Original Papers: PDF OnlyComparison of the efficacy and safety of 1.5 compared with 3.0 g oral slow-release mesalazine (Pentasa) in the maintenance treatment of ulcerative colitisFockens, Paul1; Mulder, Chris J.J.*; Tytgat, Guido N.J.1; Blok, Paul†; Ferwerda, Jaap‡ Dutch Pentasa Study Group Author Information 1From the Department of Gastroenterology, Academic Medical Centre, Amsterdam *From the Department of Hepatogastroenterology, Rijnstate Hospital, Arnhem †From the Department of Pathology, Westeinde Hospital, The Hague ‡From the Department of Gastroenterology, Kennemer Gasthuis, Haarlem, The Netherlands §For a list of members of the Dutch Pentasa Study Group see the appendix European Journal of Gastroenterology & Hepatology: November 1995 - Volume 7 - Issue 11 - p 1025-1030 Buy Abstract Objective: To investigate a possible dose–effect relationship with two dosages of oral slow-release mesalazine in patients with quiescent ulcerative colitis. Method: One hundred and sixty-nine patients with ulcerative 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 (33 compared with 46%). This difference failed to reach statistical significance (P=0.057). A significant relationship between age and relapse rate was established. No dose-related adverse events were found. Three serious drug-related adverse events were, however, reported. All of the serious adverse reactions resolved after the medication was discontinued. Conclusion: There is a trend for high doses of oral mesalazine to be more effective in prevention of relapse of ulcerative colitis. These higher doses are not associated with a higher incidence of adverse reactions. © Lippincott-Raven Publishers.