| アブストラクト | OBJECTIVES: To conduct a specialist-led disproportionality analysis of musculoskeletal adverse event reports (MSAERs) in dogs treated with bedinvetmab (Librela) compared to six comparator drugs with the same indication. Furthermore, to report the findings from a subset of dogs whose adverse event (AE) data underwent independent adjudication by an expert panel. STUDY DESIGN: Case-control study and case series analysis. SAMPLE POPULATION: The European Medicines Agency's EudraVigilance database (2004-2024) and 19 client-owned dogs. METHODS: An EBVS((R)) Veterinary Specialist in Surgery individually reviewed all MSAERs to Librela, Rimadyl((R)), Metacam((R)), Previcox((R)), Onsior((R)), Galliprant((R)), and Daxocox((R)) (2004-2024). The primary null hypothesis was that Librela's MSAER rate would not exceed that of comparator drugs by more than 50%. The secondary hypothesis was that MSAER would surge and taper following the launch of new drugs. RESULTS: The disproportionality analysis did not support the hypotheses. Ligament/tendon injury, polyarthritis, fracture, musculoskeletal neoplasia, and septic arthritis were reported ~9-times more frequently in Librela-treated dogs than the combined total of dogs treated with the comparator drugs. A review of 19 suspected musculoskeletal adverse events (MSAEs) by an 18-member expert panel unanimously concluded a strong suspicion of a causal association between bedinvetmab and accelerated joint destruction. CONCLUSION: This study supports recent FDA analyses by demonstrating an increased reporting rate of musculoskeletal adverse events in dogs treated with Librela. Further investigation and close clinical monitoring of treated dogs are warranted. IMPACT: Our findings should serve as a catalyst for large-scale investigations into bedinvetmab's risks and pharmacovigilance. |
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| ジャーナル名 | Frontiers in veterinary science |
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| Pubmed追加日 | 2025/5/26 |
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| 投稿者 | Farrell, Mike; Waibel, Felix W A; Carrera, Ines; Spattini, Giliola; Clark, Louise; Adams, Robert J; Von Pfeil, Dirsko J F; De Sousa, Ricardo J R; Villagra, Diego Bobis; Amengual-Vila, Maria; Paviotti, Annalisa; Quinn, Rob; Harper, Justin; Clarke, Stephen P; Jordan, Christopher J; Hamilton, Michael; Moores, Andy P; Greene, Mark Irwin |
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| 組織名 | Ferguson Veterinary Clinic, Glenrothes, United Kingdom.;Department of Orthopaedic Surgery, Balgrist University Hospital, Zurich,;Switzerland.;Vetoracle Teleradiology, Diss, United Kingdom.;Clinica Veterinaria Castellarano, Castellarano, Italy.;Davies Veterinary Specialists, Shillington, United Kingdom.;Paragon Veterinary Referrals, Wakefield, United Kingdom.;Small Animal Surgery Locum, PLLC, Dallas, TX, United States.;ESPEVET, Mallorca, Spain.;Vets Now Limited, Dunfermline, United Kingdom.;Frank Pet Surgeons, Leeds, United Kingdom.;Vita Referrals, Wetherby, United Kingdom.;Texas Specialty Veterinary Services, Boerne, TX, United States.;The Moores Orthopaedic Clinic, Basingstoke, United Kingdom.;Hamilton Specialist Referrals, High Wycombe, United Kingdom.;Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United;States. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40417367/ |
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