3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F11%3A33145784" target="_blank" >RIV/61989592:15110/11:33145784 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.crohns.2010.11.006" target="_blank" >http://dx.doi.org/10.1016/j.crohns.2010.11.006</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.crohns.2010.11.006" target="_blank" >10.1016/j.crohns.2010.11.006</a>

Jazyk výsledku

angličtina

Název v původním jazyce

3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.

Popis výsledku v původním jazyce

BACKGROUND AND AIMS: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD. METHODS: This wasan eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ?6 and Endoscopic Index (EI) ?4, received budesonide (Budenofalk(R) 3mg capsulesx3) ormesalazine (Salofalk(R) 1000mg granulesx3). The primary endpoint was clinical remission at week 8 (CAI ?4 with stool frequency and rectal bleeding subscores of "0"). RESULTS: 343 patients were randomised (177 budesonide, 166 mesalazine). Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). The median time to first resolution of

Název v anglickém jazyce

3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.

Popis výsledku anglicky

BACKGROUND AND AIMS: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD. METHODS: This wasan eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ?6 and Endoscopic Index (EI) ?4, received budesonide (Budenofalk(R) 3mg capsulesx3) ormesalazine (Salofalk(R) 1000mg granulesx3). The primary endpoint was clinical remission at week 8 (CAI ?4 with stool frequency and rectal bleeding subscores of "0"). RESULTS: 343 patients were randomised (177 budesonide, 166 mesalazine). Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). The median time to first resolution of

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FE - Ostatní obory vnitřního lékařství

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2011

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Crohn's and Colitis

ISSN

1873-9946

e-ISSN

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Svazek periodika

5

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

10

Strana od-do

129-138

Kód UT WoS článku

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EID výsledku v databázi Scopus

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