The safety of novel drugs used to treat irritable bowel syndrome

Expert Opinion on Drug Safety

Volumn 13, Issue 5, 2014, Pages 625-638

  Mozaffari, Shilan ^a   Nikfar, Shekoufeh ^b,c   Abdollahi, Mohammad ^a  

^a TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^b TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^c MINISTRY OF HEALTH AND MEDICAL EDUCATION   (Iran)

Author keywords

Adverse event; Asimadoline; Clinical trial; Irritable bowel syndrome; Linaclotide; Lubiprostone; New drugs; Ramosetron; Renzapride; Safety; Systematic review

Indexed keywords

ASIMADOLINE; G PROTEIN COUPLED RECEPTOR; KAPPA OPIATE RECEPTOR; KAPPA OPIATE RECEPTOR AGONIST; LINACLOTIDE; LUBIPROSTONE; PLACEBO; RAMOSETRON; RENZAPRIDE; RIFAXIMIN; SEROTONIN 3 ANTAGONIST; SEROTONIN 4 AGONIST; GASTROINTESTINAL AGENT;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ARTICLE; CONSTIPATION; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG STRUCTURE; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; IRRITABLE COLON; NAUSEA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; TREATMENT OUTCOME; COMPLICATION; IRRITABLE BOWEL SYNDROME; META ANALYSIS;

GASTROINTESTINAL AGENTS; HUMANS; IRRITABLE BOWEL SYNDROME; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84899047479     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2014.902932     Document Type: Article

References (74)

