• Je něco špatně v tomto záznamu ?

Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial

A. Dignass, S. Stoynov, AE. Dorofeyev, GA. Grigorieva, E. Tomsová, I. Altorjay, D. Tuculanu, I. Bunganič, J. Pokrotnieks, L. Kupčinskas, K. Dilger, R. Greinwald, R. Mueller, . ,

. 2014 ; 8 (9) : 970-80.

Jazyk angličtina Země Nizozemsko

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc15023573

BACKGROUND: Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no precise recommendation for budesonide dosing due to lack of comparative data. A once-daily (OD) 9 mg dose may improve adherence and thereby efficacy. METHODS: An eight-week, double-blind, double-dummy randomised trial compared budesonide 9 mg OD versus 3mg three-times daily (TID) in patients with mild-to-moderately active ileocolonic Crohn's disease. Primary endpoint was clinical remission defined as CDAI <150 at week 8 (last observation carried forward). RESULTS: The final intent-to-treat population comprised 471 patients (238 [9 mg OD], 233 [3 mg TID]). The confirmatory population for the primary endpoint analysis was the interim per protocol population (n=377; 188 [9 mg OD], 189 [3mg TID]), in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID. Clinical remission was achieved in 71.3% versus 75.1%, a difference of -3.9% (95% CI [-14.6%; 6.4%]; p=0.020 for non-inferiority). The mean (SD) time to remission was 21.9 (13.8) days versus 21.4 (14.6) days with budesonide 9 mg OD versus 3 mg TID, respectively. In a subpopulation of 122 patients with baseline SES-CD ulcer score ≥1, complete mucosal healing occurred in 32.8% (21/64) on 9 mg OD and 41.4% (24/58) on 3mg TID; deep remission (mucosal healing and clinical remission) was observed in 26.6% (17/64) and 32.8% (19/58) of patients, respectively. Treatment-emergent suspected adverse drug reactions were reported in 4.6% of 9 mg OD and 4.7% of 3 mg TID patients. CONCLUSIONS: Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn's disease.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc15023573
003      
CZ-PrNML
005      
20150729103220.0
007      
ta
008      
150709s2014 ne f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.crohns.2014.01.021 $2 doi
035    __
$a (PubMed)24534142
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a ne
100    1_
$a Dignass, Axel $u Agaplesion Markus Krankenhaus, 1st Dept. of Medicine, Goethe-University, 60431 Frankfurt am Main, Germany. Electronic address: axel.dignass@fdk.info.
245    10
$a Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial / $c A. Dignass, S. Stoynov, AE. Dorofeyev, GA. Grigorieva, E. Tomsová, I. Altorjay, D. Tuculanu, I. Bunganič, J. Pokrotnieks, L. Kupčinskas, K. Dilger, R. Greinwald, R. Mueller, . ,
520    9_
$a BACKGROUND: Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no precise recommendation for budesonide dosing due to lack of comparative data. A once-daily (OD) 9 mg dose may improve adherence and thereby efficacy. METHODS: An eight-week, double-blind, double-dummy randomised trial compared budesonide 9 mg OD versus 3mg three-times daily (TID) in patients with mild-to-moderately active ileocolonic Crohn's disease. Primary endpoint was clinical remission defined as CDAI <150 at week 8 (last observation carried forward). RESULTS: The final intent-to-treat population comprised 471 patients (238 [9 mg OD], 233 [3 mg TID]). The confirmatory population for the primary endpoint analysis was the interim per protocol population (n=377; 188 [9 mg OD], 189 [3mg TID]), in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID. Clinical remission was achieved in 71.3% versus 75.1%, a difference of -3.9% (95% CI [-14.6%; 6.4%]; p=0.020 for non-inferiority). The mean (SD) time to remission was 21.9 (13.8) days versus 21.4 (14.6) days with budesonide 9 mg OD versus 3 mg TID, respectively. In a subpopulation of 122 patients with baseline SES-CD ulcer score ≥1, complete mucosal healing occurred in 32.8% (21/64) on 9 mg OD and 41.4% (24/58) on 3mg TID; deep remission (mucosal healing and clinical remission) was observed in 26.6% (17/64) and 32.8% (19/58) of patients, respectively. Treatment-emergent suspected adverse drug reactions were reported in 4.6% of 9 mg OD and 4.7% of 3 mg TID patients. CONCLUSIONS: Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn's disease.
