OLSALAZINE VERSUS MESALAZINE IN THE TREATMENT OF MILD-TO-MODERATE ULCERATIVE-COLITIS

Aim: To compare the efficacy and tolerability of olsalazine sodium wit h enteric-coated mesalazine in inducing endoscopic remission in patien ts with mild to moderate active ulcerative colitis. Patients and Metho ds: Patients with mild to moderate active ulcerative colitis were rand omized to receive either olsalazine sodium, 3 g/day (n = 88), or mesal azine, 3 g/day (n = 80), for up to 12 weeks. Results: Of the patients treated with olsalazine sodium, 52.2% achieved endoscopic remission, c ompared with 48.8% of patients treated with mesalazine. This differenc e was not significant (P = 0.67), There was a non-significant trend fo r patients with left-sided colitis or a more severe endoscopic grade t o achieve remission if they were treated with olsalazine sodium than i f they were treated with mesalazine, Both treatments were comparable w ith respect to clinical activity index and an investigator's global as sessment. Seventy patients reported one or more adverse events; advers e events were seen in 45% of olsalazine sodium-treated patients and in 36% of mesalazine-treated patients. Eleven patients treated with olsa lazine sodium and nine patients treated with mesalazine withdrew from the study because of adverse events. One patient treated with olsalazi ne sodium compared with two treated with mesalazine stopped treatment because of diarrhoea. Serious adverse events occurred in three patient s treated with olsalazine sodium and in four treated with mesalazine. Conclusion: Therapeutic effectiveness and tolerance to the treatment d id not differ between olsalazine sodium, 3 g/day, and mesalazine, 3 g/ day, in inducing endoscopic remission in patients with mild to moderat e active ulcerative colitis within 12 weeks of treatment.