Emerging drugs for functional dyspepsia

Bibliography

• Tack J, Talley NJ, Camilleri M, Functional gastroduodenal disorders. Gastroenterology 2006;16(5):1466-79
   Google Scholar
• Brook RA, Kleinman NL, Choung RS, Functional dyspepsia impacts absenteeism and direct and indirect costs. Clin Gastroenterol Hepatol 2010;8(6):498-503
   PubMed Web of Science ®Google Scholar
• Shaib Y, El-Serag HB. The prevalence and risk factors of functional dyspepsia in a multiethnic population in the United States. Am J Gastroenterol 2004;99:2210-16
   PubMed Web of Science ®Google Scholar
• Camilleri M, Dubois D, Coulie B, Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: results of the US Upper Gastrointestinal Study. Clin Gastroenterol Hepatol 2005;3(6):543-52
   PubMed Web of Science ®Google Scholar
• Piessevaux H, de Winter B, Louis E, Dyspeptic symptoms in the general population: a factor and cluster analysis of symptom groupings. Neurogastroenterol Motil 2009;21(4):378-88
   PubMed Web of Science ®Google Scholar
• Tack J, Bisschops R, Sarnelli G. Pathophysiology and treatment of functional dyspepsia. Gastroenterology. 2004;127(4):1239-55
   PubMed Web of Science ®Google Scholar
• Lee KJ, Kindt S, Tack J. Pathophysiology of functional dyspepsia. Best Pract Res Clin Gastroenterol 2004;18:707-16
   PubMed Web of Science ®Google Scholar
• Ang D, Talley NJ, Simren M, A review of endpoints used in functional dyspepsia drug therapy trials. Aliment Pharmacol Ther 2010; In press
   Google Scholar
• US Food and Drug Administration (FDA). Guidance for Industry. Patient reported outcome measures: use in medical product development to support labeling claims. 2006
   Google Scholar
• Tack J, Talley NJ. Gastroduodenal disorders. Am J Gastroenterol 2010;105(4):757-63
   PubMed Web of Science ®Google Scholar
• von Arnim U, Peitz U, Vinson B, STW 5, a phytopharmacon for patients with functional dyspepsia: results of a multicenter, placebo-controlled double-blind study. Am J Gastroenterol 2007;102(6):1268-75
   PubMed Web of Science ®Google Scholar
• Tatsuta M, Iishi H. Effect of treatment with liu-jun-zi-tang (TJ-43) on gastric emptying and gastrointestinal symptoms in dyspeptic patients. Aliment Pharmacol Ther 1993;7(4):459-62
   PubMed Web of Science ®Google Scholar
• Suzuki H, Inadomi JM, Hibi T. Japanese herbal medicine in functional gastrointestinal disorders. Neurogastroenterol Motil 2009;21(7):688-96
   PubMed Web of Science ®Google Scholar
• Moayyedi P, Soo S, Deeks J, Eradication of helicobacter pylori for non-ulcer dyspepsia. Cochrane Database Syst Rev 2006;2:CD002096
   PubMedGoogle Scholar
• Moayyedi P, Delaney BC, Vakil N, The efficacy of proton pump inhibitors in nonulcer dyspepsia: a systematic review and economic analysis. Gastroenterology 2004;127(5):1329-37
   PubMed Web of Science ®Google Scholar
• Moayyedi P, Soo S, Deeks J, Pharmacological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev 2006;(4):CD001960
   Google Scholar
• Tack J. Prokinetics and fundic relaxants in upper functional GI disorders. Curr Opin Pharmacol 2008;8(6):690-6
   PubMed Web of Science ®Google Scholar
• Tack J, Piessevaux H, Coulie B, Role of impaired gastric accommodation to a meal in functional dyspepsia. Gastroenterology 1998;115(6):1346-52
   PubMed Web of Science ®Google Scholar
• Tack J, Caenepeel P, Fischler B, Hypersensitivity to gastric distention is associated with symptoms in functional dyspepsia. Gastroenterology 2001;121:526-35
   PubMed Web of Science ®Google Scholar
• Hojo M, Miwa H, Yokoyama T, Treatment of functional dyspepsia with antianxiety or antidepressive agents: systematic review. J Gastroenterol 2005;40(11):1036-42
   PubMed Web of Science ®Google Scholar
• Haag S, Senf W, Tagay S, Is there a benefit from intensified medical and psychological interventions in patients with functional dyspepsia not responding to conventional therapy? Aliment Pharmacol Ther 2007;25(8):973-86
   PubMed Web of Science ®Google Scholar
• Vakil N, Laine L, Talley NJ, Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials. Am J Gastroenterol 2008;103(8):1906-19
   PubMed Web of Science ®Google Scholar
