| アブストラクト | OBJECTIVE: As obesity and diabetes are on the verge of an alarming growth, so is the use of tirzepatide, a novel dual glucose-dependent insulinotropic peptide/glucagon-like peptide-1 (GLP-1) receptor agonist (RA) and currently the most effective weight loss-drug. This research aimed to identify reporting patterns related to suboptimal therapeutic outcomes and tirzepatide-related drug-use issues, mining the EudraVigilance (EV). DESIGN: Retrospective pharmacovigilance study using descriptive and disproportionality analyses of reports retrieved from the EV database. SETTINGS: Analysis of individual case safety reports involving tirzepatide in comparison with other GLP-1 RAs in the overall dataset (healthcare professionals (HP) and non-HP reports combined) and in the HP group. OUTCOME MEASURES: Reporting ORs (RORs) with 95% CIs for selected Preferred Terms (PT) related to drug-use issues. RESULTS: Among all analysed PTs, the most frequently reported were 'Off-label use' (n=1521), 'Drug ineffective' (n=425) and 'Off-label use device' (n=99). PTs in HP reports showed lower reporting odds compared with non-HP reports. In the overall dataset, reports involving tirzepatide showed lower reporting odds of the PT 'Drug ineffective' than those involving liraglutide (ROR 0.61, 95% CI 0.54 to 0.70), dulaglutide (ROR 0.72, 95% CI 0.63 to 0.82), exenatide (ROR 0.78, 95% CI 0.67 to 0.92) and semaglutide (ROR 0.81, 95% CI 0.72 to 0.91). However, in HP reports, no difference in reporting odds was observed between tirzepatide and semaglutide. A different pattern was observed for 'off-label use' in the full dataset, with higher reporting odds for tirzepatide vs lixisenatide, dulaglutide and liraglutide, but lower reporting odds vs semaglutide (ROR 0.52, 95% CI 0.49 to 0.55). In contrast, a higher reporting odd for the PT 'off-label use of device' was observed for tirzepatide versus semaglutide (ROR 43.47, 95% CI 16.00 to 118.13) in the overall reports; however, this finding should be interpreted with caution given the wide CI. CONCLUSIONS: This study complements existing evidence from clinical trials and current clinical practice. |
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| ジャーナル名 | BMJ open |
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| Pubmed追加日 | 2026/10/1 |
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| 投稿者 | Popa Ilie, Ioana Rada; Ghibu, Steliana; Butuca, Anca; Dobrea, Carmen Maximiliana; Frum, Adina; Stoicescu, Laurentiu; Homorodean, Calin; Gligor, Felicia Gabriela; Morgovan, Claudiu |
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| 組織名 | Department of Endocrinology, Faculty of Medicine, Iuliu Hatieganu University of;Medicine and Pharmacy, Cluj-Napoca, CJ, Romania.;Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy,;Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, CJ, Romania;steliana.ghibu@umfcluj.ro.;Preclinical Department, Faculty of Medicine, Lucian Blaga University of Sibiu,;Sibiu, SB, Romania.;Department of Cardiology, Vth Medical Clinic, Faculty of Medicine, Iuliu;Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, CJ, Romania.;Medical Clinic No. 1, Internal Medicine Department, Iuliu Hatieganu University of;Interventional Cardiology Department, Cluj-Napoca County Emergency Hospital,;Cluj-Napoca, CJ, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42823110/ |
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