COMPARISON OF THE EFFICACY AND SAFETY OF 1.5 COMPARED WITH 3.0 G ORALSLOW-RELEASE MESALAZINE (PENTASA) IN THE MAINTENANCE TREATMENT OF ULCERATIVE-COLITIS

Objective: To investigate a possible dose-effect relationship with two dosages of oral slow-release mesalazine in patients with quiescent ul cerative colitis. Method: One hundred and sixty-nine patients with ulc erative colitis in remission were treated with either 1.5 or 3.0 g/day mesalazine for 1 year or until relapse into active colitis. Results: Fewer of the 3.0 g dose group relapsed than of the 1.5 g dose group (3 3 compared with 46%). This difference failed to reach statistical sign ificance (P = 0.057). A significant relationship between age and relap se rate was established. No dose-related adverse events were found. Th ree serious drug-related adverse events were, however, reported. All o f the serious adverse reactions resolved after the medication was disc ontinued. Conclusion: There is a trend for high doses of oral mesalazi ne to be more effective in prevention of relapse of ulcerative colitis . These higher doses are not associated with a higher incidence of adv erse reactions.