| アブストラクト | Background: With the increasing widespread use of GLP-1 RA and dual GIP/GLP-1 RAs in the treatment of obesity, their safety profile remains a concern for healthcare professionals (HPs). Objective: This study aimed to characterize and evaluate safety data from the EudraVigilance (EV) database for semaglutide (SEM), liraglutide (LIR), and tirzepatide (TIR). Methods: A hierarchical pharmacovigilance approach was applied, integrating SOC- and PT-level analyses with SmPC-based evaluation and both frequentist (ROR, 95% CI) and Bayesian (IC025) disproportionality methods. Within each molecule, reporter type-stratified analyses were performed, while across all molecules, disproportionality analyses were conducted separately in HP reports and in the full database to identify reporting patterns and potential safety signals, including those not described in the SmPCs. Results: Some ADRs, listed in the SmPC of only one or two of the three GLP1-RAs were also reported in the EV database for the other agents whose SmPCs do not specify these ADRs including optic ischemic neuropathy (TIR: 0.28% and LIR: 0.17%), alopecia (LIR: 0.81%), headache (TIR: 2.51%), intestinal obstruction (TIR: 1.55%), angioedema (LIR: 0.19%), hypersensitivity (SEM: 0.58% and LIR: 0.73%), etc. Pancreatitis, in particular, showed a significant but low-magnitude signal, being more frequently reported by HPs compared with non-HPs across all three GLP1-RAs. Additionally, statistically significant signals (IC025 > 0) were observed in both the HPs and full datasets. For example, for SEM vs. TIR, signals were identified for optic ischemic neuropathy (0.17; 0.13), gallbladder disorder (0.09; 0.11), and dysesthesia (0.42; 0.43), respectively. For TIR vs. SEM, signals were observed for injection site erythema (0.05; 0.11), injection site pruritus (0.01; 0.11), and injection site reaction (0.02; 0.08). Conclusions: These findings suggest potential safety signals beyond current SmPC information, emphasizing the need for continuous pharmacovigilance and cautious interpretation of reporting biases. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2026/6/26 |
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| 投稿者 | Popa Ilie, Ioana Rada; Ghibu, Steliana; Butuca, Anca; Dobrea, Carmen Maximiliana; Frum, Adina; Homorodean, Calin; Chis, Adriana Aurelia; Morgovan, Claudiu |
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| 組織名 | Endocrinology Department, Faculty of Medicine, "Iuliu Hatieganu" University of;Medicine and Pharmacy, 3-5 Louis Pasteur Street, 400349 Cluj-Napoca, Romania.;Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy,;"Iuliu Hatieganu" University of Medicine and Pharmacy, 6A Louis Pasteur Street,;400349 Cluj-Napoca, Romania.;Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu,;550169 Sibiu, Romania.;Internal Medicine Department, Medical Clinic No. 1, "Iuliu Hatieganu" University;of Medicine and Pharmacy, 400006 Cluj-Napoca, Romania.;Interventional Cardiology Department, Cluj County Emergency Hospital, 400006;Cluj-Napoca, Romania.;Association for Excellence in Pharmaceutical Education and Research, 550169;Sibiu, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42356493/ |
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