OLSALAZINE VERSUS SULFASALAZINE IN MILD-TO-MODERATE CHILDHOOD ULCERATIVE-COLITIS - RESULTS OF THE PEDIATRIC GASTROENTEROLOGY COLLABORATIVE RESEARCH GROUP CLINICAL-TRIAL

The safety and efficacy of olsalazine sodium was compared to sulfasala zine over 3 months in a multicenter, randomized, double-blind study of 56 children with mild to moderate ulcerative colitis. Twenty-eight ch ildren received 30 mg/kg/day of olsalazine (maximum, 2 g/day) and 28 r eceived 60 mg/kg/day of sulfasalazine (maximum, 4 g/day). Side effects were frequent in both groups. Eleven of 28 patients (39%) on olsalazi ne reported headache, nausea, vomiting, rash, pruritus. increased diar rhea, and/or fever. Thirteen of 28 on sulfasalazine (46%) reported sim ilar side effects and/or neutropenia, and four patients had the drug s topped because of an adverse reaction. After 3 months, 11 of 28 (39%) on olsalazine were asymptomatic or clinically improved, compared to 22 of 28 (79%) on sulfasalazine (p = 0.006). In addition, 10 of 28 patie nts on olsalazine versus one on sulfasalazine required prednisone beca use of lack of response or worsening of colitis (p = 0.005). The dose of olsalazine used in this clinical trial was thought to be equivalent to a standard dose of sulfasalazine, but fewer patients on olsalazine improved and a greater number had progression of symptoms when compar ed to sulfasalazine. Although side effects were slightly less frequent for olsalazine, the number of patients was too small to detect a clin ically significant difference.