Long-term use of mesalamine (Rowasa) suppositories in remission maintenance of ulcerative proctitis

Stephen Hanauer*, Larry I. Good, Michael W. Goodman, Ronald J. Pizinger, Williamson B. Strum, Carl Lyss, Gregory Haber, C. Noel Williams, Malcolm Robinson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

66 Scopus citations


OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of a single nightly 500-mg Rowasa (mesalamine) suppository as maintenance therapy for patients with ulcerative proctitis in remission. METHODS: In this 24-month, multicenter, double-blind trial, 65 patients with ulcerative proctitis in clinical and endoscopic remission were randomized to receive either a single nightly 500-mg rectal mesalamine (Rowasa) suppository or matching placebo as sole therapy. Efficacy was assessed by time to relapse (defined as rectal bleeding or increase in stool frequency for ≥ 1 wk and active inflammation upon endoscopy). RESULTS: Mean time to relapse was 453.4 days for mesalamine-treated patients and 158.0 days for placebo-treated patients. Survival analysis demonstrated that time to relapse was significantly greater for mesalamine-treated patients than for placebo-treated patients (p < 0.001). In addition, at both 12 and 24 months, the proportion of placebo-treated patients (86% at 12 months and 89% at 24 months) who relapsed was significantly (p ≤ 0.001) greater than mesalamine-treated patients (32% and 46%, respectively). No statistically significant differences occurred between treatment groups in the reporting of any particular adverse event or the number of patients reporting adverse events. CONCLUSIONS: The results demonstrate that mesalamine suppositories are efficacious, well tolerated, and safe for the long-term maintenance of remission of ulcerative proctitis. (C) 2000 by Am. Coll. of Gastroenterology.

Original languageEnglish (US)
Pages (from-to)1749-1754
Number of pages6
JournalAmerican Journal of Gastroenterology
Issue number7
StatePublished - Jul 1 2000

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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