Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis: a double-blind, randomized study.

Abstract:

BACKGROUND:Mesalamine is the first-line drug for the treatment of ulcerative colitis (UC). We directly compared the efficacy and safety of two mesalamine formulations for the induction of remission in patients with UC. METHODS:In a multicenter, double-blind, randomized study, 229 patients with mild-to-moderate active UC were assigned to 4 groups: 66 and 65 received a pH-dependent release formulation of 2.4 g/day (pH-2.4 g) or 3.6 g/day (pH-3.6 g), respectively; 65 received a time-dependent release formulation of 2.25 g/day (Time-2.25 g), and 33 received placebo (Placebo). The drugs were administered three times daily for eight weeks. The primary endpoint was a decrease in the UC disease activity index (UC-DAI). RESULTS:In the full analysis set (n = 225) the decrease in UC-DAI in each group was 1.5 in pH-2.4 g, 2.9 in pH-3.6 g, 1.3 in Time-2.25 g and 0.3 in Placebo, respectively. These results demonstrate the superiority of pH-3.6 g over Time-2.25 g (P = 0.003) and the noninferiority of pH-2.4 g to Time-2.25 g. Among the patients with proctitis-type UC, a significant decrease in UC-DAI was observed in pH-2.4 g and pH-3.6 g as compared to Placebo, but not in Time-2.25 g. No differences were observed in the safety profiles. CONCLUSIONS:Higher dose of the pH-dependent release formulation was more effective for induction of remission in patients with mild-to-moderate active UC. Additionally, the pH-dependent release formulation was preferable to the time-dependent release formulation for patients with proctitis-type UC (UMIN Clinical Trials Registry, no. C000000288).

journal_name

Inflamm Bowel Dis

authors

Ito H,Iida M,Matsumoto T,Suzuki Y,Sasaki H,Yoshida T,Takano Y,Hibi T

doi

10.1002/ibd.21193

subject

Has Abstract

pub_date

2010-09-01 00:00:00

pages

1567-74

issue

9

eissn

1078-0998

issn

1536-4844

journal_volume

16

pub_type

杂志文章,多中心研究,随机对照试验
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    pub_type: 杂志文章,meta分析

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    更新日期:2017-12-19 00:00:00

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    pub_type: 杂志文章,随机对照试验

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    更新日期:2008-10-01 00:00:00

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    pub_type: 杂志文章,多中心研究

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    pub_type: 杂志文章

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    更新日期:2015-01-01 00:00:00

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    pub_type: 杂志文章,meta分析

    doi:10.1002/ibd.22901

    authors: Shahidi N,Fu YT,Qian H,Bressler B

    更新日期:2012-11-01 00:00:00

  • Progression and variability of TNBS colitis-associated inflammation in rats assessed by contrast-enhanced and T2-weighted MRI.

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    pub_type: 杂志文章

    doi:10.1097/MIB.0b013e318281341b

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  • Antimicrobial peptide response to blood translocation of bacterial DNA in Crohn's disease is affected by NOD2/CARD15 genotype.

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    pub_type: 杂志文章

    doi:10.1002/ibd.21537

    authors: Gutiérrez A,Holler E,Zapater P,Sempere L,Jover R,Pérez-Mateo M,Schoelmerich J,Such J,Wiest R,Francés R

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    pub_type: 杂志文章

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    pub_type: 杂志文章

    doi:10.1002/ibd.21072

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    更新日期:2010-03-01 00:00:00

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    pub_type: 杂志文章,评审

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    更新日期:2013-01-01 00:00:00

  • Dysplastic lesions in ulcerative colitis: changing paradigms.

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    pub_type: 杂志文章,评审

    doi:10.1002/ibd.21227

    authors: Allen PB,Kamm MA,De Cruz P,Desmond PV

    更新日期:2010-11-01 00:00:00

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    pub_type: 杂志文章

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    authors: Ma Y,Ohmen JD,Li Z,Bentley LG,McElree C,Pressman S,Targan SR,Fischel-Ghodsian N,Rotter JI,Yang H

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    doi:10.1097/MIB.0b013e3182a6a0f3

    authors: Hausmann M,Rechsteiner T,Caj M,Benden C,Fried M,Boehler A,Rogler G

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    doi:10.1093/ibd/izz010

    authors: Yu CS,Jung SW,Lee JL,Lim SB,Park IJ,Yoon YS,Kim CW,Yang SK,Ye BD,Park SH,Han M,Kim JC

    更新日期:2019-08-20 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/00054725-200411000-00006

    authors: Pica R,Paoluzi OA,Iacopini F,Marcheggiano A,Crispino P,Rivera M,Bella A,Consolazio A,Paoluzi P

    更新日期:2004-11-01 00:00:00

  • Plant sterol guggulsterone inhibits nuclear factor-kappaB signaling in intestinal epithelial cells by blocking IkappaB kinase and ameliorates acute murine colitis.

    abstract:BACKGROUND/AIMS:The plant sterol guggulsterone has been shown to have anti-inflammatory properties. It remains unknown, however, whether guggulsterone is effective for the treatment of inflammatory bowel disease (IBD). Therefore, we investigated anti-inflammatory effects of guggulsterone on intestinal epithelial cells ...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/01.mib.0000235830.94057.c6

    authors: Cheon JH,Kim JS,Kim JM,Kim N,Jung HC,Song IS

    更新日期:2006-12-01 00:00:00

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    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章,评审

    doi:10.1097/00054725-200005000-00007

    authors: Shanahan F

    更新日期:2000-05-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/01.MIB.0000225339.91484.fc

    authors: Henriksen M,Jahnsen J,Lygren I,Sauar J,Kjellevold Ø,Schulz T,Vatn MH,Moum B,IBSEN Study Group.

    更新日期:2006-07-01 00:00:00