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M11 Real-life outcomes of patients with COPD initiating budesonide/glycopyrronium/formoterol after a previous dual therapy in Spain. ORESTES study

thoraxjnl · 2025-11-02 · canonical JSON source

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Introduction Since 2022, triple therapy (TT) with budesonide/glycopyrronium/formoterol (BGF) has been available in Spain for COPD treatment. Real-world evidence is essential to complement data from clinical trials. The ORESTES study aimed to describe patients’ characteristics at BGF initiation, and to report key clinical outcomes after 12 months. This abstract focuses on patients who escalated to BGF from dual therapy (DT).Methods This retrospective chart review was conducted across 20 hospitals from Spain. A total of 718 patients with COPD (spirometry-confirmed) aged ≥40 years at BGF initiation were included.Results Among all patients, 295 (41.1%) escalated to BGF from DT, 49.6% transitioned from prior TT, 3.3% from monotherapy, and 6.0% were treatment-naïve. Within the DT group, 38% escalated from ICS/LABA and 62% from LABA/LAMA. The mean age was 69.9 years (SD=9.9), with 31.2% being female. The average duration of COPD was 7.3 years (SD=5.7); 48.5% had a predicted FEV1 <50%, and 60.3% had experienced at least one COPD exacerbation (ECOPD) in the previous year. Additional baseline characteristics are presented in table 1.Following initiation of BGF, reductions were observed in the incidence of ECOPD, as well as in the use of rescue medication (SABA), oral corticosteroids (OCS), and antibiotics (see table 1). The proportion of patients experiencing at least one ECOPD decreased from 60.3% to 50.2%, and the annualised exacerbation rate declined from 1.06 to 0.94. SABA actual use dropped from 43.0% prior to BGF initiation to 33.0% afterwards, with the mean annualised number of actual prescriptions used per patient decreasing from 1.00 to 0.75. The proportion of patients requiring OCS decreased from 39.3% to 35.3%, while those needing antibiotics declined from 49.8% to 42.4%. Treatment persistence with BGF at 12 months was 91.5%.Abstract M11 Table 1Baseline characteristics and main outcomes of patients initiating BGF after dual therapyConclusion In the ORESTES study conducted in Spain, patients with COPD who escalated from dual therapy to BGF showed high treatment persistence at 12 months and experienced clinically meaningful improvements, including reductions in exacerbations and decreased use of additional treatments.