Shigeo Muro, Munehiro Seki, John R Hurst, David Petullo, Jonathan Marshall, Karin Bowen, Patrick F Darken, Elizabeth A Duncan, Ayman Megally, Mehul Patel
{"title":"布地奈德/甘炔溴铵/富马酸福莫特罗二水合物三联治疗与双重治疗对COPD和哮喘表型特征患者的影响：一项KRONOS和ETHOS的综合事后分析","authors":"Shigeo Muro, Munehiro Seki, John R Hurst, David Petullo, Jonathan Marshall, Karin Bowen, Patrick F Darken, Elizabeth A Duncan, Ayman Megally, Mehul Patel","doi":"10.2147/COPD.S478349","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>We evaluated the inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β<sub>2</sub>-agonist (ICS/LAMA/LABA) triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) versus dual LAMA/LABA and ICS/LABA therapies in patients with chronic obstructive pulmonary disease (COPD) and phenotypic features of asthma (bronchodilator reversibility and elevated blood eosinophils), but no asthma diagnosis, for whom treatment guidelines are limited.</p><p><strong>Patients and methods: </strong>KRONOS (NCT02497001) and ETHOS (NCT02465567) enrolled patients with moderate-to-very-severe COPD, no current asthma diagnosis, and either ≥0 (KRONOS) or ≥1 (ETHOS) moderate/severe exacerbations in the prior year. This pooled post hoc analysis evaluated trough forced expiratory volume in 1 second (FEV<sub>1</sub>) and FEV<sub>1</sub> area under the curve from hours 0 to 4 (AUC<sub>0-4</sub>) change from baseline over 12-24 weeks, moderate/severe exacerbation rates, and St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks with ICS/LAMA/LABA (BGF 320/14.4/10 µg), LAMA/LABA (glycopyrronium/formoterol fumarate dihydrate [GFF] 14.4/10 µg), and ICS/LABA (budesonide/formoterol fumarate dihydrate [BFF] 320/10 µg) in patients with phenotypic features of asthma defined as reversibility to salbutamol and blood eosinophils ≥300 cells/mm<sup>3</sup>. Analyses were not adjusted for multiplicity.</p><p><strong>Results: </strong>BGF improved trough FEV<sub>1</sub> and FEV<sub>1</sub> AUC<sub>0-4</sub> versus GFF (least squares mean [LSM] difference [95% confidence interval (CI)] 125 [39-211] and 153 [59-247] mL) and BFF (LSM difference [95% CI] 118 [30-207] and 146 [49-243] mL). Exacerbation rates were estimated to be lower with BGF versus GFF and BFF (respective rate ratios [95% CI] 0.28 [0.19-0.43] and 0.69 [0.45-1.05]) and SGRQ total score was estimated to be improved with BGF versus GFF and BFF (respective LSM differences [95% CI] -5.18 [-8.11 to -2.24] and -1.09 [-4.08 to 1.91]).</p><p><strong>Conclusion: </strong>BGF was estimated to have benefits on lung function, exacerbations, and health-related quality of life versus dual therapies in patients with COPD and phenotypic features of asthma.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT02497001 and NCT02465567.</p>","PeriodicalId":48818,"journal":{"name":"International Journal of Chronic Obstructive Pulmonary Disease","volume":"19 ","pages":"2729-2737"},"PeriodicalIF":2.7000,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649577/pdf/","citationCount":"0","resultStr":"{\"title\":\"Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS.\",\"authors\":\"Shigeo Muro, Munehiro Seki, John R Hurst, David Petullo, Jonathan Marshall, Karin Bowen, Patrick F Darken, Elizabeth A Duncan, Ayman Megally, Mehul Patel\",\"doi\":\"10.2147/COPD.S478349\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>We evaluated the inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β<sub>2</sub>-agonist (ICS/LAMA/LABA) triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) versus dual LAMA/LABA and ICS/LABA therapies in patients with chronic obstructive pulmonary disease (COPD) and phenotypic features of asthma (bronchodilator reversibility and elevated blood eosinophils), but no asthma diagnosis, for whom treatment guidelines are limited.</p><p><strong>Patients and methods: </strong>KRONOS (NCT02497001) and ETHOS (NCT02465567) enrolled patients with moderate-to-very-severe COPD, no current asthma diagnosis, and either ≥0 (KRONOS) or ≥1 (ETHOS) moderate/severe exacerbations in the prior year. This pooled post hoc analysis evaluated trough forced expiratory volume in 1 second (FEV<sub>1</sub>) and FEV<sub>1</sub> area under the curve from hours 0 to 4 (AUC<sub>0-4</sub>) change from baseline over 12-24 weeks, moderate/severe exacerbation rates, and St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks with ICS/LAMA/LABA (BGF 320/14.4/10 µg), LAMA/LABA (glycopyrronium/formoterol fumarate dihydrate [GFF] 14.4/10 µg), and ICS/LABA (budesonide/formoterol fumarate dihydrate [BFF] 320/10 µg) in patients with phenotypic features of asthma defined as reversibility to salbutamol and blood eosinophils ≥300 cells/mm<sup>3</sup>. Analyses were not adjusted for multiplicity.