JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. A multicenter study

C A Sninsky, D H Cort, F Shanahan, B J Powers, J T Sessions, R E Pruitt, W H Jacobs, S K Lo, S R Targan, J J Cerda
Annals of Internal Medicine 1991 September 1, 115 (5): 350-5
1863024

OBJECTIVE: To evaluate the efficacy and safety of a pH-sensitive, polymer-coated oral preparation of mesalamine in patients with mildly to moderately active ulcerative colitis.

DESIGN: A multicenter, double-blind, placebo-controlled randomized trial.

SETTING: Five university-based medical centers, one inflammatory bowel disease center, and three private practice sites.

PATIENTS: A total of 158 patients with newly or previously diagnosed active ulcerative colitis.

INTERVENTION: A pH-sensitive, polymer-coated oral preparation of mesalamine (5-aminosalicylic acid) was used at 1.6 and 2.4 g/d for 6 weeks.

MEASUREMENTS: Efficacy was measured by scores for stool frequency, rectal bleeding, patient's functional assessment, sigmoidoscopic findings, and physician's global assessment. Stringent criteria for disease activity were established prospectively.

RESULTS: The analysis of protocol-compliant patients showed a significant improvement at 3 weeks in patients taking 2.4 g/d of mesalamine compared with patients taking placebo (32% versus 9%; P = 0.003). At 6 weeks, both the 1.6 g/d (43%) and 2.4 g/d (49%) doses were significantly superior to placebo (23%) (P = 0.03 and P = 0.003, respectively). In addition, more patients worsened in the placebo group compared with the 2.4 g/d group (50% versus 19%; P = 0.003); however, there was no statistically significant difference in worsening between the 1.6 g/d mesalamine group and the placebo group. The oral mesalamine tablet was well tolerated, and no clinically significant changes were observed in hematologic, hepatic, or renal laboratory profiles.

CONCLUSION: Colon-targeted oral mesalamine at 2.4 g/d is effective therapy for mildly to moderately active ulcerative colitis. It is well tolerated and should provide a viable therapeutic alternative to sulfasalazine.

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