4CPS-217 Effectiveness and safety of oral viscous budesonide in compounded formulation: real-world data
Year: 2025
Type: conference-paper
Study design: Observational Study
Abstract: Background and Importance Budesonide is a corticosteroid with anti-inflammatory properties, and its viscous formulation enhances adherence to the oesophageal mucosa, improving local action in eosinophilic esophagitis (EoE). Aim and Objectives This study aimed to evaluate the effectiveness and safety of oral viscous budesonide (OVB) in a compounded formulation (0.5 mg/ml) in patients with EoE at a 1000-bed hospital. Material and Methods Descriptive and retrospective study (March 2018 to March 2024) including patients diagnosed with EoE and treated with OVB who received at least one 6-week induction phase. Demographic and clinical variables (prior treatments and response, duration of OVB therapy, dosage, eosinophil count/mm2, clinical symptoms at 6 weeks, adverse drug reactions (ADRs), and treatment discontinuation (yes/no)) were collected from patients‘ medical records and the compounded formulation dispensing program. Effectiveness was evaluated based on histological and clinical responses after 6 weeks. Histological response was defined as an eosinophil count of <15 eosinophils/mm2 per high-power field, and clinical response as the absence of symptoms. Patients requiring endoscopic intervention were considered treatment failures. Safety was assessed based on ADRs and treatment discontinuation. Percentages represented categorical data, and medians were used for continuous variables. Data were analysed using Microsoft Excel. Results A total of 62 patients were included (77% male),with a median current age of 33 years (range:4–74) and a median age at diagnosis of 27 years (range:4–65). Most patients (92%) had previously received proton pump inhibitors, 91% had followed an elimination diet, and 87% had used swallowed fluticasone without achieving a response. The median duration of treatment was 6 months (range:2–37). Doses of 1 mg every 12 hours were administered to 53% of patients, 0.5 mg every 12 hours to 14.5%, and 1 mg every 24 hours to 17.7%. ADRs were reported in 20.9% of patients, with the most common being asymptomatic oral fungal infections (14.5%), hepatic steatosis (3.2%), and hypocortisolism (3.2%). No patients discontinued treatment due to toxicity. Conclusion and Relevance OVB proved to be an effective treatment option for patients with EoE who refractory to other therapies are, showing high rates of histological and clinical response. It demonstrated an acceptable safety profile, with manageable and well-tolerated adverse events. Further studies are needed to confirm these findings due to the limited sample size and short follow-up period. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: M Muñoz Villasur, C Rodríguez-Tenreiro Rodríguez, I Maray Mateos, I De La Fuente Villaverde, S Fernández Lastras, M Eiroa Osoro, L Oyague López, C Fadón Herrera, C Díaz Romero, A Lozano Blázquez
Institution: Hospital Universitario Central de Asturias
Language: English
Topic: Eosinophilic Esophagitis
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408376279