How to improve drug development for functional disorders

Best Practice and Research: Clinical Gastroenterology

Volumn 18, Issue 4, 2004, Pages 787-796

  Tack, Jan ^a   Corsetti, Maura ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

Functional dyspepsia; Irritable bowel syndrome; Pathophysiology; Randomized controlled trials; Therapy

Indexed keywords

ALEMCINAL; ALOSETRON; CISAPRIDE; FEDOTOZINE; GASTROINTESTINAL AGENT; KAPPA OPIATE RECEPTOR AGONIST; MACROLIDE; PLACEBO; PROKINETIC AGENT; PROTON PUMP INHIBITOR; R 137696; SEROTONIN 1 AGONIST; SEROTONIN 3 ANTAGONIST; SEROTONIN 4 ANTAGONIST; TEGASEROD; UNCLASSIFIED DRUG;

ARTICLE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DIGESTIVE SYSTEM FUNCTION DISORDER; DOSE RESPONSE; DRUG ACTIVITY; DYSPEPSIA; EPIGASTRIC PAIN; ERUCTATION; HUMAN; INTESTINE FUNCTION DISORDER; IRRITABLE COLON; NAUSEA AND VOMITING; NON INVASIVE MEASUREMENT; PATHOPHYSIOLOGY; PATIENT SELECTION; SIDE EFFECT; SYMPTOM; TACHYPHYLAXIS; TREATMENT OUTCOME; WEIGHT REDUCTION;

DRUG DESIGN; DYSPEPSIA; GASTROINTESTINAL DISEASES; HUMANS; IRRITABLE BOWEL SYNDROME; RANDOMIZED CONTROLLED TRIALS;

EID: 4344621082     PISSN: 15216918     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bpg.2004.04.011     Document Type: Article

References (67)

