Pub Date : 2019-11-01DOI: 10.15326/jcopdf.6.5.2019.0169
B. Yawn, L. Fromer
{"title":"Letter to the Editor: A Primary Care Perspective.","authors":"B. Yawn, L. Fromer","doi":"10.15326/jcopdf.6.5.2019.0169","DOIUrl":"https://doi.org/10.15326/jcopdf.6.5.2019.0169","url":null,"abstract":"","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"9 1","pages":"436-437"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79793204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-01DOI: 10.15326/jcopdf.6.5.2019.0168
{"title":"Time to Redefine? A Statement of the COPD Foundation.","authors":"","doi":"10.15326/jcopdf.6.5.2019.0168","DOIUrl":"https://doi.org/10.15326/jcopdf.6.5.2019.0168","url":null,"abstract":"","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"33 1","pages":"430-432"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74857826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-01DOI: 10.15326/jcopdf.6.5.2019.0173
P. Barnes, J. Vestbo, P. Calverley
{"title":"The Pressing Need to Redefine \"COPD\".","authors":"P. Barnes, J. Vestbo, P. Calverley","doi":"10.15326/jcopdf.6.5.2019.0173","DOIUrl":"https://doi.org/10.15326/jcopdf.6.5.2019.0173","url":null,"abstract":"","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"10 1","pages":"380-383"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88591777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-01DOI: 10.15326/jcopdf.6.5.2019.0172
B. Make
The disease we know as chronic obstructive pulmonary disease (COPD) continues a circuitous journey in its definition, characterization and clinical course. The article by Lowe et al in this issue of Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation expands our understanding of the diagnosis, progression and mortality of this heterogeneous group of disorders.1 The definition of COPD is expanded and a new diagnostic term is introduced – COPDGene® 2019. This perspective provides insights on the importance of this manuscript to clinicians, clinical researchers, and patients. Four questions are raised by this new definition of COPD: · Does COPDGene® 2019 differ from the current definition of COPD? · Is COPDGene® 2019 clinically important? · Are there opportunities for future research to improve the implementation and management of COPDGene® 2019? · How can clinicians employ COPDGene® 2019 in the management of their patients?
{"title":"COPD: A New Diagnostic Paradigm.","authors":"B. Make","doi":"10.15326/jcopdf.6.5.2019.0172","DOIUrl":"https://doi.org/10.15326/jcopdf.6.5.2019.0172","url":null,"abstract":"The disease we know as chronic obstructive pulmonary disease (COPD) continues a circuitous journey in its definition, characterization and clinical course. The article by Lowe et al in this issue of Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation expands our understanding of the diagnosis, progression and mortality of this heterogeneous group of disorders.1 The definition of COPD is expanded and a new diagnostic term is introduced – COPDGene® 2019. \u0000 \u0000This perspective provides insights on the importance of this manuscript to clinicians, clinical researchers, and patients. Four questions are raised by this new definition of COPD: \u0000 \u0000· Does COPDGene® 2019 differ from the current definition of COPD? \u0000 \u0000· Is COPDGene® 2019 clinically important? \u0000 \u0000· Are there opportunities for future research to improve the implementation and management of COPDGene® 2019? \u0000 \u0000· How can clinicians employ COPDGene® 2019 in the management of their patients?","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"35 1","pages":"438-443"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84881224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-01DOI: 10.15326/jcopdf.6.5.2019.0155
K. Young, M. Strand, M. Ragland, G. Kinney, E. Austin, E. Regan, Katherine E. Lowe, B. Make, E. Silverman, J. Crapo, J. Hokanson