650    _2
$a aplikace orální $7 D000284
650    _2
$a mladiství $7 D000293
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a budesonid $x aplikace a dávkování $7 D019819
650    _2
$a Crohnova nemoc $x farmakoterapie $x patologie $7 D003424
650    _2
$a vztah mezi dávkou a účinkem léčiva $7 D004305
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a rozvrh dávkování léků $7 D004334
650    _2
$a gastrointestinální endoskopie $7 D016099
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a následné studie $7 D005500
650    _2
$a glukokortikoidy $x aplikace a dávkování $7 D005938
650    _2
$a lidé $7 D006801
650    _2
$a střevní sliznice $x patologie $7 D007413
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a adherence pacienta $7 D010349
650    _2
$a prospektivní studie $7 D011446
650    _2
$a indukce remise $7 D012074
650    _2
$a výsledek terapie $7 D016896
650    _2
$a mladý dospělý $7 D055815
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Stoynov, Simeon $u University General Hospital for Active Treatment "Tzaritza Yoanna", Clinic of Gastroenterology, 1527 Sofia, Bulgaria. Electronic address: simeon_stoinov@abv.bg.
700    1_
$a Dorofeyev, Andrey E $u Donetsk City Clinical Hospital No. 3, Gastroenterology Dept., M. Gorkyy Donetsk National Medical University, Donetsk, 83003 Donetsk, Ukraine. Electronic address: dorofeyev@med.finfort.com.
700    1_
$a Grigorieva, Galina A $u I.M. Sechenov First Moscow Medical State University, Conservative Coloproctology Dept., 119992 Moscow, Russia.
700    1_
$a Tomsová, Eva $u District Hospital Mladá Boleslav, 293 01 Mladá Boleslav II, Czech Republic. Electronic address: evatomsova@seznam.cz.
700    1_
$a Altorjay, István $u DEOEC, II. sz. Belgyógyászati Klinika, 4012 Debrecen, Hungary. Electronic address: altorjay@med.unideb.hu. $7 gn_A_00005017
700    1_
$a Tuculanu, Daniel $u Medical Center Tuculanu, 300158 Timisoara, Romania. Electronic address: danieltuculanu@yahoo.com.
700    1_
$a Bunganič, Ivan $u Gastro I. s.r.o., Gastroenterology Dept., 080 01 Prešov, Slovakia. Electronic address: bunganic.ivan15@zoznam.sk.
700    1_
$a Pokrotnieks, Juris $u Paula Stradina University Hospital, Center of Gastroenterology, 1002 Riga, Latvia. Electronic address: pokrot@latnet.lv.
700    1_
$a Kupčinskas, Limas $u Lithuanian University of Health Sciences, Dept. of Gastroenterology, 50009 Kaunas, Lithuania. Electronic address: likup@takas.lt.
700    1_
$a Dilger, Karin $u Dr. Falk Pharma GmbH, Clinical Research & Development Dept., 79108 Freiburg, Germany. Electronic address: dilger@drfalkpharma.de.
700    1_
$a Greinwald, Roland $u Dr. Falk Pharma GmbH, Clinical Research & Development Dept., 79108 Freiburg, Germany. Electronic address: greinwald@drfalkpharma.de.
700    1_
$a Mueller, Ralph $u Dr. Falk Pharma GmbH, Clinical Research & Development Dept., 79108 Freiburg, Germany. Electronic address: mueller@drfalkpharma.de.
700    1_
$a ,
773    0_
$w MED00166945 $t Journal of Crohn's & colitis $x 1876-4479 $g Roč. 8, č. 9 (2014), s. 970-80
856    41
$u https://pubmed.ncbi.nlm.nih.gov/24534142 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20150709 $b ABA008
991    __
$a 20150729103306 $b ABA008
999    __
$a ok $b bmc $g 1083910 $s 906566
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2014 $b 8 $c 9 $d 970-80 $i 1876-4479 $m Journal of Crohn's and colitis $n J Crohns Colitis $x MED00166945
LZP    __
$a Pubmed-20150709

Najít záznam

Citační ukazatele

Možnosti archivace