Clinical alert
Budesonide led to a greater remission rate and fewer severe adverse events than did mesalamine in Crohn's disease
Thomsen OØ, Cortot A, Jewell D, et al, for the International Budesonide-Mesalamine Study Group. A comparison of budesonide and mesalamine for active Crohn's disease. N Engl J Med 1998 Aug 6;339:370-374[Abstract/Full Text]
| The first 150 words of the full text of this article appear below. |
In patients with active Crohn's disease, is budesonide more effective and safer than mesalamine for inducing remission?
DesignRandomised, double blind, controlled trial with 16 weeks follow up.
Setting25 centres in Denmark, France, the UK, Norway, Italy, Spain, Portugal, Greece, South Africa, Austria, Australia, and Ireland.
Patients182 patients (68% women) who were 18-74 years of age and had Crohn's disease confined to the distal ileum, ileocaecal region, and ascending colon which was confirmed by colonoscopy, small bowel follow through, or barium enema in the previous 24 months. Exclusion criteria were Crohn's disease in the rectum; septic complications; abscess; perforation; active fistulas; ileostomy; colostomy; resection of >100 cm of the ileum; need for immediate surgery; diabetes mellitus; active peptic ulcer disease; systemic infection; clinically significant renal, hepatic, or cardiovascular disease; pregnancy; lactation; or allergy to glucocorticoids or mesalamine.
InterventionPatients were allocated to budesonide, 9 mg once/day plus a
placebo once/day
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