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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...

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Autores principales: Steiner, Joerg M., Lainesse, Chantal, Noshiro, Yuya, Domen, Yumiko, Sedlacek, Heather, Bienhoff, Stephen E., Doucette, Kelly P., Bledsoe, David L., Shikama, Hiroshi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2023
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.
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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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