a statistically significant association between the target drug and the target AE. Results:A total of 12 402 AKI reports related to OACs were collected, including 1 313 for warfarin, 3 086 for dabigatran, 4 730 for rivaroxaban, 2 918 for apixaban, and 365 for edoxaban; 454 378 AKI reports were related to non-OACs. The overall analysis of OACs showed an ROR (lower limit of 95% CI) of 1.791 (1.759) and an IC ( IC025) of 0.813 (0.787) for AKI caused by OACs. Analysis of individual OACs showed that warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban all posed risks for AKI, with ROR (lower limit of 95% CI) of 1.220(1.156), 2.386(2.302), 2.044(1.986), 1.375(1.326), 3.003(2.706), respectively, and IC ( IC025) of 0.284(0.204), 1.231(1.178), 1.010(0.968), 0.452(0.399), 1.560(1.407), respectively. Edoxaban had the highest ROR and IC values, while warfarin had the lowest. Subgroup analysis showed that in the <18 years subgroup, neither warfarin nor rivaroxaban showed a risk of AKI; the ROR method did not show dabigatran to have a risk of AKI, but the BCPNN method did. In the 18-45 years subgroup, both methods showed that apixaban did not have a risk of AKI, while all other OACs did. In the 45-64 years subgroup, all OACs showed a risk of AKI. In the ≥65 years subgroup, warfarin and apixaban posed risks for AKI. Gender subgroup analysis showed that both methods indicated a risk of AKI with warfarin in males; all OACs showed a risk of AKI in females. Conclusions:OAC has a statistically significant risk of AKI, among which edoxaban has the highest risk intensity and warfarin has the lowest. Different OACs have different risks of AKI in patients with different ages.
