Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis

• Published in: European journal of gastroenterology & hepatology Vol. 7; no. 5; p. 391
• Main Authors: Kruis, W, Judmaier, G, Kayasseh, L, Stolte, M, Theuer, D, Scheurlen, C, Hentschel, E, Kratochvil, P
• Format: Journal Article
• Language: English
• Published: England 01-05-1995
• Subjects: Adolescent; Adult; Aged; Aminosalicylic Acids - administration & dosage; Aminosalicylic Acids - adverse effects; Aminosalicylic Acids - therapeutic use; Colitis, Ulcerative - prevention & control; Diarrhea - chemically induced; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Recurrence; Remission Induction; Safety; Sulfasalazine - administration & dosage; Sulfasalazine - adverse effects; Sulfasalazine - therapeutic use; Treatment Failure; Treatment Outcome
• ISSN: 0954-691X

To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine.
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.
Public hospitals and private practices in Germany, Austria and Switzerland.
A total of 162 patients with ulcerative colitis in remission.
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).
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.