</p><p><strong>Results: </strong>BGF improved trough FEV<sub>1</sub> and FEV<sub>1</sub> AUC<sub>0-4</sub> versus GFF (least squares mean [LSM] difference [95% confidence interval (CI)] 125 [39-211] and 153 [59-247] mL) and BFF (LSM difference [95% CI] 118 [30-207] and 146 [49-243] mL). Exacerbation rates were estimated to be lower with BGF versus GFF and BFF (respective rate ratios [95% CI] 0.28 [0.19-0.43] and 0.69 [0.45-1.05]) and SGRQ total score was estimated to be improved with BGF versus GFF and BFF (respective LSM differences [95% CI] -5.18 [-8.11 to -2.24] and -1.09 [-4.08 to 1.91]).</p><p><strong>Conclusion: </strong>BGF was estimated to have benefits on lung function, exacerbations, and health-related quality of life versus dual therapies in patients with COPD and phenotypic features of asthma.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT02497001 and NCT02465567.</p>\",\"PeriodicalId\":48818,\"journal\":{\"name\":\"International Journal of Chronic Obstructive Pulmonary Disease\",\"volume\":\"19 \",\"pages\":\"2729-2737\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2024-12-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649577/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Chronic Obstructive Pulmonary Disease\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/COPD.S478349\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Chronic Obstructive Pulmonary Disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/COPD.S478349","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS.
Background: We evaluated the inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) versus dual LAMA/LABA and ICS/LABA therapies in patients with chronic obstructive pulmonary disease (COPD) and phenotypic features of asthma (bronchodilator reversibility and elevated blood eosinophils), but no asthma diagnosis, for whom treatment guidelines are limited.
Patients and methods: KRONOS (NCT02497001) and ETHOS (NCT02465567) enrolled patients with moderate-to-very-severe COPD, no current asthma diagnosis, and either ≥0 (KRONOS) or ≥1 (ETHOS) moderate/severe exacerbations in the prior year. This pooled post hoc analysis evaluated trough forced expiratory volume in 1 second (FEV1) and FEV1 area under the curve from hours 0 to 4 (AUC0-4) change from baseline over 12-24 weeks, moderate/severe exacerbation rates, and St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks with ICS/LAMA/LABA (BGF 320/14.4/10 µg), LAMA/LABA (glycopyrronium/formoterol fumarate dihydrate [GFF] 14.4/10 µg), and ICS/LABA (budesonide/formoterol fumarate dihydrate [BFF] 320/10 µg) in patients with phenotypic features of asthma defined as reversibility to salbutamol and blood eosinophils ≥300 cells/mm3. Analyses were not adjusted for multiplicity.
Results: BGF improved trough FEV1 and FEV1 AUC0-4 versus GFF (least squares mean [LSM] difference [95% confidence interval (CI)] 125 [39-211] and 153 [59-247] mL) and BFF (LSM difference [95% CI] 118 [30-207] and 146 [49-243] mL). Exacerbation rates were estimated to be lower with BGF versus GFF and BFF (respective rate ratios [95% CI] 0.28 [0.19-0.43] and 0.69 [0.45-1.05]) and SGRQ total score was estimated to be improved with BGF versus GFF and BFF (respective LSM differences [95% CI] -5.18 [-8.11 to -2.24] and -1.09 [-4.08 to 1.91]).
Conclusion: BGF was estimated to have benefits on lung function, exacerbations, and health-related quality of life versus dual therapies in patients with COPD and phenotypic features of asthma.
Trial registration: ClinicalTrials.gov NCT02497001 and NCT02465567.
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An international, peer-reviewed journal of therapeutics and pharmacology focusing on concise rapid reporting of clinical studies and reviews in COPD. Special focus will be given to the pathophysiological processes underlying the disease, intervention programs, patient focused education, and self management protocols. This journal is directed at specialists and healthcare professionals
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