| アブストラクト | OBJECTIVE: To characterize renal injury reporting, separately for acute kidney injury (AKI) and chronic kidney disease (CKD), for proton pump inhibitors (PPIs) and the potassium-competitive acid blocker (P-CAB) vonoprazan. Reporting was analyzed in the U.S. FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) database. MATERIALS AND METHODS: We analyzed FAERS (2014Q1 - 2024Q4) and JADER (April 2004 through the April 2025 release), defining acute renal events (referred to as AKI) and CKD by MedDRA/J v28.0 preferred terms. The reporting odds ratio (ROR) (signal = lower 95% confidence interval limit > 1) was the primary disproportionality measure, with the proportional reporting ratio and information component used as supportive measures; H(2)-receptor antagonists served as an active comparator class, time-to-onset was modeled with the Weibull distribution, and analyses were stratified by sex, age, and comorbidity. RESULTS: PPIs showed disproportionate reporting of AKI and CKD in both databases (FAERS overall ROR 5.21 and 13.21; JADER 1.25 and 1.76), concordant across measures and after excluding pre-existing renal disease. Signals for vonoprazan were weaker and database-dependent (no FAERS CKD signal, ROR 0.92; weak JADER signal, 1.95). Time-to-onset was short in JADER (median 35 days); FAERS onset estimates were unreliable (median 1,520 days). The PPI signals persisted after excluding vonoprazan or dexlansoprazole. CONCLUSION: Disproportionate reporting of AKI and CKD was observed for PPIs across two databases. These hypothesis-generating findings support renal monitoring and periodic reassessment of long-term acid suppression. The renal safety profile of vonoprazan remains inconclusive, and exposure-based studies are warranted. |
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