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Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis
BACKGROUND: Currently, no specific treatment is available for acute onset pancreatitis (AP), and management relies on symptomatic and supportive standard of care (SOC). Fuzapladib is a novel leukocyte function‐associated antigen type‐1 (LFA‐1) activation inhibitor, blocking activation and subsequent...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10658511/ https://www.ncbi.nlm.nih.gov/pubmed/37811705 http://dx.doi.org/10.1111/jvim.16897 |
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author | Steiner, Joerg M. Lainesse, Chantal Noshiro, Yuya Domen, Yumiko Sedlacek, Heather Bienhoff, Stephen E. Doucette, Kelly P. Bledsoe, David L. Shikama, Hiroshi |
author_facet | Steiner, Joerg M. Lainesse, Chantal Noshiro, Yuya Domen, Yumiko Sedlacek, Heather Bienhoff, Stephen E. Doucette, Kelly P. Bledsoe, David L. Shikama, Hiroshi |
author_sort | Steiner, Joerg M. |
collection | PubMed |
description | BACKGROUND: Currently, no specific treatment is available for acute onset pancreatitis (AP), and management relies on symptomatic and supportive standard of care (SOC). Fuzapladib is a novel leukocyte function‐associated antigen type‐1 (LFA‐1) activation inhibitor, blocking activation and subsequent adhesion and migration of neutrophils, potentially decreasing the risk of pancreatitis progression and systemic inflammation. OBJECTIVE: Evaluate the safety and clinical response of dogs with AP after 3 days of administration of fuzapladib. ANIMALS: Sixty‐one client‐owned dogs with presumptive AP. METHODS: Randomized, masked, and placebo controlled multicenter study. Sixty‐one dogs with AP were included for safety assessment, whereas 35 evaluable cases (fuzapladib, n = 16; placebo, n = 19) were included for clinical evaluation. Clinical improvement was assessed based on the change in the modified clinical activity index (MCAI) score on Day 3 compared to Day 0. Secondary variables included canine acute pancreatitis clinical severity index (CAPCSI) scores and serum concentrations of canine pancreatic lipase immunoreactivity, cytokines, and C‐reactive protein. RESULTS: Fuzapladib was well tolerated by all treated dogs. Mean change in MCAI scores was significantly higher in the fuzapladib‐treated (−7.75) than the placebo group (−5.68; P = .02, 95% confidence interval [CI] for the difference, −4.33, −0.35), suggesting clinical improvement in fuzapladib‐treated dogs. No significant difference was found in any of the secondary variables between groups. CONCLUSIONS AND CLINICAL RELEVANCE: Administration of fuzapladib to dogs was safe, and a favorable response was detected in 2 clinical activity scores. Effects of fuzapladib on survival and duration of hospitalization were not studied. |
format | Online Article Text |
id | pubmed-10658511 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-106585112023-10-09 Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis Steiner, Joerg M. Lainesse, Chantal Noshiro, Yuya Domen, Yumiko Sedlacek, Heather Bienhoff, Stephen E. Doucette, Kelly P. Bledsoe, David L. Shikama, Hiroshi J Vet Intern Med SMALL ANIMAL BACKGROUND: Currently, no specific treatment is available for acute onset pancreatitis (AP), and management relies on symptomatic and supportive standard of care (SOC). Fuzapladib is a novel leukocyte function‐associated antigen type‐1 (LFA‐1) activation inhibitor, blocking activation and subsequent adhesion and migration of neutrophils, potentially decreasing the risk of pancreatitis progression and systemic inflammation. OBJECTIVE: Evaluate the safety and clinical response of dogs with AP after 3 days of administration of fuzapladib. ANIMALS: Sixty‐one client‐owned dogs with presumptive AP. METHODS: Randomized, masked, and placebo controlled multicenter study. Sixty‐one dogs with AP were included for safety assessment, whereas 35 evaluable cases (fuzapladib, n = 16; placebo, n = 19) were included for clinical evaluation. Clinical improvement was assessed based on the change in the modified clinical activity index (MCAI) score on Day 3 compared to Day 0. Secondary variables included canine acute pancreatitis clinical severity index (CAPCSI) scores and serum concentrations of canine pancreatic lipase immunoreactivity, cytokines, and C‐reactive protein. RESULTS: Fuzapladib was well tolerated by all treated dogs. Mean change in MCAI scores was significantly higher in the fuzapladib‐treated (−7.75) than the placebo group (−5.68; P = .02, 95% confidence interval [CI] for the difference, −4.33, −0.35), suggesting clinical improvement in fuzapladib‐treated dogs. No significant difference was found in any of the secondary variables between groups. CONCLUSIONS AND CLINICAL RELEVANCE: Administration of fuzapladib to dogs was safe, and a favorable response was detected in 2 clinical activity scores. Effects of fuzapladib on survival and duration of hospitalization were not studied. John Wiley & Sons, Inc. 2023-10-09 /pmc/articles/PMC10658511/ /pubmed/37811705 http://dx.doi.org/10.1111/jvim.16897 Text en © 2023 Ishihara Sangyo Kaisha, Ltd (ISK). Journal of Veterinary Internal Medicine published by Wiley Periodicals LLC on behalf of American College of Veterinary Internal Medicine. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | SMALL ANIMAL Steiner, Joerg M. Lainesse, Chantal Noshiro, Yuya Domen, Yumiko Sedlacek, Heather Bienhoff, Stephen E. Doucette, Kelly P. Bledsoe, David L. Shikama, Hiroshi Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis |
title | Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis |
title_full | Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis |
title_fullStr | Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis |
title_full_unstemmed | Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis |
title_short | Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis |
title_sort | fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis |
topic | SMALL ANIMAL |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10658511/ https://www.ncbi.nlm.nih.gov/pubmed/37811705 http://dx.doi.org/10.1111/jvim.16897 |
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