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Statements

Subject Item
n2:RIV%2F61989592%3A15110%2F11%3A33145786%21RIV14-MSM-15110___
rdf:type
skos:Concept n15:Vysledek
dcterms:description
BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. METHODS: We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-L-coated oral mesalamine (4.5 g/day). RESULTS: The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ?150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (delta70) or 100 or more (delta100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (delta70, P = .11; delta100, P = .15), or between the 2 budesonide groups (delta70, P = .38; delta100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen. BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. METHODS: We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-L-coated oral mesalamine (4.5 g/day). RESULTS: The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ?150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (delta70) or 100 or more (delta100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (delta70, P = .11; delta100, P = .15), or between the 2 budesonide groups (delta70, P = .38; delta100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen.
dcterms:title
Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease.
skos:prefLabel
Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease.
skos:notation
RIV/61989592:15110/11:33145786!RIV14-MSM-15110___
n15:predkladatel
n19:orjk%3A15110
n3:aktivita
n4:N n4:I
n3:aktivity
I, N
n3:cisloPeriodika
2
n3:dodaniDat
n13:2014
n3:domaciTvurceVysledku
n16:8238979
n3:druhVysledku
n6:J
n3:duvernostUdaju
n10:S
n3:entitaPredkladatele
n8:predkladatel
n3:idSjednocenehoVysledku
188835
n3:idVysledku
RIV/61989592:15110/11:33145786
n3:jazykVysledku
n17:eng
n3:klicovaSlova
remision; RCT; mesalazine; Mesalamine
n3:klicoveSlovo
n5:remision n5:Mesalamine n5:RCT n5:mesalazine
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[058EF812F56F]
n3:nazevZdroje
Gastroenterology
n3:obor
n9:FE
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
70
n3:rokUplatneniVysledku
n13:2011
n3:svazekPeriodika
140
n3:tvurceVysledku
Tomsová, Eva Tromm, Andreas Bunganic, Ivan Konečný, Michal
s:issn
0016-5085
s:numberOfPages
10
n14:doi
10.1053/j.gastro.2010.11.004
n18:organizacniJednotka
15110