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Gut. 1998 Feb;42(2):195-9.

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.

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1
Gastroenterology Unit, Saint-Lazare Hospital, Paris, France.

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.

Comment in

  • ACP J Club. 1998 Sep-Oct;129(2):43.
PMID:
9536943
PMCID:
PMC1727004
DOI:
10.1136/gut.42.2.195
[Indexed for MEDLINE]
Free PMC Article

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