Alimentaryy Therapeutics: Safety and tolerance of fluatecason in the treatment of eosinophilic esophagitis
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Last Update: 2020-06-21
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Source: Internet
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Author: User
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BACKGROUND: APT-1011 is an oral disintegrating tablet of fluophyanate propionate, which is currently being studied for the treatment of eosulmcic esophagitis (EoE)The purpose of this study was to assess the safety and tolerance of treatment with EoE patients using APT-1011, and to assess the effects on EoE clinical symptoms, endoscopy appearance, and increased esophagus eophilic granulocytesmethod: Researchers conducted a randomized, double-blind, placebo-controlled study at seven medical centers in the United States to assess the safety and tolerance of APT-1011 in EoE adults and adolescents over a period of 8 weeksParticipants were randomly divided into placebos (n s 8), 1.5 mg APT-1011 BID (n s 8) or 3.0 mg APT-1011 QD (n s 8)Safety and tolerance were assessed as primary results; histology and endoscopy were evaluated as secondary resultsresults: No deaths were reported in this study, and severe treatment of emergency adverse events (TEAE) occurredA participant randomly assigned to 1.5 mg APT-1011 BI observed a decrease in cortisol, but no adrenal insufficiencyCompared to placebo, treatment with APT-1011 significantly reduced the esophagus osteophilic cell count from baseline to end of treatment, EoE endoscope reference scoreconclusion: APT-1011 is safe and well tolerated in adolescents and adults with EoEImprovements in drug results for EoE histology and endoscopy were also confirmed
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