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

Philip Miner*, Stephen Hanauer, Malcolm Robinson, Jerrold Schwartz, Sanjeev Arora

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

119 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)296-304
Number of pages9
JournalDigestive diseases and sciences
Volume40
Issue number2
DOIs
StatePublished - Feb 1995

Keywords

  • 5-aminosalicylic acid
  • controlled-release mesalamine capsules
  • recurrence
  • remission maintenance
  • ulcerative colitis

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

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