A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia
- 1Sakura Life Clinic, Tokyo, Japan
- 2Department of Comprehensive Medicine, Tohoku University Hospital, Sendai, Japan
- 3Department of Gastroenterology, University of Leuven, Leuven, Belgium
- 4Zeria Pharmaceutical Co. Ltd, R&D, Tokyo, Japan
- Correspondence to Dr Kei Matsueda, Sakura Life Clinic, 1-14-7-2F, Kinshi, Sumida, Tokyo 130-0013 Japan;
Contributors KM, MH, JT and HK made substantial contribution to the intellectual content of the paper.
- Revised 9 November 2011
- Accepted 16 November 2011
- Published Online First 9 December 2011
Objective To determine the efficacy of acotiamide, an acetylcholinesterase inhibitor, in patients with functional dyspepsia (FD) in a 4-week trial
Methods A multicentre, randomised, placebo-controlled, parallel-group, phase III trial was carried out, in which patients with FD received 100 mg of acotiamide or placebo three times a day for 4 weeks, with 4 weeks post-treatment follow-up. The primary efficacy end points were global assessment of overall treatment efficacy (OTE) and elimination rate of all three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation), as derived from daily diaries. Secondary efficacy end points were individual symptom scores and quality of life. Adverse events were monitored.
Results 52.2% of those receiving acotiamide and 34.8% in the placebo group (p<0.001) were classified as responders according to a global assessment of OTE. Over 4 weeks, the elimination rate for all three meal-related symptoms was 15.3% among patients receiving acotiamide compared with 9.0% in the placebo group (p=0.004). The significant benefit of acotiamide over placebo in OTE and elimination rate was maintained during the 4 week post-treatment follow-up. All other secondary efficacy end points, including quality of life, were significantly improved with 100 mg of acotiamide as compared with placebo. The number needed to treat was 6 for OTE and 16 for symptom elimination rate. The incidence of adverse events was similar between the acotiamide group and placebo group and no significant cardiovascular effects due to treatment were seen.
Conclusions Over 4 weeks, acotiamide significantly improved symptom severity and eliminated meal-related symptoms in patients with FD.
- Gastro-oesophageal reflux disease
- enteric nervous system
- irritable bowel syndrome
- gastrointestinal motility
- visceral sensitivity
- gastric emptying
- gastroduodenal motility
- functional dyspepsia
- functional bowel disorder
- pancreatic cancer
- hepatobiliary cancer
Funding Financial support for this study was provided by Zeria Pharmaceutical Co, Ltd and Astellas Pharma Inc.
Competing interests KM has provided scientific advice to Astellas, Zeria, Ajinomoto, Abbott. MH has provided scientific advice to Astellas, Zeria, Takeda, Eisai, AstraZeneca, Sucampo. JT has provided scientific advice to Addex Pharma, Almirall, Aryx, AstraZeneca, Danone, Given, Ipsen, Menarini, Movetis, Norgine, Novartis, Nycomed, Ocera, Rose Pharma, SK Life Sciences, Smartpill, Sucampo, Theravance, Tranzyme, Xenoport and Zeria. YS and HK are employees of Zeria.
Ethics approval This study was conducted with the approval of the local institutional review boards and medical ethics committees in Japan.
Provenance and peer review Not commissioned; externally peer reviewed.
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