Charles A. Sninsky, MD; David H. Cort, MD; Fergus Shanahan, MD; Bernard J. Powers, MD; John T. Sessions, MD; Ronald E. Pruitt, MD; Walter H. Jacobs, MD; Simon K. Lo, MD; Stephan R. Targan, MD; James J. Cerda, MD; Daniel E. Gremillion, MD; William J. Snape, MD; John Sabel, MD; Horacio Jinich, MD; James M. Swinehart, MD; Michael P. DeMicco, MD
▪ 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.
Sninsky CA, Cort DH, Shanahan F, Powers BJ, Sessions JT, Pruitt RE, et al. Oral Mesalamine (Asacol) for Mildly to Moderately Active Ulcerative Colitis: A Multicenter Study. Ann Intern Med. 1991;115:350–355. doi: 10.7326/0003-4819-115-5-350
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Published: Ann Intern Med. 1991;115(5):350-355.
Gastroenterology/Hepatology, Inflammatory Bowel Disease.
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