Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis.

Abstract

BACKGROUND:

Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis.

AIM:

To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema.

METHODS:

Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index > 4 and endoscopic index > or = 4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index < or = 4) at the final/withdrawal visit (per protocol).

RESULTS:

A total of 541 patients were randomized--533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%).

CONCLUSION:

Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.

• Authors: V Gross, S Bar-Meir, A Lavy, O Mickisch, Z Tulassay, L Pronai, L Kupcinskas, G Kiudelis, J Pokrotnieks, A Kovács, M Faszczyk, A Razbadauskas, B Margus, M Stolte, R Müller, R Greinwald, International Budesonide Foam Study Group
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 23 Issue 2 Pg. 303-12 (Jan 15 2006) ISSN: 0269-2813 [Print] England
• PMID: 16393311 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Budesonide

Topics

• Administration, Rectal
• Adolescent
• Adult
• Aged
• Anti-Inflammatory Agents (administration & dosage, adverse effects)
• Budesonide (administration & dosage, adverse effects)
• Colitis, Ulcerative (drug therapy)
• Double-Blind Method
• Enema (methods)
• Female
• Humans
• Male
• Middle Aged
• Patient Satisfaction
• Proctitis (drug therapy)
• Proctocolitis (drug therapy)
• Treatment Outcome