Systematic review: FDA-approved prescription medications for adults with constipation

Gastroenterology and Hepatology

Volumn 2, Issue 10, 2006, Pages 736-749

  Cash, Brooks D ^a,b   Lacy, Brian E ^c  

^a UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES   (United States)

^b WALTER REED ARMY MEDICAL CENTER   (United States)

^c DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

Author keywords

Constipation; Lactulose; Lubiprostone; PEG 3350; Polyethylene glycol; Tegaserod

Indexed keywords

BISACODYL; DOCUSATE SODIUM; ISPAGULA; LACTULOSE; LAXATIVE; LUBIPROSTONE; MACROGOL 3350; MAGNESIUM SULFATE; PLACEBO; SENNA EXTRACT; TEGASEROD;

ABDOMINAL CRAMP; ABDOMINAL DISCOMFORT; ABDOMINAL DISTENSION; ABDOMINAL PAIN; BLOATING; CHRONIC DISEASE; CLINICAL TRIAL; CONSTIPATION; DATA BASE; DEPRESSION; DIARRHEA; DOSE RESPONSE; DRUG APPROVAL; DRUG EFFICACY; DRUG HYPERSENSITIVITY; EMBASE; FEVER; FLATULENCE; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEARTBURN; HUMAN; MEDICAL LITERATURE; MEDICAL SPECIALIST; MEDLINE; META ANALYSIS; NAUSEA; PRESCRIPTION; PUBLICATION; QUALITY CONTROL; REVIEW; SCORING SYSTEM; SYSTEMATIC REVIEW; TREATMENT DURATION; UNITED STATES;

EID: 33845231169     PISSN: 15547914     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (56)

1. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004;99:750-759.
2. Pare P, Ferrazzi S, Thompson WG, et al. An epidemiological survey of constipation in Canada: definitions, rates, demographics, and predictors of health care seeking. Am J Gastroenterol. 2001;96:3130-3137.
3. Irvine EJ, Ferrazzi S, Pare P, et al. Health-related quality of life in functional GI disorders: focus on constipation and resource utilization. Am J Gastroenterol. 2002;97:1986-1993.
4. Dennison C, Prasad M, Lloyd A, et al. The health-related quality of life and economic burden of constipation. PharmacoEconomics. 2005;23:461-476.
5. Harris LA. Prevalence and ramifications of chronic constipation. Manag Care Interface. 2005:23-30.
6. Muller-Lissner SA, Kamm MA, Scarpignato C, Wald A. Myths and misconceptions about chronic constipation. Am J Gastroenterol. 2005;100:232-242.
7. Johanson JF, Gargano MA, Holland PC, et al. Multicenter open-label study of oral lubiprostone for the treatment of chronic constipation [abstract]. Am J Gastroenterol. 2005;100(suppl):S331.
8. Johanson JF, Gargano MA, Patchen ML, Ueno R. Efficacy and safety of a novel compound, RU-0211, for the treatment of constipation [abstract]. Gastroenterology. 2002;122:A-315.
9. Johanson JF, Gargano MA, Holland PC, et al. Phase III efficacy and safety of RU-0211, a novel chloride channel activator, for the treatment of constipation [abstract]. Gastroenterology, 2003;124:A104.
10. Johanson JF, Gargano MA, Holland PC, et al. Initial and sustained effects of lubiprostone, a chloride channel-2 (CIC-2) activator for the treatment of constipation: data from a 4-week phase III study [abstract]. Am J Gastroenterol. 2005;100(suppl):S324-S325.
11. Johanson JF, Gargano MA, Holland PC, et al. Phase III patient assessments of the effects of lubiprostone, a chloride channel-2 (CIC-2) activator, for the treatment of consitpation [abstract]. Am J Gastroenterol. 2005;100(suppl):S329- S330.
12. Johanson JF, Gargano MA, Holland PC, et al. Phase III, randomized withdrawal study of RU-0211, a novel chloride channel activator for the treatment of constipation [abstract]. Gastroenterology. 2004;126(suppl 2):A100.
13. Johanson JF, Gargano MA, Holland PC, et al. Phase III study of lubiprostone, a chloride channel-2 (CIC-2) activator for the treatment of constipation: safety and primary efficacy [abstract]. Am J Gastroenterol. 2005;100:(suppl):S328-S329.
14. Johanson JF, Panas R, Hotland P, Ueno R. A dose-ranging, double-blind, placebo-controlled study of lubiprostone in subjects with irritable bowel syndrome and constipation (C-IBS) [abstract]. Abstract presented at: Digestive Disease Week; May 20-25, 2006; Los Angeles, Calif. Abstract 131.
15. Johanson JF, Panas R, Holland P, Ueno R. Long-term efficacy of lubiprostone for the treatment of chronic constipation [abstract]. Abstract presented at: Digestive Disease Week; May 20-25, 2006; Los Angeles, Calif. Abstract 1171.
16. Joswick TR, Ueno R, Wahle A, et al. Efficacy and safety of lubiprostone for the treatment of chronic constipation in elderly vs non-elderly subjects [abstract]. Abstract presented at: Digestive Disease Week: May 20-25, 2006; Los Angeles, Calif. Abstract 51262.
17. Ueno R, Osama H, Engelke KJ. Effects of lubiprostone on morphine-induced constipation and analgesia [abstract]. Abstract presented at: Digestive Disease Week; May 20-25, 2006; Los Angeles, Calif. Abstract M1810.
18. Panas R, Ueno R, Wahle B, et al. Long-term safety and efficacy of lubiprostone for the treatment of chronic constipation in elderly subjects [abstract]. Abstract presented at: Digestive Disease Week; May 20-25, 2006; Los Angeles, Calif. Abstract S1200.
19. Joswick TR, Ueno R, Wahle et al. Efficacy and safety of lubiprostone for the treatment of chronic constipation in male vs female subjects [abstract]. Abstract presented at: Digestive Disease Week; May 20-25, 2006; Los Angeles, Calif. Abstract M1195.
20. Veldhuyzen Van Zanten SJ, Talley NJ, Bytzer P, et al. Design of treatment trials for functional gastrointestinal disorders. Gut. 1999;45(suppl 2):II69-II77.
21. Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials. N Engl J Med. 1983;309:1358-1361.
22. Urganci N, Akyildiz B, Polat TB. A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Pediatr Int. 2005;47:15-19.
23. Freedman MD, Schwartz HJ, Roby R, Fleisher S. Tolerance and efficacy of polyethylene glycol 3350/electrolyte solution versus lactulose in relieving opiate induced constipation: a double-blinded placebo-controlled trial. J Clin Pharmacol. 1997;37:904-907.
24. Lactulose (Chronulac) for constipation. Med Lett Drugs Ther. 1980;22:2-4.
25. Christie AH, Culbert P, Guest JF. Economic impact of low dose polyethylene glycol 3350 plus electrolytes compared with lactulose in the management of idiopathic constipation in the UK. PharmacoEconomics. 2002;20:49-60.
26. Passmore AP, Davies KW, Flanagan PG, et al. A comparison of Agiolax and lactulose in elderly patients with chronic constipation. Pharmacology. 1993;47(suppl 1):249-252.
