Naslov
Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease

Autori
Tromm, A. ; Bunganič, I. ; Tomsová, E. ; Tulassay, Z. ; Lukáš, M. ; Kykal, J. ; Bátovský, M. ; Fixa, B. ; Gabalec, L. ; Safadi, R. ; Kramm, H.J. ; Altorjay, I. ; Löhr, H. ; Koutroubakis, I. ; Bar-Meir, S. ; Štimac, Davor ; Schäffeler, E. ; Glasmacher, C. ; Dilger, K. ; Mohrbacher, R. ; Greinwald, R.

Izvornik
Gastroenterology (New York, N.Y. 1943) (0016-5085) 140 (2011), 2; 425-434

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
mesalamine; mesalazine; RCT; remission

Sažetak
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. 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). 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 (Δ70) or 100 or more (Δ100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Δ70, P = .11 ; Δ100, P = .15), or between the 2 budesonide groups (Δ70, P = .38 ; Δ100, 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. 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

Napomena
International Budenofalk Study Group

POVEZANOST RADA