International journal of chronic obstructive pulmonary disease · 2026
Real-World Effectiveness and Safety of Extrafine Triple Therapy in COPD Patients with Comorbid and Cardiovascular Conditions.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rogliani Paola, Bakakos Petros, Stolz Daiana, Piraino Alessio, Franzini Laura, Nudo Elena, Di Palma Luca, Brusselle Guy
Аннотация
PURPOSE: This study evaluated the real-world effectiveness and safety of extrafine single-inhaler triple therapy (SITT) with beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) in chronic obstructive pulmonary disease (COPD) patients with diverse comorbidity burdens, cardiovascular (CV) history, or CV risk.
PATIENTS AND METHODS: A pooled analysis of six observational studies assessed outcomes in subgroups with 1-2 or ≥3 comorbidities, CV history, or CV risk. Endpoints included COPD Assessment Test (CAT) scores, exacerbation, lung function (FEV1), adherence (TAI-10), and cardiopulmonary events, evaluated at 3, 6, and 12 months. Comparisons were made with reference populations (0 comorbidities, no CV history, and no CV risk).
RESULTS: Among 5356 patients, 2431 had 1-2 comorbidities, 1087 had ≥3, 312 had a CV history, and 117 met CV-risk criteria. CAT scores decreased significantly in all subgroups following SITT initiation. Patients with comorbidities showed smaller CAT improvements vs those without, while CV history/risk groups showed greater CAT improvements than their reference groups up to month 6. Regardless of comorbidity burden or CV history, most patients remained exacerbation-free and FEV1 improved, with no long-term differences between groups. Adherence improved as well, with patients with ≥3 comorbidities potentially showing higher adherence over the long term. Cardiopulmonary events were more frequent in higher-comorbidity groups early on but became similar over time. Patients with a CV history consistently reported more cardiopulmonary events than those without, while those with CV risk achieved similar results compared to no-risk group at any time point.
CONCLUSION: This analysis provides real-world evidence supporting extrafine BDP/FF/GB SITT as an effective and safe option for COPD patients with comorbidities, including CV history or risk. These findings help address an evidence gap in vulnerable populations and support timely initiation of SITT in high-risk patients in clinical practice.
PATIENTS AND METHODS: A pooled analysis of six observational studies assessed outcomes in subgroups with 1-2 or ≥3 comorbidities, CV history, or CV risk. Endpoints included COPD Assessment Test (CAT) scores, exacerbation, lung function (FEV1), adherence (TAI-10), and cardiopulmonary events, evaluated at 3, 6, and 12 months. Comparisons were made with reference populations (0 comorbidities, no CV history, and no CV risk).
RESULTS: Among 5356 patients, 2431 had 1-2 comorbidities, 1087 had ≥3, 312 had a CV history, and 117 met CV-risk criteria. CAT scores decreased significantly in all subgroups following SITT initiation. Patients with comorbidities showed smaller CAT improvements vs those without, while CV history/risk groups showed greater CAT improvements than their reference groups up to month 6. Regardless of comorbidity burden or CV history, most patients remained exacerbation-free and FEV1 improved, with no long-term differences between groups. Adherence improved as well, with patients with ≥3 comorbidities potentially showing higher adherence over the long term. Cardiopulmonary events were more frequent in higher-comorbidity groups early on but became similar over time. Patients with a CV history consistently reported more cardiopulmonary events than those without, while those with CV risk achieved similar results compared to no-risk group at any time point.
CONCLUSION: This analysis provides real-world evidence supporting extrafine BDP/FF/GB SITT as an effective and safe option for COPD patients with comorbidities, including CV history or risk. These findings help address an evidence gap in vulnerable populations and support timely initiation of SITT in high-risk patients in clinical practice.
Предметные рубрики MeSH
HumansPulmonary Disease, Chronic ObstructiveTreatment OutcomeFemaleCardiovascular DiseasesComorbidityDrug CombinationsAgedAdministration, InhalationMaleBeclomethasoneGlycopyrrolateBronchodilator AgentsTime FactorsLungFormoterol FumarateAdrenergic beta-2 Receptor AgonistsMiddle AgedRecovery of FunctionMuscarinic AntagonistsForced Expiratory VolumeMedication AdherenceHeart Disease Risk FactorsRisk FactorsGlucocorticoidsNebulizers and VaporizersDisease Progression