1. Ding Y, Lu B, Chen D, et al. Proteomic analysis of colonic mucosa in a rat model of irritable bowel syndrome. Proteomics 2010;10:2620-30
2. Mozaffari S, Rahimi R, Abdollahi M. Implications of melatonin therapy in irritable bowel syndrome: a systematic review. Curr Pharm Des 2010;16:3646-55
3. Liebregts T, Adam B, Bredack C, et al. Immune activation in patients with irritable bowel syndrome. Gastroenterology 2007;132:913-20
4. Ford AC, Talley NJ, Spiegel BMR, et al. Effect of fiber, antispasmodics, and peppermint oil in irritable bowel syndrome: systematic review and meta-analysis. Br Med J 2008;337:1388-92
5. Rahimi R, Nikfar S, Rezaie A, Abdollahi M. Efficacy of tricyclic antidepressants in irritable bowel syndrome: a meta-analysis. World J Gastroenterol 2009;15:1548-53
6. Rahimi R, Nikfar S, Abdollahi M. Selective serotonin reuptake inhibitors for the management of irritable bowel syndrome: a meta-analysis of randomized controlled trials. Arch Med Sci 2008;4:71-6
7. Sainsbury A, Ford AC. Treatment of irritable bowel syndrome: beyond fiber and antispasmodic agents. Therap Adv Gastroenterol 2011;4:115-27
8. Nikfar S, Rahimi R, Rahimi F, et al. Efficacy of probiotics in irritable bowel syndrome: a meta-analysis of randomized, controlled trials. Dis Colon Rectum 2008;51:1775-80
9. Hosseini A, Nikfar S, Abdollahi M. Probiotics use to treat irritable bowel syndrome. Expert Opin Biol Ther 2012;12:1323-34
10. Rezaie A, Nikfar S, Abdollahi M. The place of antibiotics in management of irritable bowel syndrome: a systematic review and meta-analysis. Arch Med Sci 2010;6:49-55
11. Rahimi R, Nikfar S, Abdollahi M. Efficacy and tolerability of alosetron for the treatment of irritable bowel syndrome in women and men: a meta-analysis of eight randomized, placebo-controlled, 12-week trials. Clin Ther 2008;30:884-901
12. Atkinson W, Lockhart S, Whorwell PJ, et al. Altered 5-hydroxytryptamine signaling in patients with constipation and diarrhea-predominant irritable bowel syndrome. Gastroenterology 2006;130:34-43
13. Rahimi R, Abdollahi M. Herbal medicines for the management of irritable bowel syndrome: a comprehensive review. World J Gastroenterol 2012;18:589-600
14. Asadi-Shahmirzadi A, Mozaffari S, Sanei Y, et al. Benefit of Aloe vera and Matricaria recutita mixture in rat irritable bowel syndrome: combination of antioxidant and spasmolytic effects. Chin J Integr Med 2012. [Epub ahead of print]
15. Mozaffari S, Esmaily H, Rahimi R, et al. Effects of Hypericum perforatum extract on rat irritable bowel syndrome. Pharmacogn Mag 2011;7:213-23
16. Mozaffari S, Nikfar S, Abdollahi M. Systematic review/meta- analysisefficacy and tolerability of renzapride in irritable bowel syndrome: a meta-analysis of randomized, controlled clinical trials including 2528 patients. Arch Med Sci 2014;10:10-18.
17. Mozaffari S, Nikfar S, Abdollahi M. Metabolic and toxicological considerations for the latest drugs used to treat irritable bowel syndrome. Expert Opin Drug Metab Toxicol 2013;9:403-21
18. Fukudo S, Hongo M, Kaneko H, Ueno R. Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study. Neurogastroenterol Motil 2011;23:544-e205
19. Drossman DA, Chey WD, Johanson JF, et al. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome - results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther 2009;29:329-41
20. Chamberlain SM, Rao SS. Safety evaluation of lubiprostone in the treatment of constipation and irritable bowel syndrome. Expert Opin Drug Saf 2012;11:841-50
21. Camilleri M, Bharucha AE, Ueno R, et al. Effect of a selective chloride channel activator, lubiprostone, on gastrointestinal transit, gastric sensory, and motor functions in healthy volunteers. Am J Physiol Gastrointest Liver Physiol 2006;290:G942-7
22. Chey WD, Drossman DA, Johanson JF, et al. Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2012;35:587-99
23. Johanson JF, Drossman DA, Panas R, et al. Clinical trial: phase 2 study of lubiprostone for irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2008;27:685-96
24. Johanson JF, Morton D, Geenen J, Ueno R. Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of lubiprostone, a locally-acting type-2 chloride channel activator, in patients with chronic constipation. Am J Gastroenterol 2008;103:170-7
25. Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation. Sucampo Pharmaceuticals, Inc. 2006. Available from: http://www. clinicaltrial.gov/ct2/show/record/NCT00399542?term=NCT +00399542&rank=1
26. Lembo AJ, Johanson JF, Parkman HP, et al. Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation. Dig Dis Sci 2011;56:2639-45
27. Sherid M, Sifuentes H, Samo S, et al. Lubiprostone induced ischemic colitis. World J Gastroenterol 2013;19:299-303
28. Hyman PE, Di Lorenzo C, Prestridge LL, et al. An open-label, multicenter, safety and effectiveness study of lubiprostone for the treatment of functional constipation in children. J Pediatr Gastroenterol Nutr 2013. [Epub ahead of print]
29. Lee N, Wald A. The pharmacokinetics, pharmacodynamics, clinical efficacy, safety and tolerability of linaclotide. Expert Opin Drug Metab Toxicol 2011;7:651-9.
30. Lembo AJ, Kurtz CB, Macdougall JE, et al. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology 2010;138:886-95
31. Lembo AJ, Schneier HA, Shiff SJ, et al. Two randomized trials of linaclotide for chronic constipation. N Engl J Med 2011;365:527-36
32. Andresen V, Camilleri M, Busciglio IA, et al. Effect of 5 days linaclotide on transit and bowel function in females with constipation- predominant irritable bowel syndrome. Gastroenterology 2007;133:761-8
33. Rao S, Lembo AJ, Shiff SJ, et al. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation. Am J Gastroenterol 2012;107:1714-24
34. Currie MG, Kurtz CB, Mahajan-Miklos S, et al. Effects of a single dose administration of MD-1100 on safety, tolerability, exposure, and stool consistency in healthy subjects. Am J Gastoenterol 2005;100:S328
35. Kurtz CB, Fitch D, Busby RW, et al. Effects of multidose administration of MD-1100 on safety, tolerability, exposure, and pharmacodynamics in healthy subjects. Gastroenterology 2006;130:A26
36. Johnston JM, Kurtz CB, Macdougall JE, et al. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology 2010;139:1877-86
37. Chey WD, Lembo AJ, Lavins BJ, et al. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebocontrolled trial to evaluate efficacy and safety. Am J Gastroenterol 2012;107:1702-12
38. An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation. Forest Laboratories. 2008. Available from: http://www.clinicaltrial.gov/ct2/show/ NCT00765999? term=NCT00765999&rank=1
39. An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation. Ironwood Pharmaceuticals, Inc. 2008. Available from: http://www.clinicaltrial.gov/ct2/ show/NCT00730171? term=NCT00730171&rank=1
40. Corsetti M, Tack J. Linaclotide: a new drug for the treatment of chronic constipation and irritable bowel syndrome with constipation. United Eur Gastroenterol J 2013;1:7-20
41. Delvaux M, Beck A, Jacob J, et al. Effect of asimadoline, a kappa opioid agonist, on pain induced by colonic distension in patients with irritable bowel syndrome. Aliment Pharmacol Ther 2004;20:237-46
42. Mangel AW, Bornstein JD, Hamm LR, et al. Clinical trial: asimadoline in the treatment of patients with irritable bowel syndrome. Aliment Pharmacol Ther 2008;28:239-49
43. Kramer HJ, Uhl W, Ladstetter B, Backer A. Influence of asimadoline, a new kappa-opioid receptor agonist, on tubular water absorption and vasopressin secretion in man. Br J Clin Pharmacol 2000;50:227-35
44. Delgado-Aros S, Chial HJ, Cremonini F, et al. Effects of asimadoline, a kappa-opioid agonist, on satiation and postprandial symptoms in health. Aliment Pharmacol Ther 2003;18:507-14
45. Szarka LA, Camilleri M, Burton D, et al. Efficacy of on-demand asimadoline, a peripheral kappa-opioid agonist, in females with irritable bowel syndrome. Clin Gastroenterol Hepatol 2007;5:1268-75
46. Talley NJ, Choung RS, Camilleri M, et al. Asimadoline, a kappa-opioid agonist, and satiation in functional dyspepsia. Aliment Pharmacol Ther 2008;27:1122-31
47. Asimadoline for the Treatment of Post- Operative Ileus. Tioga Pharmaceuticals. 2007. Available from: http://www. clinicaltrial.gov/ct2/show/ NCT00443040? term=%28NCT00443040%29&rank=1
48. Mangel AW, Hicks GA. Asimadoline and its potential for the treatment of diarrhea-predominant irritable bowel syndrome: a review. Clin Exp Gastroenterol 2012;5:1-10
49. Kadokura T, den Adel M, Krauwinkel WJ, et al. The effect of fluvoxamine on the pharmacokinetics, safety, and tolerability of ramosetron in healthy subjects. Eur J Clin Pharmacol 2008;64:691-5
