Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study
Background/AimsThe therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for ind...
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| Format: | Article |
| Language: | English |
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Korean Association for the Study of Intestinal Diseases
2016-01-01
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| Series: | Intestinal Research |
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| Online Access: | http://www.irjournal.org/upload/pdf/ir-14-50.pdf |
| _version_ | 1817995808376619008 |
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| author | Yasuo Suzuki Mitsuo Iida Hiroaki Ito Isamu Saida Toshifumi Hibi |
| author_facet | Yasuo Suzuki Mitsuo Iida Hiroaki Ito Isamu Saida Toshifumi Hibi |
| author_sort | Yasuo Suzuki |
| collection | DOAJ |
| description | Background/AimsThe therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC).MethodsIn a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates.ResultsIn the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups.ConclusionsThe results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others. |
| first_indexed | 2024-04-14T02:13:08Z |
| format | Article |
| id | doaj.art-6372a6aae4d6470889fe7a62af4b199c |
| institution | Directory Open Access Journal |
| issn | 1598-9100 2288-1956 |
| language | English |
| last_indexed | 2024-04-14T02:13:08Z |
| publishDate | 2016-01-01 |
| publisher | Korean Association for the Study of Intestinal Diseases |
| record_format | Article |
| series | Intestinal Research |
| spelling | doaj.art-6372a6aae4d6470889fe7a62af4b199c2022-12-22T02:18:22ZengKorean Association for the Study of Intestinal DiseasesIntestinal Research1598-91002288-19562016-01-01141505910.5217/ir.2016.14.1.50184Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group studyYasuo Suzuki0Mitsuo Iida1Hiroaki Ito2Isamu Saida3Toshifumi Hibi4Department of Internal Medicine, Toho University Sakura Medical Center, Chiba, Japan.Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.Kinshukai Infusion Clinic, Osaka, Japan.Zeria Pharmaceutical Co., Ltd., Tokyo, Japan.Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.Background/AimsThe therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC).MethodsIn a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates.ResultsIn the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups.ConclusionsThe results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.http://www.irjournal.org/upload/pdf/ir-14-50.pdfAsacolpH-dependent-release mesalamineColitis, ulcerativeDouble-blind method |
| spellingShingle | Yasuo Suzuki Mitsuo Iida Hiroaki Ito Isamu Saida Toshifumi Hibi Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study Intestinal Research Asacol pH-dependent-release mesalamine Colitis, ulcerative Double-blind method |
| title | Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study |
| title_full | Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study |
| title_fullStr | Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study |
| title_full_unstemmed | Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study |
| title_short | Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study |
| title_sort | efficacy and safety of two ph dependent release mesalamine doses in moderately active ulcerative colitis a multicenter randomized double blind parallel group study |
| topic | Asacol pH-dependent-release mesalamine Colitis, ulcerative Double-blind method |
| url | http://www.irjournal.org/upload/pdf/ir-14-50.pdf |
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