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Efficacy and Safety of Orally Administered Acotiamide Extended-Release Tablets Among Functional Dyspepsia-Postprandial Distress Syndrome Patients: A Randomized, Double-Blind, Multicenter Study.

Cureus 2021 Apr 8;13(4):e14361. Epub 2021 Apr 8.

Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.

Background: Acotiamide, is the world's first-in-class, prokinetic drug and world's first approved treatment for postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). An extended-release (ER) formulation of this drug product, developed first-time in the world has been evaluated in phase 3, a comparative trial to explore the efficacy and safety in patients with FD-PDS.

Methods: In this study, 219 patients with FD-PDS aged 18-65 years were randomized (1:1) to receive either acotiamide ER 300 mg once daily or acotiamide 100 mg three times daily for four weeks. Read More

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Georgian Med News 2021 Mar(312):61-67

1Bogomolets National Medical University, Kyiv; Ukraine.

Functional dyspepsia - postprandial distress-syndrome (FD-PDS) is one of the most common reasons for seeking medical attention of general practitioners, internists and gastroenterologists worldwide. Standard approaches to the treatment of patients with postprandial distress syndrome are only effective in small amount of cases. Aim of the study - comparative assessment of the effectiveness of combined eradication and prokinetic therapy and eradication therapy only in the treatment of FD-PDS by studying their effect on the clinical manifestations of the disease, patients' psychological status and quality of life. Read More

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Unaltered Brain GABA Concentrations and Resting fMRI Activity in Functional Dyspepsia With and Without Comorbid Depression.

Front Psychiatry 2020 11;11:549749. Epub 2020 Sep 11.

Institute of Digestive Disease, Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.

Background: GABA-deficit characterizes depression (MDD), which is highly comorbid with Functional Dyspepsia (FD). We examined brain GABA concentrations and resting activities in post-prandial distress subtype FD (FD-PDS) patients with and without MDD.

Methods: 24 female age/education-matched FD-PDS with comorbid MDD (FD-PDS-MDD), non-depressed FD-PDS, and healthy controls each were compared on GABA concentrations, resting fMRI (fALFF) in bilateral pregenual anterior cingulate (pgACC), left dorsolateral prefrontal cortex (DLPFC), insula, and somatosensory cortex (SSC). Read More

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September 2020

Therapeutic strategy for the patients with coexisting gastroesophageal reflux disease and postprandial distress syndrome of functional dyspepsia.

JGH Open 2020 Aug 3;4(4):582-588. Epub 2020 Feb 3.

Department of Gastoroenterology, Isshi Gastro-Intestinal Clinic Tokyo Japan.

Background And Aim: Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) frequently overlap. However, no accepted treatment has yet been established for such patients. This study was conducted to identify an adequate initial treatment for patients with GERD accompanied by the postprandial distress syndrome type of FD (FD-PDS). Read More

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The effect of rikkunshito on gastrointestinal symptoms and gastric motor function: The first study in a Belgian functional dyspepsia population.

Neurogastroenterol Motil 2020 02 14;32(2):e13739. Epub 2019 Oct 14.

Translational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.

Background: Rikkunshito, a traditional Kampo medicine, has shown efficacy to treat functional dyspepsia (FD) in controlled trials in Japan. Its putative benefit for European patients and mechanism of action has not been established.

Methods: This study examined the effect of rikkunshito on gastric motility and GI symptom perception in FD-PDS patients in a randomized, placebo-controlled, cross-over study. Read More

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February 2020

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

Neurogastroenterol Motil 2018 06 8;30(6):e13284. Epub 2018 Jan 8.

Zeria Shinyaku Kogyo Kabushiki Kaisha, Chuo-ku, Tokyo, Japan.

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. Read More

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Rational and precise development of amorphous polymeric systems with dapsone by response surface methodology.

Int J Biol Macromol 2015 Nov 24;81:662-71. Epub 2015 Aug 24.

UCIBIO, REQUIMTE, Departamento de Ciências Químicas, Faculdade de Farmácia, Universidade do Porto, Porto, Portugal. Electronic address:

This work aimed to design dapsone (DAP) amorphous Polymeric Dispersions (PD) using design of experiments (DoE) and response surface methodology (RSM) as optimization tools in order to tailor the biopharmaceutical properties toward its oral delivery. A two-factor, three-level (3(2)) statistical design was implemented to study the influence of input variables (amount of PVP K30 and Pluronic F68) on the equilibrium solubility of DAP of the physical mixture (PM), kneaded (KN) and freeze dried (FD) PDs. Through the analysis, it was found that equilibrium solubility of DAP was improved with increasing of PVP K30, mainly for FD PDs, but decreased with increasing Pluronic F68 concentration. Read More

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November 2015

Functional dyspepsia: outcome of focus groups for the development of a questionnaire for symptom assessment in patients suffering from postprandial distress syndrome (PDS).

Neurogastroenterol Motil 2014 Sep 29;26(9):1266-74. Epub 2014 Jul 29.

KU Leuven, TARGID, Leuven, Belgium.

Background: To date, no patient reported outcomes (PRO) instrument is available for evaluation of treatment efficacy in functional dyspepsia (FD)/postprandial distress syndrome (PDS). The aim of our study was to perform focus group interviews for the development of a new questionnaire for assessing symptom pattern and severity in PDS.

Methods: Random ambulatory patients diagnosed with FD/PDS based on Rome III criteria and no predominant gastro-esophageal reflux disease (GERD) symptoms were invited to participate. Read More

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September 2014
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