Rationale We classified individuals into pulmonary disease subtypes based on 2 underlying pathophysiologic disease axes (airway-predominant and emphysema-predominant) and their increased mortality risk. Our next objective was to determine whether some subcomponents of these subtypes are additionally associated with unique patterns of Global initiative for chronic Obstructive Lung Disease (GOLD) spirometry stage progression. Methods After accounting for intra-individual measurement variability in spirometry measures between baseline (Phase 1) and the 5-year follow up (Phase 2) of the COPD Genetic Epidemiology (COPDGene®) study, 4615 individuals had complete data that would characterize patterns of disease progression over 5 years (2033 non-Hispanic whites; 827 African Americans; 48% female). Individuals could express increased risk for mortality on one or both of the primary subtype axes (airway-predominant or emphysema-predominant) and thus they were further classified into 6 groups: high-risk airway-predominant disease only (APD-only), moderate-risk airway-predominant disease only (MR-APD-only), high-risk emphysema-predominant disease only (EPD-only), combined high-risk airway- and emphysema-predominant disease (combined APD-EPD), combined moderate-risk airway- and emphysema-predominant disease (combined MR-APD-EPD), and no high-risk pulmonary subtype. Outcomes were dichotomized for GOLD spirometry stage progression from Phase 1 to Phase 2. Logistic regression of the progression outcomes on the pulmonary subtypes were adjusted for age, sex, race, and change in smoking status. Results The MR-APD-only group was associated with conversion from GOLD 0 to preserved ratio-impaired spirometry (PRISm) status (odds ratio [OR] 11.3, 95% confidence interval [CI] 5.7-22.1) and GOLD 0 to GOLD 2-4 (OR 6.0, 95% CI 2.0-18.0). The EPD-only group was associated with conversion from GOLD 0 to GOLD 1 (OR 2.4, 95% CI 1.2-4.6), and GOLD 1 to GOLD 2-4 (OR 2.6, 95% CI 1.0-6.9). Conversion between PRISm and GOLD 2-4 (31%-38%) occurred in both the APD-only and the MR-APD-only groups. Conclusion Differential conversion occurs from GOLD 0 to PRISm and GOLD 0 to GOLD 1 based on groups expressing airway-predominant disease or emphysema-predominant disease independently or in combination. Airway-predominant and emphysema-predominant subtypes are highly important in determining patterns of early disease progression.
{"title":"Pulmonary Subtypes Exhibit Differential Global Initiative for Chronic Obstructive Lung Disease Spirometry Stage Progression: The COPDGene® Study.","authors":"K. Young, M. Strand, M. Ragland, G. Kinney, E. Austin, E. Regan, Katherine E. Lowe, B. Make, E. Silverman, J. Crapo, J. Hokanson","doi":"10.15326/jcopdf.6.5.2019.0155","DOIUrl":"https://doi.org/10.15326/jcopdf.6.5.2019.0155","url":null,"abstract":"Rationale\u0000We classified individuals into pulmonary disease subtypes based on 2 underlying pathophysiologic disease axes (airway-predominant and emphysema-predominant) and their increased mortality risk. Our next objective was to determine whether some subcomponents of these subtypes are additionally associated with unique patterns of Global initiative for chronic Obstructive Lung Disease (GOLD) spirometry stage progression.\u0000\u0000\u0000Methods\u0000After accounting for intra-individual measurement variability in spirometry measures between baseline (Phase 1) and the 5-year follow up (Phase 2) of the COPD Genetic Epidemiology (COPDGene®) study, 4615 individuals had complete data that would characterize patterns of disease progression over 5 years (2033 non-Hispanic whites; 827 African Americans; 48% female). Individuals could express increased risk for mortality on one or both of the primary subtype axes (airway-predominant or emphysema-predominant) and thus they were further classified into 6 groups: high-risk airway-predominant disease only (APD-only), moderate-risk airway-predominant disease only (MR-APD-only), high-risk emphysema-predominant disease only (EPD-only), combined high-risk airway- and emphysema-predominant disease (combined APD-EPD), combined moderate-risk airway- and emphysema-predominant disease (combined MR-APD-EPD), and no high-risk pulmonary subtype. Outcomes were dichotomized for GOLD spirometry stage progression from Phase 1 to Phase 2. Logistic regression of the progression outcomes on the pulmonary subtypes were adjusted for age, sex, race, and change in smoking status.