Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate After Dual and Triple Therapy in Spain: A Sub-Study of the ORESTES Study

Chronic obstructive pulmonary disease (COPD) is a progressive lung condition associated with high morbidity and mortality. Single-inhaler triple therapy (SITT), such as budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF), is recommended for patients with COPD who are not adequately controlled by dual therapy (DT). Escalation from DT or switching from triple therapy (TT)—SITT or multiple-inhaler TT (MITT)—are key real-world treatment pathways. The observational, retrospective, multicenter ORESTES study included adults (≥ 40 years) with COPD initiating BGF in routine clinical practice. This secondary analysis focuses on the following treatment pathways: escalation from DT and switch from TT. Patients’ characteristics, exacerbations, additional COPD treatments, and healthcare resource utilization (HCRU) were assessed. A total of 295 patients escalated from DT and 356 switched from TT (SITT: 147; MITT: 209) to BGF. 66.8% of patients escalating from DT and 78.5% switching from TT showed a high-risk GesEPOC phenotype; 77.9% and 80.0% had mMRC grade ≥ 2, and 91.2% and 96.1% had ≥ 3 comorbidities. Following BGF initiation, the annualized exacerbation rate decreased by 11.6% (from 1.06 to 0.94) in patients escalating from DT and by 15.5% (from 1.60 to 1.35) in patients switching from TT (after SITT: 17.8% reduction; after MITT: 14.1%). Rescue medication use declined overall, and specifically short-acting beta-2 agonists (SABA) use declined by 23.2% and 19.4% (SITT: 21.9%; MITT: 18.4%). Emergency room visits and hospitalizations decreased by 19.7% and 19.0% in patients escalating from DT, and by 29.4% and 25.5% among those switching from TT (SITT: 25.0%/18.3%; MITT: 32.4%/29.9%). In this real-world Spanish cohort of patients with COPD not adequately controlled with DT or TT, reductions in exacerbations, rescue medication use, and HCRU were observed after BGF initiation, supporting the potential value of earlier introduction of BGF in patients with persistent symptoms and/or frequent exacerbations despite high-intensity therapy. NCT06321731. Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that causes breathing difficulties. People with COPD often have ongoing symptoms and experience flare-ups, also known as exacerbations, that require additional treatment or hospital care. Even with standard treatment using two (dual therapy) or three medicines (triple therapy), many patients still have symptoms and exacerbations. This observational study used data from clinical practice from adults with COPD in Spain who initiated treatment with a triple therapy in a single inhaler containing budesonide, glycopyrronium, and formoterol fumarate dihydrate (BGF). Patients had previously used either dual therapy or another triple therapy. Researchers examined medical records for the year before and the year after the treatment change. Most patients in the study were considered high risk because of their symptoms and other health conditions. After starting BGF, patients had fewer exacerbations, used fewer additional medications (such as short-acting bronchodilators, oral corticosteroids, and antibiotics), and had fewer hospital admissions and emergency room visits. These improvements were seen in patients who had previously used dual therapy or other triple therapy. The findings suggest that changing to BGF may provide clinical benefits for patients with COPD who are not well controlled on their previous treatments, and support consideration of earlier initiation of BGF in high-risk patients with persistent symptoms or frequent exacerbations.