50. Lee KJ, Kim NY, Kwon JK, 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 2011;23:1098-104
51. Matsueda K, Harasawa S, Hongo M, 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 2008;77:225-35
52. Matsueda K, Harasawa S, Hongo M, et al. A randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndrome. Scand J Gastroenterol 2008;43:1202-11
53. Matsueda K, Arakawa T, Matsumoto T, Sasaki D. Long-term study of YM060 (ramosetron hydrochloride) in Japanese patients (male) with diarrheapredominant irritable bowel syndrome. Rinsho Iyaku 2008;24:655-78
54. Descombe JJ, Dubourg D, Picard M, Palazzini E. Pharmacokinetic study of rifaximin after oral administration in healthy volunteers. Int J Clin Pharmacol Res 1994;14:51-6
55. Menees SB, Maneerattannaporn M, Kim HM, Chey WD. The efficacy and safety of rifaximin for the irritable bowel syndrome: a systematic review and meta-analysis. Am J Gastroenterol 2012;107:28-35.
56. Pimentel M, Lembo A, Chey WD, et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med 2011;364:22-32.
57. Sharara AI, Aoun E, Abdul-Baki H, et al. A randomized double-blind placebo controlled trial of rifaximin in patients with abdominal bloating and flatulence. Am J Gastroenterol 2006;101:326-33
58. Lembo AZ, Ferreira SF, Ringel Nl, et al. Rifaximin for the treatment of diarrheaassociated irritable bowel syndrome: short term treatment leading to long term sustained response. Gastroenterology 2008;134:P-255
59. Scarpellini E, Giorgio V, Gabrielli M, et al. Rifaximin treatment for small intestinal bacterial overgrowth in children with irritable bowel syndrome. Eur Rev Med Pharmacol Sci 2013;17:1314-20
60. Meyers NL, Hickling RI. Pharmacology and metabolism of renzapride: a novel therapeutic agent for the potential treatment of irritable bowel syndrome. Drugs R D 2008;9:37-63
61. Tack J, Middleton SJ, Horne MC, et al. Pilot study of the efficacy of renzapride on gastrointestinal motility and symptoms in patients with constipationpredominant irritable bowel syndrome. Aliment Pharmacol Ther 2006;23:1655-65
62. Camilleri M, McKinzie S, Fox J, et al. Effect of renzapride on transit in constipation-predominant irritable bowel syndrome. Clin Gastroenterol Hepatol 2004;2:895-904
63. Spiller RC, Meyers NL, Hickling RI. Identification of patients with non-d, non-C irritable bowel syndrome and treatment with renzapride: an exploratory, multicenter, randomized, double-blind, placebo-controlled clinical trial. Dig Dis Sci 2008;53:3191-200
64. Lembo AJ, Cremonini F, Meyers N, Hickling R. Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation - a doubleblind, randomized, placebo-controlled, study. Aliment Pharmacol Ther 2010;31:979-90
65. George AM, Meyers NL, Hickling RI. Clinical trial: renzapride therapy for constipation-predominant irritable bowel syndrome - multicentre, randomized, placebo-controlled, double-blind study in primary healthcare setting. Aliment Pharmacol Ther 2008;27:830-7
66. Ford AC, Brandt LJ, Young C, et al. Efficacy of 5-HT3 antagonists and 5-HT4 agonists in irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol 2009;104:1831-43
67. Meyers NL, Hickling RI. The cardiovascular safety profile of renzapride, a novel treatment for irritable bowel syndrome. J Int Med Res 2007;35:848-66
68. Meyers NL, Tack J, Middleton SJ, et al. Efficacy and safety of renzapride in patients with constipation-predominant irritable bowel syndrome. Gut 2002;51(SIII):A10
69. George A, Meyers NL, Palmer RMJ. Efficacy and safety of renzapride in constipation-predominant IBS: a phase IIb study in the UK primary healthcare setting. Gut 2003;52(SVI):A91
70. Gras-Miralles B, Cremonini F. A critical appraisal of lubiprostone in the treatment of chronic constipation in the elderly. Clin Interv Aging 2013;8:191-200
71. Shah E, Kim S, Chong K, et al. Evaluation of harm in the pharmacotherapy of irritable bowel syndrome. Am J Med 2012;125:381-93
72. Wensel TM, Luthin DR. Linaclotide: a novel approach to the treatment of irritable bowel syndrome. Ann Pharmacother 2011;45:1535-43
73. Quigley EM, Tack J, Chey WD, et al. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther 2013;37:49-61
74. Gale JD. The use of novel promotility and prosecretory agents for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation. Adv Ther 2009;26:519-30