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Safety and efficacy of controlled-release mesalamine for maintenance of remission in ulcerative colitis

  • Intestinal Disorders, Inflammatory Bowel Disease, Immunology, And Microbiology
  • Published:
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Abstract

This 12-month, double-blind, placebo-controlled study randomized 205 ulcerative colitis patients in remission to placebo or controlled-release mesalamine at 4 g/day for 12 months. Patients were stratified to either pancolitis or left-sided disease, based on previous diagnosis. Maintenance of remission was defined as a sigmoidoscopic index of <5, less than five stools per day, and the absence of rectal bleeding. A significantly greater number of patients maintained remission on mesalamine 4 g/day than on placebo at each of five study visits, following the first one-month visit (P<0.05). The estimated 12-month remission rates for the mesalamine group were 64% (38% for placebo,P=0.0004). Baseline subgroups (disease location, time since last flare of active disease, and previous response to oral/rectal steroids or sulfasalazine) did not influence remission rates. Treatment-related adverse events were rare. Controlled-release mesalamine is a safe and efficacious single agent for maintaining remission of ulcerative colitis.

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Author information

Authors and Affiliations

  1. University of Kansas Medical Center, 39th & Rainbow Boulevard, 66103, Kansas City, Kansas

    Philip Miner Jr. MD, Stephen Hanauer MD, Malcolm Robinson MD, Jerrold Schwartz MD & Sanjeev Arora MD

  2. University of Chicago School of Medicine, Chicago, Illinois

    Philip Miner Jr. MD, Stephen Hanauer MD, Malcolm Robinson MD, Jerrold Schwartz MD & Sanjeev Arora MD

  3. HCA Presbyterian Hospital, Oklahoma City, Oklahoma

    Philip Miner Jr. MD, Stephen Hanauer MD, Malcolm Robinson MD, Jerrold Schwartz MD & Sanjeev Arora MD

  4. Northwest Gastroenterologists, Arlington Heights, Illinois

    Philip Miner Jr. MD, Stephen Hanauer MD, Malcolm Robinson MD, Jerrold Schwartz MD & Sanjeev Arora MD

  5. New England Medical Center, Boston, Massachusetts

    Philip Miner Jr. MD, Stephen Hanauer MD, Malcolm Robinson MD, Jerrold Schwartz MD & Sanjeev Arora MD

Authors
  1. Philip Miner Jr. MD
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  2. Stephen Hanauer MD
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  3. Malcolm Robinson MD
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  4. Jerrold Schwartz MD
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  5. Sanjeev Arora MD
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Consortia

