Renal injury in NSAIDs: a real-world analysis based on the FAERS database.

Abstract

Objective: This study aims to evaluate the reporting risk of renal injury associated with non-steroidal anti-inflammatory drugs (NSAIDs), with a particular focus on the reporting risk levels and onset times of different NSAIDs.

Methods: A pharmacovigilance study was conducted using data from the FAERS database from January 2004 to December 2023. Reports of renal injury were identified, and signal detection was performed using reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) methods. The study compared the incidence, mortality rates, and onset times of renal injury across five NSAIDs.

Results: Among the 7436 cases of NSAID-associated renal injury analyzed, elderly patients are at an increased risk of renal injury associated with NSAID usage. Ibuprofen had the highest number of reports (3475 cases, 46.7%), while celecoxib had the lowest (542 cases, 7.3%). Ibuprofen showed the highest signal with renal injury (ROR 3.3, IC025 1.7), whereas celecoxib exhibited the lowest (ROR 1.4, IC025 0.4). Aspirin had the highest mortality rate associated with renal injury (18.7%), while ibuprofen had the lowest (3.8%). The median onset time for renal injury was 6 days, with 79.3% of adverse events occurring within the first 30 days of use.

Conclusion: The study indicates that ibuprofen presents the highest signal of renal injury, while celecoxib shows the lowest signal. The likelihood of NSAID-associated renal injury is heightened in elderly patients, and all five studied NSAIDs are linked to an increased likelihood of acute renal injury. NSAID-related renal damage tends to occur early in the treatment process, potentially leading to serious consequences. Due to the inherent limitations of pharmacovigilance studies, certain findings require additional validation like cohort studies. Nonetheless, the potential for an increased risk of renal injury must be taken into account in patient care.