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 treatment for ulcerative colitis (UC), patients still report troublesome symptoms, often nocturnally. Aim: To compare the efficacy and safety of balsalazide (Colazide) with mesalazine (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. Balsalazide 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 their stools or on the toilet paper, mucus with their stools or with sleep disturbance resulting from symptoms or lavatory visits (each P < 0.05). Fewer balsalazide patients relapsed within 3 months (10% vs. 28%; P = 0.0354). Remission at 12 months was 58% in both groups. Similar proportions of patients reported adverse events (61% balsalazide vs. 65% mesalazine). There were five serious adverse events (two balsalazide, three mesalazine) and four withdrawals due to unacceptable adverse events (three balsalazide, one mesalazine), of which one in each group was also a serious adverse event. Conclusions: Balsalazide 3 g/day and mesalazine 1.2 g/day effectively maintain UC remission and are equally well tolerated over 12 months. At this dose balsalazide prevents more relapses during the first 3 months of treatment and controls nocturnal symptoms more effectively.