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One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis
BACKGROUND: Mesalazine (Asacol) is still widely prescribed in divided doses for ulcerative colitis (UC), despite evidence that adherence is improved by once-daily (OD) prescribing. We aimed to investigate whether OD Asacol was as effective as three times (TDS) daily dosing, and to evaluate the role...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wiley Subscription Services, Inc., A Wiley Company
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3746130/ https://www.ncbi.nlm.nih.gov/pubmed/22081522 http://dx.doi.org/10.1002/ibd.21938 |
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author | Hawthorne, A Barney Stenson, Rachel Gillespie, David Swarbrick, Edwin T Dhar, Anjan Kapur, Kapil C Hood, Kerry Probert, Chris SJ |
author_facet | Hawthorne, A Barney Stenson, Rachel Gillespie, David Swarbrick, Edwin T Dhar, Anjan Kapur, Kapil C Hood, Kerry Probert, Chris SJ |
author_sort | Hawthorne, A Barney |
collection | PubMed |
description | BACKGROUND: Mesalazine (Asacol) is still widely prescribed in divided doses for ulcerative colitis (UC), despite evidence that adherence is improved by once-daily (OD) prescribing. We aimed to investigate whether OD Asacol was as effective as three times (TDS) daily dosing, and to evaluate the role of treatment adherence. METHODS: An investigator-blind randomized trial was undertaken comparing OD Asacol (three 800 mg tablets) versus one 800 mg TDS in maintenance of remission of UC over 1 year. The primary endpoint was relapse rate, and noninferiority would be concluded if the lower limit of the two-sided 95% confidence interval (CI) of the difference in proportions relapsing (TDS-OD) exceeded −10%. Adherence was measured by tablet counts and self-reported adherence. A subgroup of patients used a bottle cap that recorded all bottle opening events. RESULTS: In all, 213 patients were randomized. In the intention-to-treat (ITT) population, relapse rates were 31% (95% CI 22%–40%) in the OD and 45% (95% CI 35%–54%) in the TDS group. Primary analysis confirmed the noninferiority of OD dosing. Two of the study populations, ITT and per-protocol (PP), showed potential superiority of OD dosing. All measures of adherence showed that it was significantly better in the OD group. Multivariate analysis, however, showed OD dosing was associated with lower relapse risk independently of adherence. CONCLUSIONS: OD dosing with Asacol 2.4 g is as safe and effective as TDS dosing, and secondary analysis confirmed significantly reduced relapse rates. The benefit, however, was clinically borderline and may relate in part to ease of adherence. (Inflamm Bowel Dis 2012) |
format | Online Article Text |
id | pubmed-3746130 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Wiley Subscription Services, Inc., A Wiley Company |
record_format | MEDLINE/PubMed |
spelling | pubmed-37461302013-08-20 One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis Hawthorne, A Barney Stenson, Rachel Gillespie, David Swarbrick, Edwin T Dhar, Anjan Kapur, Kapil C Hood, Kerry Probert, Chris SJ Inflamm Bowel Dis Original Clinical Articles BACKGROUND: Mesalazine (Asacol) is still widely prescribed in divided doses for ulcerative colitis (UC), despite evidence that adherence is improved by once-daily (OD) prescribing. We aimed to investigate whether OD Asacol was as effective as three times (TDS) daily dosing, and to evaluate the role of treatment adherence. METHODS: An investigator-blind randomized trial was undertaken comparing OD Asacol (three 800 mg tablets) versus one 800 mg TDS in maintenance of remission of UC over 1 year. The primary endpoint was relapse rate, and noninferiority would be concluded if the lower limit of the two-sided 95% confidence interval (CI) of the difference in proportions relapsing (TDS-OD) exceeded −10%. Adherence was measured by tablet counts and self-reported adherence. A subgroup of patients used a bottle cap that recorded all bottle opening events. RESULTS: In all, 213 patients were randomized. In the intention-to-treat (ITT) population, relapse rates were 31% (95% CI 22%–40%) in the OD and 45% (95% CI 35%–54%) in the TDS group. Primary analysis confirmed the noninferiority of OD dosing. Two of the study populations, ITT and per-protocol (PP), showed potential superiority of OD dosing. All measures of adherence showed that it was significantly better in the OD group. Multivariate analysis, however, showed OD dosing was associated with lower relapse risk independently of adherence. CONCLUSIONS: OD dosing with Asacol 2.4 g is as safe and effective as TDS dosing, and secondary analysis confirmed significantly reduced relapse rates. The benefit, however, was clinically borderline and may relate in part to ease of adherence. (Inflamm Bowel Dis 2012) Wiley Subscription Services, Inc., A Wiley Company 2012-10 2011-11-13 /pmc/articles/PMC3746130/ /pubmed/22081522 http://dx.doi.org/10.1002/ibd.21938 Text en Copyright © 2011 Crohn's & Colitis Foundation of America, Inc. http://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. |
spellingShingle | Original Clinical Articles Hawthorne, A Barney Stenson, Rachel Gillespie, David Swarbrick, Edwin T Dhar, Anjan Kapur, Kapil C Hood, Kerry Probert, Chris SJ One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis |
title | One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis |
title_full | One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis |
title_fullStr | One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis |
title_full_unstemmed | One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis |
title_short | One-year Investigator-blind Randomized Multicenter Trial Comparing Asacol 2.4 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis |
title_sort | one-year investigator-blind randomized multicenter trial comparing asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis |
topic | Original Clinical Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3746130/ https://www.ncbi.nlm.nih.gov/pubmed/22081522 http://dx.doi.org/10.1002/ibd.21938 |
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