Details

Autor(en) / Beteiligte

• Miehlke, Stephan
• Hruz, Petr
• Vieth, Michael
• Bussmann, Christian
• von Arnim, Ulrike
• Bajbouj, Monther
• Schlag, Christoph
• Madisch, Ahmed
• Fibbe, Christiane
• Wittenburg, Henning
• Allescher, Hans Dieter
• Reinshagen, Max
• Schubert, Stefan
• Tack, Jan
• Müller, Michaela
• Krummenerl, Patrick
• Arts, Joris
• Mueller, Ralph
• Dilger, Karin
• Greinwald, Roland
• Straumann, Alex

Titel

A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis

Ist Teil von

• Gut, 2016-03, Vol.65 (3), p.390-399

Ort / Verlag

England: BMJ Publishing Group LTD

Erscheinungsjahr

2016

Quelle

BMJ Journals Archiv - DFG Nationallizenzen

Beschreibungen/Notizen

• ObjectiveTo investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE).DesignAdults with active EoE (n=76) randomly received 14 days’ treatment with either BET 2×1 mg/day (BET1, n=19) or BET 2×2 mg/day (BET2, n=19), or BVS 2×5 mL (0.4 mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16 eosinophils/mm2 hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation.ResultsHistological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients.ConclusionsBET or BVS was highly effective and safe for short-term treatment of EoE. The 1 mg (twice daily) dosage was equally effective as the 2 mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation.ClinicalTrials.gov numberNCT02280616; EudraCT number, 2009-016692-29.