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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
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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
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