Your browser doesn't support javascript.
loading
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
Intestinal Research ; : 255-266, 2018.
Article Dans Anglais | WPRIM | ID: wpr-714185
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.
Sujets)

Texte intégral: Disponible Indice: WPRIM (Pacifique occidental) Sujet Principal: Ulcère / Rectocolite hémorragique / Méthode en double aveugle / Mésalazine Type d'étude: Essai clinique contrôlé / Guide de pratique Limites du sujet: Humains langue: Anglais Texte intégral: Intestinal Research Année: 2018 Type: Article

Documents relatifs à ce sujet

MEDLINE

...
LILACS

LIS

Texte intégral: Disponible Indice: WPRIM (Pacifique occidental) Sujet Principal: Ulcère / Rectocolite hémorragique / Méthode en double aveugle / Mésalazine Type d'étude: Essai clinique contrôlé / Guide de pratique Limites du sujet: Humains langue: Anglais Texte intégral: Intestinal Research Année: 2018 Type: Article