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 eVective in preventing relapse of ulcerative proctitis. Maintenance of remission with lower doses would be an advantage. Aim-The eYcacy 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 eVective for preventing relapses of cryptogenetic proctitis. Increasing the dose to 1 g/day is eVective in a high proportion of subjects who relapsed.

Should maintenance therapy be performed in ulcerative proctitis? How long should it be continued?

“…In conclusion, in maintenance treatment, mesalamine suppository treatments were found to be superior to placebo, mesalamine enema treatment was found to be superior to mesalamine oral treatment, and combined treatment (oral + rectal) was found to be superior to oral treatment (1,(12)(13)(14)17,18). Budesonide enema was not found to be effective in maintenance treatment (15).…”

“…Mesalamine suppository 1 g (3 days/week for 6 months, 12 months, 24 months) and placebo (3 days/week for 6 months, 12 months, 24 months) were compared, and mesalamine treatment was found to be superior in the maintenance of remission (13). Mesalamine suppository 500 mg (12 months, 24 months) and placebo (12 months, 24 months) were compared, and mesalamine treatment was found to be superior in the maintenance of remission (1).…”

Ulcerative proctitis: an update on the pharmacotherapy and management

“…seems to be the most efficient therapeutic regimen for maintenance with a cumulative relapse rate of 10% at 12 months (95% CI: 0 --21) [71]. However, even intermittent topical treatment is more efficient maintenance treatment than placebo [72,73].…”

Discussion About Treatment of Ulcerative Colitis.

“…Daily (500 mg) and every-other-day (1000 mg) administration of mesalamine suppositories was more effective than placebo in maintaining remission in patients with mild-to-moderate ulcerative proctitis at 1 and 2 years. [11,12] Several studies, including a meta-analysis published in 2000, confirmed the efficacy of 5-ASA in an enema formulation in both inducing and maintaining remission in left-sided ulcerative colitis (defined as distal to the splenic flexure). [13][14][15][16] The addition of topical 5-ASA to oral therapy increases mucosal levels of mesalamine by 3-fold in the descending colon and over 20-fold in the rectum.…”