Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis.
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abstract
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 3days 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.
Steiner, J. M., Lainesse, C., Noshiro, Y., Domen, Y., Sedlacek, H., Bienhoff, S. E., ... Shikama, H.
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Steiner, Joerg M||Lainesse, Chantal||Noshiro, Yuya||Domen, Yumiko||Sedlacek, Heather||Bienhoff, Stephen E||Doucette, Kelly P||Bledsoe, David L||Shikama, Hiroshi
