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Lower Gastrointestinal Adverse Events with Naproxen/Esomeprazole: A Disproportionality Analysis Using the WHO Pharmacovigilance Database

Year: 2025

Type: article

Abstract: Objective: This study evaluated the reporting patterns of lower gastrointestinal adverse events (LGI-AEs) associated with nonsteroidal anti-inflammatory drug (NSAID)/proton pump inhibitor (PPI) combination therapy compared with NSAID monotherapy and cyclooxygenase-2 selective inhibitors (COX-2 SIs) using VigiBase, a global adverse event (AE) database.Methods: A disproportionality analysis was conducted using individual case safety reports (ICSRs) recorded in VigiBase from 2010 to 2024.The study drug was naproxen/esomeprazole, with all other NSAIDs as the primary comparator and COX-2 SIs as the secondary comparator.Reporting odds ratios (RORs) and 95% confidence intervals (CIs) were calculated for LGI-AEs.A signal was defined as ROR ≥ 1 with χ 2 ≥ 4 and at least three reports.Results: Among 4,641,540 drug-AE pairs, 22,627 were associated with the study drug, with 135 LGI-AEs.The ROR for LGI-AEs was 0.71 (95% CI: 0.60-0.84)compared with all other NSAIDs, and 0.78 (95% CI: 0.64-0.95)compared with COX-2 SIs.Conclusion: Naproxen/esomeprazole showed a lower disproportionality signal for LGI-AEs compared to other NSAIDs and COX-2 SIs.These results suggest a different reporting pattern but do not imply reduced risk or causality.Further studies are needed to validate these findings.(PeRM 2025;17:146-157)

Source: Journal of Pharmacoepidemiology and Risk Management

DOI: 10.56142/perm.25.0016

Authors: So Yeon Jeong, Ju-Young Shin, Ju Hwan Kim

Institution: Sungkyunkwan University

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: hybrid

Funder: Ministry of Food and Drug Safety