A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1g at Bedtime and 500mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis

• Published in: Digestive diseases and sciences 2011-02, Vol.56 (2), p.513-522
• Main Author: Lamet, Mark
• Format: Article
• Language: English
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-010-1334-y

Background: Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity and mortality. Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP. Methods: We evaluated effects of mesalamine 1-g suppository administered QHS compared with 500-mg suppository administered BID on UP activity (e.g., disease extension/mucosal appearance), remission, onset of response, safety and compliance in 97 patients with UP. A 6-week, randomized, multicenter, parallel-group, noninferiority study was conducted (and published) with Disease Activity Index (DAI) at week 6 as the primary efficacy variable and individual components of DAI at week 6 (i.e., stool frequency, rectal bleeding, mucosal appearance, global assessment) as secondary variables. Unreported outcomes were remission (DAI70%) after 6weeks in both groups. Mesalamine was well tolerated. Compliance was >96%. Conclusions: Mesalamine 500-mg BID and 1-g QHS suppositories are safe and effective for patients with UP. Most patients reported significant improvement within 3weeks and UP remission and reduced disease extension after 6weeks of treatment. Validity of QHS administration was confirmed.