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A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis
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-m...
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Formato: | Texto |
Lenguaje: | English |
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Springer US
2010
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3029674/ https://www.ncbi.nlm.nih.gov/pubmed/20676771 http://dx.doi.org/10.1007/s10620-010-1334-y |
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author | Lamet, Mark |
author_facet | Lamet, Mark |
author_sort | Lamet, Mark |
collection | PubMed |
description | 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 6 weeks 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 6 weeks 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 3 weeks, and disease extension was reduced (>70%) after 6 weeks 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 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed. |
format | Text |
id | pubmed-3029674 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-30296742011-03-16 A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis Lamet, Mark Dig Dis Sci Original Article 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 6 weeks 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 6 weeks 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 3 weeks, and disease extension was reduced (>70%) after 6 weeks 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 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed. Springer US 2010-07-30 2011 /pmc/articles/PMC3029674/ /pubmed/20676771 http://dx.doi.org/10.1007/s10620-010-1334-y Text en © The Author(s) 2010 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. |
spellingShingle | Original Article Lamet, Mark A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis |
title | A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis |
title_full | A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis |
title_fullStr | A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis |
title_full_unstemmed | A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis |
title_short | A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis |
title_sort | multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg twice daily in patients with active mild-to-moderate ulcerative proctitis |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3029674/ https://www.ncbi.nlm.nih.gov/pubmed/20676771 http://dx.doi.org/10.1007/s10620-010-1334-y |
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