\u0000\u0000\u0000Results\u0000The MR-APD-only group was associated with conversion from GOLD 0 to preserved ratio-impaired spirometry (PRISm) status (odds ratio [OR] 11.3, 95% confidence interval [CI] 5.7-22.1) and GOLD 0 to GOLD 2-4 (OR 6.0, 95% CI 2.0-18.0). The EPD-only group was associated with conversion from GOLD 0 to GOLD 1 (OR 2.4, 95% CI 1.2-4.6), and GOLD 1 to GOLD 2-4 (OR 2.6, 95% CI 1.0-6.9). Conversion between PRISm and GOLD 2-4 (31%-38%) occurred in both the APD-only and the MR-APD-only groups.\u0000\u0000\u0000Conclusion\u0000Differential conversion occurs from GOLD 0 to PRISm and GOLD 0 to GOLD 1 based on groups expressing airway-predominant disease or emphysema-predominant disease independently or in combination. Airway-predominant and emphysema-predominant subtypes are highly important in determining patterns of early disease progression.","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"20 1","pages":"414-429"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79968965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-01DOI: 10.15326/jcopdf.6.5.2019.0150
K. Young, E. Regan, M. Han, S. Lutz, M. Ragland, P. Castaldi, G. Washko, M. Cho, M. Strand, D. Curran-Everett, T. Beaty, R. Bowler, E. Wan, D. Lynch, B. Make, E. Silverman, J. Crapo, J. Hokanson, G. Kinney
Background Previous attempts to explore the heterogeneity of chronic obstructive pulmonary disease (COPD) clustered individual patients using clinical, demographic, and disease features. We developed continuous multidimensional disease axes based on radiographic and spirometric variables that split into an airway-predominant axis and an emphysema-predominant axis. Methods The COPD Genetic Epidemiology study (COPDGene®) is a cohort of current and former smokers, > 45 years, with at least 10 pack years of smoking history. Spirometry measures, blood pressure and body mass were directly measured. Mortality was assessed through continuing longitudinal follow-up and cause of death was adjudicated. Among 8157 COPDGene® participants with complete spirometry and computed tomography (CT) measures, the top 2 deciles of the airway-predominant and emphysema-predominant axes previously identified were used to categorize individuals into 3 groups having the highest risk for mortality using Cox proportional hazard ratios. These groups were also assessed for causal mortality. Biomarkers of COPD (fibrinogen, soluble receptor for advanced glycation end products [sRAGE], C-reactive protein [CRP], clara cell secretory protein [CC16], surfactant-D [SP-D]) were compared by group. Findings High-risk subtype classification was defined for 2638 COPDGene® participants who were in the highest 2 deciles of either the airway-predominant and/or emphysema-predominant axis (32% of the cohort). These high-risk participants fell into 3 groups: airway-predominant disease only (APD-only), emphysema-predominant disease only (EPD-only) and combined APD-EPD. There was 26% mortality for the APD-only group, 21% mortality for the EPD-only group, and 54% mortality for the combined APD-EPD group. The APD-only group (n=1007) was younger, had a lower forced expiratory volume in 1 second (FEV1) percent (%) predicted and a strong association with the preserved ratio-impaired spirometry (PRISm) quadrant. The EPD-only group (n=1006) showed a relatively higher FEV1 % predicted and included largely GOLD stage 0, 1 and 2 partipants. Individuals in each of the 3 high-risk groups were at greater risk for respiratory mortality, while those in the APD-only group were additionally at greater risk for cardiovascular mortality. Biomarker analysis demonstrated a significant association of the APD-only group with CRP, and sRAGE demonstrated greatest significance with both the EPD-only and the combined APD-EPD groups. Interpretation Among current and former smokers, individuals in the highest 2 deciles for mortality risk on the airway-predominant axis and the emphysema-predominant axis have unique associations to spirometric patterns, different imaging characteristics, biomarkers and causal mortality.
