Real-World Outcomes across Baseline Risk Profiles in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate in Spain: Insights from the ORESTES Study

Abstract

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder characterized by persistent symptoms such as dyspnea and cough, as well as exacerbations. Triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) is recommended for patients not adequately controlled by dual therapy. Key clinical parameters guide COPD management. METHODS: The observational, retrospective ORESTES study included adults ? 40 years with COPD initiating BGF in routine practice. In this analysis, patients were grouped according to exacerbation history, airflow obstruction (forced expiratory volume in 1 s [FEV(1)] % predicted), and blood eosinophil count. Exacerbations, additional COPD medications, and healthcare resource utilization (HCRU) were evaluated. RESULTS: Among 114 patients with only one moderate exacerbation (and no severe exacerbations) and 363 with ? 1 severe and/or ? 2 moderate exacerbations in the previous year, the proportion experiencing at least one exacerbation decreased by 43.9% and 35.0% (relative differences), respectively, after BGF initiation. Regarding airflow obstruction, reductions were 22.3% for patients with FEV(1) < 50% predicted (N = 156) and 24.0% for those with FEV(1) ? 50% predicted (N = 155). According to blood eosinophil count, decreases were 29.8% (< 100 cells/µL, N = 110) and 25.8% (? 100 cells/µL, N = 208). Across all subgroups, reductions in moderate and severe exacerbations ranged from 18.9% to 54.4% and from 10.9% to 45.5%, respectively, except for the expected increases in severe events and related hospitalizations in the group with only one prior moderate exacerbation. Use of rescue medication (including short-acting beta-2 agonists [SABA]), emergency room visits, and hospitalizations generally declined, with reductions across subgroups ranging from 7.8% to 45.5%. CONCLUSION: Consistent improvements were observed across all subgroups, with reductions in exacerbations, rescue medication use, and HCRU regardless of prior exacerbation history, lung function, or blood eosinophil levels. These findings suggest that BGF may lead to improvements across a broad disease spectrum, further supporting the hypothesis that earlier introduction may be beneficial. TRIAL REGISTRATION: NCT06321731.