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Efficacy of Long-Term 4.0 g/Day Mesalazine (Pentasa) for Maintenance Therapy in Ulcerative Colitis

Fuminao Takeshima, Masato Matsumura, Kazuya Makiyama, Kazuo Ohba, Masaki Yamakawa, Hitoshi Nishiyama, Takuji Yamao, Yuko Akazawa, Naoyuki Yamaguchi, Ken Ohnita, Tatsuki Ichikawa, Hajime Isomoto, Kazuhiko Nakao

Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

Med Sci Monit 2014; 20:1314-1318

DOI: 10.12659/MSM.890567

Available online:

Published: 2014-07-27


Background: High-dose (4.0 g/day) mesalazine is typically used for induction therapy, but its efficacy as maintenance therapy remains to be determined. We conducted a multicenter retrospective study to investigate the efficacy of continuous treatment with 4.0 g/day of mesalazine.
Material and Methods: Japanese ulcerative colitis (UC) patients receiving acute induction therapy with 4.0 g/day mesalazine were enrolled and followed. Those who clinically improved or who achieved clinical remission were categorized into 2 sub-groups according to the median duration of treatment with 4.0 g/day of mesalazine. The clinical relapse frequency and the time to relapse were analyzed.
Results: We enrolled 180 patients with active UC, and then 115 patients who clinically improved or who achieved clinical remission after treatment with 4.0 g/day mesalazine were categorized into 2 sub-groups according to the median of treatment duration: a short-term treatment group (≤105 days, n=58) and a long-term treatment group (>105 days, n=57). Overall, 45 (39.1%) patients relapsed: 28 (48.3%) in the short-term treatment group and 17 (29.8%) in the long-term treatment group. This difference was statistically significant (p<0.05). The relapse-free rate in the long-term treatment group was significantly higher than that in the short-term treatment group (p<0.05). The mean time to relapse in the long-term treatment group was significantly longer than that in the short-term treatment group (425.6±243.8 days vs. 277.4±224.5 days; p<0.05).
Conclusions: Long-term continuous treatment with high-dose mesalazine (4.0 g/day) may be more effective than short-term treatment for maintenance of remission in UC patients.

Keywords: Colitis, Ulcerative - prevention & control, Cohort Studies, Dose-Response Relationship, Drug, Japan, Kaplan-Meier Estimate, Maintenance Chemotherapy - statistics & numerical data, Mesalamine - therapeutic use, Recurrence



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