Use of mesalazine slow release suppositories 1 g three times per week to maintain remission of ulcerative proctitis: a randomised double blind placebo controlled multicentre study.

Abstract

BACKGROUND:

Daily administration of rectal formulations of mesalazine is effective in preventing relapse of ulcerative proctitis. Maintenance of remission with lower doses would be an advantage.

AIM:

The efficacy of mesalazine suppositories (Pentasa) 1 g three times a week v placebo to maintain remission in patients with cryptogenetic proctitis was studied.

METHODS:

Ninety five patients with cryptogenetic proctitis were randomised within two weeks of remission to receive for one year or until relapse three suppositories per week of either Pentasa (n = 48) or placebo (n = 47). In the case of a relapse, the patients received one suppository/day.

RESULTS:

It was found that 25 of 48 subjects v 18 of 47 remained in remission in the mesalazine and placebo groups respectively. The relapse rate was lower in the mesalazine group for the following time intervals: 0-90 days (19% v 38%, p = 0.035), 0-180 days (29% v 54%, p = 0.017), 0-270 days (38% v 60%, p = 0.031), and 0-365 days (48% v 62%, p = 0.18). Treatment of relapse with one suppository/day induced remission in 11 of 18 and 2 of 26 patients in the mesalazine and placebo groups respectively (p = 0.001). Overall, 61% v 28% patients remained in the protocol and were in remission at one year (p = 0.001). Tolerance was good.

CONCLUSION:

Mesalazine suppositories 1 g three times a week are effective for preventing relapses of cryptogenetic proctitis. Increasing the dose to 1 g/day is effective in a high proportion of subjects who relapsed.

• Authors: P Marteau, J Crand, M Foucault, J C Rambaud
• Journal: Gut (Gut) Vol. 42 Issue 2 Pg. 195-9 (Feb 1998) ISSN: 0017-5749 [Print] England
• PMID: 9536943 (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
• Delayed-Action Preparations
• Suppositories
• Mesalamine

Topics

• Adult
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, therapeutic use)
• Colitis, Ulcerative (prevention & control)
• Delayed-Action Preparations
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Mesalamine (administration & dosage, therapeutic use)
• Recurrence
• Suppositories