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001-es BibID:	BIBFORM064920
Első szerző:	Dignass, Axel
Cím:	Once versus three times daily dosing of oral budesonide for active Crohn's disease : a double-blind, double-dummy, randomised trial / Axel Dignass, Simeon Stoynov, Andrey E. Dorofeyev, Galina A. Grigorieva, Eva Tomsová, István Altorjay, Daniel Tuculanu, Ivan Bunganič, Juris Pokrotnieks, Limas Kupčinskas, Karin Dilger, Roland Greinwald, Ralph Mueller, International Budenofalk Study Group
Dátum:	2014
ISSN:	1873-9946
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Journal of Crohns & Colitis 8 : 9 (2014), p. 970-980. -
További szerzők:	Stoynov, Simeon Dorofeyev, Andrey E. Grigorieva, Galina A. Tomsová, Eva Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) Tuculanu, Daniel Bunganič, Ivan Pokrotnieks, Juris Kupčinskas, Limas Dilger, Karin Greinwald, Roland Mueller, Ralph Kacska Sándor (1975-) (belgyógyász) International Budenofalk Study Group
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001-es BibID:	BIBFORM036070
Első szerző:	Tromm, Andreas
Cím:	Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease / Andreas Tromm, Ivan Bunganič, Eva Tomsová, Zsolt Tulassay, Milan Lukáš, Jan Kykal, Marian Bátovský, Bohumil Fixa, Libor Gabalec, Rifaat Safadi, Heinz-Jochen Kramm, István Altorjay, Hanns Löhr, Ioannis Koutroubakis, Simon Bar-Meir, Davor Štimac, Elke Schäffeler, Christoph Glasmacher, Karin Dilger, Ralf Mohrbacher, Roland Greinwald, and the International Budenofalk Study Group
Dátum:	2011
ISSN:	0016-5085
Megjegyzések:	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 (70) or 100 or more (100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (70, P = .11; 100, P = .15), or between the 2 budesonide groups (70, P = .38; 100, 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.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban külföldön készült közlemény
Megjelenés:	Gastroenterology 140 : 2 (2011), p. 425-434. -
További szerzők:	Bunganič, Ivan Tomsová, Eva Tulassay Zsolt (1944-) (belgyógyász, gasztroenterológus) Lukas, Milan Kykal, Jan Bátovský, Marian Fixa, Bohumil Gabalec, Libor Safadi, Rifaat Kramm, Heinz-Jochen Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) Löhr, Hanns Koutroubakis, Ioannis Bar-Meir, Simon Štimac, Davor Schäffeler, Elke Glasmacher, Christoph Dilger, Karin Mohrbacher, Ralf Greinwald, Roland International Budenofalk Study Group
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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