Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial.

Mario Cottone, Mario Cottone, Stefano Marconi, Herbert Lochs, Giacomo Carlo Sturniolo, Marina Rizzi, Angelo Casa, Cosimo Prantera, Vito Annese

Risultato della ricerca: Article

11 Citazioni (Scopus)

Abstract

Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects.AIM:To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement.METHODS:Patients (n=84) with active Crohn's disease who achieved remission during a 2-week prednisone run-in period were randomised to receive beclomethasone dipropionate for 24 weeks or continue prednisone for a further 2 weeks followed by placebo for 22 weeks. The primary outcome was relapse rate (Crohn's Disease Activity Index score>150 and an increase of ≥60 points from baseline) or withdrawal due to disease deterioration.RESULTS:The relapse rate was 23.3% and 53.8% in beclomethasone dipropionate and placebo groups, respectively (p=0.027). According to Kaplan-Meier analysis, the cumulative relapse rate was 38.0% in the beclomethasone dipropionate group and 56.0% in the placebo group (p=0.025). Six percent and 1.7% of all adverse events in the beclomethasone dipropionate and placebo groups, respectively, were endocrine-related.CONCLUSION:These results demonstrate that beclomethasone dipropionate significantly reduces the relapse rate in post-active Crohn's ileitis patients compared with placebo after induction of remission with a short course of systemic steroids, and is well tolerated.
Lingua originaleEnglish
pagine (da-a)459-464
Numero di pagine6
RivistaDigestive and Liver Disease
Volume43
Stato di pubblicazionePublished - 2011

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Ileitis
Beclomethasone
Placebos
Crohn Disease
Recurrence
Steroids
Prednisone
Remission Induction
Kaplan-Meier Estimate

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cita questo

Cottone, M., Cottone, M., Marconi, S., Lochs, H., Sturniolo, G. C., Rizzi, M., ... Annese, V. (2011). Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial. Digestive and Liver Disease, 43, 459-464.

Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial. / Cottone, Mario; Cottone, Mario; Marconi, Stefano; Lochs, Herbert; Sturniolo, Giacomo Carlo; Rizzi, Marina; Casa, Angelo; Prantera, Cosimo; Annese, Vito.

In: Digestive and Liver Disease, Vol. 43, 2011, pag. 459-464.

Risultato della ricerca: Article

Cottone, M, Cottone, M, Marconi, S, Lochs, H, Sturniolo, GC, Rizzi, M, Casa, A, Prantera, C & Annese, V 2011, 'Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial.', Digestive and Liver Disease, vol. 43, pagg. 459-464.
Cottone M, Cottone M, Marconi S, Lochs H, Sturniolo GC, Rizzi M e altri. Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial. Digestive and Liver Disease. 2011;43:459-464.
Cottone, Mario ; Cottone, Mario ; Marconi, Stefano ; Lochs, Herbert ; Sturniolo, Giacomo Carlo ; Rizzi, Marina ; Casa, Angelo ; Prantera, Cosimo ; Annese, Vito. / Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial. In: Digestive and Liver Disease. 2011 ; Vol. 43. pagg. 459-464.
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AU - Cottone, Mario

AU - Cottone, Mario

AU - Marconi, Stefano

AU - Lochs, Herbert

AU - Sturniolo, Giacomo Carlo

AU - Rizzi, Marina

AU - Casa, Angelo

AU - Prantera, Cosimo

AU - Annese, Vito

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N2 - Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects.AIM:To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement.METHODS:Patients (n=84) with active Crohn's disease who achieved remission during a 2-week prednisone run-in period were randomised to receive beclomethasone dipropionate for 24 weeks or continue prednisone for a further 2 weeks followed by placebo for 22 weeks. The primary outcome was relapse rate (Crohn's Disease Activity Index score>150 and an increase of ≥60 points from baseline) or withdrawal due to disease deterioration.RESULTS:The relapse rate was 23.3% and 53.8% in beclomethasone dipropionate and placebo groups, respectively (p=0.027). According to Kaplan-Meier analysis, the cumulative relapse rate was 38.0% in the beclomethasone dipropionate group and 56.0% in the placebo group (p=0.025). Six percent and 1.7% of all adverse events in the beclomethasone dipropionate and placebo groups, respectively, were endocrine-related.CONCLUSION:These results demonstrate that beclomethasone dipropionate significantly reduces the relapse rate in post-active Crohn's ileitis patients compared with placebo after induction of remission with a short course of systemic steroids, and is well tolerated.

AB - Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects.AIM:To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement.METHODS:Patients (n=84) with active Crohn's disease who achieved remission during a 2-week prednisone run-in period were randomised to receive beclomethasone dipropionate for 24 weeks or continue prednisone for a further 2 weeks followed by placebo for 22 weeks. The primary outcome was relapse rate (Crohn's Disease Activity Index score>150 and an increase of ≥60 points from baseline) or withdrawal due to disease deterioration.RESULTS:The relapse rate was 23.3% and 53.8% in beclomethasone dipropionate and placebo groups, respectively (p=0.027). According to Kaplan-Meier analysis, the cumulative relapse rate was 38.0% in the beclomethasone dipropionate group and 56.0% in the placebo group (p=0.025). Six percent and 1.7% of all adverse events in the beclomethasone dipropionate and placebo groups, respectively, were endocrine-related.CONCLUSION:These results demonstrate that beclomethasone dipropionate significantly reduces the relapse rate in post-active Crohn's ileitis patients compared with placebo after induction of remission with a short course of systemic steroids, and is well tolerated.

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