Gastroenterology
Volume 137, Issue 6 , Pages 1934-1943.e3 , December 2009

Delayed-Release Oral Mesalamine 4.8 g/day (800-mg Tablet) Is Effective for Patients With Moderately Active Ulcerative Colitis

  • William J. Sandborn

      Affiliations

    • Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
    • Corresponding Author InformationReprint requests Address requests for reprints to: William J. Sandborn, MD, Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905. fax: (507) 266-0335
    • ,
  • Jaroslaw Regula

      Affiliations

    • Medical Center for Postgraduate Education and the Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland
    • ,
  • Brian G. Feagan

      Affiliations

    • Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
    • ,
  • Elena Belousova

      Affiliations

    • Moscow Regional Research Clinical Institute, Moscow, Russian Federation
    • ,
  • Njegica Jojic

      Affiliations

    • KBC Zvezdara University Centre, Belgrade, Serbia
    • ,
  • Milan Lukas

      Affiliations

    • General Faculty Hospital, Prague, Czech Republic
    • ,
  • Bruce Yacyshyn

      Affiliations

    • University of Cincinnati, Cincinnati, Ohio
    • ,
  • Piotr Krzeski

      Affiliations

    • Procter & Gamble Pharmaceuticals, Inc, Egham, United Kingdom
    • ,
  • Chyon–Hwa Yeh

      Affiliations

    • Procter & Gamble Pharmaceuticals, Inc, Mason, Ohio
    • ,
  • Christi A. Messer

      Affiliations

    • Procter & Gamble Pharmaceuticals, Inc, Mason, Ohio
    • ,
  • Stephen B. Hanauer

      Affiliations

    • University of Chicago, Chicago, Illinois

Received 26 April 2009 ,Accepted 27 August 2009.

References 

  1. Sutherland L, MacDonald JK. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006;Apr 19(2):CD000543. Review.
  2. Sutherland L, MacDonald JK. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006;Apr 19(2):CD000544. Review
  3. Carter MJ, Lobo AJ, Travis SP IBD Section British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2004;53(Suppl 5):V1–V16
  4. Kornbluth A, Sachar DB Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2004;99:1371–1385
  5. Travis SPL, Stange EF, Lémann M, et al. European evidence-based consensus on the management of ulcerative colitis: current management. J Crohns Colitis. 2008;2:24–62
  6. Baron JH, Connell AM, Lennard-Jones JE, et al. Sulfasalazine and salicylazosulphadimidine in ulcerative colitis. Lancet. 1962;1:1094–1096
  7. Dick AP, Grayson AP, Carpenter RG, et al. A controlled trial of sulphasalazine in the treatment of ulcerative colitis. Gut. 1964;5:437–442
  8. Sandborn WJ. Oral 5-ASA therapy in ulcerative colitis: what are the implications of the new formulations?. J Clin Gastroenterol. 2008;42:338–344
  9. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis (A randomized study). N Engl J Med. 1987;317:1625–1629
  10. Sninsky CA, Cort DH, Shanahan F, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis (A multicenter study). Ann Intern Med. 1991;115:350–355
  11. Hanauer SB, Sandborn WJ, Dallaire C, et al. Delayed-release oral mesalamine 4.8 g/day (800 mg tablets) compared to 2.4 g/day (400 mg tablets) for the treatment of mildly to moderately active ulcerative colitis: the ASCEND I trial. Can J Gastroenterol. 2007;21:827–834
  12. Hanauer SB, Sandborn WJ, Kornbluth A, 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
  13. Baron JH, Connell AM, Lennard-Jones JE. Variation between observers in describing mucosal appearances in proctocolitis. Br Med J. 1964;1:89–92
  14. Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily high concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007;132:66–75
  15. Lichtenstein GR, Kamm MA, Boddu P, 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
  16. Shire LLC. Prescribing information for Lialda (mesalamine) delayed release tablets. Package insert. 2007;
  17. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476
  18. Hanauer SB, Ramsey D, Sandborn WJ. Efficacy of delayed-release oral mesalamine in patients who received previous ulcerative colitis treatment. Gastroenterology. 2008;134(Suppl 1):A490
  19. Kamm MA, Lichtenstein GR, Sandborn WJ, et al. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009;15:1–8
  20. D'Haens G, Sandborn WJ, Feagan BG, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007;132:763–786

 This article has an accompanying continuing medical education activity on page 2158. Learning Objective: Upon completion of reading this article, successful learners will be able to apply the results of the study to their practice by weighing the potential benefits of mesalamine dosed at 2.4 or 4.8 g/d in individual patients with moderate ulcerative colitis.

 Conflicts of interest The authors disclose the following: Dr Sandborn has served as a consultant for and received research funding from Procter & Gamble Pharmaceuticals and Shire Pharmaceuticals, and has served as a consultant for Salix Pharmaceuticals. Dr Regula has obtained lecture fees from Abbott and Schering Plough. Dr Feagan has received honorariums from Procter & Gamble Pharmaceuticals. Dr Yacyshyn was previously employed by Procter & Gamble Pharmaceuticals. Drs Krzeski, Yeh, and Messer are employees of Procter & Gamble Pharmaceuticals. Dr Hanauer has served as a consultant for and received clinical research support from Procter & Gamble Pharmaceuticals and has served as a consultant to Shire Pharmaceuticals, Ferring Pharmaceuticals, and Salix Pharmaceuticals. The remaining authors disclose no conflicts.

 Funding This study was funded by Procter & Gamble Pharmaceuticals, Inc, Mason, Ohio.

PII: S0016-5085(09)01570-4

doi: 10.1053/j.gastro.2009.08.069

Gastroenterology
Volume 137, Issue 6 , Pages 1934-1943.e3 , December 2009

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