• Chey WD, Howden CW, Tack J, Long-term tegaserod treatment for dysmotility-like functional dyspepsia: results of two identical 1-year cohort studies. Dig Dis Sci 2010;55:684-97
   PubMed Web of Science ®Google Scholar
• Pasricha PJ. Desperately seeking serotonin. A commentary on the withdrawal of tegaserod and the state of drug development for functional and motility disorders. Gastroenterology. 2007;132(7):2287-90
   PubMed Web of Science ®Google Scholar
• Tack J. Prucalopride: a new drug for the treatment of chronic constipation. Expert Rev Gastroenterol Hepatol 2009;3(4):337-43
   PubMedGoogle Scholar
• Bouras EP, Camilleri M, Burton DD, McKinzie S. Selective stimulation of colonic transit by the benzofuran 5HT4 agonist, prucalopride, in healthy humans. Gut 1999;44(5):682-6
   PubMed Web of Science ®Google Scholar
• Bouras EP, Camilleri M, Burton DD, Prucalopride accelerates gastrointestinal and colonic transit in patients with constipation without a rectal evacuation disorder. Gastroenterology 2001;120(2):354-60
   PubMed Web of Science ®Google Scholar
• Sanger GJ. Translating 5-HT receptor pharmacology. Neurogastroenterol Motil 2009;21(12):1235-8
   PubMed Web of Science ®Google Scholar
• Camilleri M, Vazquez-Roque MI, Burton D, Pharmacodynamic effects of a novel prokinetic 5-HT receptor agonist, ATI-7505, in humans. Neurogastroenterol Motil 2007;19(1):30-8
   PubMed Web of Science ®Google Scholar
• Palme M, Milner P, Ellis D, A novel gastrointestinal prokinetic, ATI-7505, increased spontaneous bowel movements in a phase II randomized placebo-controlled study of patients with chronic idiopathic constipation. Gastroenterology 2010;238:S128-9
   Google Scholar
• ATI-7505 product fact sheet. Available from: http://www.aryx.com/wt/page/ati7505
   Google Scholar
• Tack J, Camilleri M, Chang L, Systematic review of cardiovascular safety profile of 5-HT4 agonists developed for GI disorders. Submitted for publication 2010
   Google Scholar
• Hallerback BI, Bommelaer G, Bredberg E, Dose finding study of mosapride in functional dyspepsia: a placebo-controlled, randomized study. Aliment Pharmacol Ther 2002;16:959-67
   PubMed Web of Science ®Google Scholar
• Janssens J, Peeters TL, Vantrappen G, Improvement of gastric emptying in diabetic gastroparesis by erythromycin. Preliminary studies. N Engl J Med 1990;322:1028-31
   PubMed Web of Science ®Google Scholar
• Talley NJ, Verlinden M, Snape W, Failure of a motilin receptor agonist (ABT-229) to relieve the symptoms of functional dyspepsia in patients with and without delayed gastric emptying: a randomized double-blind placebo-controlled trial. Aliment Pharmacol Ther 2000;14(12):1653-61
   PubMed Web of Science ®Google Scholar
• McCallum RW, Cynshi O.; US investigative team. Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi-center, placebo-controlled trial. Aliment Pharmacol Ther 2007;26(1):107-16
   PubMed Web of Science ®Google Scholar
• Russo A, Stevens JE, Giles N, Effect of the motilin agonist KC 11458 on gastric emptying in diabetic gastroparesis. Aliment Pharmacol Ther 2004;20(3):333-8
   PubMed Web of Science ®Google Scholar
• Broad J, Leming S, Matthews KL, GSK962040: a small molecule motilin receptor agonist which increases gastrointestinal (GI) motility in dogs [abstract 293]. Neurogastroenterol Motility 2010;22(Suppl 1):84
   Google Scholar
• Broad J, Mukherjee S, Boundouki G, Different abilities of [Nle13]-motilin and the motilin receptor agonist GSK962040 to facilitate cholinergic and nitrergic activity in human isolated stomach [abstract 294]. Neurogastroenterol Motility 2010;22(Suppl 1):84
   Google Scholar
• Sanger GJ, Westaway SM, Barnes AA, GSK962040: a small molecule, selective motilin receptor agonist, effective as a stimulant of human and rabbit gastrointestinal motility. Neurogastroenterol Motil 2009;21(6):657-64, e30-1
   PubMedGoogle Scholar
• Dukes G, Barton M, Dewit O, Pharmacokinetics, safety/tolerability, and effect on gastric emptying of the oral motilin receptor agonist, GSK962040, in healthy male and female volunteers. Neurogastroenterolol Motil 2009;21(Suppl 1):84
   Google Scholar
• Hellstrom PM, Tack J, Barton ME, A double-blind, randomized placebo-controlled phase II study to evaluate the pharmacodynamics, safety, tolerability, and pharmacokinetics of single doses of the oral motilin receptor agonist GSK962040, in patients with type I diabetes mellitus (T1DM) and gastroparesis [abstract]. Gastroenterology 2011; In press