背景:以往研究慢性阻塞性肺疾病(COPD)异质性的尝试使用临床、人口统计学和疾病特征对个体患者进行聚类。我们根据放射学和肺活量学变量开发了连续的多维疾病轴，分为气道主导轴和肺气肿主导轴。方法COPD遗传流行病学研究(COPDGene®)是一组年龄在45岁以上、吸烟史至少10包年的吸烟者和戒烟者。直接测量肺活量、血压和体重。通过持续的纵向随访评估死亡率，并确定死亡原因。在8157名具有完整肺活量测定和计算机断层扫描(CT)测量的COPDGene®参与者中，使用Cox比例风险比将先前确定的气道优势轴和肺气肿优势轴的前2十分位数将个体分为死亡风险最高的3组。对这些组的因果死亡率也进行了评估。各组COPD生物标志物(纤维蛋白原、晚期糖基化终产物可溶性受体[sRAGE]、c反应蛋白[CRP]、clara细胞分泌蛋白[CC16]、表面活性剂- d [SP-D])比较。发现2638名COPDGene®参与者(占队列的32%)处于气道显性轴和/或肺气肿显性轴的最高2十分位数，定义了高风险亚型分类。这些高风险参与者分为3组:仅气道显性疾病组(APD-only)、仅肺气肿显性疾病组(EPD-only)和APD-EPD联合组。单纯apd组死亡率为26%，单纯epd组死亡率为21%，APD-EPD联合组死亡率为54%。仅apd组(n=1007)更年轻，预测的1秒用力呼气量(FEV1)百分比(%)更低，与保留比率受损肺活量(PRISm)象限有很强的相关性。纯epd组(n=1006)显示出相对较高的FEV1 %预测，主要包括GOLD期0、1和2期参与者。3个高危组中的每一个人都有更高的呼吸死亡风险，而仅apd组的人心血管死亡风险更高。生物标志物分析显示APD-only组与CRP显著相关，而sRAGE在APD-only组和APD-EPD联合组中均表现出最大的相关性。在现在和以前的吸烟者中，在气道优势轴和肺气肿优势轴上死亡风险最高的2十分位数的个体与肺活量测量模式、不同的成像特征、生物标志物和因果死亡率具有独特的关联。
{"title":"Subtypes of COPD Have Unique Distributions and Differential Risk of Mortality.","authors":"K. Young, E. Regan, M. Han, S. Lutz, M. Ragland, P. Castaldi, G. Washko, M. Cho, M. Strand, D. Curran-Everett, T. Beaty, R. Bowler, E. Wan, D. Lynch, B. Make, E. Silverman, J. Crapo, J. Hokanson, G. Kinney","doi":"10.15326/jcopdf.6.5.2019.0150","DOIUrl":"https://doi.org/10.15326/jcopdf.6.5.2019.0150","url":null,"abstract":"Background\u0000Previous attempts to explore the heterogeneity of chronic obstructive pulmonary disease (COPD) clustered individual patients using clinical, demographic, and disease features. We developed continuous multidimensional disease axes based on radiographic and spirometric variables that split into an airway-predominant axis and an emphysema-predominant axis.\u0000\u0000\u0000Methods\u0000The COPD Genetic Epidemiology study (COPDGene®) is a cohort of current and former smokers, > 45 years, with at least 10 pack years of smoking history. Spirometry measures, blood pressure and body mass were directly measured. Mortality was assessed through continuing longitudinal follow-up and cause of death was adjudicated. Among 8157 COPDGene® participants with complete spirometry and computed tomography (CT) measures, the top 2 deciles of the airway-predominant and emphysema-predominant axes previously identified were used to categorize individuals into 3 groups having the highest risk for mortality using Cox proportional hazard ratios. These groups were also assessed for causal mortality. Biomarkers of COPD (fibrinogen, soluble receptor for advanced glycation end products [sRAGE], C-reactive protein [CRP], clara cell secretory protein [CC16], surfactant-D [SP-D]) were compared by group.\u0000\u0000\u0000Findings\u0000High-risk subtype classification was defined for 2638 COPDGene® participants who were in the highest 2 deciles of either the airway-predominant and/or emphysema-predominant axis (32% of the cohort). These high-risk participants fell into 3 groups: airway-predominant disease only (APD-only), emphysema-predominant disease only (EPD-only) and combined APD-EPD. There was 26% mortality for the APD-only group, 21% mortality for the EPD-only group, and 54% mortality for the combined APD-EPD group. The APD-only group (n=1007) was younger, had a lower forced expiratory