Linaclotide: Evidence for its potential use in irritable bowel syndrome and chronic constipation

Core Evidence

Volumn 7, Issue , 2012, Pages 39-47

  Lee, Noel ^a   Wald, Arnold ^a  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

Constipation; Efficacy; Irritable bowel syndrome; Linaclotide; Safety

Indexed keywords

BISACODYL; GUANYLATE CYCLASE; GUANYLIN; LINACLOTIDE; PLACEBO; UROGUANYLIN;

ABDOMINAL PAIN; CHRONIC DISEASE; COLON CARCINOMA; CONSTIPATION; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG STABILITY; DRUG TOLERABILITY; ELECTROLYTE DISTURBANCE; FECES IMPACTION; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; HUMAN; INTESTINAL SECRETION; INTESTINE EPITHELIUM; INTESTINE MOTILITY; IRRITABLE COLON; OUTCOME ASSESSMENT; PROTEIN DEGRADATION; QUALITY OF LIFE; RECURRENT DISEASE; REVIEW; SINGLE DRUG DOSE;

EID: 84870401184     PISSN: 15551741     EISSN: None     Source Type: Journal    
DOI: 10.2147/CE.S25240     Document Type: Review

References (25)

1. Thompson WG, Irvine EJ, Pare P, et al. Functional gastrointestinal disorders in Canada: first population-based survey using Rome II criteria with suggestions for improving the questionnaire. Dig Dis Sci. 2002;47:225-235. (Pubitemid 34075042)
2. Hungin AP, Whorwell PJ, Tack J, Mearin F. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40,000 subjects. Aliment Pharmacol Ther. 2003;17:643-650. (Pubitemid 36418887)
3. Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. 1991;100:998-1005.
4. Sandler RS, Everhart JE, Donowitz M, et al. The burden of selected digestive diseases in the United States. Gastroenterology. 2002;122:1500-1511. (Pubitemid 34465190)
5. Longstreth GF, Thompson WG, Chey WD, et al. Functional bowel disorders. Gastroenterology. 2006;130:1480-1491.
6. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004;99:750-759. (Pubitemid 38612817)
7. Bharucha AE, Waldman SA. Taking a lesson from microbial diarrheagenesis in the management of chronic constipation. Gastroenterology. 2010;138:813-825.
8. Bryant AP, Busby RW, Bartolini WP, et al. Linaclotide is a potent and selective guanylate cyclase C agonist that elicits pharmacological effects locally in the gastrointestinal tract. Life Sci. 2010;8:760-765.
9. Lucas KA, Pitari GM, Kazerounian S, et al. Guanylyl cyclases and signaling by cyclic GMP. Pharmacol Rev. 2000;52:375-414.
10. Busby RW, Bryant AP, Bartolini WP, et al. Linaclotide, through activation of guanylate cyclase C, acts locally in the gastrointestinal tract to elicit enhanced intestinal secretion and transit. Eur J Pharm. 2010;649:328-335.
11. 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 Gastroenterol. 2005;100:S328.
12. 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 Suppl 2:A26.
13. Stewart WF, Liberman JN, Sandler RS, et al. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic tures. Am J Gastroenterol. 1994;94:3530-3540.
14. Johnston JM, Kurtz CB, Drossman DA, et al. Pilot study on the effects of linaclotide in patients with chronic constipation. Am J Gastroenterol. 2009;104:125-132.
15. Lembo AJ, Johnston JM, MacDougall JE, et al. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010;138:886-895.
16. Lembo AJ, Schneier H, Shiff S, et al. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011;365:527-536.
17. Andresen V, Camilleri M, Busciglio IA, et al. Effect of 5 days of linaclotide on transit and bowel function in females with constipation- predominant irritable bowel syndrome. Gastroenterology. 2007;133:761-768. (Pubitemid 47374145)
18. 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. Gastroenterology. 2010;139:1877-1886.
19. Rao S, Lembo A, Shiff SJ, et al. Efficacy and safety of once daily linaclotide in patients with irritable bowel syndrome with constipation: a 12-week, randomized, double-blind, placebo-controlled Phase 3 trial followed by a 4-week randomized withdrawal period. Gastroenterology. 2011;140:S138.
20. Chey WD, Lembo A, MacDougall JE, et al. Efficacy and safety of once-daily linaclotide administered orally for 26 weeks in patients with IBS-C: results from a randomized, double-blind, placebo-controlled Phase 3 trial. Gastroenterology. 2011;140:S135.
21. Carson R, Tourkodimitris S, Lewis BE, Johnston JM. Effect of linaclotide on quality of life in adults with irritable bowel syndrome with constipation: pooled results from two randomized, double-blind, placebo-controlled Phase 3 trials. Gastroenterology. 2011:140-151.
22. Kamm MA, Muller-Lissner S, Wald A, et al. Oral bisacodyl is effective and well-tolerated in patients with chronic constipation. Clin Gastroenterol Hepatol. 2011;9:577-583.
23. DiPalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007;102:1436-1441. (Pubitemid 46976282)
24. Al-Judaibi B, Chande N, Gregor JC. Safety and efficacy of tegaserod therapy in patients with irritable bowel syndrome or chronic constipation. Can J Clin Pharmacol. 2010;17:e194-e200.
25. Ambizas EM, Ginzburg R. Lubiprostone: a chloride channel activator for treatment of chronic constipation. Ann Pharmacother. 2007;41:957-964. (Pubitemid 46917622)