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

Volumn 84, Issue 4, 2011, Pages 261-268

  Matsueda, K ^a   Hongo, M ^b   Ushijima, S ^c   Akiho, H ^c  

^a Sakura Life Clinic   (Japan)

^b TOHOKU UNIVERSITY   (Japan)

^c ASTELLAS PHARMA INC   (Japan)

Author keywords

Acetylcholinesterase inhibitor; Acotiamide; Functional dyspepsia; Prokinetic agent; Rome III; Z 338

Indexed keywords

ACOTIAMIDE;

ADULT; AGED; ARTICLE; BILIRUBIN BLOOD LEVEL; BLOATING; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG ELIMINATION; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; FUNCTIONAL DYSPEPSIA; HUMAN; JAPAN; LEUKOCYTE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; REMISSION; RHINOPHARYNGITIS; SATIETY; SIDE EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; TRIACYLGLYCEROL BLOOD LEVEL;

ABDOMINAL PAIN; ADULT; BENZAMIDES; DYSPEPSIA; FEMALE; HUMANS; MALE; MIDDLE AGED; MUSCARINIC AGONISTS; POSTPRANDIAL PERIOD; SATIATION; SENSATION; THIAZOLES; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84055200125     PISSN: 00122823     EISSN: 14219867     Source Type: Journal    
DOI: 10.1159/000332404     Document Type: Article

References (32)

