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The Scientific World Journal
Volume 2014, Article ID 541950, 9 pages
http://dx.doi.org/10.1155/2014/541950
Review Article

Efficacy and Safety of Acotiamide for the Treatment of Functional Dyspepsia: Systematic Review and Meta-Analysis

1Department of Pediatrics, West China Second Hospital, Sichuan University, No. 20, Section 3, Renmin Nanlu, Chengdu, Sichuan 610041, China
2Department of Pediatrics, The Medical Center of Dujiangyan, Chengdu 611830, China
3Department of Pediatrics, Sichuan Academy of Medical Science and Sichuan Provincial People’s Hospital, Chengdu 610072, China

Received 10 May 2014; Accepted 15 July 2014; Published 12 August 2014

Academic Editor: Giovanni Sarnelli

Copyright © 2014 Guoguang Xiao et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. J. Tack, N. J. Talley, M. Camilleri et al., “Functional gastroduodenal disorders,” Gastroenterology, vol. 130, no. 5, pp. 1466–1479, 2006. View at Publisher · View at Google Scholar · View at Scopus
  2. R. A. Brook, N. L. Kleinman, R. S. Choung, A. K. Melkonian, J. E. Smeeding, and N. J. Talley, “Functional dyspepsia impacts absenteeism and direct and indirect costs,” Clinical Gastroenterology and Hepatology, vol. 8, no. 6, pp. 498–503, 2010. View at Publisher · View at Google Scholar · View at Scopus
  3. J. Tack, P. Caenepeel, B. Fischler, H. Piessevaux, and J. Janssens, “Symptoms associated with hypersensitivity to gastric distention in functional dyspepsia,” Gastroenterology, vol. 121, no. 3, pp. 526–535, 2001. View at Google Scholar · View at Scopus
  4. S. Kindt and J. Tack, “Impaired gastric accommodation and its role in dyspepsia,” Gut, vol. 55, no. 12, pp. 1685–1691, 2006. View at Publisher · View at Google Scholar · View at Scopus
  5. J. Tack, H. Piessevaux, B. Coulie, P. Caenepeel, and J. Janssens, “Role of impaired gastric accommodation to a meal in functional dyspepsia,” Gastroenterology, vol. 115, no. 6, pp. 1346–1352, 1998. View at Publisher · View at Google Scholar · View at Scopus
  6. G. Sarnelli, P. Caenepeel, B. Geypens, J. Janssens, and J. Tack, “Symptoms associated with impaired gastric emptying of solids and liquids in functional dyspepsia,” The American Journal of Gastroenterology, vol. 98, no. 4, pp. 783–788, 2003. View at Publisher · View at Google Scholar · View at Scopus
  7. V. Stanghellini, C. Tosetti, A. Paternico et al., “Risk indicators of delayed gastric emptying of solids in patients with functional dyspepsia,” Gastroenterology, vol. 110, no. 4, pp. 1036–1042, 1996. View at Publisher · View at Google Scholar · View at Scopus
  8. J. Tack, “Prokinetics and fundic relaxants in upper functional GI disorders,” Current Opinion in Pharmacology, vol. 8, no. 6, pp. 690–696, 2008. View at Publisher · View at Google Scholar · View at Scopus
  9. J. Tack, T. Masaoka, and P. Janssen, “Functional dyspepsia,” Current Opinion in Gastroenterology, vol. 27, no. 6, pp. 549–557, 2011. View at Publisher · View at Google Scholar · View at Scopus
  10. J. Tack and P. Janssen, “Acotiamide (Z-338, YM443), a new drug for the treatment of functional dyspepsia,” Expert Opinion on Investigational Drugs, vol. 20, no. 5, pp. 701–712, 2011. View at Publisher · View at Google Scholar · View at Scopus
  11. H. Kusunoki, K. Haruma, N. Manabe et al., “Therapeutic efficacy of acotiamide in patients with functional dyspepsia based on enhanced postprandial gastric accommodation and emptying: randomized controlled study evaluation by real-time ultrasonography,” Neurogastroenterology and Motility, vol. 24, no. 6, pp. 540–545, e250–e251, 2012. View at Publisher · View at Google Scholar · View at Scopus
