Efficacy of Pentasa tablets for the treatment of inflammatory bowel disease
Journal
Journal of the Formosan Medical Association
Journal Volume
102
Journal Issue
9
Pages
613-619
Date Issued
2003
Author(s)
Abstract
Background and Purpose: The Eudgragit S formulation of delayed-release 5-aminosalicylic acid (5-ASA), Asacol? tablets (AT), has limited efficacy in maintaining remission in patients with inflammatory bowel disease (IBD). This study evaluated the effect of switching patients with unsatisfactory results under treatment with AT to a microgranule delayed-release formulation of 5-ASA, Pentasa? tablets (PT). Methods: A 12-week, open drug-switching study was conducted in 15 IBD patients, including 9 with ulcerative colitis (UC) and 6 with Crohn's disease (CD) who were evaluated at the time of switching from routine AT (2.4 g/day) treatment (for more than 3 months)to PT (4 g/day). UC patients were those under AT remission maintenance and they were defined as prone-to-relapse because of endoscopy scores ? 2. CD patients were those under acute treatment with AT who had not attained a complete remission. The primary endpoint was the change in UC Disease Activity Index (UC-DAI) or the CD Activity Index scores after switching to PT therapy. Drug safety profile and patient acceptability were secondary endpoints. Results: Twelve weeks after switching to PT treatment, the mean (± SEM) UC-DAI score was reduced significantly, from 8.18 ± 0.58 to 6.81 ± 0.72 (p = 0.013) in UC patients. Subcategory scores indicated improvements in endoscopy scores and in physician global assessment. Though the change in clinical outcomes did not reach significance for CD patients, a trend towards a therapeutic benefit was observed. No adverse event was observed during the 12-week clinical trial. Conclusion: PT may provide a better alternative for IBD patients with unsatisfactory response to AT therapy.
Subjects
Aminosalicyclic acids; Comparative study; Delayed-action preparations; Inflammatory bowel diseases; Mesalamine
SDGs
Other Subjects
mesalazine; adult; article; clinical article; clinical trial; controlled clinical trial; controlled study; Crohn disease; delayed release formulation; disease activity; drug efficacy; drug safety; endoscopy; enteritis; female; hematologic disease; human; kidney dysfunction; liver dysfunction; maintenance therapy; male; open study; patient compliance; relapse; remission; scoring system; statistical significance; treatment outcome; ulcerative colitis; Adult; Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Inflammatory Bowel Diseases; Male; Mesalamine; Middle Aged; Treatment Outcome
Type
journal article
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