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Hiroyuki Kuroda, Toshiko Kinomoto, Shuji Ogawa, Mayumi Kawabe, Mayuko Suguro, Hitoshi Naraoka, Kazuhiko Takamatsu, Yuji Oishi
Although acotiamide hydrochloride hydrate (acotiamide-HH) has not been reported to have genotoxic findings in any of the genotoxicity studies or treatment-related toxicological findings in reproductive and developmental studies, suspicious uterine tumorigenesis was observed in the results of a long-term rat carcinogenicity study. To clarify the uterine tumorigenesis of acotiamide-HH, we performed a 2-stage uterine carcinogenicity model in the transgenic rasH2 mouse initiated by N-Ethyl-N-nitrosourea (ENU). This model facilitated the short-term detection of uterine carcinogenic potential, and it appears to be a very useful testing method for assessing the safety of chemicals that may affect uterine tumorigenesis...
January 2018: Journal of Toxicologic Pathology
Hiroshi Yamawaki, Seiji Futagami, Mako Wakabayashi, Noriko Sakasegawa, Shuhei Agawa, Kazutoshi Higuchi, Yasuhiro Kodaka, Katsuhiko Iwakiri
Patients with functional dyspepsia, defined in the 2016 Rome IV criteria as bothersome clinical dyspepsia symptoms, experience markedly reduced quality of life. Several etiologies have been associated with the disorder. In the Rome IV criteria, the brain-gut axis was acknowledged as an important factor in the etiology of functional gastrointestinal (GI) disorders. The distinct subgroups of functional dyspepsia, epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS), are treated differently: acid secretion inhibitors are recommended with patients with EPS, whereas prokinetic drugs as mosapride and acotiamide are recommended for patients with PDS...
January 2018: Therapeutic Advances in Chronic Disease
J Tack, J Pokrotnieks, G Urbonas, C Banciu, V Yakusevich, I Bunganic, H Törnblom, Y Kleban, P Eavis, M Tsuchikawa, T Miyagawa
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...
January 8, 2018: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
Atsushi Miki, Takatsugu Yamamoto, Kyohei Maruyama, Naohiro Nakamura, Hitoshi Aoyagi, Akari Isono, Koichiro Abe, Hiroto Kita
BACKGROUND: Acotiamide is known as an effective agent for functional dyspepsia. However, clinical factors related to its effectiveness have not been fully elucidated, so it is difficult to predict the drug's effectiveness prior to its administration in patients. AIMS: The present retrospective study was conducted to examine the relationship between clinical factors and the effectiveness of acotiamide for functional dyspepsia. MATERIALS AND METHODS: The study subjects were 149 patients with functional dyspepsia who were prescribed acotiamide...
October 26, 2017: International Journal of Clinical Pharmacology and Therapeutics
Toshihisa Takeuchi, Yoshiaki Takahashi, Shinpei Kawaguchi, Kazuhiro Ota, Satoshi Harada, Yuichi Kojima, Hiroki Sakamoto, Takanori Kuramoto, Keishi Kojima, Makoto Sanomura, Masahiro Hoshimoto, Takeshi Higashino, Tsukasa Itabashi, Ko Takada, Masahiro Sakaguchi, Kazunari Tominaga, Motoyasu Kusano, Kazuhide Higuchi
BACKGROUND AND AIM: Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) often coexist or overlap. In this study, the efficacy of acotiamide in combination with a standard dose of rabeprazole for GERD and FD was compared with that of a double dose of rabeprazole. METHODS: Patients with overlap between GERD and FD experiencing heartburn and epigastric fullness symptoms after standard-dose proton pump inhibitor (PPI) for ≥ 8 weeks were randomized into two groups and received either acotiamide 300 mg/day + rabeprazole 10 mg/day or rabeprazole 20 mg/day for 4 weeks...
March 2018: Journal of Gastroenterology and Hepatology
Koichi Sugimoto, Takahiro Akiyama, Nobutaka Shimizu, Naoki Matsumura, Mamoru Hashimoto, Takafumi Minami, Kazuhiro Nose, Masahiro Nozawa, Kazuhiro Yoshimura, Hirotsugu Uemura
Acute urinary retention is the most common urological emergency. To resolve this emergency, urethral catheterization is performed. If the procedure fails and permanent transurethral catheterization is required, the patient's quality of life is significantly affected. Therefore, catheter-free treatment is the ideal goal of therapy for patients with acute urinary retention. Especially, for women, placement of a catheter poses a cosmetic problem. Therefore, the aim of this study was to treat female patients who had already received urapidil/distigmine bromide with acotiamide...
