Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis
| العنوان: | Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis |
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| المؤلفون: | Chris Compton, Ana R. Sousa, Gregory Feldman, Lee Tombs, David A. Lipson, Ian Naya, Isabelle Boucot, Bernardino Alcázar Navarrete |
| المصدر: | Pulmonary Therapy |
| بيانات النشر: | Springer Science and Business Media LLC, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Pulmonary and Respiratory Medicine, medicine.medical_specialty, Combination therapy, Long-acting β2-agonist, medicine.drug_class, Population, LABA, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Maintenance therapy, Respiratory Care, Internal medicine, Bronchodilator, medicine, COPD, Umeclidinium, Vilanterol, 030212 general & internal medicine, education, Original Research, education.field_of_study, business.industry, Tiotropium, Olodaterol, LAMA, medicine.disease, Crossover study, Long-acting muscarinic antagonist, 030228 respiratory system, chemistry, Maintenance-naïve, business |
| الوصف: | Introduction Appropriate timing for dual bronchodilator therapy initiation in chronic obstructive pulmonary disease (COPD) management is uncertain. Combination therapy is recommended as step-up from monotherapy or first-line treatment in patients with persistent symptoms. In this setting, umeclidinium/vilanterol (UMEC/VI) demonstrated improved lung function and reduced rescue medication use over tiotropium/olodaterol (TIO/OLO). This subgroup analysis explored efficacy differences between these combinations in patients naïve to COPD maintenance therapy before study entry. Methods Post hoc analysis of an 8-week, randomized, open-label, assessor-blind, two-period crossover study (204990; NCT02799784) comparing UMEC/VI 62.5/25 mcg and TIO/OLO 5/5 mcg, focused on maintenance-naïve (MN) patients with moderate COPD and persistent symptoms (modified Medical Research Council dyspnea score ≥ 2). Change from baseline (CFB) in trough forced expiratory volume in 1 s (FEV1), percentage of FEV1 responders (CFB ≥ 100 ml), rescue medication use and safety were evaluated. Results The MN population comprised 63% of the intent-to-treat (ITT) population (148/236 patients) and had similar baseline demographics. At week 8, adjusted mean (standard error) improvements in trough FEV1 from baseline were clinically meaningful for both combinations (UMEC/VI: 167 [17] ml; TIO/OLO 110 [18] ml; adjusted mean difference [95% confidence interval (CI)]: 57 [23–92] ml; p = 0.001; %CFB: 11 vs. 8%). Proportion of FEV1 responders was greater with UMEC/VI versus TIO/OLO at week 8 (60 vs. 42%; odds ratio [95% CI] 1.90 [1.12–3.22]; p = 0.018). Reduction in rescue medication use was 0.20 (95% CI 0.07–0.34) puffs/day greater with UMEC/VI versus TIO/OLO over weeks 1–8 (p = 0.003). Adverse events incidence was similar (UMEC/VI: 24%; TIO/OLO: 29%). Conclusions These results highlight that the efficacy difference between UMEC/VI and TIO/OLO demonstrated in the ITT population is maintained in MN patients. Greater lung function improvements with UMEC/VI versus TIO/OLO were accompanied by symptom improvements, as reflected in a significantly lower need for supplemental rescue medication. Funding GSK. Trial registration NCT02799784 |
| تدمد: | 2364-1746 2364-1754 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e1c34b3cde582b2c8ef338cbb8e75127Test https://doi.org/10.1007/s41030-018-0057-7Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e1c34b3cde582b2c8ef338cbb8e75127 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 23641746 23641754 |
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