caa a22 4500 445797290 CHVBK 20180317145129.0 cr unu---uuuuu 170323e20110201xx s 000 0 eng 10.1007/s10620-010-1334-y doi (NATIONALLICENCE)springer-10.1007/s10620-010-1334-y Lamet Mark Center for Gastrointestinal Disorders, 1150 North 35th Avenue 445, 33021, Hollywood, FL, USA aut 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 [Elektronische Daten] [Mark Lamet] Abstract : 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 (DAI<3 at weeks 3 and 6), disease extension, and complete response to treatment (DAI=0; post-hoc, exploratory analysis). Results: DAI values after 6weeks were significantly reduced (±SD) from 6.6±1.5 to 1.6±2.3 (500-mg BID); and from 6.1±1.5 to 1.3±2.2 (1-g QHS). Mucosal appearance significantly improved from baseline after 3 and 6weeks of treatment from 1.8±0.5 to 0.8±0.7 and 0.5±0.7 (500-mg BID; P≤0.0062) and from 1.7±0.5 to 0.9±0.5 and 0.4±0.6 (1-g QHS; P≤0.0001), respectively. Remission was comparable (78.3-86.1%); onset of response generally occurred within 3weeks, and disease extension was reduced (>70%) 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. The Author(s), 2010 Mesalamine nationallicence Ulcerative proctitis nationallicence Suppository nationallicence Inflammatory bowel disease nationallicence Digestive Diseases and Sciences Springer US; http://www.springer-ny.com 56/2(2011-02-01), 513-522 0163-2116 56:2<513 2011 56 10620 https://doi.org/10.1007/s10620-010-1334-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10620-010-1334-y text/html Onlinezugriff via DOI NATIONALLICENCE 100 1- Lamet Mark Center for Gastrointestinal Disorders, 1150 North 35th Avenue 445, 33021, Hollywood, FL, USA aut NATIONALLICENCE 773 0- Digestive Diseases and Sciences Springer US; http://www.springer-ny.com 56/2(2011-02-01), 513-522 0163-2116 56:2<513 2011 56 10620 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer