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
Abstract
Introduction 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. Methods 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. Results 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…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 295 participants or records.
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