1. Klein K.B. Controlled treatment trials in the irritable bowel syndrome: A critique Gastroenterology 59 1988 232-241
2. Camilleri M. Review article: Clinical evidence to support current therapies of irritable bowel syndrome Aliment. Pharmacol. Ther. 13 suppl 2 1999 48-53
3. Soo S. Moayyedi P. Deeks J. et al. Pharmacological interventions for non-ulcer dyspepsia Cochrane Database Syst. Rev. 2 2000 CD001960
4. Camilleri M. Northcutt A.R. Kong S.A. et al. Efficacy and safety of alosetron in women with irritable bowel syndrome: A randomised, placebo-controlled trial Lancet 355 2000 1035-1040
5. Camilleri M. Mayer E.A. Drossman D.A. et al. Improvement in pain and bowel function in female irritable bowel patients zith alosetron, a 5-HT3 antagonist Aliment. Pharmacol. Ther. 13 1999 1149-1159
6. Muller-Lissner S.A. Fumagalli I. Bardhan K.D. et al. Tegaserod, a 5-HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation Aliment. Pharmacol. Ther. 15 2001 1655-1666
7. Kellow J. Lee O.Y. Chang F.Y. et al. An Asia-Pacific, double-blind, placebo controlled, randomised study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome Gut 52 2003 671-676
8. Novick J. Miner P. Krause R. et al. A randomised, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation Aliment. Pharmacol. Ther. 16 2002 1877-1888
9. Thompson C.A. Alosetron withdrawn from market Am. J. Health Syst. Pharm. 58 2001 13
10. Barbey J.T. Lazzara R. Zipes D.P. Spontaneous adverse event reports of serious ventricula arrhythmias, QT prolongation, Syncope, and sudden death in patients treated with cisapride Cardiovasc. Pharmacol. Ther. 283 2002 H126-H138
11. Talley N.J. Functional dysypepsia: Should treatment be targeted on disturbed physiology? Aliment Pharmacol. Ther. 9 1995 107-115
12. Drossman D.A. Thompson W.G. Talley N.J. et al. Identification of subgroups of functional gastrointestinal disorders Gastroenterol. Int. 3 1990 159-171
13. Talley N.J. Zinsmeister A.R. Schleck C.D. Melton L.J.3rd Dyspepsia and dyspepsia subgroups: A population-based study Gastroenterology 102 1993 1259-1268
14. Agreus L. Svardsudd K. Nyren O. et al. Irritable bowel syndrome and dyspepsia in the general population: Overlap and lack of stability over time Gastroenterology 109 1995 671-680
15. Stanghellini V. Tosetti C. PaternicoÁ A. et al. Predominant symptoms identify different subgroups in functional dyspepsia Am. J. Gastroenterol. 94 1999 2080-2085
16. Tack J. Caenepeel P. Degreef A. Janssens J. Symptom severity and subtypes in functional dyspepsia: Rome II criteria or a pathophysiological approach? Gastroenterology 118 2000 A619
17. Stanghellini V. Tosetti C. Paternico A. et al. Risk indicators of delayed gastric emptying of solids in patients with functional dyspepsia Gastroenterology 110 1996 1036-1042
18. Perri F. Clemente R. Festa V. et al. Patterns of symptoms in functional dyspepsia: Role of Helicobacter pylori infection and delayed gastric emptying Am. J. Gastroenterol. 93 1998 2082-2088
19. Sarnelli G. Caenepeel P. Geypens B. Janssens J. Tack J. Symptoms associated with impaired gastric emptying of solids and liquids in functional dyspepsia Am. J. Gastroenterol. 98 2003 783-788
20. Tack J. Piessevaux H. Coulie B. Caenepeel P. Janssens J. Role of impaired gastric accommodation to a meal in functional dyspepsia Gastroenterology 115 1998 1346-1352
21. Tack J. Caenepeel P. Fischler B. Piessevaux H. Janssens J. Symptoms associated with hypersensitivity to gastric distention in functional dyspepsia Gastroenterology 121 2001 526-535
22. Tack J. Demedts I. Dehondt G. et al. Clinical and pathophysiological characteristics of acute-onset functional dyspepsia Gastroenterology 122 2002 1738-1747
23. Talley N.J. Verlinden M. Jones M. Can symptoms discriminate among those with delayed or normal gastric emptying in dysmotility-like dyspepsia? Am. J. Gastroenterol. 96 2001 1422-1428