2017: Research and Reports in Urology
Mohit Thummar, Prinesh N Patel, Gananadhamu Samanthula, Srinivas Ragampeta
RATIONALE: The presence of impurities and degradation products will affect the pharmacokinetic, pharmacodynamic properties and alter the safety of a drug. Hence, the development of a stability-indicating assay method is an integral part of quality product development and is crucial for the regulatory approval of drug products. METHODS: Acotiamide was subjected to stress degradation under hydrolytic, oxidative, photo and thermal stress conditions. The resulted degradation products (DPs), as well as a process-related impurity (IMP), were selectively separated from the drug on a Waters Acquity HSS cyano column (100 × 2...
November 15, 2017: Rapid Communications in Mass Spectrometry: RCM
Jan Tack, Florencia Carbone
PURPOSE OF REVIEW: This review summarizes recent progress in the epidemiology, pathophysiology and treatment of functional dyspepsia and gastroparesis. RECENT FINDINGS: The definition of functional dyspepsia and its subgroups has been revised in the recent Rome IV consensus. In gastroparesis, the symptom pattern and its similarities and differences from functional dyspepsia have been a focus of recent research. In functional dyspepsia, pathophysiological research continued to evaluate gastric sensorimotor dysfunctions, but low-grade inflammatory changes and loss of mucosal integrity in the duodenum is a new topic of intense research...
November 2017: Current Opinion in Gastroenterology
Hidekazu Suzuki
The Rome criteria were amended as Rome IV. For functional esophageal disorders, the exclusion criteria have been more specifically revised based on further understanding of other esophageal disorders, including eosinophilic esophagitis and spastic and hypercontractile motor disorders. Another revised point is the more restrictive definition of gastroesophageal reflux disease, indicating that sensitivity to a physiological reflux burden may be placed more firmly within the functional group. For functional dyspepsia (FD), only minor changes were introduced, mainly to improve specificity...
July 30, 2017: Journal of Neurogastroenterology and Motility
Young Joo Yang, Chang Seok Bang, Gwang Ho Baik, Tae Young Park, Suk Pyo Shin, Ki Tae Suk, Dong Joon Kim
BACKGROUND: Controversies persist regarding the effect of prokinetics for the treatment of functional dyspepsia (FD). This study aimed to assess the comparative efficacy of prokinetic agents for the treatment of FD. METHODS: Randomized controlled trials (RCTs) of prokinetics for the treatment of FD were identified from core databases. Symptom response rates were extracted and analyzed using odds ratios (ORs). A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method in WinBUGS and NetMetaXL...
June 26, 2017: BMC Gastroenterology
Mariko Hojo, Akihito Nagahara, Daisuke Asaoka, Tsutomu Takeda, Kentaro Izumi, Kohei Matsumoto, Hiroya Ueyama, Yuji Shimada, Kenshi Matsumoto, Shuko Nojiri, Sumio Watanabe
BACKGROUND/AIMS: Acotiamide, a prokinetic drug, is used to treat functional dyspepsia (FD), especially postprandial distress syndrome (PDS). However, a treatment for FD patients with PDS and/or epigastric pain syndrome (EPS) has not been established. We investigated the efficacy of famotidine in combination with acotiamide for FD. METHODS: Fifty blindly randomized FD patients received placebo with acotiamide, or famotidine with acotiamide, for 4 weeks. Treatment efficacy was assessed by overall treatment effects (OTE), total, PDS and EPS symptom scores, and impairment of quality of life (QOL)...
2017: Digestion
Eikichi Ihara, Kazumasa Muta, Keita Fukaura, Kazuhiko Nakamura
BACKGROUND: Based on Chicago Classification version 3.0, the disorders of esophagogastric junction outflow obstruction (EGJOO) include achalasia (types I, II and III) and EGJOO. Although no curative treatments are currently available for the treatment of the disorders of EGJOO, medical treatments, endoscopic pneumatic dilation (PD), laparoscopic Heller myotomy (LHM), and per-oral endoscopic myotomy (POEM) are usually the sought-after modes of treatment. Since the etiology and pathogenesis might vary depending on the types of EGJOO disorders, treatment strategies should be considered based on those subtypes...
2017: Digestion
Prinesh N Patel, Pradipbhai D Kalariya, Mohit Thummar, S Gananadhamu, R Srinivas
Acotiamide hydrochloride (ACT) is a drug used for the treatment of functional dyspepsia. Understanding which metabolites are likely to be formed in vivo is essential for interpreting pharmacology, pharmacokinetic and toxicology data. The metabolism of ACT has been investigated using a specific and sensitive liquid chromatography positive ion electrospray ionization high-resolution tandem mass spectrometry method. In vivo samples including rat plasma, urine and feces were collected separately after dosing healthy Sprague-Dawley rats at a dose of 20 mg kg (-1) ACT at different time points up to 24 h...
