0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Articles |

An Oral Preparation of Mesalamine as Long-Term Maintenance Therapy for Ulcerative Colitis: A Randomized, Placebo-Controlled Trial

Stephen B. Hanauer, MD; Charles A. Sninsky, MD; Malcom Robinson, MD; Bernard J. Powers, MD; James D. McHattie, MD; James E Mayle, MD; Charles O. Elson, MD; Michael P. DeMicco, MD; James H. Butt, MD; Ronald E. Pruitt, MD; John M. Bozdech, MD; and Michael A. Safdi, MD
[+] Article and Author Information

The Mesalamine Study Group* Acknowledgments: The authors thank Mary G. Royer for assistance in preparing the manuscript. Grant Support: In part by a clinical grant from Procter & Gamble Pharmaceuticals, Cincinnati, Ohio. Requests for Reprints: Stephen B. Hanauer, MD, Division of Gastroenterology, University of Chicago Hospital, 5841 South Maryland Avenue, Box 400, Chicago, IL 60637. Current Author Addresses: Dr. Hanauer: Division of Gastroenterology, University of Chicago Hospital, 5841 South Maryland Avenue, Box 400, Chicago, IL 60637.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1996;124(2):204-211. doi:10.7326/0003-4819-124-2-199601150-00003
Text Size: A A A

Objective: To compare the safety and efficacy of a pH-sensitive, polymer-coated oral formulation of mesalamine (Asacol, Procter & Gamble Pharmaceuticals, Cincinnati, Ohio) with those of placebo in maintaining remission in patients with ulcerative colitis.

Design: Multicenter, double-blind, placebo-controlled, randomized clinical trial.

Setting: Eight private practices, five university-based medical centers, and four hospitals or clinics.

Patients: 264 patients with ulcerative colitis that had been maintained in remission for at least 1 month while the patients were receiving stable doses of sulfasalazine or any oral mesalamine product.

Intervention: Coated mesalamine at oral dosages of 0.8 g/d or 1.6 g/d or matching placebo for 6 months.

Measurements: Treatment success, defined as maintenance of remission after 6 months, and treatment failure, defined as relapse during the study (as indicated by proctosigmoidoscopy at 1, 3, or 6 months of treatment) or withdrawal due to adverse events. Safety was assessed on the basis of laboratory analyses and patient- and investigator-noted adverse events.

Results: 189 patients were compliant with the protocol for 6 months or stopped receiving therapy because of relapse or adverse events. Of these 189 patients, 25 of the 63 patients (39.7%) in the placebo group had treatment success compared with 40 of the 68 patients (58.8% [95% CI, 46.4% to 71.3%]) in the group receiving mesalamine, 0.8 g/d (P = 0.036) and 38 of the 58 patients (65.5% [CI, 52.4% to 78.6%]) in the group receiving mesalamine, 1.6 g/d (P = 0.006). In the intention-to-treat analysis of all patients, 42 of the 87 patients (48.3%) in the placebo group had treatment success compared with 57 of the 90 patients (63.3% [CI, 52.8% to 73.8%]) in the group receiving mesalamine, 0.8 g/d (P = 0.050) and 61 of the 87 patients (70.1% [CI, 59.9% to 80.3%]) in the group receiving mesalamine, 1.6 g/d (P = 0.005). Age, sex, and race were not found to predict treatment success or failure. The mesalamine tablet was well tolerated, and no clinically significant changes were seen in hematologic, hepatic, or renal laboratory profiles.

Conclusion: Coated mesalamine at oral dosages of 0.8 g/d and 1.6 g/d is safe and effective in maintaining remission in patients with quiescent ulcerative colitis.

*For a listing of members of The Mesalamine Study Group, see the Appendix.

Figures

Grahic Jump Location
Figure 1.
Percentage of patients with ulcerative colitis who remained in remission during treatment with placebo; with mesalamine, 0.P

8 g/d; or with mesalamine, 1.6 g/d. values are for comparisons between treatment and placebo.

Grahic Jump Location

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Related Point of Care
Topic Collections
PubMed Articles

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)