| アブストラクト | Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, introduces a mechanistically distinct approach within incretin-based therapies. While its efficacy is established, real-world data comparing post-marketing safety with established GLP-1 receptor agonists remain limited. This study assessed System Organ Class (SOC)-level reporting patterns for tirzepatide versus semaglutide and liraglutide using EudraVigilance data. Aggregated individual case safety reports (ICSRs) were analyzed using pairwise disproportionality analyses based on a case/non-case approach. Reporting odds ratios (RORs) with 95% confidence intervals were calculated. False discovery rate (FDR) correction using the Benjamini-Hochberg procedure and sensitivity analyses restricted to serious and healthcare professional-reported cases were performed to assess robustness. After FDR adjustment, 20 SOCs were significant in tirzepatide-semaglutide and 23 in tirzepatide-liraglutide comparisons; eight SOCs remained significant across all analytical conditions. Compared with semaglutide, tirzepatide showed higher reporting for immune (ROR 1.97, 95% CI 1.75-2.21) and hepatobiliary disorders (ROR 1.71, 95% CI 1.61-1.82). Versus liraglutide, higher odds occurred for musculoskeletal (ROR 2.02, 95% CI 1.85-2.21) and psychiatric disorders (ROR 2.14, 95% CI 1.99-2.30), and lower odds for neoplasms (ROR 0.28, 95% CI 0.26-0.31). Tirzepatide shows heterogeneous reporting patterns compared with GLP-1 receptor agonists, with consistent excess reporting for hepatobiliary, immune, and musculoskeletal disorders. These findings are hypothesis-generating and warrant confirmation in exposure-adjusted studies. |
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| ジャーナル名 | International journal of molecular sciences |
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| Pubmed追加日 | 2026/4/14 |
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| 投稿者 | Marin, Ruxandra Cristina; Vesa, Cosmin Mihai; Tit, Delia Mirela; Radu, Andrei-Flavius; Bungau, Gabriela S |
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| 組織名 | Doctoral School of Biological and Biomedical Sciences, University of Oradea,;410087 Oradea, Romania.;Department of Pharmacology, Clinical Pharmacology and Pharmacotherapy, Faculty of;Medicine, "Carol Davila" University of Medicine and Pharmacy, 050474 Bucharest,;Romania.;Department of Preclinical Disciplines, Faculty of Medicine and Pharmacy,;University of Oradea, 410073 Oradea, Romania.;Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea,;410028 Oradea, Romania.;Department of Psycho-Neuroscience and Recovery, Faculty of Medicine and Pharmacy, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41977175/ |
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