  12. K. Seto, T. Sasaki, K. Katsunuma, N. Kobayashi, K. Tanaka, and J. Tack, “Acotiamide hydrochloride (Z-338), a novel prokinetic agent, restores delayed gastric emptying and feeding inhibition induced by restraint stress in rats,” Neurogastroenterology and Motility, vol. 20, no. 9, pp. 1051–1059, 2008. View at Publisher · View at Google Scholar · View at Scopus
  13. Y. Matsunaga, T. Tanaka, K. Yoshinaga et al., “Acotiamide hydrochloride (Z-338), a new selective acetylcholinesterase inhibitor, enhances gastric motility without prolonging QT interval in dogs: comparison with cisapride, itopride, and mosapride,” Journal of Pharmacology and Experimental Therapeutics, vol. 336, no. 3, pp. 791–800, 2011. View at Publisher · View at Google Scholar · View at Scopus
  14. K. Nagahama, Y. Matsunaga, M. Kawachi et al., “Acotiamide, a new orally active acetylcholinesterase inhibitor, stimulates gastrointestinal motor activity in conscious dogs,” Neurogastroenterology and Motility, vol. 24, no. 6, pp. 566–e256, 2012. View at Publisher · View at Google Scholar · View at Scopus
  15. B. Adam, T. Liebregts, N. B. Zschau et al., “T1266 Z-338 improves meal-induced symptoms in functional dyspepsia: a double-blind, randomized, placebo controlled crossover study,” Gastroenterology, vol. 136, no. 5, supplement 1, p. A-535, 2009. View at Publisher · View at Google Scholar
  16. K. Matsueda, M. Hongo, J. Tack, H. Aoki, Y. Saito, and H. Kato, “Clinical trial: dose-dependent therapeutic efficacy of acotiamide hydrochloride (Z-338) in patients with functional dyspepsia 100 mg t.i.d. is an optimal dosage,” Neurogastroenterology and Motility, vol. 22, no. 6, pp. 618–e173, 2010. View at Publisher · View at Google Scholar · View at Scopus
  17. J. Tack, A. Masclee, R. Heading et al., “A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia,” Neurogastroenterology and Motility, vol. 21, no. 3, pp. 272–280, 2009. View at Publisher · View at Google Scholar · View at Scopus
  18. N. Talley, J. Tack, D. Kowalski, M. Borton, and A. Barve, “A novel acetylcholine esterase inhibitor acotiamide hydrochloride (YM443) in functional dyspepsia: efficacy in a randomized, double-blind, placebo-controlled dose ranging trial,” Gastroenterology, vol. 134, supplement 1, pp. A157–A158, 2008. View at Google Scholar
  19. A. R. Jadad, R. A. Moore, D. Carroll et al., “Assessing the quality of reports of randomized clinical trials: is blinding necessary?” Controlled Clinical Trials, vol. 17, no. 1, pp. 1–12, 1996. View at Publisher · View at Google Scholar · View at Scopus
  20. B. K. Enestvedt, C. Tofani, L. A. Laine, A. Tierney, and M. B. Fennerty, “4-Liter split-dose polyethylene glycol is superior to other bowel preparations, based on systematic review and meta-analysis,” Clinical Gastroenterology and Hepatology, vol. 10, no. 11, pp. 1225–1231, 2012. View at Publisher · View at Google Scholar · View at Scopus
  21. J. P. T. Higgins and S. G. Thompson, “Quantifying heterogeneity in a meta-analysis,” Statistics in Medicine, vol. 21, no. 11, pp. 1539–1558, 2002. View at Publisher · View at Google Scholar · View at Scopus
  22. J. P. Higgins, S. G. Thompson, J. J. Deeks, and D. G. Altman, “Measuring inconsistency in meta-analyses,” British Medical Journal, vol. 327, no. 7414, pp. 557–560, 2003. View at Publisher · View at Google Scholar · View at Scopus
