Gastroenterology
Volume 138, Issue 4 , Pages 1286-1296.e3 , April 2010

Once-Daily Dosing of Delayed-Release Oral Mesalamine (400-mg Tablet) Is as Effective as Twice-Daily Dosing for Maintenance of Remission of Ulcerative Colitis

  • William J. Sandborn

      Affiliations

    • 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
    • ,
  • Joshua Korzenik

      Affiliations

    • Crohn's & Colitis Center and Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts
    • ,
  • Bret Lashner

      Affiliations

    • Digestive Disease Institute, Cleveland Clinic, Cleveland, Ohio
    • ,
  • Jonathan A. Leighton

      Affiliations

    • Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona
    • ,
  • Uma Mahadevan

      Affiliations

    • Center for Colitis and Crohn's Disease, University of California, San Francisco, California
    • ,
  • James F. Marion

      Affiliations

    • Department of Medicine, Division of Gastroenterology, Mt. Sinai School of Medicine, New York, New York
    • ,
  • Michael Safdi

      Affiliations

    • Ohio Gastroenterology and Liver Institute, Cincinnati, Ohio
    • ,
  • Charles A. Sninsky

      Affiliations

    • Digestive Disease Associates, Gainesville, Florida
    • ,
  • Raman M. Patel

      Affiliations

    • High Desert Gastroenterology, Inc, Lancaster, California
    • ,
  • Keith A. Friedenberg

      Affiliations

    • Great Lakes Gastroenterology, Mentor, Ohio
    • ,
  • Preston Dunnmon

      Affiliations

    • Procter & Gamble Pharmaceuticals, Inc, Mason, Ohio
    • ,
  • David Ramsey

      Affiliations

    • Procter & Gamble Pharmaceuticals, Inc, Mason, Ohio
    • ,
  • Sunanda Kane

      Affiliations

    • Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota

Received 14 October 2009 ,Accepted 28 December 2009.

  • Image Result

    Patient disposition. A total of 1023 patients were randomized to either a once-daily or twice-daily treatment regimen and dosed with delayed-release mesalamine 1.6–2.4 g/day.

    Patient disposition. A total of 1023 patients were randomized to either a once-daily or twice-daily treatment regimen and dosed with delayed-release mesalamine 1.6–2.4 g/day.

  • Image Result

    (A) Maintenance of clinical remission at months 3, 6, and 12. The once-daily dosing regimen was noninferior to the twice-daily dosing regimen for the end point of maintaining clinical remission at mon

    (A) Maintenance of clinical remission at months 3, 6, and 12. The once-daily dosing regimen was noninferior to the twice-daily dosing regimen for the end point of maintaining clinical remission at months 3, 6, and 12. (B) Time to relapse (month 6). At month 6 the time to relapse was similar between the once-daily and twice-daily dosing regimens (hazard ratio, 1.17; 95% CI, 0.76, 1.80). (C) Time to relapse (month 12). At month 12 the time to relapse was similar between the once-daily and twice-daily dosing regimens (hazard ratio, 1.01; 95% CI, 0.71, 1.42).

  • Image Result
    MARS (months 3, 6, and 12) medication adherence between the once-daily and twice-daily dosing regimens was significantly different at month 3 (P = .04) but not at month 6 (P = .18) or month 12 (P = .1

    MARS (months 3, 6, and 12) medication adherence between the once-daily and twice-daily dosing regimens was significantly different at month 3 (P = .04) but not at month 6 (P = .18) or month 12 (P = .12).

  • Image Result
    Treatment outcome by subgroups at month 12. The maintenance of clinical remission rate was consistent among most subgroups for the once-daily and twice-daily dosing regimens.

    Treatment outcome by subgroups at month 12. The maintenance of clinical remission rate was consistent among most subgroups for the once-daily and twice-daily dosing regimens.

 This article has an accompanying continuing medical education activity on page e11. Learning Objective: Upon completion of reading this article, successful learners will become familiar with the comparative efficacy of once-daily dosing of delayed-release mesalamine as compared with divided dosing in patients with ulcerative colitis.

 Conflicts of interest These authors disclose the following: William Sandborn has served as a consultant for and received research funding from Procter & Gamble Pharmaceuticals, Inc, and Shire Pharmaceuticals, and has served as a consultant for Salix Pharmaceuticals, Inc; Joshua Korzenik has served as a consultant for Procter & Gamble Pharmaceuticals, Shire, CytokinePharma, Eurand, Zyogenetics, and received research funding from Procter & Gamble Pharmaceuticals; Bret Lashner has served on the Advisory Board/Speakers Bureau for Procter & Gamble Pharmaceuticals, Salix, Shire, UCB, Abbott, and Prometheus; Jonathan Leighton has served as a consultant for Procter & Gamble Pharmaceuticals and received research funding from Procter & Gamble Pharmaceuticals, Abbott, Bristol Myers Squibb, Otsuka, and Centocor; Uma Mahadevan has served as a consultant for Procter & Gamble Pharmaceuticals and Shire; James F. Marion has served as a consultant for Procter & Gamble Pharmaceuticals and has served on the Speakers Bureau for Procter & Gamble Pharmaceuticals, Shire, and UCB; Michael Safdi has received research funding from Forest Research Institute, Conatus, Shire, Tibotec, Millennium, Cosmo, Abbott, Centocor, Pfizer, Elan, Procter & Gamble Pharmaceuticals, Salix Pharmaceuticals, Biolex, Gilead, Roche, Vertex, Celltech, Eisai, BMS, and Lexicon, has served as a consultant for Procter & Gamble Pharmaceuticals, and has served on the Speakers Bureau for Procter & Gamble Pharmaceuticals, Shire, and Centocor; Charles A. Sninsky has served on Advisory Boards and Speakers Bureau for Procter & Gamble Pharmaceuticals, Shire, Centocor, Abbott, UCB, and Prometheus; Keith A. Friedenberg owns shares of Procter & Gamble stock; Preston Dunnmon and David Ramsey are employees of Procter & Gamble Pharmaceuticals; and Sunanda Kane has served as a consultant for and received research funding from Procter & Gamble Pharmaceuticals and Shire. The remaining authors disclose no conflicts: Raman M. Patel.

 Funding This study was funded by Procter & Gamble Pharmaceuticals, Inc, Mason, Ohio. ClinicalTrials.gov Identifier NCT00505778.

 View this article's video abstract at www.gastrojournal.org.

PII: S0016-5085(10)00006-5

doi: 10.1053/j.gastro.2009.12.054

Gastroenterology
Volume 138, Issue 4 , Pages 1286-1296.e3 , April 2010

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