Oral high dose Beclomethasone dipropionate for treatment of active ulcerative colitis

Simona Di Caro,Benedetto Mangiavillano,Ennio La Rocca,Antonino De Lorenzo,Enzo Masci,Alberto Mariani,Antonio Gasbarrini,Laura Di Renzo,Dario Raimondo

doi:10.4081/gi.2012.e9

Abstract

Oral corticosteroids (CS) have been widely used for treatment of ulcerative colitis (UC) at the price of systemic side effects. Role of topically active oral beclomethasone dipropionate (BDP) in clinical practice is still unclear. The aim of this paper is to investigate efficacy and tolerability of a high dose BDP regimen in mild to moderately active UC. Twenty-five patients (9 males, aged 25-40 years) with mild to moderately active UC, unresponsive to oral and topical 5-ASA (4.8 gr daily) and BDP (5 mg daily), were enrolled. All patients continued 5-ASA plus high dose oral BDP (15 mg od for 4 weeks and than tapered). Clinical, endoscopic, histological and laboratory parameters were monitored. Mean disease activity index (DAI) score at study entry was 8.82±4. Response to treatment was observed in all patients after 2 weeks. Remission was observed in all patients within 4-6 weeks from entering the study (mean DAI score: 2.34±0.5) and maintained throughout 6-month follow-up. No major adverse events were documented. Quality of life global evaluation score improved. This study provides the first evidence of efficacy and safety of high dose oral BDP-scheme in UC demonstrating excellent tolerability and favourable acceptability profile. This new BDPscheme might be a valid alternative to conventional oral CS when standard dose BDP is not effective. Future studies are needed to explore further clinical indications.

Highlights

Ulcerative colitis (UC), an idiopathic chronic inflammatory bowel disease, is characterized by a spectrum of gastrointestinal (GI) and Benedetto Mangiavillano,[4] Enzo Masci,[4] Alberto Mariani,[5] Antonio Gasbarrini,[6] Antonino De Lorenzo,[2] Laura Di Rienzo,[2] Ennio La Rocca[3]Key words: oral beclomtethasone dipropionate, ulcerative colitis, treatment, quality of life
The e aim of this paper is to investigate efficacy and tolerability of a high dose beclomethasone dipropionate r (BDP) regimen in mild m to moderately active UC
Twenty-five subjects assessment (vital signs, systolic and diastolic evaluated by a binomial score.Effect on pitu, who failed to blood pressure, body weight and physical itary-adrenal function was assessed by clinical respond to initial therapy were enrolled into examination) and UC clinical parameters evaluation

Summary

Introduction

Ulcerative colitis (UC), an idiopathic chronic inflammatory bowel disease, is characterized by a spectrum of gastrointestinal (GI) and Benedetto Mangiavillano,[4] Enzo Masci,[4] Alberto Mariani,[5] Antonio Gasbarrini,[6] Antonino De Lorenzo,[2] Laura Di Rienzo,[2] Ennio La Rocca[3]

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Results

Conclusion