DOUBLE-BLIND DOSE-FINDING STUDY OF OLSALAZINE VERSUS SULFASALAZINE ASMAINTENANCE THERAPY FOR ULCERATIVE-COLITIS

Objective: To determine the therapeutic efficacy and safety of three d oses of olsalazine compared with the standard dose of sulphasalazine. Design: Randomized double-blind multicentre 6-month study comparing th ree doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission in patients with ulcerative col itis. Setting: Public hospitals and private practices in Germany, Aust ria and Switzerland. Patients: A total of 162 patients with ulcerative colitis in remission. Results: According to intention-to-treat analys is, the failure rates of the different treatment groups were not signi ficantly different (36, 49 and 24% for 0.5, 1.25 and 2.0 g olsalazine daily and 32% for 2.0 g sulphasalazine daily). Olsalazine and sulphasa lazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effe cts was 4%, the most frequent single event being diarrhoea (2.5, 5.2 a nd 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasal azine daily). Conclusion: This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine dai ly. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine.