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Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial
BACKGROUND AND AIMS: Multiple studies have demonstrated the efficacy of aminosalicylates in maintaining remission in ulcerative colitis (UC). A newer formulation of mesalamine can be administered once daily. We aimed to examine the efficacy and tolerability of pH-dependent mesalamine for long-term m...
Autores principales: | , , , |
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Formato: | Texto |
Lenguaje: | English |
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Dove Medical Press
2008
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770408/ https://www.ncbi.nlm.nih.gov/pubmed/19920971 |
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author | Kane, Sunanda Holderman, William Jacques, Peter Miodek, Todd |
author_facet | Kane, Sunanda Holderman, William Jacques, Peter Miodek, Todd |
author_sort | Kane, Sunanda |
collection | PubMed |
description | BACKGROUND AND AIMS: Multiple studies have demonstrated the efficacy of aminosalicylates in maintaining remission in ulcerative colitis (UC). A newer formulation of mesalamine can be administered once daily. We aimed to examine the efficacy and tolerability of pH-dependent mesalamine for long-term maintenance, and compare the rates of medication consumption between groups over a prolonged period. METHODS: Subjects whose UC had been quiescent for at least 4 months, and who had been receiving mesalamine for maintenance only, were randomized to once daily or conventional dosing for 12 months. Disease activity and medication consumption was assessed every 3 months. The primary endpoint was the percentage of those with quiescent disease at 12 months. RESULTS: We enrolled 20 patients, 12 to once daily and 8 to conventional dosing. Six of the 12 patients (50%) in the once daily group compared with 5 of the 8 patients (62.5%) in the conventional group experienced a flare (p = 0.31). Only 5 of the 12 (42%) patients in the once daily group were adherent compared with 3 of 8 patients (37.5%) in the conventional dosing group (p = NS). Median amount consumed in the once daily group was 63% (range 0%–100%) and in the conventional group 55% (range 0%–100%), (p > 0.5). None of the adherent subjects in the once daily group experienced a flare, while 6 out of 7 (86%) who were non-adherent experienced a flare (p < 0.01). In the conventional dosing group, 1 in 3 adherent patients (33%) experienced a flare compared with 4 out of 5 (80%) in the non-adherent group (p < 0.01). CONCLUSION: Adherence, rather than medication regimen, appeared to be important in disease outcome at 12 months. |
format | Text |
id | pubmed-2770408 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2008 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-27704082009-11-17 Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial Kane, Sunanda Holderman, William Jacques, Peter Miodek, Todd Patient Prefer Adherence Original Research BACKGROUND AND AIMS: Multiple studies have demonstrated the efficacy of aminosalicylates in maintaining remission in ulcerative colitis (UC). A newer formulation of mesalamine can be administered once daily. We aimed to examine the efficacy and tolerability of pH-dependent mesalamine for long-term maintenance, and compare the rates of medication consumption between groups over a prolonged period. METHODS: Subjects whose UC had been quiescent for at least 4 months, and who had been receiving mesalamine for maintenance only, were randomized to once daily or conventional dosing for 12 months. Disease activity and medication consumption was assessed every 3 months. The primary endpoint was the percentage of those with quiescent disease at 12 months. RESULTS: We enrolled 20 patients, 12 to once daily and 8 to conventional dosing. Six of the 12 patients (50%) in the once daily group compared with 5 of the 8 patients (62.5%) in the conventional group experienced a flare (p = 0.31). Only 5 of the 12 (42%) patients in the once daily group were adherent compared with 3 of 8 patients (37.5%) in the conventional dosing group (p = NS). Median amount consumed in the once daily group was 63% (range 0%–100%) and in the conventional group 55% (range 0%–100%), (p > 0.5). None of the adherent subjects in the once daily group experienced a flare, while 6 out of 7 (86%) who were non-adherent experienced a flare (p < 0.01). In the conventional dosing group, 1 in 3 adherent patients (33%) experienced a flare compared with 4 out of 5 (80%) in the non-adherent group (p < 0.01). CONCLUSION: Adherence, rather than medication regimen, appeared to be important in disease outcome at 12 months. Dove Medical Press 2008-02-02 /pmc/articles/PMC2770408/ /pubmed/19920971 Text en © 2008 Kane et al publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. |
spellingShingle | Original Research Kane, Sunanda Holderman, William Jacques, Peter Miodek, Todd Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial |
title | Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial |
title_full | Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial |
title_fullStr | Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial |
title_full_unstemmed | Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial |
title_short | Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial |
title_sort | once daily versus conventional dosing of ph-dependent mesalamine long-term to maintain quiescent ulcerative colitis: preliminary results from a randomized trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770408/ https://www.ncbi.nlm.nih.gov/pubmed/19920971 |
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