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  • Title: Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis.
    Author: Kruis W, Judmaier G, Kayasseh L, Stolte M, Theuer D, Scheurlen C, Hentschel E, Kratochvil P.
    Journal: Eur J Gastroenterol Hepatol; 1995 May; 7(5):391-6. PubMed ID: 7614099.
    Abstract:
    OBJECTIVE: To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine. DESIGN: Randomized double-blind multicentre 6-month study comparing three 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 colitis. SETTING: Public hospitals and private practices in Germany, Austria and Switzerland. PATIENTS: A total of 162 patients with ulcerative colitis in remission. RESULTS: According to intention-to-treat analysis, the failure rates of the different treatment groups were not significantly 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 sulphasalazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effects was 4%, the most frequent single event being diarrhoea (2.5, 5.2 and 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasalazine daily). CONCLUSION: This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine daily. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine.
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