July 2017: Biomedical Chromatography: BMC
Fermín Mearin, Enrique Rey, Agustín Balboa
This article discusses the most interesting presentations at Digestive Disease Week, held in San Diego, in the field of functional and motor gastrointestinal disorders. One of the most important contributions was undoubtedly the presentation of the new Rome IV diagnostic criteria for functional gastrointestinal disorders. We therefore devote some space in this article to explaining these new criteria in the most common functional disorders. In fact, there has already been discussion of data comparing Rome IV and Rome III criteria in the diagnosis of irritable bowel syndrome, confirming that the new criteria are somewhat more restrictive...
September 2016: Gastroenterología y Hepatología
K Ikeo, T Oshima, H Sei, T Kondo, H Fukui, J Watari, H Miwa
BACKGROUND: Gastric accommodation is a reflex reaction related to gastric reservoir function. Psychological stress, such as anxiety, inhibits gastric accommodation in humans. Acotiamide enhances the effect of acetylcholine in the enteric nervous system, enhances gastric contractility, and accelerates delayed gastric emptying. However, the effect of acotiamide on stress-induced impaired gastric accommodation remains unclear. Therefore, we examined the effect of acotiamide on gastric accommodation and stress-induced impaired gastric accommodation using a conscious guinea pig model...
November 14, 2016: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
Satoshi Shinozaki, Hiroyuki Osawa, Hirotsugu Sakamoto, Yoshikazu Hayashi, Alan Kawarai Lefor, Hironori Yamamoto
The effect of acotiamide on gastrointestinal symptoms is undefined. The aim of this study is to evaluate the effect of acotiamide on abdominal symptoms in patients with functional dyspepsia. We retrospectively reviewed 51 patients treated with acotiamide. We evaluated patient quality of life using the Izumo scale that detects changes in quality of life caused by abdominal symptoms. Acotiamide ameliorated the symptoms of functional dyspepsia at one and three months (improved: 61% vs 80%, p=0.029 and resolved: 17% vs 33%, p=0...
2016: Journal of Medical Investigation: JMI
Kumiko Nakamura, Toshihiko Tomita, Tadayuki Oshima, Haruki Asano, Takahisa Yamasaki, Takuya Okugawa, Takashi Kondo, Tomoaki Kono, Katsuyuki Tozawa, Yoshio Ohda, Hirokazu Fukui, Fukushima Kazuhito, Shozo Hirota, Jiro Watari, Hiroto Miwa
BACKGROUND: Acotiamide is widely used to improve symptoms in patients with functional dyspepsia (FD) in multiple large-scale clinical studies, but there are few reports about the drug's mechanism of action. The aim of this study was to assess the effects of acotiamide on gastric accommodation and gastric emptying, gastrointestinal symptoms, and health-related quality of life (HR-QOL) in a placebo-controlled study. METHODS: We conducted a randomized, double-blind placebo-controlled study...
May 2017: Journal of Gastroenterology
Kazumasa Muta, Eikichi Ihara, Keita Fukaura, Osamu Tsuchida, Toshiaki Ochiai, Kazuhiko Nakamura
BACKGROUND AND AIM: Acotiamide is a newly developed prokinetic drug that is clinically used to treat functional dyspepsia (FD). The objective of this study was to assess the therapeutic effects of acotiamide in patients with esophageal motility disorders (EMDs). METHODS: Twenty-nine patients with both symptoms of FD and symptoms suspicious of EMDs were enrolled. Esophageal motility function was evaluated by high-resolution manometry before and after 2 weeks administration of acotiamide (100 mg) 3 times per day...
2016: Digestion
Masahiro Ueda, Eisuke Iwasaki, Hidekazu Suzuki
Efficacy of acotiamide for improving symptoms in patients with functional dyspepsia was shown by several clinical trials. In a randomized, double-blind, placebo-controlled, parallel-group comparative Phase III trial conducted in Japan, 100 mg of acotiamide three times a day for 4 weeks was more effective than a placebo for improving symptoms, and quality of life. Acotiamide was well-tolerated treatment, with no significant adverse events. The aim of this review was to summarize the current evidence of the efficacy of acotiamide in the treatment of patients with functional dyspepsia...
2016: Clinical and Experimental Gastroenterology
Ryo Kato, Kiyokazu Nakajima, Tsuyoshi Takahashi, Yasuhiro Miyazaki, Tomoki Makino, Yukinori Kurokawa, Makoto Yamasaki, Shuji Takiguchi, Masaki Mori, Yuichiro Doki
The majority of systemic sclerosis (SSc) patients have gastrointestinal tract involvement, but therapies of prokinetic agents are usually unsatisfactory. Patients are often compromised by the use of steroid; therefore, a surgical indication including fundoplication has been controversial. There is no report that advanced SSc with severe gastroesophageal reflux disease (GERD) is successfully treated with acotiamide, which is the acetylcholinesterase (AChE) inhibitor designed for functional dyspepsia (FD). We report a 44-year-old woman of SSc with severe GERD successfully treated with acotiamide...
December 2016: Surgical Case Reports
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