|
KMID : 0988920180160020255
|
|
Intestinal Research
2018 Volume.16 No. 2 p.255 ~ p.266
|
|
|
Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g/day with other 5-aminosalicylic acid preparation in active ulcerative colitis: a randomized, double-blind study
|
|
Ogata Haruhiko
Yokoyama Tadashi
Mizushima Seiichi
Hagino Atsushi
Hibi Toshifumi
|
|
|
Abstract
|
|
|
Background/Aims: This study compared the efficacy of multimatrix mesalazine 2.4 g/day and 4.8 g/day with controlled-release mesalazine 2.25 g/day.
Methods: In this multicenter, randomized, double-blind study, 251 patients with mildly to moderately active ulcerative colitis received multimatrix mesalazine 2.4 g/day once daily (Multimatrix-2.4), 4.8 g/day once daily (Multimatrix-4.8), or controlled-release (time-dependent) mesalazine 2.25 g/day 3 times daily (Time-2.25) for 8 weeks. The primary efficacy endpoint was the change in the ulcerative colitis-disease activity index (UC-DAI) score.
Results: The mean change in the UC-DAI score and standard deviation in the per protocol set was ?1.9±2.5 for Multimatrix-2.4 and ?2.4±2.8 for Time-2.25. The difference between Multimatrix-2.4 and Time-2.25 was 0.3 (two-sided 95% confidence interval [CI], ?0.5 to 1.1), thus non-inferiority was not demonstrated based on the pre-defined non-inferiority margin (1.0). In the full analysis set, the difference between Multimatrix-4.8 and Time-2.25 was ?1.2 (two-sided 95% CI, ?2.0 to ?0.5), and the mean change in UC-DAI score in the FAS was ?3.3 (two-sided 95% CI, ?3.9 to ?2.8) for Multimatrix-4.8 and ?1.9 (two-sided 95% CI, ?2.5 to ?1.3) for Multimatrix-2.4, indicating that Multimatrix-4.8 was more effective than Time-2.25 and Multimatrix-2.4. There was no difference among the treatment groups in terms of safety.
Conclusions: This study showed that the efficacy of multimatrix mesalazine 2.4 g/day was comparable to controlled release mesalazine 2.25 g/day, although non-inferiority was not demonstrated. Importantly, this was the first study to indicate that multimatrix mesalazine 4.8 g/day was more effective than 2.4g/day with no associated safety concerns.
|
|
|
KEYWORD
|
|
|
Colitis, ulcerative, Active, Mesalazine, Multimatrix
|
|
|
FullTexts / Linksout information
|
|
 
|
|
|
Listed journal information
|
|
  
|
|