1. Drossman DA, Corazziari E, Delvaux M, Spiller RC, Talley NJ, Thompson WG, Whitehead WE (eds): Rome III: The Functional Gastrointestinal Disorders, ed 3. McLean, Degnon Associates Inc., 2006.
2. Stanghellini V: Three-month prevalence rates of gastrointestinal symptoms and the influence of demographic factors: Results from the Domestic/ International Gastroenterology Surveillance Study (DIGEST). Scand J Gastroenterol 1999; 231: 20-28. (Pubitemid 29510674)
3. Kawamura A, Adachi K, Takashima T, Murao M, Katsube T, Yuki M, Watanabe M, Kinoshita Y: Prevalence of functional dyspepsia and its relationship with Helicobacter pylori infection in a Japanese population. J Gastroenterol Hepatol 2001; 16: 384-388. (Pubitemid 32397649)
4. Talley NJ, McNeil D, Hayden A, Colreavy C, Piper DW: Prognosis of chronic unexplained dyspepsia. A prospective study of potential predictor variables in patients with endoscopically diagnosed nonulcer dyspepsia. Gastroenterology 1987; 92: 1060-1066. (Pubitemid 17046326)
5. Brook RA, Kleinman NL, Choung RS, Melkonian AK, Smeeding JE, Talley NJ: Functional dyspepsia impacts absenteeism and direct and indirect costs. Clin Gastroenterol Hepatol 2010; 8: 498-503.
6. Talley NJ, Vakil NB, Moayyedi P: American Gastroenterological Association technical review on the evaluation of dyspepsia. Gastroenterology 2005; 129: 1756-1780. (Pubitemid 41597412)
7. Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V: Functional gastroduodenal disorders. Gastroenterology 2006; 130: 1466-1479.
8. Tack J, Piessevaux H, Coulie B, Caenepeel P, Janssens J: Role of impaired gastric accommodation to a meal in functional dyspepsia. Gastroenterology 1998; 115: 1346-1352. (Pubitemid 28545984)
9. Ogishima M, Kaibara M, Ueki S, Kurimoto T, Taniyama K: Z-338 facilitates acetylcholine release from enteric neurons due to blockade of muscarinic autoreceptors in guinea pig stomach. J Pharmacol Exp Ther 2000; 294: 33-37. (Pubitemid 30434667)
10. Nakajima T, Nawata H, Ito Y: Z-338 a newly synthesized carboxyamide derivative, stimulates gastric motility through enhancing the excitatory neurotransmission. J Smooth Muscle Res 2000; 36: 69-81.
11. Seto K, Sasaki T, Katsunuma K, Kobayashi N, Tanaka K, Tack J: Acotiamide hydrochloride (Z-338), a novel prokinetic agent, restores delayed gastric emptying and feeding inhibition induced by restraint stress in rats. Neurogastroenterol Motil 2008; 20: 1051-1059.
12. Matsueda K, Hongo M, Tack J, Aoki H, Saito Y, Kato H: 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. Neurogastroenterol Motil 2010; 22: 618-627.
13. Tack J, Masclee A, Heading R, Berstad A, Piessevaux H, Popiela T, Vandenberghe A, Kato H: A dose-ranging, placebo-controlled, pilot trial of acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil 2009; 21: 272-280.
14. Talley N, Tack J, Kowalski D, Borton M, Barve A: A novel acetylcholine esterase inhibitor acotiamide hydrochloride (YM443) in functional dyspepsia: Efficacy in a randomized, double-blind, placebo-controlled dose ranging trial. Gastroenterology 2008; 134:A157.
15. Tack J, Talley N, Kowalski D, Bortin M, Barve A: Influence of PPI run-in, pH monitoring and nutrient tolerance on efficacy outcomes of acotiamide hydrochloride (YM443), a novel acetylcholine esterase inhibitor, in functional dyspepsia. Gastroenterology 2008; 134:A143.16.
16. Veldhuyzen van Zanten SJ, Jones MJ, Verlinden M, Talley NJ: Efficacy of cisapride and domperidone in functional (nonulcer) dyspepsia: A meta-analysis. Am J Gastroenterol 2001; 96: 689-696. (Pubitemid 32240716)
17. Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, Peterson TC, Nyren O, Bradley LA, Verlinden M, Tytgat GN: Drug treatment of functional dyspepsia: A systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol 1996; 91: 660-673. (Pubitemid 26117940)
18. Blum AL, Talley NJ, O'Morain C, Van Zanten SV, Labenz J, Stolte M, Louw JA, Stubberod A, Theodors A, Sundin M, Bollingsternevald E, Junghard O: 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. N Engl J Med 1998; 339: 1875-1881.
19. Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, Barkun A, Thomson A, Smyth S, Escobedo S, Lee J, Sinclair P: A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in Helicobacter pylori negative, primary care patients with dyspepsia: The CADET-HN study. Am J Gastroenterol 2005; 100: 1477-1488. (Pubitemid 41032350)
20. Chiba N, Van Zanten SJ, Sinclair P, Ferguson RA, Escobedo S, Grace E: Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: The Canadian Adult Dyspepsia Empiric Treatment- Helicobacter pylori Positive (CADET-HP) randomised controlled trial. BMJ 2002; 324: 1012-1016. (Pubitemid 34457514)
21. Armstrong D, Veldhuyzen van Zanten SJ, Barkun A, Chiba N, Thomson AB, Smyth S, Sinclair P, Chakraborty B, White RJ, CADET- HR Study Group. Heartburn-dominant, uninvestigated dyspepsia: A comparison of 'PPI-Start' and 'H2-RA-Start' management strategies in primary care. The CADET-HR Study. Aliment Pharmacol Ther 2005; 21: 1189-1202. (Pubitemid 40733484)
22. Van Zanten SV, Armstrong D, Chiba N, Flook N, White RJ, Chakraborty B, Gasco A: Esomeprazole 40 mg once a day in patients with functional dyspepsia: The randomized, placebo-controlled 'ENTER' trial. Am J Gastroenterol 2006; 101: 2096-2106. (Pubitemid 44337636)
23. Guyatt GH, Townsend M, Berman LB, Keller JL: A comparison of Likert and visual analogue scales for measuring change in function. J Chronic Dis 1987; 40: 1129-1133. (Pubitemid 17158144)
24. Jaeschke R, Singer J, Guyatt GH: Measurement of health status: Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407-415. (Pubitemid 20025670)
25. Fass R, Tougas G: Functional heartburn: The stimulus, the pain, and the brain. Gut 2002; 51: 885-892. (Pubitemid 35408615)
26. Talley NJ, Vakil N: Guideline for the management of dyspepsia. Am J Gastroenterol 2005; 100: 2324-2337.
27. Hallerback BI, Bommelaer G, Bredberg E, Campbell M, Hellblom M, Lauritsen K, Wienbeck M, Holmgren LL: Dose finding study of mosapride in functional dyspepsia: A placebo-controlled, randomized study. Aliment Pharmacol Ther 2002; 16: 959-967. (Pubitemid 34461766)
28. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C: A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med 2006; 354: 832-840. (Pubitemid 43290921)
29. Talley NJ, Tack J, Ptak T, Gupta R, Giguere M: Itopride in functional dyspepsia: Results of two phase III multicentre, randomised, double-blind, placebo-controlled trials. Gut 2008; 57: 740-746. (Pubitemid 351716964)
30. Tack J, Delia T, Ligozio G, et al: A phase II placebo controlled randomized trial with tegaserod in functional dyspepsia patients with normal gastric emptying. Gastroenterology 2002; 122(suppl 1):154.
31. Vakil N, Laine L, Talley NJ, Zakko SF, Tack J, Chey WD, Kralstein J, Earnest DL, Ligozio G, Cohard-Radice M: Tegaserod treatment for dysmotility-like functional dyspepsia: Results of two randomized, controlled trials. Am J Gastroenterol 2008; 103: 1906-1919.
32. Halder SL, Talley NJ: Functional dyspepsia: A new Rome III paradigm. Curr Treat Options Gastroenterol 2007; 10: 259-272. (Pubitemid 47193510)