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Oral Mesalamine (Asacol) for Mildly to Moderately Active Ulcerative Colitis: A Multicenter Study

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; and Michael P. DeMicco, MD
[+] Article, Author, and Disclosure Information

Presented in part at the World Congress of Gastroenterology, Sydney, Australia, August 1990.

Grant Support: This study was supported by a clinical grant from Norwich Eaton Pharmaceuticals, Inc., Norwich, New York.

Requests for Reprints: Charles A. Sninsky, MD, Veterans Affairs Medical Center, Gastroenterology Section (111C), Gainesville, FL 32608-1197.

Current Author Addresses: Drs. Sninsky and Cerda: University of Florida, Box J-214 UF Health Center, Gainesville, FL 32610.

Dr. Cort: Digestive Disease Consultants, 222 South Woods Mill Road, Suite 520 North, Chesterfield, MO 63017.

Dr. Shanahan: UCLA Center for Health Sciences, Room 44138, Los Angeles, CA 90024.

Dr. Powers: Arapahoe Gastroenterology, 3535 S. Lafayette, Englewood CO 80110.

Dr. Sessions: University of North Carolina, CB #7080, Room 324, Burnett-Womack Building, Chapel Hill, NC 27599-7080.

Drs. Pruitt and Gremillion:Medical Research Institute, 397 Wallace Road, Suite 407, Nashville, TN 37211.

Dr. Jacobs: Menorah Medical Center, 4949 Rockhill Road, Kansas City, MO 64110.

Drs. Lo and Snape: Harbor-UCLA IBD Center, 1124 West Carson Street, Annex A-4, Torrance, CA 90502.

Dr. Targan: UCLA Department of Medicine, 24-156 Warren Hall, 900 Veteran Avenue, Los Angeles, CA 90024.

Dr. Sabel: South Denver Gastroenterology, 601 Hampden, Suite 260, Englewood, CO 80110.

Dr. Jinich: University of California at San Diego, 225 Dickinson Street, Room H811D, San Diego, CA 92103.

Dr. Swinehart: Colorado Medical Research Center, 950 E. Harvard Avenue, Suite 630, Denver, CO 80210.

Dr. DeMicco: 1211 West LaPalma, Suite 306, Anaheim, CA 92801.

Ann Intern Med. 1991;115(5):350-355. doi:10.7326/0003-4819-115-5-350
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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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