Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT
| العنوان: | Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT |
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| المؤلفون: | José M Echave-Sustaeta, C. Elaine Jones, Beatriz Velasco, Sergi Pascual-Guardia, Sally Kilbride, José M Marín, Juan Roldán, Luis Mateos, David A. Lipson, Maria V Pardo |
| المصدر: | Zaguán. Repositorio Digital de la Universidad de Zaragoza instname Zaguán: Repositorio Digital de la Universidad de Zaragoza Universidad de Zaragoza Therapeutic Advances in Respiratory Disease, Vol 14 (2020) Therapeutic Advances in Respiratory Disease |
| بيانات النشر: | SAGE Publications, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Male, Quinuclidines, Time Factors, law.invention, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Glucocorticoid, Randomized controlled trial, law, Medicine, Pharmacology (medical), 030212 general & internal medicine, Lung, Original Research, Aged, 80 and over, COPD, biology, LAMA, Middle Aged, Lama, Bronchodilator Agents, Drug Combinations, Treatment Outcome, Cohort, Disease Progression, Female, Randomized clinical trial, medicine.drug, Adult, Pulmonary and Respiratory Medicine, medicine.medical_specialty, LABA, Subgroup analysis, Chronic obstructive pulmonary disease (COPD), Muscarinic Antagonists, Chlorobenzenes, Fluticasone propionate, 03 medical and health sciences, Double-Blind Method, Internal medicine, Administration, Inhalation, Humans, In patient, Triple therapy, Glucocorticoids, Benzyl Alcohols, Aged, lcsh:RC705-779, business.industry, Nebulizers and Vaporizers, Inhaler, Recovery of Function, lcsh:Diseases of the respiratory system, medicine.disease, biology.organism_classification, Androstadienes, 030228 respiratory system, Spain, business |
| الوصف: | Objectives: The IMPACT trial has compared the benefit in the reduction of moderate/severe exacerbations of single inhaler triple therapy (SITT) with fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus dual therapy with FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA) in the treatment of patients with chronic obstructive disease (COPD). This study performs a subgroup analysis of the cohort from Spain in the IMPACT study. Materials and Methods: In IMPACT, a 52-week randomized, double-blind, parallel-group, multicenter study ( N = 10,355), patients ⩾40 years of age with COPD and ⩾1 moderate/severe exacerbations in the previous year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Here, we present a subgroup analysis of the 499 patients from Spain, included in the intent-to-treat (ITT) population in the study. Endpoint assessed included exposure-adjusted rate of moderate and severe exacerbations. Results: In the Spain cohort, the exposure-adjusted rate of on-treatment moderate/severe COPD exacerbations per year for FF/UMEC/VI was 1.31 versus 1.43 and 1.57 for FF/VI and UMEC/VI, respectively. No new adverse events were identified. The results are consistent with those observed in the overall ITT study population. Conclusion: In the Spain cohort of the IMPACT study, patients receiving triple therapy with FF/UMEC/VI had a lower exposure-adjusted rate of exacerbations compared with FF/VI and UMEC/VI, similar to the overall population. Study Title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=CTT116855/ https://clinicaltrials.gov/ct2/show/NCT02164513 Registration number: GSK (CTT116855/NCT02164513). The reviews of this paper are available via the supplemental material section. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d0e5151aeb8f492efaa30b527fc5c22d http://hdl.handle.net/10230/52530 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....d0e5151aeb8f492efaa30b527fc5c22d |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |