Ramosetron Reduces Symptoms of Irritable Bowel Syndrome with Diarrhea and Improves Quality of Life in Women

Gastroenterology

Volumn 150, Issue 2, 2016, Pages 358-366.e8

  Fukudo, Shin ^a   Kinoshita, Yoshikazu ^b   Okumura, Toshikatsu ^c   Ida, Motoko ^d   Akiho, Hiraku ^d   Nakashima, Yoshihiro ^d   Nishida, Akito ^d   Haruma, Ken ^e  

^a TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b SHIMANE UNIVERSITY   (Japan)

^c ASAHIKAWA MEDICAL COLLEGE   (Japan)

^d ASTELLAS PHARMA INC   (Japan)

^e KAWASAKI MEDICAL SCHOOL   (Japan)

Author keywords

5 HT; 5 Hydroxytryptamine 3 Receptor Antagonist; Abdominal Pain; Discomfort

Indexed keywords

PLACEBO; RAMOSETRON; BENZIMIDAZOLE DERIVATIVE; GASTROINTESTINAL AGENT; SEROTONIN 3 ANTAGONIST;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG SAFETY; FECES; FEMALE; HARD FECES; HUMAN; IRRITABLE BOWEL SYNDROME WITH DIARRHEA; IRRITABLE COLON; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; OUTPATIENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; TREATMENT RESPONSE; CHEMICALLY INDUCED; CLINICAL TRIAL; IRRITABLE BOWEL SYNDROME; JAPAN; MIDDLE AGED; MULTICENTER STUDY; PSYCHOLOGY; SEX DIFFERENCE; TIME FACTOR; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; BENZIMIDAZOLES; CONSTIPATION; DIARRHEA; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; IRRITABLE BOWEL SYNDROME; JAPAN; MIDDLE AGED; PROSPECTIVE STUDIES; QUALITY OF LIFE; RISK FACTORS; SEROTONIN 5-HT3 RECEPTOR ANTAGONISTS; SEX FACTORS; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84975861217     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2015.10.047     Document Type: Article

References (48)

