Details

Autor(en) / Beteiligte

• Lucendo, Alfredo J.
• Miehlke, Stephan
• Schlag, Christoph
• Vieth, Michael
• von Arnim, Ulrike
• Molina-Infante, Javier
• Hartmann, Dirk
• Bredenoord, Albert Jan
• Ciriza de los Rios, Constanza
• Schubert, Stefan
• Brückner, Stefan
• Madisch, Ahmed
• Hayat, Jamal
• Tack, Jan
• Attwood, Stephen
• Mueller, Ralph
• Greinwald, Roland
• Schoepfer, Alain
• Straumann, Alex
• Vanuytsel, Tim
• Louis, Hubert
• Musala, Carmen
• Frederking, Dorothea
• Bajbouj, Monther
• Nennstiel, Simon
• Schmelz, Renate
• Heimerl, Schmelz
• Stephan, Anna-Magdalena
• Fibbe, Christiane
• Liedtke (née Laschinsky), Niels
• Keller, Jutta
• Rosien, Ulrich
• Haag, Sebastian
• Schneider, Arne
• Schmöcker, Christoph
• Buchholz, Hendrik
• Lammert, Frank
• Casper, Markus
• Reichert, Matthias
• Sommer, Dirk
• Mönnikes, Hubert
• Stengel, Miriam
• Schmidtmann, Marco
• Müller, Michaela
• Eckardt, Alexander
• Wehrmann, Till
• Armerding, Peter
• Hofmann, Wolf Peter
• Liceni, Thomas
• Kandulski, Arne
• Weigt, Jochen
• Börner, Norbert
• Lutz-Vorderbrügge, Anne
• Albert, Jörg
• Zeuzem, Stefan
• Blumenstein, Irina
• Sprinzl, Kathrin
• Hausmann, Johannes
• Bredenoord, Arjan
• Warners, Marijn
• Villarin, Alfredo Lucendo
• Arias, Ángel Arias
• Tejero Bustos, Maria Ángeles
• Carrillo Ramos, María Jesús
• Olalla Gallardo, José María
• Tosina, Rocío Juárez
• Zamorano, José
• Vaquero, Cecilio Santander
• Francés, Sergio Casabona
• Pérez, Teresa
• Rodriguez, Teresa
• Ciriza de los Ríos, Constanza
• Rodríguez-Valcárcel, Fernando Canga
• Castel de Lucas, Isabel
• Juan, Antonia Perelló
• Barenys, Merce
• Pons, Carlos
• Martinez, Isabel Perez
• Lauret, M. Eugenia
• García, Andrés Castaño
• Rubio, Esmeralda
• Hruz, Petr
• Brunner, Simon
• Poullis, Andrew

Titel

Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial

Ist Teil von

• Gastroenterology (New York, N.Y. 1943), 2019-07, Vol.157 (1), p.74-86.e15

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2019

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0–10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily). At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent. In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029. [Display omitted]