International journal of chronic obstructive pulmonary disease · 2025
Characteristics of Patients Receiving Budesonide/Glycopyrronium/Formoterol for Chronic Obstructive Pulmonary Disease in Spain: The AURA Study.
СтатьяНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Calle Rubio Myriam, Trigueros Carrero Juan Antonio, Chaparro Briones Paula, Escudero Herrera Luciano, Pollack Michael, Hernández Subirá Ignacio, Sánchez-Covisa Joaquín
Аннотация
BACKGROUND: Single-inhaler triple therapy with budesonide/glycopyrronium/formoterol fumarate (BGF; Trixeo Aerosphere®) was approved in the European Union in December 2020 for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by dual therapy, and has been available in Spain since February 2022. This real-world, observational, retrospective cohort study, AURA Spain, describes the demographics, clinical characteristics, and healthcare resource utilization of patients initiating single-inhaler BGF triple therapy.
METHODS: Electronic medical records in the Spanish Healthcare System anonymized, integrated BIG-PAC® database were analyzed to identify COPD patients aged ≥40 years initiating single-inhaler BGF between 1 February 2022 and 31 January 2023.
RESULTS: Patients (N=482) had a mean (standard deviation, SD) age of 71.5 (10.0) years, mean BMI of 29.6 (6.2) kg/m2, most were aged ≥65 years (73.7%) and male (62.5%). Most were former (62.7%) or current (24.5%) smokers. Applying GOLD FEV1 thresholds, severity of COPD was moderate in 49.8% of patients, severe (41.9%), and very severe (6.5%). The most common comorbidities were hypertension (62.2%), dyslipidemia (56.8%), and anxiety (42.5%), and 85.9% had one or more cardiovascular-related comorbidity. Overall, 57.3% experienced at least one moderate or severe exacerbation in the 12-month baseline period, 9.5% visited the emergency department for COPD-related reasons; and 12.7% were hospitalized for COPD (median length of stay 7 [interquartile range: 6-8] days). Patients initiating single-inhaled BGF triple therapy escalated from monotherapy (2.3%) or dual therapy (62.7%), switched from other triple therapies (31.3%), or were treatment-naïve (3.7%).
CONCLUSION: Single-inhaler BGF triple therapy was initiated mostly as an escalation from dual maintenance therapy, with many switching from triple therapy, in patients with a high burden of disease, as demonstrated by their frequent exacerbation profile, advanced COPD severity (moderate to very severe obstruction) and the high frequency of several comorbidities, including cardiovascular diseases.
METHODS: Electronic medical records in the Spanish Healthcare System anonymized, integrated BIG-PAC® database were analyzed to identify COPD patients aged ≥40 years initiating single-inhaler BGF between 1 February 2022 and 31 January 2023.
RESULTS: Patients (N=482) had a mean (standard deviation, SD) age of 71.5 (10.0) years, mean BMI of 29.6 (6.2) kg/m2, most were aged ≥65 years (73.7%) and male (62.5%). Most were former (62.7%) or current (24.5%) smokers. Applying GOLD FEV1 thresholds, severity of COPD was moderate in 49.8% of patients, severe (41.9%), and very severe (6.5%). The most common comorbidities were hypertension (62.2%), dyslipidemia (56.8%), and anxiety (42.5%), and 85.9% had one or more cardiovascular-related comorbidity. Overall, 57.3% experienced at least one moderate or severe exacerbation in the 12-month baseline period, 9.5% visited the emergency department for COPD-related reasons; and 12.7% were hospitalized for COPD (median length of stay 7 [interquartile range: 6-8] days). Patients initiating single-inhaled BGF triple therapy escalated from monotherapy (2.3%) or dual therapy (62.7%), switched from other triple therapies (31.3%), or were treatment-naïve (3.7%).
CONCLUSION: Single-inhaler BGF triple therapy was initiated mostly as an escalation from dual maintenance therapy, with many switching from triple therapy, in patients with a high burden of disease, as demonstrated by their frequent exacerbation profile, advanced COPD severity (moderate to very severe obstruction) and the high frequency of several comorbidities, including cardiovascular diseases.
Предметные рубрики MeSH
HumansMalePulmonary Disease, Chronic ObstructiveFemaleAgedRetrospective StudiesSpainMiddle AgedFormoterol FumarateTreatment OutcomeBronchodilator AgentsAdministration, InhalationGlycopyrrolateLungBudesonideAdrenergic beta-2 Receptor AgonistsDrug CombinationsTime FactorsSeverity of Illness IndexAged, 80 and overDrug Therapy, CombinationMuscarinic Antagonists