   Google Scholar
• Gale JD, Colman PJ, Kantaridis C, PF-04548043, a novel motilin receptor agonist, increases gastric emptying in healthy volunteers and does not undergo tachyphyllaxis [abstract]. Gastroenterology 2009;136:A45
   Web of Science ®Google Scholar
• Tack J, Depoortere I, Bisschops R, Influence of ghrelin on interdigestive gastrointestinal motility in man. Gut 2006;55:327-33
   PubMed Web of Science ®Google Scholar
• Tack J, Depoortere I, Bisschops R, Influence of ghrelin on gastric emptying and meal-related symptoms in idiopathic gastroparesis. Aliment Pharmacol Ther 2005;22:847-53
   PubMed Web of Science ®Google Scholar
• Ejskjaer N, Vestergaard ET, Hellstrom PM, Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis. Aliment Pharmacol Ther 2009;29(11):1179-87
   PubMed Web of Science ®Google Scholar
• Ejskjaer N, Dimcevski G, Wo J, Safety and efficacy of ghrelin agonist TZP-101 in relieving symptoms in patients with diabetic gastroparesis: a randomized, placebo-controlled study. Neurogastroenterol Motil 2010;22(10):1069-e281
   PubMed Web of Science ®Google Scholar
• Available from: http://www.tranzyme.com/press_releases/2010/20100629_tranzyme_pharma_announces_positive_results_from_phase_2_study.html
   Google Scholar
• Karamanolis G, Tack J. Promotility medications – now and in the future. Dig Dis 2006;24(3-4):297-307
   PubMed Web of Science ®Google Scholar
• Holtmann G, Talley NJ, Liebregts T, A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med 2006;354(8):832-40
   PubMed Web of Science ®Google Scholar
• Talley NJ, Tack J, Ptak T, Itopride in functional dyspepsia: results of two phase III multicenter, randomized, double-blind, placebo-controlled trials. Gut 2008;57(6):740-6
   PubMedGoogle Scholar
• Scarpellini E, Vos R, Blondeau K, The effects of itopride on oesophageal motility and lower oesophageal sphincter function in man. Aliment Pharmacol Ther 2011;33(1):99-105
   PubMed Web of Science ®Google Scholar
• Kim YS, Kim TH, Choi CS, Effect of itopride, a new prokinetic, in patients with mild GERD: a pilot study. World J Gastroenterol 2005;11(27):4210-14
   PubMed Web of Science ®Google Scholar
• Van Oudenhove L, Kindt S, Vos R, Influence of buspirone on gastric sensorimotor function in man. Aliment Pharmacol Ther 2008;28(11-12):1326-33
   PubMed Web of Science ®Google Scholar
• Miwa H, Nagahara A, Tominaga K, Efficacy of the 5-HT1A agonist tandospirone citrate in improving symptoms of patients with functional dyspepsia: a randomized controlled trial. Am J Gastroenterol 2009;104(11):2779-87
   PubMed Web of Science ®Google Scholar
• Boeckxstaens GE, Tytgat GN, Wajs E, The influence of the novel 5-HT1A agonist R137696 on the proximal stomach function in healthy volunteers. Neurogastroenterol Motil 2006;18(10):919-26
   PubMed Web of Science ®Google Scholar
• Tack J, van den Elzen B, Tytgat G, A placebo-controlled trial of the 5-HT agonist R-137696 on symptoms, visceral hypersensitivity and on impaired accommodation in functional dyspepsia. Neurogastroenterol Motil 2009;21(6):619-26, e23-4
   PubMedGoogle Scholar
• Thumshirn M, Camilleri M, Choi MG, Zinsmeister AR. Modulation of gastric sensory and motor functions by nitrergic and alpha2-adrenergic agents in humans. Gastroenterology 1999;116(3):573-85
   PubMed Web of Science ®Google Scholar
• Tack J, Caenepeel P, Corsetti M, Janssens J. Role of tension receptors in dyspeptic patients with hypersensitivity to gastric distention. Gastroenterology 2004;127:1058-66
   PubMed Web of Science ®Google Scholar
• Ogishima M, Kaibara M, Ueki S, Z-338 facilitates acetylcholine release from enteric neurons due to blockade of muscarinic autoreceptors in guinea pig stomach. J Pharmacol Exp Ther 2000;294:33-7
   PubMed Web of Science ®Google Scholar
• Nakajima T, Nawata H, Ito Y. Z-338, a newly synthetized carboxyamide derivative, stimulates gastric motility through enhancing the excitatory neurotransmission. J Smooth Muscle Res 2000;36:69-81
   PubMedGoogle Scholar
