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      Long-term health-related quality-of-life and symptom response profiles with arformoterol in COPD: results from a 52-week trial

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          Abstract

          Background

          Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of arformoterol on HRQoL in COPD patients, measured by St George’s Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles.

          Methods

          We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores.

          Results

          SGRQ Total score improved by 4.24 points with arformoterol and 2.02 points with placebo ( P=0.006). Significantly greater improvements occurred for arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points ( P<0.001; 95% confidence interval: 17.6–23.9). Compared with nonresponders, responders were more likely current smokers (55.52% vs 44.02%, P=0.0021) and had more severe COPD (forced expiratory volume in 1 second [FEV 1]: 1.16 vs 1.23 L, P=0.0419), more exacerbations (0.96 vs 0.69, P=0.0018), and worse mean SGRQ Total (59.81 vs 40.57, P<0.0001), Clinical COPD Questionnaire (3.29 vs 2.05, P<0.0001), and Modified Medical Research Council Dyspnea Scale (3.13 vs 2.75, P<0.0001) scores. Arformoterol-receiving responders exhibited significantly greater improvements in FEV 1 (0.09 vs 0.008, P=0.03) and fewer hospitalizations (0.13 vs 0.24, P=0.02) than those receiving placebo.

          Conclusion

          In this study, arformoterol treatment significantly improved HRQoL reflected by SGRQ. For the analysis performed on these data, arformoterol may be particularly effective in improving lung function and reducing hospitalizations among patients who are unable to quit smoking or present with more severe symptoms.

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          Most cited references 22

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          Functional status and quality of life in chronic obstructive pulmonary disease.

          Exertional dyspnea often causes patients with chronic obstructive pulmonary disease (COPD) to unconsciously reduce their activities of daily living (ADLs) to reduce the intensity of their distress. The reduction in ADLs leads to deconditioning which, in turn, further increases dyspnea. Both dyspnea and fatigue are important factors affecting health-related quality of life (HRQOL). The functional status of patients relates to how well they perform ADLs. Activities, however, may not be severely limited until the disease becomes advanced. The elimination of an ADL depends on the necessity or desirability of that activity and the intensity of the associated symptoms. HRQOL is measured using symptoms, functional status, and a rating of their impact on the individual. The Pulmonary Functional Status Scale (PFSS) and the Pulmonary Functional Status and Dyspnea Questionnaire (PFSDQ) are 2 COPD-specific functional status questionnaires. Pedometers or accelerometers can quantify the levels of activity of patients with COPD. HRQOL is measured with validated multidimensional questionnaires that cover symptoms, physical, psychological, and social domains. Ideally, these instruments are discriminative (i.e., separate degrees of impairment) and evaluative (i.e., detect small changes after therapy). HRQOL questionnaires may be generic (e.g., Medical Outcomes Study Short Form-36 [SF-36]) and can measure favorable changes after intervention, such as pulmonary rehabilitation, or they can be disease specific with disease-related domains, e.g., Chronic Respiratory Disease Questionnaire (CRQ) with domains of dyspnea, fatigue, emotion, and mastery; and St. George's Respiratory Questionnaire (SGRQ) with domains of symptoms, activity, and psychosocial impact. A case is presented that depicts how these tools may be used to evaluate improvement with intervention in a patient with COPD.
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            Assessment of the economic burden of COPD in the U.S.: a review and synthesis of the literature.

            The costs of chronic obstructive pulmonary disease (COPD) pose a major economic burden to the United States. Studies evaluating COPD costs have generated widely variable estimates; we summarized and critically compared recent estimates of the annual national and per-patient costs of COPD in the U.S. Thirteen articles reporting comprehensive estimates of the direct costs of COPD (costs related to the provision of medical goods and services) were identified from searches of relevant primary literature published since 1995. Few papers reported indirect costs of COPD (lost work and productivity). The National Heart, Lung, and Blood Institute (NHLBI) provides the single current estimate of the total (direct plus indirect) annual cost of COPD to the U.S., $38.8 billion in 2005 dollars. More than half of this cost ($21.8 billion) was direct, aligning with the $20-26 billion range reported by two other recent analyses of large national datasets. For per-patient direct costs (in $US 2005), studies using recent data yield attributable cost estimates (costs deemed to be related to COPD) in the range of $2,700-$5,900 annually, and excess cost estimates (total costs incurred by COPD patients minus total costs incurred by non-COPD patients) in the range of $6,100-$6,600 annually. Studies of both national and per-patient costs that use data approximately 8-10 years old or older have produced estimates that tend to deviate from these ranges. Cost-of-illness studies using recent data underscore the substantial current cost burden of COPD in the U.S.
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              COPD, a multicomponent disease: implications for management.

               Alvar Agustí (2005)
              Chronic obstructive pulmonary disease (COPD) is a multicomponent disease. These components affect both the lungs and organs outside the lungs (the so-called systemic effects of COPD) and can be of either a structural (including airway remodelling, emphysema, skeletal muscle wasting) or functional nature (inflammation, apoptosis, senescence). Further, these components are interdependent in a closely linked 'vicious cycle'. Accordingly, optimal therapies should therefore aim to address more than one of these components to break such a cycle. This needs to be considered not only in the development of future treatments but also in the current clinical management of patients with COPD. In this paper, evidence that supports the concept that COPD is a multicomponent disease is presented. The effects of currently available therapeutic options, including long-acting anticholinergics and long-acting beta2-agonist/inhaled corticosteroid combination therapies, upon each of these components is reviewed. In addition, potential new avenues for drug development and improved patient care are highlighted. By developing a better understanding of how different therapies impact upon the 'vicious cycle' of COPD, treatment regimens can be optimised to provide the greatest benefits to patients.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2018
                05 February 2018
                : 13
                : 499-508
                Affiliations
                [1 ]Department of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC
                [2 ]Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Princeton, NJ
                [3 ]Data Analytics and Design Strategy
                [4 ]Psychometrics, RTI Health Solutions, Research Triangle Park, NC
                [5 ]Agile Outcomes Research, Inc., Rochester, MN
                [6 ]Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA
                Author notes
                Correspondence: James F Donohue, Department of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, CB 7020, 130 Mason Farm Road, Chapel Hill, NC 27599, USA, Tel +1 919 966 2531, Email jdonohue@ 123456med.unc.edu
                Article
                copd-13-499
                10.2147/COPD.S141729
                5804733
                © 2018 Donohue et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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