| アブストラクト | BACKGROUND/OBJECTIVES: Rabeprazole differs from other proton pump inhibitors (PPIs) in its activation and lower dependence on CYP2C19. We compared its System Organ Class (SOC)-level reporting profile with those of esomeprazole, pantoprazole, omeprazole and lansoprazole in EudraVigilance individual case safety reports (ICSRs). METHODS: Aggregated ICSR counts were retrieved from adrreports.eu (data lock point 4 October 2026). Rabeprazole was compared head-to-head with each comparator using reporting odds ratios (RORs) with 95% confidence intervals across 27 MedDRA SOCs, with Benjamini-Hochberg false discovery rate control over all 108 tests. Bonferroni correction and serious-only analyses were sensitivity analyses; female-only and male-only analyses were exploratory. RESULTS: Of 232,045 ICSRs, 7960 involved rabeprazole. Hepatobiliary disorders were the only SOC reported more often with rabeprazole than with all four comparators (ROR 1.29-1.96); the excess met the Bonferroni threshold and persisted among serious reports (ROR 1.19-1.97) and in both sexes. Skin and subcutaneous tissue disorders were reported more often than with three comparators and, among serious reports, than with all four (ROR 1.14-1.83). Eight SOCs showed consistently lower reporting odds, alongside fewer SOCs per rabeprazole ICSR and a different reporter mix. CONCLUSIONS: Rabeprazole showed a consistent hepatobiliary reporting signal within the PPI class, in line with earlier FAERS findings. This is a reporting signal, not a clinical signal: without exposure data, the results describe relative reporting, not incidence, comparative risk or causality, and lower reporting odds do not imply lower clinical risk. |
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| 投稿者 | Moleriu, Radu Dumitru; Cioaca, Gabriela Ramona; Muntean, Calin; Ilie, Adrian-Cosmin; Vlad, Daliborca Cristina; Piros, Teodora; Marin, Ruxandra-Cristina |
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| 組織名 | Department III Functional Science, Discipline of Medical Informatics and;Biostatistics, "Victor Babes" University of Medicine and Pharmacy, 300041;Timisoara, Romania.;Doctoral School, "Victor Babes" University of Medicine and Pharmacy, 300041;Department of Immunology, Allergology and Biology, Department III-Functional;Sciences, "Victor Babes" University of Medicine and Pharmacy, Timisoara, 300041;Department III Functional Science, Discipline of Public Health and Health;Management, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara,;Romania.;Department IV, Biochemistry and Pharmacology, Discipline of Pharmacology, "Victor;Babes" University of Medicine and Pharmacy, 300041 Timisoara, Romania.;Discipline of Pharmacology, Clinical Pharmacology and Pharmacotherapy, "Carol;Davila" University of Medicine and Pharmacy, 050474 Bucharest, Romania.;Doctoral School of Biological and Biomedical Sciences, University of Oradea,;410087 Oradea, Romania. |
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