Olsalazine in maintenance of clinical remission in patients with ulcerative colitis

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 (2 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.

One-year investigator-blind randomized multicenter trial comparing asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis

“…Analysis of 14 trials of maintenance therapy with mesalazine of 1 year duration show great variability, with relapse rates from 23%–63% 12–24. The mean relapse rate of these pooled trials (involving 1540 patients) was 42%.…”

How effective are the usual treatments for ulcerative colitis?

“…We identified eight placebo-controlled trials of 5-ASA in maintenance of remission in ulcerative colitis, [22][23][24][25][26][27][28][29] including three using sulfasalazine (Table 3). Follow-up was between 6 months and 1 year.…”

PPARs in Irradiation-Induced Gastrointestinal Toxicity

“…Early randomized trials of olsalazine [96] and mesalamine [97] were disappointing, with mesalamine showing no benefit and olsalazine showing an increased incidence of diarrhea. The negative result for olsalazine was not surprising, because a similar increase in diarrhea prevalence was seen in IBD patients [98]. A study of balsalazide found that it did not significantly alleviate clinical symptoms [99].…”