  23. M. Egger, G. D. Smith, M. Schneider, and C. Minder, “Bias in meta-analysis detected by a simple, graphical test,” British Medical Journal, vol. 315, no. 7109, pp. 629–634, 1997. View at Publisher · View at Google Scholar · View at Scopus
  24. K. Matsueda, M. Hongo, D. Sasaki et al., “Therapeutic efficacy of novel agent (Z-338) in functional dyspepsia (FD),” Gastroenterology, vol. 128, supplement 2, article A467, 2005. View at Google Scholar
  25. K. Matsueda, M. Hongo, J. Tack, Y. Saito, and H. Kato, “A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia,” Gut, vol. 61, no. 6, pp. 821–828, 2012. View at Publisher · View at Google Scholar · View at Scopus
  26. M. Camilleri, A. W. Mangel, S. E. Fehnel, D. A. Drossman, E. A. Mayer, and N. J. Talley, “Primary endpoints for irritable bowel syndrome trials: a review of performance of endpoints,” Clinical Gastroenterology and Hepatology, vol. 5, no. 5, pp. 534–540, 2007. View at Publisher · View at Google Scholar · View at Scopus
  27. A. L. Blum, N. J. Talley, C. O'Morain et al., “Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia. Omeprazole plus Clarithromycin and Amoxicillin Effect One Year after Treatment (OCAY) Study Group,” The New England Journal of Medicine, vol. 339, no. 26, pp. 1875–1881, 1998. View at Google Scholar
  28. J. Tack, T. Delia, G. Ligozio, S. Sue, M. Lefkowitz, and L. Vandeplassche, “A phase II placebo controlled randomized trial with tegaserod in functional dyspepsia patients with normal gastoric emptying,” Gastroenterology, vol. 122, supplement 4, article A154, 2002. View at Google Scholar
  29. S. V. Van Zanten, D. Armstrong, N. Chiba et al., “Esomeprazole 40 mg once a day in patients with functional dyspepsia: the randomized, placebo-controlled “ENTER” trial,” The American Journal of Gastroenterology, vol. 101, no. 9, pp. 2096–2106, 2006. View at Publisher · View at Google Scholar · View at Scopus
  30. N. Vakil, L. Laine, N. J. Talley et al., “Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials,” American Journal of Gastroenterology, vol. 103, no. 8, pp. 1906–1919, 2008. View at Publisher · View at Google Scholar · View at Scopus
  31. R. Cuomo, G. Sarnelli, R. Grasso et al., “Functional dyspepsia symptoms, gastric emptying and satiety provocative test: analysis of relationships,” Scandinavian Journal of Gastroenterology, vol. 36, no. 10, pp. 1030–1036, 2001. View at Publisher · View at Google Scholar · View at Scopus
  32. M. Simrén, R. Vos, J. Janssens, and J. Tack, “Unsuppressed postprandial phasic contractility in the proximal stomach in functional dyspepsia: relevance to symptoms,” The American Journal of Gastroenterology, vol. 98, no. 10, pp. 2169–2175, 2003. View at Publisher · View at Google Scholar · View at Scopus
  33. E. Altan, T. Masaoka, R. Farré, and J. Tack, “Acotiamide, a novel gastroprokinetic for the treatment of patients with functional dyspepsia: Postprandial distress syndrome,” Expert Review of Gastroenterology and Hepatology, vol. 6, no. 5, pp. 533–544, 2012. View at Publisher · View at Google Scholar · View at Scopus
  34. K. Matsueda, M. Hongo, S. Ushijima, and H. Akiho, “A Long-term study of acotiamide in patients with functional dyspepsia: results from an open-label phase III trial in Japan on efficacy, safety and pattern of administration,” Digestion, vol. 84, no. 4, pp. 261–268, 2011. View at Publisher · View at Google Scholar · View at Scopus
  35. M. Corsetti and J. Tack, “FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome?” Neurogastroenterology and Motility, vol. 25, no. 6, pp. 453–457, 2013. View at Publisher · View at Google Scholar · View at Scopus