27. Passmore AP, Wilson-Davies K, Stoker C, Scott ME. Chronic constipation in long stay elderly patients: a comparison of lactulose and a senna-fibre combination. BMJ. 1993;307:769-771.
28. Dettmar PW, Sykes J. A multi-centre, general practice comparison of ispaghula husk with lactulose and other laxatives in the treatment of simple constipation. Curr Med Res Opin. 1998;14:227-233.
29. Bouhnik Y, Neut C, Raskine L, et al. Prospective, randomized, parallel-group trial to evaluate the effects of lactulose and polyethylene glycol-4000 on colonie flora in chronic idiopathic constipation. Aliment Pharmacol Ther. 2004;19:889-899.
30. Attar A, Lemann M, Ferguson A, et al. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999;44:226-230.
31. Kinnunen O, Winblad I, Koistinen P, Salokannel J. Safety and efficacy of a bulk laxative containing senna versus lactulose in the treatment of chronic constipation in geriatric patients. Pharmacology. 1993;47(suppl 1):253-255.
32. Rouse M, Chapman N, Mahapatra M, et al. An open, randomised, parallel group study of lactulose versus ispaghula in the treatment of chronic constipation in adults. Br J Clin Pract. 1991;45:28-30.
33. Lederle FA, Busch DL, Mattox KM, et al. Cost-effective treatment of constipation in the elderly: a randomized double-blind comparison of sorbitol and lactulose. Am J Med. 1990;89:597-601.
34. Bass P, Dennis S. The laxative effects of lactulose in normal and constipated subjects. J Clin Gastroenterol. 1981;3(suppl 1):23-28.
35. Sanders JF. Lactulose syrup assessed in a double-blind study of elderly constipated patients. J Am Geriatr Soc. 1978;26:236-239.
36. Wesselius-De Casparis A, Braadbaart S, Bergh-Bohlken GE, Mimica M. Treatment of chronic constipation with lactulose syrup: results of a double-blind study. Gut. 1968;9:84-86.
37. Chaussade S, Minic M. Comparison of efficacy and safety of two doses of two different polyethylene glycol-based laxatives in the treatment of constipation. Aliment Pharmacol Ther. 2003;17:165-172.
38. Bazzocchi G. Polyethylene glycol solution in subgroups of chronic constipation patients: experience in obstructed defaecation. Ital J Gastroenterol Hepatol. 1999;31(suppl 3):S257-S259.
39. Lee DKC, Haggart K, Currie GP, et al. Effects of hydrofluoroalkane formulations of ciclesonide 400 micrograms once daily vs fluticasone 250 micrograms twice daily on methacholine hyper-responsiveness in mild-to-moderate persistent asthma. Br J Clin Pharmacol. 2004;58:26-33.
40. Ferguson A, Culbert P, Gillett H, Barras N. New polyethylene glycol electrolyte solution for the treatment of constipation and faecal impaction. Ital Gastroenterol Hepatol. 1999;31(suppl 3):S249-S252.
41. Corazziari E, Badiali D, Bazzocchi G, et al. Long term efficacy, safety, and tolerability of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation. Gut. 2000;46:522-526.
42. Klauser AG, Muhldorfer BE, Voderholzer WA, et al. Polyethylene glycol 4000 for slow transit constipation. Z Gastroenterol. 1995;33:5-8.
43. Neri I, Blasi I, Castro P, et al. Polyethylene glycol electrolyte solution (Isocolan) for constipation during pregnancy: an observational open-label study. J Midwifery Women's Health. 2004;49:355-358.
44. Corazziari E, Badiali D, Habib FI, et al. Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation. Dig Dis Sci. 1996;41:1636-1642.
45. Andorsky RI, Goldner F. Colonic lavage solution (polyethylene glycol electrolyte lavage solution) as a treatment for chronic constipation: a double-blind, placebo-controlled study. Am J Gastroenterol. 1990;85:261-265.
46. DiPalma JA, MacRae DH, Reichelderfer M, et al. Braintree polyethylene glycol (peg) laxative for ambulatory and long-term car facility constipation patients: report of randomized, cross-over trials. Online J Dig Health. 1999;1:1-7.
47. DiPalma JA, DeRidder PH, Orlando RC, et al. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol. 2000;95:446-450.
48. DiPalma AM, DiPalma JA. Women's colonic digestive health. Gastroenterol Nurs. 2002;25:3-8.
49. Cleveland MV, Flavin DP, Ruben RA, et al. New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. South Med J. 2001;94:478-481.
50. Kamm MA, Muller-Lissner S, Talley NJ, et al. Tegaserod for the treatment of chronic constipation: a randomized, double-blind, placebo-controlled multinational study [published correction appears in Am J Gastroenterol. 2005;100:735]. Am J Gastroenterol. 2005;100:362-372.
51. Johanson JF, Wald A, Tougas G, et al. Effect of tegaserod in chronic constipation: a randomized, double-blind, controlled trial. Clin Gastroenterol Hepatol. 2004;2:796-805.
52. DiPalma JA. Current treatment options for chronic constipation. Rev Gastroenterol Disord. 2004;4(suppl 2):S34-S42.
53. Enck P, Klosterhalfen S. The placebo response in functional bowel disorders: perspectives and putative mechanisms. Neurogastroenterol Motil. 2005;17:325-331.
54. Lacy BE, Yu S. Tegaserod: a new 5-HT4 agonist. J Clin Gastroenterol. 2002;34:27-33.
55. Orr KK. Lubiprostone: a novel chloride channel activator for the treatment of constipation. Formulary. 2006;41:118-120, 122, 128-129.
56. Lubiprostone: RU 0211, SPI 0211. Drugs Res Dev. 2005;6:245-248.