volume in 1 second (FEV1) percent (%) predicted and a strong association with the preserved ratio-impaired spirometry (PRISm) quadrant. The EPD-only group (n=1006) showed a relatively higher FEV1 % predicted and included largely GOLD stage 0, 1 and 2 partipants. Individuals in each of the 3 high-risk groups were at greater risk for respiratory mortality, while those in the APD-only group were additionally at greater risk for cardiovascular mortality. Biomarker analysis demonstrated a significant association of the APD-only group with CRP, and sRAGE demonstrated greatest significance with both the EPD-only and the combined APD-EPD groups.\u0000\u0000\u0000Interpretation\u0000Among current and former smokers, individuals in the highest 2 deciles for mortality risk on the airway-predominant axis and the emphysema-predominant axis have unique associations to spirometric patterns, different imaging characteristics, biomarkers and causal mortality.","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"85 1","pages":"400-413"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88244861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-23DOI: 10.15326/jcopdf.6.4.2019.0127
M. Navaie, B. Celli, Zhun Xu, Soojin Cho-Reyes, C. Dembek, T. Gilmer
Background Long-acting beta2-agonists (LABAs), with or without inhaled corticosteroids (ICSs), delivered by handheld inhalers or nebulizers are recommended as maintenance therapy in chronic obstructive pulmonary disease (COPD). This study evaluated exacerbations, health resource utilization (HRU), and costs among Medicare beneficiaries with COPD on handheld ICS+LABA who switched to nebulized arformoterol (ARF) or continued ICS+LABA following a respiratory event. Methods Using Medicare claims, we identified beneficiaries with COPD (international classification of disease, 9th revision, clinical modification [ICD-9-CM] 490-492.xx, 494.xx, 496.xx) between 2010-2014 who had ≥ 1 year of continuous enrollment in Parts A, B, and D; ≥ 2 COPD-related outpatient visits ≥ 30 days apart or ≥ 1 hospitalization(s); ICS+LABA use 90-days before ARF initiation; and a respiratory event (COPD-related hospitalization or emergency department [ED] visit < 30 days before ARF initiation). Using propensity scores, 423 beneficiaries who switched to ARF were matched to 423 beneficiaries who continued on handheld ICS+LABA (controls). Difference-in-difference regression models examined outcomes at 180-days follow-up. Results Beneficiaries who switched to ARF had 1.5 fewer exacerbations (p=0.015) but no difference in hospitalizations and ED visits compared to controls. Durable medical equipment (DME) costs were higher among ARF users than controls ($1590), yet total health care costs were similar due to cost offsets by ARF in pharmacy (-$794), inpatient (-$524), and outpatient care (-$65). ARF accounted for 55% ($886.63) of DME costs, with the remaining costs attributed to oxygen therapy ($428.10) and nebulized corticosteroids ($590.85). Conclusions Switching from handheld ICS+LABA to nebulized ARF resulted in fewer COPD exacerbations among Medicare beneficiaries. Nebulized LABAs may improve outcomes in selected patients with COPD.
