Intestinal Research

Mitsuo Iida

1 Article

Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study: Yasuo Suzuki, Mitsuo Iida, Hiroaki Ito, Isamu Saida, Toshifumi Hibi; Intest Res 2016;14(1):50-59. Published online January 26, 2016; DOI: https://doi.org/10.5217/ir.2016.14.1.50

<b>Background/Aims</b><br/>

The 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).

Methods

In 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.

Results

In 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.

Conclusions

The 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.

Citations

Citations to this article as recorded by

Colitis and Crohn’s Foundation (India) consensus statements on use of 5-aminosalicylic acid in inflammatory bowel disease
Ajit Sood, Vineet Ahuja, Vandana Midha, Saroj Kant Sinha, C. Ganesh Pai, Saurabh Kedia, Varun Mehta, Sawan Bopanna, Philip Abraham, Rupa Banerjee, Shobna Bhatia, Karmabir Chakravartty, Sunil Dadhich, Devendra Desai, Manisha Dwivedi, Bhabhadev Goswami, Kir
Intestinal Research.2020; 18(4): 355. CrossRef
Nonimmunity against hepatitis B virus infection in patients newly diagnosed with inflammatory bowel disease
Seong Jae Yeo, Hyun Seok Lee, Byung Ik Jang, Eun Soo Kim, Seong Woo Jeon, Sung Kook Kim, Kyeong Ok Kim, Yoo Jin Lee, Hyun Jik Lee, Kyung Sik Park, Yun Jin Jung, Eun Young Kim, Chang Heon Yang
Intestinal Research.2018; 16(3): 400. CrossRef
Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study
Haruhiko Ogata, Nobuo Aoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi
Intestinal Research.2017; 15(3): 368. CrossRef
Remission endpoints in ulcerative colitis: A systematic review
Maki Jitsumura, Rory Frederick Kokelaar, Dean Anthony Harris
World Journal of Meta-Analysis.2017; 5(4): 85. CrossRef
Potential Benefits of Dietary Fibre Intervention in Inflammatory Bowel Disease
Celestine Wong, Philip Harris, Lynnette Ferguson
International Journal of Molecular Sciences.2016; 17(6): 919. CrossRef
What is the real-life maintenance mesalazine dose in ulcerative colitis?
Alicia Algaba, Iván Guerra, Ana García García de Paredes, María Hernández Tejero, Carlos Ferre, Daniel Bonillo, Lara Aguilera, Antonio López-Sanromán, Fernando Bermejo
Revista Española de Enfermedades Digestivas.2016;[Epub] CrossRef

5,771 View
66 Download
6 Web of Science
6 Crossref

Author index