Bernardino Alcázar-Navarrete, Juan Marco Figueira-Gonçalves, Carmen Corregidor-García, Eunice Fitas, Joaquín Sánchez-Covisa
{"title":"在西班牙开始布地奈德/甘炔溴铵/富马酸福莫特罗脱水的COPD患者的真实世界结果：ORESTES研究","authors":"Bernardino Alcázar-Navarrete, Juan Marco Figueira-Gonçalves, Carmen Corregidor-García, Eunice Fitas, Joaquín Sánchez-Covisa","doi":"10.1007/s12325-025-03361-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Chronic obstructive pulmonary disease (COPD) often results in progressive airflow limitation and is a major cause of morbidity, mortality, and healthcare resource utilization (HCRU). Single-inhaler triple therapy with budesonide/glycopyrronium/formoterol fumarate dehydrate (BGF) is recommended for maintenance in adults with moderate-to-severe COPD not adequately controlled by dual therapy. The ORESTES study aimed to describe the occurrence of exacerbations, clinical characteristics, and HCRU in patients with COPD initiating BGF in a real-life setting in Spain.</p><p><strong>Methods: </strong>Observational, retrospective, multicenter study in patients with COPD aged ≥ 40 years starting BGF treatment at their physician's discretion in routine clinical practice. Data were retrieved 12 months before and up to 12 months after BGF initiation. Occurrence of exacerbations, HCRU, and use of additional COPD medications, together with the patient demographic and clinical profiles, were evaluated.</p><p><strong>Results: </strong>A total of 718 patients were evaluated, of whom 89.3% completed 12 months of BGF treatment. At BGF initiation, most patients were classified as having high-risk phenotype (72.3%), 78.4% presented with dyspnea (mMRC grade ≥ 2), 50.9% were GOLD E, 93.0% had ≥ 3 comorbidities, and 79.7% ≥ 1 cardiovascular comorbidity. Prior initiation of BGF, 41.1% had received dual therapy and 49.6% triple therapy. After BGF initiation, the proportions of patients experiencing moderate and severe exacerbations decreased by 20.8% and 23.1%, respectively. Additionally, the use of all rescue medication decreased by 21.3%, with a similar reduction (21.1%) observed specifically for short-acting beta-2 agonists (SABA). Oral corticosteroids and antibiotics use decreased 17.1%, and 18.2%, respectively. Primary care visits, admissions to the emergency room, and hospitalizations decreased by 18.0%, 25.5%, and 24.7%, respectively.</p><p><strong>Conclusions: </strong>These real-world findings suggest that BGF may provide clinical benefit with high treatment persistence in complex, high-risk patients with COPD, even following high-intensity therapy. The observed improvements, despite advanced disease, raise the possibility that earlier initiation of BGF may help optimize outcomes; however, further study is warranted.</p><p><strong>Clinical trial registration: </strong>NCT06321731.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dehydrate in Spain: ORESTES Study.\",\"authors\":\"Bernardino Alcázar-Navarrete, Juan Marco Figueira-Gonçalves, Carmen Corregidor-García, Eunice Fitas, Joaquín Sánchez-Covisa\",\"doi\":\"10.1007/s12325-025-03361-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Chronic obstructive pulmonary disease (COPD) often results in progressive airflow limitation and is a major cause of morbidity, mortality, and healthcare resource utilization (HCRU). Single-inhaler triple therapy with budesonide/glycopyrronium/formoterol fumarate dehydrate (BGF) is recommended for maintenance in adults with moderate-to-severe COPD not adequately controlled by dual therapy. The ORESTES study aimed to describe the occurrence of exacerbations, clinical characteristics, and HCRU in patients with COPD initiating BGF in a real-life setting in Spain.</p><p><strong>Methods: </strong>Observational, retrospective, multicenter study in patients with COPD aged ≥ 40 years starting BGF treatment at their physician's discretion in routine clinical practice. Data were retrieved 12 months before and up to 12 months after BGF initiation. Occurrence of exacerbations, HCRU, and use of additional COPD medications, together with the patient demographic and clinical profiles, were evaluated.</p><p><strong>Results: </strong>A total of 718 patients were evaluated, of whom 89.3% completed 12 months of BGF treatment. At BGF initiation, most patients were classified as having high-risk phenotype (72.3%), 78.4% presented with dyspnea (mMRC grade ≥ 2), 50.9% were GOLD E, 93.0% had ≥ 3 comorbidities, and 79.7% ≥ 1 cardiovascular comorbidity. Prior initiation of BGF, 41.1% had received dual therapy and 49.6% triple therapy. After BGF initiation, the proportions of patients experiencing moderate and severe exacerbations decreased by 20.8% and 23.1%, respectively. Additionally, the use of all rescue medication decreased by 21.3%, with a similar reduction (21.1%) observed specifically for short-acting beta-2 agonists (SABA). Oral corticosteroids and antibiotics use decreased 17.1%, and 18.2%, respectively. 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Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dehydrate in Spain: ORESTES Study.
Introduction: Chronic obstructive pulmonary disease (COPD) often results in progressive airflow limitation and is a major cause of morbidity, mortality, and healthcare resource utilization (HCRU). Single-inhaler triple therapy with budesonide/glycopyrronium/formoterol fumarate dehydrate (BGF) is recommended for maintenance in adults with moderate-to-severe COPD not adequately controlled by dual therapy. The ORESTES study aimed to describe the occurrence of exacerbations, clinical characteristics, and HCRU in patients with COPD initiating BGF in a real-life setting in Spain.
Methods: Observational, retrospective, multicenter study in patients with COPD aged ≥ 40 years starting BGF treatment at their physician's discretion in routine clinical practice. Data were retrieved 12 months before and up to 12 months after BGF initiation. Occurrence of exacerbations, HCRU, and use of additional COPD medications, together with the patient demographic and clinical profiles, were evaluated.
Results: A total of 718 patients were evaluated, of whom 89.3% completed 12 months of BGF treatment. At BGF initiation, most patients were classified as having high-risk phenotype (72.3%), 78.4% presented with dyspnea (mMRC grade ≥ 2), 50.9% were GOLD E, 93.0% had ≥ 3 comorbidities, and 79.7% ≥ 1 cardiovascular comorbidity. Prior initiation of BGF, 41.1% had received dual therapy and 49.6% triple therapy. After BGF initiation, the proportions of patients experiencing moderate and severe exacerbations decreased by 20.8% and 23.1%, respectively. Additionally, the use of all rescue medication decreased by 21.3%, with a similar reduction (21.1%) observed specifically for short-acting beta-2 agonists (SABA). Oral corticosteroids and antibiotics use decreased 17.1%, and 18.2%, respectively. Primary care visits, admissions to the emergency room, and hospitalizations decreased by 18.0%, 25.5%, and 24.7%, respectively.
Conclusions: These real-world findings suggest that BGF may provide clinical benefit with high treatment persistence in complex, high-risk patients with COPD, even following high-intensity therapy. The observed improvements, despite advanced disease, raise the possibility that earlier initiation of BGF may help optimize outcomes; however, further study is warranted.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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