24. Boeckxstaens G.E. Hirsch D.P. Kuiken S.D. Heisterkamp S.H. Tytgat G.N. The proximal stomach and postprandial symptoms in functional dyspeptics Am. J. Gastroenterol. 97 2002 40-48
25. Rhee P.L. Kim Y.H. Son H.J. et al. Evaluation of individual symptoms acannot predict presence of gastric hypersensitivity in functional dyspepsia Dig. Dis. Sci. 45 2000 1680-1684
26. Tack J. Bisschops R. Degreef T. Janssens J. Can symptoms predict underlying pathophysiological mechanisms in functional dyspepsia? Gastroenterology 120 suppl 1 2001 429
27. Fischler B. Vandenberghe J. Persoons P. et al Evidence-based subtypes in functional dyspepsia with confirmatory factor analysis: Psychosocial and physiopathological correlates Gastroenterology 120 2001 268-276
28. Hungin A.P. Whorwell P. Tack J. Mearin F. The prevalence, patterns and impact of irritable bowel syndrome: An international survey of 40000 subjects Aliment. Pharmacol. Ther. 17 2003 643-650
29. Rome II: A multinational consensus document on functional gastrointestinal disorders. Gut (1999) 45 (suppl 11)
30. Mearin F. Balboa A. Badia X. et al. Irritable bowel syndrome subtypes according to bowel habit: Revisiting the alternating subtype Eur. J. Gastroenterol. Hepatol. 15 2003 165-172
31. Kuiken, S., Lei, A., Tytgat, G.N.J., Boeckxstaens, G.E. (2004). Possible role of nitric oxide in visceral hypersensitivity in patients with irritable bowel syndrome. Submitted for publication
32. Coffin B. Bouhassira D. Chollet R. et al. Effect of the kappa agonist fedotozine on perception of gastric distension in healthy humans Aliment. Pharmacol. Ther. 10 1996 919-925
33. Read N.W. Abitbol J.L. Bardhan K.D. Whorwell P.J. Fraitag B. Efficacy and safety of the peripheral kappa agonist fedotozine versus placebo in the treatment of functional dyspepsia Gut 41 1997 664-668
34. Verhagen M.A. Samsom M. Maes B. et al. Effects of a new motilide, ABT-229, on gastric emptying and postprandial antroduodenal motility in healthy volunteers Aliment. Pharmacol. Ther. 11 1997 1077-1086
35. Talley N.J. Verlinden M. Snape W. et al. 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. 14 2000 1653-1661
36. Talley N.J. Verlinden M. Geenen D.J. et al. Effects of a motilin receptor agonist (ABT-229) on upper gastrointestinal symptoms in type 1 diabetes mellitus: A randomised, double blind, placebo controlled trial Gut 49 2001 395-401
37. Tack J. Peeters T. What comes after macrolides and other motilin stimulants? Gut 49 2001 317-318
38. Troncon L.E.A. Bennett R.J.M. Ahluwalia N.K. Thompson D.G. Abnormal distribution of food during gastric emptying in functional dyspepsia patients Gut 35 1994 327-332
39. Gilja O.H. Hausken T. Wilhelmsen I. Berstad A. Impaired accommodation of proximal stomach to a meal in functional dyspepsia Dig. Dis. Sci. 41 1996 689-696
40. Salet G.A.M. Samsom M. Roelofs J.M.M. et al. Responses to gastric distention in functional dyspepsia Gut 42 1998 823-829
41. Boeckxstaens G. Tytgat G. Wajs E. et al. The influence of the 5-HT1A agonist R-137696 on proximal stomach function in healthy volunteers Gastroenterology DDW 2004 abstract
42. A agonist R-137696 on symptoms, visceral hypersensitivity and on impaired accommodation in functional dyspepsia Gastroenterology DDW 2004 abstract
43. Talley N.J. Phillips S.F. Haddad A. et al. Effect of selective 5HT3 antagonist (GR38032F) on small intestinal transit and release of gastrointestinal peptides Dig. Dis. Sci. 34 1989 1511-1515
44. Prather C.M. Camilleri M. Zinsmeister A.R. McKinzie S. Thomforde S. Tegaserod accelerates orocecal transit in patients with constipation-predominant irritable bowel syndrome Gastroenterology 118 2000 462-468
45. Coffin B. Farmachidi J.P. Ruegg P. Bastie A. Bouhassira D. Tegaserod, a 5-HT4 Receptor Partial Agonist, Decreasees Sensitivity to Rectal Distension in Healthy Subjects 2003
46. Thumshirn M. Coulie B. Camilleri M. et al. Effects of alosetron on gastrointestinal transit time and rectal sensation in patients with irritable bowel syndrome Aliment. Pharmacol. Ther. 14 2000 869-878
