Clinical trial: Effects of an oral preparation of mesalazine at 4 g/day on
moderately active ulcerative colitis. A phase III parallel-dosing study.
Author(s): Hiwatashi N, Suzuki Y, Mitsuyama K, Munakata A, Hibi T.
Affiliation(s): Department of Gastroenterology, Iwaki Kyoritsu General Hospital, 16 Kusehara,
Mimayamachi, Uchigo, Iwaki, 973-8555, Japan.
incho@iwaki-kyoritsu.iwaki.fukushima.jp
Publication date & source: 2011, J Gastroenterol. , 46(1):46-56
BACKGROUND AND AIMS: Oral mesalazine formulations are effective in the treatment
of active ulcerative colitis (UC). It is not clear what induction dose of
mesalazine is optimal for treating patients with active UC. We aimed to evaluate
the efficacy and safety of 4 versus 2.25 g/day for selected patients with active
UC.
METHODS: A multicenter, randomized, double-blind, parallel-group clinical study
in 39 Japanese medical institutions. A total of 123 patients with moderately
active UC received 4 g/day (two divided doses) versus 2.25 g/day (three divided
doses) for 8 weeks. Primary endpoint was the ulcerative colitis-disease activity
index (UC-DAI) score before and after 8 weeks of treatment. The improvement of
each individual UC-DAI variable, remission, and efficacy rates were secondary
endpoints. Safety was determined by laboratory data, vital signs, subjective
symptoms, and objective findings.
RESULTS: Patients receiving 4 g/day achieved a change in UC-DAI score
significantly superior to those receiving 2.25 g/day [-3.0 (95% confidence
intervals (CI) -3.8 to -2.3) vs. -0.8 (95% CI -1.8 to 0.1), respectively]. There
were significant differences in all UC-DAI variables between the groups.
Remission rates were 22.0% (4 g/day) and 15.3% (2.25 g/day). The efficacy rate
was significantly better with 4 versus 2.25 g/day [76.3 vs. 45.8%, respectively
(95% CI 13.8-47.2); P = 0.001]. No difference was seen in adverse events or
adverse drug reactions.
CONCLUSIONS: A dose of 4 g/day was significantly superior to 2.25 g/day in terms
of UC-DAI score for patients with moderately active UC. Safety profiles were
similar for both doses.
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