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

Area of Science:

• Pharmacovigilance
• Nephrology
• Drug Safety

Background:

• Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for pain and inflammation.
• NSAIDs are associated with various adverse events, including renal injury.
• Understanding the comparative risk profiles of different NSAIDs is crucial for patient safety.

Purpose of the Study:

• To evaluate the reporting risk of renal injury linked to NSAID use.
• To compare the reporting risk levels and onset times of five different NSAIDs.
• To identify patient populations at higher risk for NSAID-induced renal injury.

Main Methods:

• A pharmacovigilance study utilizing the FAERS database (2004-2023).
• Signal detection for renal injury using Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN).
• Comparison of incidence, mortality, and onset times for five NSAIDs: ibuprofen, celecoxib, aspirin, naproxen, and diclofenac.

Main Results:

• Elderly patients face an elevated risk of NSAID-associated renal injury.
• Ibuprofen had the highest reporting frequency (46.7%) and signal for renal injury (ROR 3.3).
• Celecoxib showed the lowest reporting frequency (7.3%) and signal (ROR 1.4); aspirin had the highest mortality rate (18.7%).
• Median onset time for renal injury was 6 days, with 79.3% occurring within 30 days of use.

Conclusions:

• Ibuprofen exhibits the highest signal for renal injury, while celecoxib has the lowest.
• Elderly individuals are more susceptible to NSAID-induced renal injury.
• NSAID-related renal damage typically manifests early in treatment, necessitating careful patient monitoring.
• Findings highlight the need for vigilance regarding NSAID-associated renal risks in clinical practice.