Long-term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)—results from the European phase 3 open-label safety trial

J. Tack, J. Pokrotnieks, G. Urbonas, C. Banciu, V. Yakusevich, I. Bunganic, H. Törnblom, Y. Kleban, P. Eavis, M. Tsuchikawa, T. Miyagawa

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27 Citations (Scopus)
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Abstract

Backgrounds: Acotiamide is a novel acetylcholinesterase inhibitor for treatment of postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). This European phase 3 open-label safety trial has been conducted to evaluate the long-term safety of acotiamide and explore the efficacy of acotiamide on PDS symptoms using the validated LPDS, quality of life using SF-36 and SF-NDI, and work productivity using WPAI. Methods: FD-PDS patients (defined by ROME III criteria) aged ≥18 years with active PDS symptoms and without predominant overlapping symptoms of epigastric pain syndrome and related disorders were enrolled to receive 100 mg acotiamide three times daily for 1 year. Patients' safety profile and efficacy of acotiamide were monitored. Key Results: The majority of patients (81.6%) maintained exposure to acotiamide for >50 weeks, with a mean duration of 320.3 days. No specific clinically significant safety concerns have been shown, with no deaths, treatment-related severe/serious adverse events, or any clinically significant laboratory test results. Although being an open-label 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-related symptoms), and showed improvement of quality of life and work productivity from the first measurement (at week 12) up to 1 year. Conclusions & Inferences: The long-term safety of acotiamide treatment was confirmed. A clinically important change for PDS symptoms, QoL, and work productivity was suggested; however a controlled trial is required to confirm this hypothetic efficacy of acotiamide. (NCT01973790).

Original languageEnglish
Article numbere13284
JournalNeurogastroenterology and Motility
Volume30
Issue number6
DOIs
Publication statusPublished - Jun 2018

Keywords*

  • acotiamide
  • functional dyspepsia
  • motility
  • phase 3
  • postprandial distress syndrome

Field of Science*

  • 3.1 Basic medicine
  • 3.2 Clinical medicine

Publication Type*

  • 1.1. Scientific article indexed in Web of Science and/or Scopus database

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