{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T21:37:36Z","timestamp":1776893856336,"version":"3.51.2"},"reference-count":34,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,1,8]],"date-time":"2018-01-08T00:00:00Z","timestamp":1515369600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Zeria Pharmaceutical Co., Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Backgrounds<\/jats:title><jats:p>Acotiamide is a novel acetylcholinesterase inhibitor for treatment of postprandial distress syndrome (<jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content>) symptoms of functional dyspepsia (<jats:styled-content style=\"fixed-case\">FD<\/jats:styled-content>).<\/jats:p><jats:p>This European phase 3 open\u2010label safety trial has been conducted to evaluate the long\u2010term safety of acotiamide and explore the efficacy of acotiamide on <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content> symptoms using the validated <jats:styled-content style=\"fixed-case\">LPDS<\/jats:styled-content>, quality of life using <jats:styled-content style=\"fixed-case\">SF<\/jats:styled-content>\u201036 and <jats:styled-content style=\"fixed-case\">SF<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">NDI<\/jats:styled-content>, and work productivity using <jats:styled-content style=\"fixed-case\">WPAI<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">FD<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content> patients (defined by <jats:styled-content style=\"fixed-case\">ROME III<\/jats:styled-content> criteria) aged \u226518\u00a0years with active <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content> symptoms and without predominant overlapping symptoms of epigastric pain syndrome and related disorders were enrolled to receive 100\u00a0mg acotiamide three times daily for 1\u00a0year. Patients' safety profile and efficacy of acotiamide were monitored.<\/jats:p><\/jats:sec><jats:sec><jats:title>Key Results<\/jats:title><jats:p>The majority of patients (81.6%) maintained exposure to acotiamide for &gt;50\u00a0weeks, with a mean duration of 320.3\u00a0days. No specific clinically significant safety concerns have been shown, with no deaths, treatment\u2010related severe\/serious adverse events, or any clinically significant laboratory test results.<\/jats:p><jats:p>Although being an open\u2010label trial, acotiamide showed a change in severity larger than the minimum clinically important difference at weeks 1 and 2 for postprandial fullness and early satiation (meal\u2010related symptoms), and showed improvement of quality of life and work productivity from the first measurement (at week 12) up to 1\u00a0year.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions &amp; Inferences<\/jats:title><jats:p>The long\u2010term safety of acotiamide treatment was confirmed. A clinically important change for <jats:styled-content style=\"fixed-case\">PDS<\/jats:styled-content> symptoms, QoL, and work productivity was suggested; however a controlled trial is required to confirm this hypothetic efficacy of acotiamide. 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