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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
Abstract
▪ 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.
Article and Author Information
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From the Veteran Affairs Medical Center and University of Florida College of Medicine, Gainesville, Florida; Washington University School of Medicine, St. Louis, Missouri; University of California at Los Angeles, Los Angeles, California; Colorado Medical Research Center, Denver, Colorado; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Medical Research Institute, Nashville, Tennessee; Menorah Medical Center, Kansas City, Missouri; University of California at San Diego, San Diego, California; and Harbor-UCLA Inflammatory Bowel Disease Center, Torrance, California. For current author addresses, see end of text.
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Grant Support: This study was supported by a clinical grant from Norwich Eaton Pharmaceuticals, Inc., Norwich, New York.
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Requests for Reprints: Charles A. Sninsky, MD, Veterans Affairs Medical Center, Gastroenterology Section (111C), Gainesville, FL 32608-1197.
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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.
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