Bone mineral density in relation to efficacy and side effects of budesonide and prednisolone in Crohn's disease.
OBJECTIVE
Osteoporosis frequently occurs in Crohn's disease, often because of corticosteroids. Budesonide as controlled release capsules is a locally acting corticosteroid with low systemic bioavailability. We investigated its effects on bone compared with prednisolone.


METHODS
In 34 international centers, 272 patients with Crohn's disease involving ileum and/or colon ascendens were randomized to once daily treatment with budesonide or prednisolone for 2 years at doses adapted to disease activity. One hundred eighty-one corticosteroid-free patients had active disease (98 had never received corticosteroids, corticosteroid naive; 83 had received corticosteroids previously, corticosteroid exposed), and 90 had quiescent disease, receiving long-term low doses of corticosteroids, corticosteroid-dependent; in 1 patient, no efficacy data were obtained. Bone mineral density and fractures were assessed in a double-blinded fashion; disease activity, side effects, and quality of life were monitored.


RESULTS
Neither the corticosteroid-free nor the corticosteroid-dependent patients treated with budesonide differed significantly in bone mineral density from those receiving prednisolone. However, corticosteroid-naive patients receiving budesonide had smaller reductions in bone mineral density than those on prednisolone (mean, -1.04% vs -3.84%; P = .0084). Treatment-emergent corticosteroid side effects were less frequent with budesonide. Efficacy was similar in both groups.


CONCLUSIONS
Treatment with budesonide is associated with better preserved bone mass compared with prednisolone in only the corticosteroid-naive patients with active ileocecal Crohn's disease. In both the corticosteroid-free and corticosteroid-dependent groups, budesonide and prednisolone were equally effective for up to 2 years, but budesonide caused fewer corticosteroid side effects.
Schoon
Erik J
EJ
Department of Gastroenterology, University Hospital Maastricht, The Netherlands.
Bollani
Simona
S
Mills
Peter R
PR
Israeli
Eran
E
Felsenberg
Dieter
D
Ljunghall
Sverker
S
Persson
Tore
T
Haptén-White
Louise
L
Graffner
Hans
H
Bianchi Porro
Gabriele
G
Vatn
Morten
M
Stockbrügger
Reinhold W
RW
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D015519:Bone Density / Q000187:drug effects; D019819:Budesonide / Q000009:adverse effects* / Q000627:therapeutic use; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced* / Q000503:physiopathology; D011239:Prednisolone / Q000009:adverse effects* / Q000627:therapeutic use; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method
D019819:Budesonide; D011239:Prednisolone