{"title":"Exacerbations, Health Resource Utilization, and Costs Among Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease Treated with Nebulized Arformoterol Following a Respiratory Event.","authors":"M. Navaie, B. Celli, Zhun Xu, Soojin Cho-Reyes, C. Dembek, T. Gilmer","doi":"10.15326/jcopdf.6.4.2019.0127","DOIUrl":"https://doi.org/10.15326/jcopdf.6.4.2019.0127","url":null,"abstract":"Background\u0000Long-acting beta2-agonists (LABAs), with or without inhaled corticosteroids (ICSs), delivered by handheld inhalers or nebulizers are recommended as maintenance therapy in chronic obstructive pulmonary disease (COPD). This study evaluated exacerbations, health resource utilization (HRU), and costs among Medicare beneficiaries with COPD on handheld ICS+LABA who switched to nebulized arformoterol (ARF) or continued ICS+LABA following a respiratory event.\u0000\u0000\u0000Methods\u0000Using Medicare claims, we identified beneficiaries with COPD (international classification of disease, 9th revision, clinical modification [ICD-9-CM] 490-492.xx, 494.xx, 496.xx) between 2010-2014 who had ≥ 1 year of continuous enrollment in Parts A, B, and D; ≥ 2 COPD-related outpatient visits ≥ 30 days apart or ≥ 1 hospitalization(s); ICS+LABA use 90-days before ARF initiation; and a respiratory event (COPD-related hospitalization or emergency department [ED] visit < 30 days before ARF initiation). Using propensity scores, 423 beneficiaries who switched to ARF were matched to 423 beneficiaries who continued on handheld ICS+LABA (controls). Difference-in-difference regression models examined outcomes at 180-days follow-up.\u0000\u0000\u0000Results\u0000Beneficiaries who switched to ARF had 1.5 fewer exacerbations (p=0.015) but no difference in hospitalizations and ED visits compared to controls. Durable medical equipment (DME) costs were higher among ARF users than controls ($1590), yet total health care costs were similar due to cost offsets by ARF in pharmacy (-$794), inpatient (-$524), and outpatient care (-$65). ARF accounted for 55% ($886.63) of DME costs, with the remaining costs attributed to oxygen therapy ($428.10) and nebulized corticosteroids ($590.85).\u0000\u0000\u0000Conclusions\u0000Switching from handheld ICS+LABA to nebulized ARF resulted in fewer COPD exacerbations among Medicare beneficiaries. Nebulized LABAs may improve outcomes in selected patients with COPD.","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77109005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-23DOI: 10.15326/jcopdf.6.4.2019.0160
J. Crapo
{"title":"Fifty Years of the Division of Lung Diseases and the Evolution of Pulmonary Research and Medicine.","authors":"J. Crapo","doi":"10.15326/jcopdf.6.4.2019.0160","DOIUrl":"https://doi.org/10.15326/jcopdf.6.4.2019.0160","url":null,"abstract":"","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"178 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73246174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-23DOI: 10.15326/jcopdf.6.4.2019.0131
D. Mahler, E. Kerwin, L. Murray, C. Dembek
Background Chronic cough, dyspnea, and excessive sputum production, the characteristic symptoms of chronic obstructive pulmonary disease (COPD), can negatively affect patients' health-related quality of life (HRQoL). The fixed-dose combination of a long-acting beta2-adrenergic agonist and a long-acting muscarinic antagonist (LABA/LAMA) have been shown to improve HRQoL and COPD symptoms as measured by the St George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnea Index (TDI) total scores. However, the impact of a LABA/LAMA on the individual components of HRQoL and dyspnea with daily activities is unknown. Methods Secondary analysis of pooled data from 2 replicate, phase 3, 12-week, randomized, placebo, and active-controlled trials of twice-daily indacaterol/glycopyrrolate (IND/GLY) were analyzed. Change from baseline in HRQoL and dyspnea was measured by SGRQ and TDI, respectively. Total and component scores were evaluated using linear mixed models. Logistic regression was used to analyze the proportion of patients achieving minimum clinically important difference. Study outcomes were further explored in patient subgroups. Results A total of 2038 patients from FLIGHT1/FLIGHT2 studies were evaluated. IND/GLY significantly improved SGRQ component scores (symptoms [-7.3], activity [-3.6], and impacts [-5.0]); all P < 0.001 compared with placebo. IND/GLY also significantly improved symptoms scores compared with IND and GLY (-3.5 and -3.7, respectively; both P < 0.001). Patients treated with IND/GLY also had significant improvements in TDI component scores compared with placebo: functional impairment (0.48), magnitude of task (0.61), and magnitude of effort (0.54); all P < 0.001. All component scores were significantly higher for IND/GLY compared with IND and GLY (P ≤ 0.002 for all). Conclusions Twice-daily IND/GLY significantly improved total scores as well as components of HRQoL and dyspnea in patients with COPD. These data demonstrate multiple clinical benefits of LABA/LAMA maintenance therapy in the COPD population. ClinicalTrials.gov: NCT01727141 and NCT01712516.