1. D.A. Drossman The functional gastrointestinal disorders and the Rome III process Gastroenterology 130 2006 1377 1390
2. L. Chang, B.B. Toner, S. Fukudo, and et al. Gender, age, society, culture, and the patient's perspective in the functional gastrointestinal disorders Gastroenterology 130 2006 1435 1446
3. N.A. Koloski, M. Jones, J. Kalantar, and et al. The brain-gut pathway in functional gastrointestinal disorders is bidirectional: a 12-year prospective population-based study Gut 61 2012 1284 1290
4. G.F. Longstreth, W.G. Thompson, W.D. Chey, and et al. Functional bowel disorders Gastroenterology 130 2006 1480 1491
5. L. Kux Department of Health and Human Services, Food and Drug Administration [docket no. FDA-2012-D-0146]: guidance for industry on irritable bowel syndrome - clinical evaluation of drugs for treatment: availability Fed Register 77 2012 32124 32125
6. M. Camilleri, A.R. Northcutt, S. Kong, and et al. Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial Lancet 355 2000 1035 1040
7. V. Andresen, V.M. Montori, J. Keller, and et al. Effects of 5-hydroxytryptamine (serotonin) type 3 antagonists on symptom relief and constipation in nonconstipated irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials Clin Gastroenterol Hepatol 6 2008 545 555
8. D. Friedel, R. Thomas, and R.S. Fisher Ischemic colitis during treatment with alosetron Gastroenterology 120 2001 557 560
9. K. Miyata, T. Kamato, A. Nishida, and et al. Pharmacologic profile of (R)-5-[(1-methyl-3-indolyl)carbonyl]-4,5,6,7-tetrahydro-1H-benzimidazole hydrochloride (YM060), a potent and selective 5-hydroxytryptamine3 receptor antagonist, and its enantiomer in the isolated tissue J Pharmacol Exp Ther 259 1991 15 21
10. K. Miyata, T. Kamato, A. Nishida, and et al. Role of the serotonin3 receptor in stress-induced defecation J Pharmacol Exp Ther 261 1992 297 303
11. 3 receptor in CRH-induced defecation in rats Am J Physiol 274 1998 G827 G831
12. K. Matsueda, S. Harasawa, M. Hongo, and et al. A phase II trial of the novel serotonin type 3 receptor antagonist ramosetron in Japanese male and female patients with diarrhea-predominant irritable bowel syndrome Digestion 77 2008 225 235
13. K. Matsueda, S. Harasawa, M. Hongo, and et al. A randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetoron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndrome Scand J Gastroenterol 43 2008 1202 1211
14. S. Fukudo, M. Ida, H. Akiho, and et al. Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea Clin Gastroenterol Hepatol 12 2014 953 959.e4
15. K.J. Lee, N.Y. Kim, J.K. Kwon, and et al. Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine Neurogastroenterol Motil 23 2011 1098 1104
16. K.W. Heaton, S. Ghosh, and F.E. Braddon How bad are the symptoms and bowel dysfunction of patients with the irritable bowel syndrome? A prospective, controlled study with emphasis on stool form Gut 32 1991 73 79
17. D.L. Patrick, D.A. Drossman, I.O. Frederick, and et al. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure Dig Dis Sci 43 1998 400 411
18. M. Kanazawa, D.A. Drossman, M. Shinozaki, and et al. Translation and validation of a Japanese version of the irritable bowel syndrome-quality of life measure (IBS-QOL-J) Biopsychosoc Med 1 2007 6
19. S. Fukudo, K. Matsueda, K. Haruma, and et al. Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: a randomized, placebo-controlled phase II trial Gastroenterology 148 Suppl 1 2015 S-659
20. International Conference on Harmonisation: guidance on statistical principles for clinical trials - availability: FDA Notice. Fed Register 63 1998 49583 49598
21. K. Miyata, M. Yamano, T. Kamato, and et al. Effect of serotonin (5-HT)3-receptor antagonists YM060, YM114 (KAE-393), ondansetron and granisetron on 5-HT4 receptors and gastric emptying in rodents Jpn J Pharmacol 69 1995 205 214
22. A.E. Foxx-Orenstein, J.F. Kuemmerle, and J.R. Grider Distinct 5-HT receptors mediate the peristaltic reflex induced by mucosal stimuli in human and guinea pig intestine Gastroenterology 111 1996 1281 1290
23. M. Kanazawa, O.S. Palsson, S.I. Thiwan, and et al. Contributions of pain sensitivity and colonic motility to IBS symptom severity and predominant bowel habits Am J Gastroenterol 103 2008 2550 2561
24. S.P. Dunlop, N.S. Coleman, E. Blackshaw, and et al. Abnormalities of 5-hydroxytryptamine metabolism in irritable bowel syndrome Clin Gastroenterol Hepatol 3 2005 349 357
25. L.A. Kilpatrick, J.S. Labus, K. Coveleskie, and et al. The HTR3A polymorphism c. -42C>T is associated with amygdala responsiveness in patients with irritable bowel syndrome Gastroenterology 140 2011 1943 1951
26. 3 receptor antagonists on stress-induced colonic hyperalgesia and diarrhoea in rats: a comparative study with opioid receptor agonists, a muscarinic receptor antagonist and a synthetic polymer Neurogastroenterol Motil 20 2008 557 565
27. H. Furuie, M. Kanda, S. Imazuya, and et al. Pharmacokinetics study of YM060-the influence of gender Rinshoiyaku 23 2007 755 763
28. M. Grover, and M. Camilleri Ramosetron in irritable bowel syndrome with diarrhea: new hope or the same old story? Clin Gastroenterol Hepatol 12 2014 960 962
29. 3 antagonist in subjects with diarrhea-predominant irritable bowel syndrome Am J Gastroenterol 96 2001 2671 2676
30. K.M. Koch, B.W. Corrigan, J. Manzo, and et al. Alosetron repeat dose pharmacokinetics, effects on enzyme activities, and influence of demographic factors Aliment Pharmacol Ther 20 2004 223 230
31. 3 receptor antagonist, alosetron, on brain responses to visceral stimulation in irritable bowel syndrome patients Aliment Pharmacol Ther 16 2002 1357 1366
32. B.D. Naliboff, S. Berman, L. Chang, and et al. Sex-related differences in IBS patients: central processing of visceral stimuli Gastroenterology 124 2003 1738 1747
33. S. Yadav, M. Dave, J. Edakkanambeth Varayil, and et al. A population-based study of incidence, risk factors, clinical spectrum, and outcomes of ischemic colitis Clin Gastroenterol Hepatol 13 2015 731 738
34. D.A. Drossman, C.B. Morris, Y. Hu, and et al. Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment Am J Gastroenterol 102 2007 1442 1453
35. C.Y. Francis, J. Morris, and P.J. Whorwell The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress Aliment Pharmacol Ther 11 1997 395 402
36. S. Fukudo, H. Kaneko, H. Akiho, and et al. Evidence-based clinical practice guidelines for irritable bowel syndrome J Gastroenterol 50 2015 11 30
37. G.F. Longstreth, W.G. Thompson, W.D. Chey, and et al. Functional bowel disorders Gastroenterology 130 2006 1480 1491
38. K.W. Heaton, S. Ghosh, and F.E. Braddon How bad are the symptoms and bowel dysfunction of patients with the irritable bowel syndrome? A prospective, controlled study with emphasis on stool form Gut 32 1991 73 79
39. L. Kux Department of Health and Human Services, Food and Drug Administration [docket no. FDA-2012-D-0146]: guidance for industry on irritable bowel syndrome - clinical evaluation of drugs for treatment: availability Fed Register 77 2012 32124 32125
40. S. Fukudo, M. Ida, H. Akiho, and et al. Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea Clin Gastroenterol Hepatol 12 2014 953 959.e4
41. International Conference on Harmonisation: guidance on statistical principles for clinical trials - availability: FDA Notice. Fed Register 63 1998 49583 49598
42. K. Matsueda, S. Harasawa, M. Hongo, and et al. A phase II trial of the novel serotonin type 3 receptor antagonist ramosetron in Japanese male and female patients with diarrhea-predominant irritable bowel syndrome Digestion 77 2008 225 235
43. K. Matsueda, S. Harasawa, M. Hongo, and et al. A randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetoron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndrome Scand J Gastroenterol 43 2008 1202 1211
44. M. Camilleri, A.R. Northcutt, S. Kong, and et al. Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial Lancet 355 2000 1035 1040
45. K.J. Lee, N.Y. Kim, J.K. Kwon, and et al. Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine Neurogastroenterol Motil 23 2011 1098 1104
46. M. Camilleri, E. Atanasova, P.J. Carlson, and et al. Serotonin-transporter polymorphism pharmacogenetics in diarrhea-predominant irritable bowel syndrome Gastroenterology 123 2002 425 432
47. J. Gelernter, H. Kranzler, and J.F. Cubells Serotonin transporter protein (SLC6A4) allele and haplotype frequencies and linkage disequilibria in African- and European-American and Japanese populations and in alcohol-dependent subjects Hum Genet 101 1997 243 246
48. V. Andresen, V.M. Montori, J. Keller, and et al. Effects of 5-hydroxytryptamine (serotonin) type 3 antagonists on symptom relief and constipation in nonconstipated irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials Clin Gastroenterol Hepatol 6 2008 545 555