Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis

Abstract

Background:Mesalazine suppositories at 500 mg b.d. are a safe and effective treatment for patients with ulcerative proctitis or distal proctosigmoiditis. Recently a mesalazine 1 g suppository (Pentasa) has been developed.Methods:Fifty patients with active ulcerative colitis extending not beyond 20 cm from the anus on sigmoidoscopy, participated in a randomized single‐blind study comparing the efficacy, tolerance and acceptance of the new Pentasa mesalazine 1 g suppository, given once daily versus Claversal mesalazine 500 mg suppository b.d.Results:After 2 weeks, clinical remission was observed in 16 of 25 (64%) in the Pentasa group and in 7 of 25 (28%) in the Claversal 500 mg b.d. treated group; sigmoidoscopic remission occurred in 13 of 25 (52%) in the Pentasa group and in six of 25 (24%) in the Claversal group (P < 0.01). After 4 weeks, clinical and sigmoidoscopic remission were observed, respectively, in 84 and 76% of patients treated with Pentasa suppositories, and in 80 and 72% of patients treated with Claversal suppositories 500 mg b.d. (P= N.S.). The patients' evaluation for tolerability and practicality showed that the Pentasa suppository was significantly superior to the Claversal suppository.Conclusions:Pentasa 1 g suppository once daily induces a quicker clinical and sigmoidoscopic remission, and was better tolerated, than the Claversal 500 mg suppository b.d., and it may represent an advance for the topical treatment of distal proctosigmoiditis.

Topical Therapies in Inflammatory Bowel Disease

“…However, all topical 5-ASA formulations are equally efficacious in the treatment of proctitis [9]. Suppositories with 1,000 mg 5-ASA are effective and appear to be the most feasible topical therapy [7,10,11,12]. Suppositories can induce remission in about two thirds of patients with ulcerative proctitis [13].…”

“…A meta-analysis of 11 studies showed that topical 5-ASA induces remission in 67% of patients versus only 7–11% induced by placebo therapy. More than 1,000 mg topical 5-ASA did not show a greater benefit [11]. Topical 5-ASA is clearly more potent in inducing remission than topical steroids [14] which are the second-line therapy for patients who do not tolerate the topical 5-ASA therapy (this is rare).…”

“…Topical therapies may have disturbing side effects including leakage, problems with retention and bloating [11]. Serious complications such as rectal perforation are only described on the level of case reports [23] and can be assumed to be absolute rarities.…”

Consensus guidelines for the management of inflammatory bowel disease

“…Mesalazine suppositories are more efficient than topical treatments with corticosteroids (27) , which must be limited to patients intolerant or insensitive to mesalazine (73) . Mesalazine enema when well applied may reach the splenic angle and is the favorite drug to treat proctosigmoiditis, but it promotes a lower concentration of 5-ASA in the rectum when compared with suppositories.…”

Which 5-ASA?

“…Suppositories are often appropriate for proctitis because >90% liquid 5-ASA enemas bypass the rectum. 4 For active proctitis, a 1 g Pentasa suppository is more rapidly effective than two 500 mg Claversal (similar to Asacol) suppositories 5 and also maintains remission. 6 For distal or left sided disease, suppositories can be combined with enemas.…”