Naslov
Both Budesonide (9mg) As Well As High-Dose Eudragit-L-Coated Mesalamine (4.5g) Lead to High Remission Rates in Moderately Active Crohn's Disease Patients: A Double-Blind, Double Dummy Randomized, Multicenter Study

Autori
Tromm, Andreas ; Bunganic, Ivan ; Tomsova, Eva ; Tulassay, Zsolt ; Lukas, Milan ; Kykal, Jan ; Batovsky, Marian ; Fixa, Bohumil ; Gabalec, Libor ; Safadi, Rifaat ; Kramm, Heinz-Jochen ; Altorjay, Istvan ; Loehr, Hanns ; Koutroubakis, Ioannis E. ; Bar-Meir, Simon ; Stimac, Davor ; Mohrbacher, Ralf ; Greinwald, Roland

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Gastroenterology / - : W B SAUNDERS CO-ELSEVIER INC, 2009, A65-A65

Skup
Digestive Disease Week

Mjesto i datum
Chicago (IL), Sjedinjene Američke Države, 30.05.2009. - 04.06.2009

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
Budesonide; mesalamine; RCT

Sažetak
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 (Delta 70) or 100 or more (Delta 100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Delta 70, P = .11 ; Delta 100, P = .15), or between the 2 budesonide groups (Delta 70, P = .38 ; Delta 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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

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