| Long-term use of mesalamine (Rowasa) suppositories in remission maintenance of ulcerative proctitis. | |
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MedLine Citation:
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PMID: 10925979 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of a single nightly 500-mg Rowasa (mesalamine) suppository as maintenance therapy for patients with ulcerative proctitis in remission. METHODS: In this 24-month, multicenter, double-blind trial, 65 patients with ulcerative proctitis in clinical and endoscopic remission were randomized to receive either a single nightly 500-mg rectal mesalamine (Rowasa) suppository or matching placebo as sole therapy. Efficacy was assessed by time to relapse (defined as rectal bleeding or increase in stool frequency for > or =1 wk and active inflammation upon endoscopy). RESULTS: Mean time to relapse was 453.4 days for mesalamine-treated patients and 158.0 days for placebo-treated patients. Survival analysis demonstrated that time to relapse was significantly greater for mesalamine-treated patients than for placebo-treated patients (p < 0.001). In addition, at both 12 and 24 months, the proportion of placebo-treated patients (86% at 12 months and 89% at 24 months) who relapsed was significantly (p < or = 0.001) greater than mesalamine-treated patients (32% and 46%, respectively). No statistically significant differences occurred between treatment groups in the reporting of any particular adverse event or the number of patients reporting adverse events. CONCLUSIONS: The results demonstrate that mesalamine suppositories are efficacious, well tolerated, and safe for the long-term maintenance of remission of ulcerative proctitis. |
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Authors:
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S Hanauer; L I Good; M W Goodman; R J Pizinger; W B Strum; C Lyss; G Haber; C N Williams; M Robinson |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The American journal of gastroenterology Volume: 95 ISSN: 0002-9270 ISO Abbreviation: Am. J. Gastroenterol. Publication Date: 2000 Jul |
Date Detail:
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Created Date: 2000-08-24 Completed Date: 2000-08-24 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0421030 Medline TA: Am J Gastroenterol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 1749-54 Citation Subset: IM |
Affiliation:
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University of Chicago Medical Center, Illinois 60637, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Anti-Inflammatory Agents, Non-Steroidal / administration & dosage* Colitis, Ulcerative / drug therapy*, prevention & control Double-Blind Method Female Humans Male Mesalamine / administration & dosage* Middle Aged Recurrence Remission Induction Suppositories Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 0/Suppositories; 89-57-6/Mesalamine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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