{"title":"The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease.","authors":"D. Mahler, E. Kerwin, L. Murray, C. Dembek","doi":"10.15326/jcopdf.6.4.2019.0131","DOIUrl":"https://doi.org/10.15326/jcopdf.6.4.2019.0131","url":null,"abstract":"Background\u0000Chronic cough, dyspnea, and excessive sputum production, the characteristic symptoms of chronic obstructive pulmonary disease (COPD), can negatively affect patients' health-related quality of life (HRQoL). The fixed-dose combination of a long-acting beta2-adrenergic agonist and a long-acting muscarinic antagonist (LABA/LAMA) have been shown to improve HRQoL and COPD symptoms as measured by the St George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnea Index (TDI) total scores. However, the impact of a LABA/LAMA on the individual components of HRQoL and dyspnea with daily activities is unknown.\u0000\u0000\u0000Methods\u0000Secondary analysis of pooled data from 2 replicate, phase 3, 12-week, randomized, placebo, and active-controlled trials of twice-daily indacaterol/glycopyrrolate (IND/GLY) were analyzed. Change from baseline in HRQoL and dyspnea was measured by SGRQ and TDI, respectively. Total and component scores were evaluated using linear mixed models. Logistic regression was used to analyze the proportion of patients achieving minimum clinically important difference. Study outcomes were further explored in patient subgroups.\u0000\u0000\u0000Results\u0000A total of 2038 patients from FLIGHT1/FLIGHT2 studies were evaluated. IND/GLY significantly improved SGRQ component scores (symptoms [-7.3], activity [-3.6], and impacts [-5.0]); all P < 0.001 compared with placebo. IND/GLY also significantly improved symptoms scores compared with IND and GLY (-3.5 and -3.7, respectively; both P < 0.001). Patients treated with IND/GLY also had significant improvements in TDI component scores compared with placebo: functional impairment (0.48), magnitude of task (0.61), and magnitude of effort (0.54); all P < 0.001. All component scores were significantly higher for IND/GLY compared with IND and GLY (P ≤ 0.002 for all).\u0000\u0000\u0000Conclusions\u0000Twice-daily IND/GLY significantly improved total scores as well as components of HRQoL and dyspnea in patients with COPD. These data demonstrate multiple clinical benefits of LABA/LAMA maintenance therapy in the COPD population. ClinicalTrials.gov: NCT01727141 and NCT01712516.","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82655655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-23DOI: 10.15326/jcopdf.6.4.2019.0137
D. Mahler, J. Ohar, C. Barnes, E. Moran, S. Pendyala, G. Crater
Background Patients with chronic obstructive pulmonary disease (COPD) and suboptimal peak inspiratory flow rate (sPIFR) may not benefit optimally from dry powder inhalers (DPI) because of inadequate inspiratory flow. Nebulized bronchodilators may provide a better alternative. We compared bronchodilation with the long-acting muscarinic antagonist (LAMA) revefenacin for nebulization versus the DPI LAMA tiotropium, in patients with COPD and sPIFR (< 60 L/min against the resistance of Diskus®). Methods This was a randomized, double-blind, double-dummy, 28-day Phase 3b study in patients with COPD enrolled based on sPIFR. The primary endpoint was trough forced expiratory volume in 1 second (FEV1) on Day 29 for revefenacin for nebulization versus tiotropium HandiHaler® DPI. Results We enrolled 206 patients with