Abstract
Frequent minor side effects are associated with sulfasalazine. The realization that it is the 5-aminosalicylic acid moiety that is the active component of sulfasalazine and that the side effects are probably due to the sulfapyridine has prompted the search for a similar but safer compound. Olsalazine, consisting of two molecules of 5-ASA without sulfasalazine may avoid the problems due to sulfasalazine. One hundred one patients were entered into a double-blind placebo-controlled study of the use of olsalazine 92 g daily) in preventing relapse in patients who had recently recovered from an acute attack of ulcerative colitis. Patients were treated for 12 months. Forty-nine were randomized to olsalazine (39 with limited and 10 with extensive disease) and 52 to placebo (42 with limited and 10 with extensive disease). Life-table analysis showed that the median time to relapse in patients on olsalazine was 342 days, which was significantly longer than the 100 days in the placebo group (P=0.024). The most important side effect experienced with olsalazine that necessitated withdrawal from the study was “drug-induced diarrhea” in 16% (8/49). There was a similar incidence of minor side effects reported in the two groups, and in no patients were major or dangerous side effects reported. In patients who did not develop diarrhea, olsalazine was well tolerated and successfully prevented rapid relapse in the recently ill patients entered into this study.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Misiewicz JJ, Lennard-Jones JE, Connell AM, Baron JH, Jones AF: Controlled trial of sulfasalazine in maintenance therapy of ulcerative colitis. Lancet 1:185–188, 1965
Dissanayake AS, Truelove SC: A controlled therapeutic trial of long-term maintenance treatment of ulcerative colitis with sulfasalazine (Salazopyrin). Gut 14:923–926, 1973
Das KM, Eastwood MA, McManus JPA, Sircus W: Adverse reactions during salicylazosulfapyridine therapy and the relation with drug metabolism and acetylator phenotype. N Engl J Med 289:491–495, 1973
Taffet SL, Das KM: Sulfasalazine: Adverse effects and desensitization. Dig Dis Sci 28:833–842, 1983
Nielsen OH: Sulfasalazine intolerance. A retrospective survery of the reasons for discontinuing treatment with sulfasalazine in patients with chronic inflammatory bowel disease. Scand J Gastroenterol 17:389–393, 1982
Schröder H, Campbell DES: Absorption, metabolism, and excretion of salicylazosulfapyridine in man. Clin Pharmacol Ther 13:539–551, 1972
Peppercorn MA, Goldman P: Distribution studies of salicylazosulfapyridine and its metabolites. Gastroenterology 64:240–245, 1973
Azad Khan AK, Piris J, Truelove SC: An experiment to determine the active therapeutic moiety of sulfasalazine. Lancet 2:892–895, 1977
van Hees PAM, Bakker JH, van Tongeren JHM: Effect of sulfapyridine, 5-aminosalicylic, and placebo in patients with idiopathic proctitis: a study to determine the active therapeutic moiety of sulfasalazine. Gut 21:632–635, 1980
Willoughby CP, Aronsson JK, Agback H, Boin NO, Truelove SC: Distribution and metabolism in healthy volunteers of disodium azodisalicylate, a potential therapeutic agent for ulcerative colitis. Gut 23:1081–1087, 1982
Jewell DP, Truelove SC: Disodium azodisalicylate in ulcerative colitis. Lancet 2:1168–1169, 1981
Selby WS, Barr GD, Ireland A, Mason CH, Jewell DP: Olsalazine in active ulcerative colitis. Br Med J 291:1373–1375, 1985
Rao SSC, Dundas SAC, Holdsworth CD, Cann PA, Palmer KR, Corbett CL: Olsalazine or sulfasalazine in first attacks of ulcerative colitis? A double blind study. Gut 30:675–679, 1989
Feurle GE, Theuer D, Velasco S, Barry BA, Wordehoff D, Sommer A, Jantschek G, Kruis W: Olsalazine versus placebo in the treatment of mild to moderate ulcerative colitis: A randomized double blind trial. Gut 30:1354–1361, 1989
Meyers S, Sachar DB, Present DH, Janowitz HD: Olsalazine sodium in the treatment of ulcerative colitis among patients intolerant of sulfasalazine. A prospective, randomized, placebo-controlled, double-blind, dose-ranging clinical trial. Gastroenterology 93:1255–1262, 1987
Truelove SC, Witts LJ: Cortisone in ulcerative colitis. Br Med J 2:1041–1048, 1956
Whitehead R: Mucosal Biopsy of the Gastrointestinal Tract. Philadelphia, WB Saunders, 1985, pp 215–237
Harvey RF, Bradshaw JM: A simple index of Crohn's disease activity. Lancet 1:154, 1980
Järnerot G: Clinical tolerance of olsalazine. Scand J Gastroenterol 23(suppl):21–23, 1988
Sandberg-Gertzen H, Järnerot G, Bukhave K, Laurisen K, Rash-Masden F: Effect of azodisal sodium and sulfasalazine on ileostomy output of fluid, PGE2 and PGF2α in subjects with a permanent ileostomy. Gut 27:1306–1311, 1986
Sandberg-Gertzen H, Järnerot G, Kraaz W: Azodisal sodium in the treatment of ulcerative colitis. A study of tolerance and relapse prevention properties. Gastroenterology 90:1024–1030, 1986
Ireland A, Mason CH, Jewell DP: Controlled trial comparing olsalazine and sulfasalazine for the maintenance treatment of ulcerative colitis. Gut 29:835–837, 1988
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Wright, J.P., O'Keefe, E.A., Cuming, L. et al. Olsalazine in maintenance of clinical remission in patients with ulcerative colitis. Digest Dis Sci 38, 1837–1842 (1993). https://doi.org/10.1007/BF01296107
Received:
Revised:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF01296107