Maintenance of remission of ulcerative colitis: a comparison between balsalazide 3 g daily and mesalazine 1.2 g daily over 12 months

Background: Despite widespread use of aminosalicylates as maintenance treat ment for ulcerative colitis (UC), patients still report troublesome symptom s, often nocturnally. Aim: To compare the efficacy and safety of balsalazide (Colazide) with mesa lazine (Asacol) in maintaining UC remission. Methods: A randomized, double-blind comparison of balsalazide 3 g daily (1. 04 g 5-ASA) and mesalazine 1.2 g daily for 12 months, in 99 (95 evaluable) patients in UC remission. Results: Balsalazide patients experienced more asymptomatic nights (90% vs, 77%, P = 0.0011) and days (58% vs. 50%, N.S.) during the first 3 months. B alsalazide patients experienced more symptom-free nights per week (6.4 +/- 1.7 vs. 4.7 +/- 2.8; P = 0.0006) and fewer nights per week with blood on th eir stools or on the toilet paper, mucus with their stools or with sleep di sturbance resulting from symptoms or lavatory visits (each P < 0.05). Fewer balsalazide patients relapsed within 3 months (10% vs. 28%; P = 0.0354). R emission at 12 months was 58% in both groups, Similar proportions of patien ts reported adverse events (61% balsalazide vs. 65% mesalazine). There were five serious adverse events (two balsalazide, three mesalazine) and four w ithdrawals due to unacceptable adverse events (three balsalazide, one mesal azine), of which one in each group was also a serious adverse event. Conclusions: Balsalazide 3 g/day and mesalazine 1.2 g/day effectively maint ain UC remission and are equally well tolerated over 12 months, At this dos e balsalazide prevents more relapses during the first 3 months of treatment and controls nocturnal symptoms more effectively.