Pentasa UC Maintenance Study Group

Additional information

The members of the Pentasa Study Group are as follows: Austin Diagnostic Clinic, Austin, Texas: Rambie L. Briggs, MD (Chief Investigator), V. Lawlis, MD, C. Felger, MD, G. Kitzmiller, MD, T. Liebermann, MD, Robert Frachtman, MD, Cindy Fischer, RN; San Francisco General Hospital, San Francisco, California: John P. Cello, MD (Chief Investigator), James Grendell, MD, Julie Satow, RN; University of Chicago School of Medicine, Chicago, Illinois: Stephen B. Hanauer, MD (Chief Investigator), Ira Hanan, MD, Pat Schultz, RN, Debbie James, RN; Nalle Clinic, Charlotte, North Carolina: James Mertesdorf, MD (Chief Investigator), Fitzgerald Hiestand, Jr., MD, Paul Tucker, Jr., MD, Thomas Roberts, MD, Pepper Brundage, CMA, Theresa Griffin, Medical Assistant, Janet E. Beck, CMA; Gastrointestinal Association, PA, Shawnee Mission, Kansas: Gregory Rick, Jr., MD (Chief Investigator), William Hartong, MD, William Buser, MD, Stanley Brand, MD, Peggy Bryant, RN, Michelle Kliewer, RN; HCA Presbyterian Hospital, Oklahoma City, Oklahoma: Malcolm Robinson, MD (Chief Investigator), Mark Mellow, MD, Robert McFadden, MD, David Neumann, MD, Karen Helin, Connie J. Privett-Cointepas, Rosemary R. Meek; Forsyth Medical Specialists, Winston-Salem, North Carolina: Walter Roufail, MD (Chief Investigator), Robert Brice, MD, Thomas P. Hughes, MD, Michael Fina, MD, Daniel Murphy, MD, Lacole Clinard, RN, Debbie Allman, Brenda Bowen; Northwest Gastroenterologists, Arlington Heights, Illinois: Jerrold L. Schwartz, MD (Chief Investigator), Igor Jurcik, MD, Loren B. White, MD, Michael Cohen, MD, David Sales, MD, PhD, Sandra Gochnour, RN, Nora M. York, RN; Digestive Healthcare, Minneapolis, Minnesota: David Weinberg, MD (Chief Investigator), Richard A. Dubow, MD, James Pries, MD, Joseph Tombers, MD, Stephen Gilberstadt, MD, Philip Hanna, MD, Mary Jane Watson, PharmD, Michele Mattison, LPN; Greater Cincinnati Gastroenterology Associates, Cincinnati, Ohio: Michael Safdi, MD (Chief Investigator), Alan Safdi, MD, Ronald Schneider, MD, George Waissbluth, MD, Michael D. Kraines, MD, Linda Magaw, CRC, Nancy Emrath, CRC; New England Medical Center, Boston, Massachusetts: Sanjeev Arora, MD, Marshall Kaplan, MD, Augusta McKusick, RN; Gastroenterology of Lake City, Waukegan, Illinois: Fred Rosenberg, MD (Chief Investigator), E.P. Kirch, MD, Hugh A. Allen, MD, Beth Weber, RN, Valley Health Care Medical Group, Binghamton, New York: Marcelo A. Barriero, MD (Chief Investigator), Leslie Bank, MD, Linda Gitchell, RN; Scripps Clinic Medicine Group, Inc, La Jolla, California: Williamson B. Strum, MD (Chief Investigator), Leona Goodman; University of Kansas Medical Center, Kansas City, Kansas: Philip Miner, MD (Chief Investigator), Steven Matter, MD, Dace Miller, MD, Clark Antonson, MD, Roland Christian, MD, Wendy Biddle, RN, Susan Clark, RN, Dorinda S. Sutton, RN; Oregon Health Sciences University, Portland, Oregon: Ronald M. Katon, MD (Chief Investigator), Fred Smith, MD, Kent Benner, MD, Emmet Keeffe, MD, David Lieberman, MD, Clifford Melnyk, MD, Flordeliz Lindenburg, Sue Webster; Medical College of Virginia, Richmond, Virginia: Alvin Zfass, MD, Donald Kirby, MD, Alfred Lee, MD, Yuen San Yee, MD, Paula Goshgarian-Patrick; Wake Research Associates, Raleigh, North Carolina: Charles Barish, MD, Philip Ashburn, MD, Diedrich C. Waterman, MD, Patricia M. Patterson, RN; Birmingham Gastroenterology Associates, Birmingham, Alabama: W. Roger Carlisle, MD (Chief Investigator), Leonard OuTim, MD, Raymond Tobias, MBChB, J. Lynn Cochran, MD, Walter J. Bristow, III, MD, Peter D. Miller, MD, Sarah Ingle, RN; Bowman-Gray School of Medicine, Wake Forest University, Winston-Salem, North Carolina: Robert M. Kerr, MD, Donald Castell, MD, Wallace C. Wu, MD, Joel E. Richter, MD, John H. Gilliam, III, MD, Greg Stark, PA; Marion Merrell Dow Inc., Kansas City, Missouri: Ruthanna Law, BSN, MA, Neil Malone, MA, Larry Roi, PhD, Michael Coen, MA, Doug Moore, BA, Mike McPherson, PharmD, MBA.

Grant support for this trial was provided by Marion Merrell Dow Inc.

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Miner, P., Hanauer, S., Robinson, M. et al. Safety and efficacy of controlled-release mesalamine for maintenance of remission in ulcerative colitis. Digest Dis Sci 40, 296–304 (1995). https://doi.org/10.1007/BF02065413

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