mean (standard deviation) age, 65 (8) years; percent predicted FEV1, 37 (16)%; PIFR, 45 (12) L/min. In the intent-to-treat (ITT) population, revefenacin improved trough FEV1 from baseline; however, the difference versus tiotropium was not significant (least squares [LS] mean difference [standard error], 17.0 [22.4] mL, P=0.4461). In a prespecified analysis of patients with FEV1 < 50% predicted, revefenacin produced an LS mean difference (95% confidence interval [CI]), 49.1 (6.3-91.9) mL in trough FEV1 and 103.5 (7.7-199.3) mL in forced vital capacity versus tiotropium. Revefenacin produced >100 mL increase in FEV1 in 41.6% versus 34.4% of patients with tiotropium in ITT and 41.4% versus 25.7% of patients in FEV1 < 50% predicted populations. Conclusions Revefenacin did not produce significant improvements in FEV1 versus tiotropium in the ITT population, but increased trough FEV1 in patients with FEV1 < 50% predicted and sPIFR. Clinical Trial Registration (www.Clinicaltrials.gov): Study 0149 (NCT03095456).
{"title":"Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate.","authors":"D. Mahler, J. Ohar, C. Barnes, E. Moran, S. Pendyala, G. Crater","doi":"10.15326/jcopdf.6.4.2019.0137","DOIUrl":"https://doi.org/10.15326/jcopdf.6.4.2019.0137","url":null,"abstract":"Background\u0000Patients with chronic obstructive pulmonary disease (COPD) and suboptimal peak inspiratory flow rate (sPIFR) may not benefit optimally from dry powder inhalers (DPI) because of inadequate inspiratory flow. Nebulized bronchodilators may provide a better alternative. We compared bronchodilation with the long-acting muscarinic antagonist (LAMA) revefenacin for nebulization versus the DPI LAMA tiotropium, in patients with COPD and sPIFR (< 60 L/min against the resistance of Diskus®).\u0000\u0000\u0000Methods\u0000This was a randomized, double-blind, double-dummy, 28-day Phase 3b study in patients with COPD enrolled based on sPIFR. The primary endpoint was trough forced expiratory volume in 1 second (FEV1) on Day 29 for revefenacin for nebulization versus tiotropium HandiHaler® DPI.\u0000\u0000\u0000Results\u0000We enrolled 206 patients with mean (standard deviation) age, 65 (8) years; percent predicted FEV1, 37 (16)%; PIFR, 45 (12) L/min. In the intent-to-treat (ITT) population, revefenacin improved trough FEV1 from baseline; however, the difference versus tiotropium was not significant (least squares [LS] mean difference [standard error], 17.0 [22.4] mL, P=0.4461). In a prespecified analysis of patients with FEV1 < 50% predicted, revefenacin produced an LS mean difference (95% confidence interval [CI]), 49.1 (6.3-91.9) mL in trough FEV1 and 103.5 (7.7-199.3) mL in forced vital capacity versus tiotropium. Revefenacin produced >100 mL increase in FEV1 in 41.6% versus 34.4% of patients with tiotropium in ITT and 41.4% versus 25.7% of patients in FEV1 < 50% predicted populations.\u0000\u0000\u0000Conclusions\u0000Revefenacin did not produce significant improvements in FEV1 versus tiotropium in the ITT population, but increased trough FEV1 in patients with FEV1 < 50% predicted and sPIFR. Clinical Trial Registration (www.Clinicaltrials.gov): Study 0149 (NCT03095456).","PeriodicalId":10249,"journal":{"name":"Chronic obstructive pulmonary diseases","volume":"212 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76149747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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