• Doi Y, Murasaki O, Kaibara M, Characterization of functional effect of Z-338, a novel gastroprokinetic agent, on the muscarinic M1, M2, and M3 receptors expressed in Xenopus oocytes. Eur J Pharmacol 2004;505:31-5
   PubMed Web of Science ®Google Scholar
• Matsunaga Y, Tanaka T, Yoshinaga K, Acotiamide hydrochloride (Z-338), a new selective acetylcholinesterase inhibitor, enhances gastric motility without prolonging QT interval in dogs: comparison with cisapride, itopride and mosapride. J Pharmacol Exp Ther 2010. [Epub ahead of print]
   Google Scholar
• Seto K, Sasaki T, Katsunuma K, Acotiamide hydrochloride (Z-338), a novel prokinetic agent, restores delayed gastric emptying and feeding inhibition induced by restraint stress in rats. Neurogastroenterol Motil 2008;20:1051-9
   PubMed Web of Science ®Google Scholar
• Adam B, Liebregts T, Zschau NB, Z-338 Improves meal-induced symptoms in functional dyspepsia: a double-blind, randomized, placebo controlled crossover study [abstract]. Gastroenterology 2009;136:A535
   Web of Science ®Google Scholar
• Tack J, Masclee A, Heading R, A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil 2009;21(3):272-80
   PubMed Web of Science ®Google Scholar
• Kusunoki H, Haruma K, Imamura H, Therapeutic efficacy of Z-338 (Acotiamide Hydrochloride) in patients with functional dyspepsia is based on enhanced post-prandial gastric accommodation and emptying: confirmed by real-time ultrasonography [abstract]. Gastroenterology 2010;138(5 Suppl 1):S154-5
   Google Scholar
• Suzuki H, Hibi T. Acotiamide (Z-338) as a possible candidate for the treatment of functional dyspepsia. Neurogastroentrol Motil 2010;22(6):595-9
   PubMed Web of Science ®Google Scholar
• Matsueda K, Hongo M, Sasaki D, Therapeutic efficacy of novel agent (Z-338) in functional dyspepsia. Gastroenterology 2005;128:A467
   Web of Science ®Google Scholar
• Talley NJ, Tack J, Kowalski D, A novel acetylcholine esterase inhibitor acotiamide hydrochloride (YM443) in functional dyspepsia: efficacy in a randomized, double-blind, placebo-controlled dose ranging trial [abstract]. Gastroenterology 2008;134:A-157
   Google Scholar
• Tack J, Talley NJ, Kowalski D, Influence of PPI run-in, pH monitoring and nutrient tolerance on efficacy outcomes of acotiamide hydrochloride (YM443), a novel acetylcholine esterase inhibitor, in functional dispepsia [abstract]. Gastroenterology 2008;134:A143
   Web of Science ®Google Scholar
• Matsueda K, Hongo M, Tack J, 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-e173
   PubMed Web of Science ®Google Scholar
• Available from: http://www.zeria.co.jp/english/pdf/press20090303.pdf
   Google Scholar
• Camilleri M, Coulie B, Tack J. Visceral hypersensitivity: Facts, speculations and challenges. Gut 2001;48:125-31
   PubMed Web of Science ®Google Scholar
• Read NW, Abitbol JL, Bardhan KD, Efficacy and safety of the peripheral kappa agonist fedotozine versus placebo in the treatment of functional dyspepsia. Gut 1997;41(5):664-8
   PubMed Web of Science ®Google Scholar
• Talley NJ, Choung RS, Camilleri M, Asimadoline, a kappa-opioid agonist, and satiation in functional dyspepsia. Aliment Pharmacol Ther 2008;27(11):1122-31
   PubMed Web of Science ®Google Scholar
• Suzuki H, Nishizawa T, Hibi T. Therapeutic strategies for functional dyspepsia and the introduction of the Rome III classification. J Gastroenterol 2006;41(6):513-23
   PubMed Web of Science ®Google Scholar
• van Kerkhoven LA, Laheij RJ, Aparicio N, Effect of the antidepressant venlafaxine in functional dyspepsia: a randomized, double-blind, placebo-controlled trial. Clin Gastroenterol Hepatol 2008;6(7):746-52
   PubMed Web of Science ®Google Scholar
• Van Oudenhove L, Tack J. Is the antidepressant venlafaxine effective for the treatment of functional dyspepsia? Nat Clin Pract Gastroenterol Hepatol 2009;6(2):74-5
   PubMedGoogle Scholar
• Tack J, Broekaert D, Coulie B, Fischler B, Janssens J. Influence of the selective serotonin reuptake inhibitor paroxetine on gastric sensorimotor function in man. Aliment Pharmacol Ther 2003;17:603-8
   PubMed Web of Science ®Google Scholar
• Hashash JG, Abdul-Baki H, Azar C, Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia. Aliment Pharmacol Ther 2008;27(11):1148-55
   PubMed Web of Science ®Google Scholar