MMX mesalamine for induction and maintenance therapy in mild-to-moderate ulcerative colitis

Gastroenterology and Hepatology

Volumn 5, Issue 7, 2009, Pages 494-500

  Hanauer, Stephen B ^a   Lichtenstein, Gary R ^b   Kamm, Michael A ^c   Sandborn, William J ^d   Lees, Kirstin H ^e   Barrett, Karen ^f   Karlstadt, Robyn G ^e   Diebold, Ron ^e   Joseph, Raymond E ^e  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c ST VINCENT S HOSPITAL   (Australia)

^d MAYO CLINIC   (United States)

^e SHIRE   (United States)

^f Shire Pharmaceuticals   (United Kingdom)

Author keywords

5 aminosalicylic acid; MMX mesalamine; Ulcerative colitis

Indexed keywords

MESALAZINE; PLACEBO; SPD 476301; SPD 476302; SPD 476303; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DELAYED RELEASE FORMULATION; DISEASE SEVERITY; DRUG DOSE COMPARISON; DRUG EFFECT; FEMALE; HUMAN; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REMISSION; ULCERATIVE COLITIS;

EID: 68349092536     PISSN: 15547914     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. Brunner M, Assandri R, Kletter K, Tschurlovits M, Corrado ME, et al. Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation. Aliment Pharmacol Ther. 2003;17:395-402. (Pubitemid 36259402)
2. Prantera C, Viscido A, Biancone L, Francavilla A, Giglio L, Campieri M. A new oral delivery system for 5-ASA: preliminary clinical findings for MMx. Inflamm Bowel Dis. 2005;11:421-427. (Pubitemid 40704075)
3. Tenjarla S, Romasanta V, Zeijdner E, Villa R, Moro L. Release of 5-aminosalicylate from the MMX™ mesalamine tablet during transit through a simulated gastrointestinal tract system. Adv Ther. 2007;24:826-840. (Pubitemid 351612256)
4. Lichtenstein GR, Kamm MA, Boddu P, Gubergrits N, Lyne A, et al. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007;5:95-102. (Pubitemid 46096842)
5. Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, et al. Once-daily high concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007;132:66-75. (Pubitemid 46108735)
6. Lichtenstein GR, Kamm MA, Sandborn WJ, Lyne A, Joseph RE. MMX Mesalamine for the induction of remission of mild-to-moderately active ulcerative colitis: efficacy and tolerability in patient subpopulations. Aliment Pharmacol Ther. 2008;27:1094-1102. (Pubitemid 351614894)
7. Kamm MA, Colombel J-F, Kornbluth A, Diebold R, Barrett K, et al. A randomized comparison of once- versus twice-daily MMX mesalamine for the maintenance of remission in mild-to-moderate ulcerative colitis [abstract]. Gut. 2008;57:893-902.
8. Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, et al. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009;15:1-8.
9. Sandborn WJ, Kamm MA, Lichtenstein GR, Lyne A, Butler T, Joseph RE. Multi Matrix System (MMX®) mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Aliment Pharmacol Ther. 2007;26:205-215. (Pubitemid 46985493)
10. D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, et al. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007;132:763-786. (Pubitemid 46306135)
11. Hanauer SB, Sandborn WJ, Kornbluth A, Katz S, Safdi M, et al. Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol. 2005;100:2478-2485. (Pubitemid 43919680)
12. Kruis W, Bar-Meir S, Feher J, Mickisch O, Mlitz H, et al. The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: a dose-finding study with newly developed mesalamine. Clin Gastroenterol Hepatol. 2003;1:36-43. (Pubitemid 37254470)
13. Green JR, Lobo AJ, Holdsworth CD, Leicester RJ, Gibson JA, et al. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. The Abacus Investigator Group. Gastroenterology 1998;114:15-22.
14. Green JR, Mansfield JC, Gibson JA, Kerr GD, Thornton PC. A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis. Aliment Pharmacol Ther. 2002;16:61-68. (Pubitemid 34123865)
15. Hanauer SB, Barish C, Pambianco D, Sigmon R, Gannon R, Koval G. A multi-center, double-blind, placebo-controlled, dose-ranging trial of olsalazine for mild-moderately active ulcerative colitis [abstract]. Gastroenterology. 1996;110:A921.
16. Mahmood A, Melley L, Fitzgerald AJ, Ghosh S, Playford RJ. Trial of trefoil factor 3 enemas, in combination with oral 5-aminosalicylic acid, for the treatment of mild-to-moderate left-sided ulcerative colitis. Aliment Pharmacol Ther. 2005;21:1357-1364. (Pubitemid 40813682)
17. Sinha A, Nightingale J, West KP, Berlanga-Acosta J, Playford RJ. Epidermal growth factor enemas with oral mesalamine for mild-to-moderate left-sided ulcerative colitis or proctitis. N Engl J Med. 2003;349:350-357. (Pubitemid 36886241)
18. Biddle WL, Miner PB Jr. Long-term use of mesalamine enemas to induce remission in ulcerative colitis. Gastroenterology. 1990;99:113-118.
19. Meucci G, Fasoli R, Saibeni S, Valpiani D, Gullotta R, et al. Prognostic significance of endoscopy remission in patients with active ulcerative colitis treated with oral and topical mesalazine: preliminary results of a prospective, multicenter study [abstract]. Gastroenterology. 2006;130:A-197.
20. Rutgeerts P, Colombel JF, Reinisch W, Feagan BG, Rachmilewitz D, et al. Infliximab induces and maintains mucosal healing in patients with active ulcerative colitis: the ACT trial experience [abstract]. Gut. 2005;54:A-58.
21. Velayos FS, Terdiman JP, Walsh JM. Effect of 5-aminosalicylate use on colorectal cancer and dysplasia risk: a systematic review and meta-analysis of observational studies. Am J Gastroenterol. 2005;100:1345-1353.
22. Paoluzi OA, Iacopini F, Pica R, Crispino P, Marcheggiano A, et al. Comparison of two different daily dosages (2.4 vs. 1.2 g) of oral mesalazine in maintenance of remission in ulcerative colitis patients: 1-year follow-up study. Aliment Pharmacol Ther. 2005;21:1111-1119. (Pubitemid 40646537)
23. Kruis W, Schreiber S, Theuer D, Brandes JW, Schütz E, et al. Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses. Gut. 2001;49:783-789. (Pubitemid 33096035)
24. Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003;114:39-43. (Pubitemid 36126514)
25. Bernstein CN, Ediger JP, Graff LA, Rawsthorne P, Rogala L, et al. The Manitoba IBD cohort study: assessing the nature of medication adherence [abstract]. Gastroenterology. 2006;130 (4 suppl 2):W1167.
26. Kane S, De Vos M, Riley S, Frieri G, Mittmann U. Compliance issues in inflammatory bowel disease. Rev Gastroenterol Disord. 2005;5:101-106.
27. Kane SV, Cohen RD, Aikens JE, Hanauer SB. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001;96:2929-2933.
28. Kane SV. Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2006;23:577-585.