Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis

Authors: GROSS, V.¹; BAR-MEIR, S.²; LAVY, A.³; MICKISCH, O.⁴; TULASSAY, Z.⁵; PRONAI, L.; KUPCINSKAS, L.⁶; KIUDELIS, G.⁶; POKROTNIEKS, J.⁷; KOVÁCS, Á.⁸; FASZCZYK, M.⁹; RAZBADAUSKAS, A.¹⁰; MARGUS, B.¹¹; STOLTE, M.¹²; MÜLLER, R.¹³; GREINWALD, R.¹³

Source: Alimentary Pharmacology & Therapeutics, Volume 23, Number 2, January 2006 , pp. 303-312(10)

Publisher: Blackwell Publishing

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Abstract:

Summary 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 ≥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 ≤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.

Document Type: Research article

DOI: 10.1111/j.1365-2036.2006.02743.x

Affiliations: 1: Hospital St. Marien, Amberg, Germany; 2: Chaim Sheba Medical Center, Tel Hashomer and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel 3: Bnai Tzion Medical Center, Haifa, Israel 4: Practice for Gastroenterology, Mannheim, Germany 5: SOTE II, Belgyógyászati Klinika, Budapest, Hungary 6: Kaunas Medical University Hospital, Kaunas, Lithuania 7: Paula Stradina University Hospital, Riga, Latvia 8: Erzsébet Kórház-Rendelöintézet, Budapest, Hungary 9: Barzilai Medical Center, Ashkelon, Israel 10: Klaipėdos Jūrininku lignine, Klaipėda, Lithuania 11: East Tallinn Central Hospital, Tallinn, Estonia 12: Institute of Pathology, Hospital Bayreuth, Bayreuth, Germany 13: Dr Falk Pharma GmbH, Freiburg, Germany

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