47. Hammer J. Phillips S.F. Talley N.J. Camillei M. Effect of a 5-HT3 antagonist on rectal sensitivity and compliance in health and in the irritable bowel syndrome Aliment. Pharamacol. Ther. 7 1993 543-551
48. Delvaux M. Louvel D. Mamet J.P. Campos-Oriola R. Frexions J. Effect of alosetron on responses to colonic distension in patients with the irritable bowel syndrome Aliment. Pharmacol. Ther. 12 1998 849-855
49. Delvaux M. Louvel D. Lagier E. et al. The kappa agonist fedotozine relieves hypersensitivity to colonic distention in patients with irritable bowel syndrome Gastroenterology 116 1999 38-45
50. Dapoigny M. Abitbol J.L. Fraitag B. Efficacy of peripheral kappa agonist fedotozine versus placebo in treatment of irritable bowel syndrome. A multicenter dose-response study Dig. Dis. Sci. 40 1995 2244-2249
51. Talley N.J. Meineche-Schmidt V. Pare P. et al. Efficacy of omeprazole in functional dyspepsia: Double-blind, randomized, placebo-controlled trials (the Bond and Opera studies) Aliment. Pharmacol. Ther. 12 1998 1055-1065
52. Nyrén O. Adami H.O. Bates S. et al. Absence of therapeutic benefit from antacids or cimetidine in non-ulcer dyspepsia N. Engl. J. Med. 314 1986 339-343
53. Johnsson F. Roth Y. Damgaard Pedersen N.E. Joelsson B. Cimetidine improves GERD symptoms in patients selected by a validated GERD questionnaire Aliment. Pharmacol. Ther. 7 1993 81-86
54. Lauritsen K. Aalykke C. Havelund T. et al. Effect of omeprazole in functional dyspepsia: A double-blind, randomized, placebo-controlled study Gastroenterology 110 suppl 1996 A702
55. Hansen J.M. Bytzer P. Schaffalitzky de Muckadell O.B. Placebo-controlled trial of cisapride and nizatidine in unselected patients with functional dyspepsia Am. J. Gastroenterol. 93 1998 368-374
56. Mason I. Millar L.J. Sheikh R.R. et al. The management of acid-related dyspepsia in general practice: A comparison of an omeprazole versus an antacid-alginate/ranitidine management strategy Aliment. Pharmacol. Ther. 12 1998 263-271
57. Small P.K. Loudon M.A. Waldron B. Smith D. Campbell F.C. Importance of reflux symptoms in functional dyspepsia Gut 36 1995 189-192
58. Kahrilas P.J. Quigley E.M. Clinical esophageal pH recording: A technical review for practice guideline development Gastroenterology 110 1996 1982-1996
59. Carlsson R. Dent J. Bolling-Sternevald E. et al. The usefulness of a structured questionnaire in the assessment of symptomatic gastroesophageal reflux disease Scand. J. Gastroenterol. 33 1998 1023-1029
60. Fennerty M.B. Use of antisecretory agents as a trial of therapy Gut 50 suppl 4 2002 iv 3-iv 6
61. Dent J. Definitions of reflux disease and its separation from dyspepsia Gut 50 suppl 4 2002 iv17-iv20
62. Koch K.L. Hong S.P. Xu L. Reproducibility of gastric myoelectrical activity and the water load test in patients with dysmotility-like dyspepsia symptoms and in control subjects J. Clin. Gastroenterol. 31 2000 125-129
63. Tosetti C. Salvioli B. Stanghellini V. et al. Reproducibility of a water load test in health subjects and symptom profile compared to patients with functional dyspepsia Gastroenterology 116 1999 A336
64. Bisschops R. Geypens B. Ghoos I. Tack J. Timing of symptoms in relation to the meal in pain-predominant versus discomfort-predominant dyspepsia Gastroenterology 118 2000 2544
65. Boeckxstaens G.E. Hirsch D.P. Van Den Elzen B.D. Heisterkamp S.H. Tytgat G.N. Impaired drinking capacity in patients with functional dyspepsia: Relationship with proximal stomach function Gastroenterology 121 2001 1054-1063
66. Tack J. Caenepeel P. Piessevaux H. Cuomo R. Janssens J. Assessment of meal-induced gastric accommodation by a satiety drinking test in health and in severe functional dyspepsia Gut 52 2003 1271-1277
67. Arts, J., Caenepeel, P., Demedts, I., Verbeke, K., Tack, J. (2003). Influence of erythromycin on gastric emptying and meal-related symptoms in functional dyspepsia with delayed gastric emptying. Submitted for publication