Balsalazide is used in the management of mildly to moderately active ulcerative colitis. Safety and efficacy of balsalazide therapy have not been established beyond 12 weeks.
Safety and efficacy of balsalazide have been evaluated in 2 randomized, double-blind studies of 8 weeks' duration in patients with mildly to moderately active ulcerative colitis with sigmoidoscopic findings of friable or spontaneously bleeding mucosa. In these studies, improvements in rectal bleeding, stool frequency, or sigmoidoscopic findings were reported in 55-65, 49-59, or 74-79% of patients, respectively, who received balsalazide 6.75 g daily for 8 weeks. Balsalazide also reduced abdominal pain and improved functional assessment scores.
Results of clinical studies indicate that balsalazide 6.75 g daily appears to be at least as effective as sulfasalazine 3 g daily or mesalamine 2.4 g daily in improving symptoms in patients with ulcerative colitis who received the drugs orally for up to 12 weeks. In one randomized, double-blind study, symptomatic improvement or complete remission (defined as asymptomatic or with mild symptoms, sigmoidoscopy grade 0 or 1, and no rectal steroid use within 4 days) was achieved in 88 or 62%, respectively, of patients receiving balsalazide 6.75 mg daily and in 57 or 37%, respectively, of those who received mesalamine 2.4 g daily for 12 weeks. Treatment with balsalazide appears to be associated with more rapid symptomatic improvement (12-14 days earlier) compared to that with mesalamine. However, some clinicians state that a relative therapeutic advantage of balsalazide over mesalamine remains to be established.
Although controlled studies assessing the efficacy of balsalazide are lacking, limited data indicate that use of the drug may be beneficial in the management of Crohn's disease involving the colon.