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

Abstract

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 > or =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 < or = 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.

• Authors: S Hanauer, L I Good, M W Goodman, R J Pizinger, W B Strum, C Lyss, G Haber, C N Williams, M Robinson
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 95 Issue 7 Pg. 1749-54 (Jul 2000) ISSN: 0002-9270 [Print] United States
• PMID: 10925979 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Suppositories
• Mesalamine

Topics

• Adult
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
• Colitis, Ulcerative (drug therapy, prevention & control)
• Double-Blind Method
• Female
• Humans
• Male
• Mesalamine (administration & dosage)
• Middle Aged
• Recurrence
• Remission Induction
• Suppositories
• Time Factors