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      Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease

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          Abstract

          Rationale: The IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial demonstrated a significant reduction in all-cause mortality (ACM) risk with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) at risk of future exacerbations. Five hundred seventy-four patients were censored in the original analysis owing to incomplete vital status information.

          Objectives: Report ACM and impact of stepping down therapy, following collection of additional vital status data.

          Methods: Patients were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg, or UMEC/VI 62.5/25 μg following a run-in on their COPD therapies. Time to ACM was prespecified. Additional vital status data collection and subsequent analyses were performed post hoc.

          Measurements and Main Results: We report vital status data for 99.6% of the intention-to-treat population ( n = 10,355), documenting 98 (2.36%) deaths on FF/UMEC/VI, 109 (2.64%) on FF/VI, and 66 (3.19%) on UMEC/VI. For FF/UMEC/VI, the hazard ratio for death was 0.72 (95% confidence interval, 0.53–0.99; P = 0.042) versus UMEC/VI and 0.89 (95% confidence interval, 0.67–1.16; P = 0.387) versus FF/VI. Independent adjudication confirmed lower rates of cardiovascular and respiratory death and death associated with the patient’s COPD.

          Conclusions: In this secondary analysis of an efficacy outcome from the IMPACT trial, once-daily single-inhaler FF/UMEC/VI triple therapy reduced the risk of ACM versus UMEC/VI in patients with symptomatic COPD and a history of exacerbations.

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          The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial.

          Nicholas Anthonisen, Melissa A Skeans, Robert Wise … (2005)
          Randomized clinical trials have not yet demonstrated the mortality benefit of smoking cessation. To assess the long-term effect on mortality of a randomly applied smoking cessation program. The Lung Health Study was a randomized clinical trial of smoking cessation. Special intervention participants received the smoking intervention program and were compared with usual care participants. Vital status was followed up to 14.5 years. 10 clinical centers in the United States and Canada. 5887 middle-aged volunteers with asymptomatic airway obstruction. All-cause mortality and mortality due to cardiovascular disease, lung cancer, and other respiratory disease. The intervention was a 10-week smoking cessation program that included a strong physician message and 12 group sessions using behavior modification and nicotine gum, plus either ipratropium or a placebo inhaler. At 5 years, 21.7% of special intervention participants had stopped smoking since study entry compared with 5.4% of usual care participants. After up to 14.5 years of follow-up, 731 patients died: 33% of lung cancer, 22% of cardiovascular disease, 7.8% of respiratory disease other than cancer, and 2.3% of unknown causes. All-cause mortality was significantly lower in the special intervention group than in the usual care group (8.83 per 1000 person-years vs. 10.38 per 1000 person-years; P = 0.03). The hazard ratio for mortality in the usual care group compared with the special intervention group was 1.18 (95% CI, 1.02 to 1.37). Differences in death rates for both lung cancer and cardiovascular disease were greater when death rates were analyzed by smoking habit. Results apply only to individuals with airway obstruction. Smoking cessation intervention programs can have a substantial effect on subsequent mortality, even when successful in a minority of participants.
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            Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group.

            WA Conway, EO Coates, PA Kvale (1980)
            At six centers, 203 patients with hypoxemic chronic obstructive lung disease were randomly allocated to either continuous oxygen (O2) therapy or 12-hour nocturnal O2 therapy and followed for at least 12 months (mean, 19.3 months). The two groups were initially well matched in terms of physiological and neuropsychological function. Compliance with each oxygen regimen was good. Overall mortality in the nocturnal O2 therapy group was 1.94 times that in the continuous O2 therapy group (P = 0.01). This trend was striking in patients with carbon dioxide retention and also present in patients with relatively poor lung function, low mean nocturnal oxygen saturation, more severe brain dysfunction, and prominent mood disturbances. Continuous O2 therapy also appeared to benefit patients with low mean pulmonary artery pressure and pulmonary vascular resistance and those with relatively well-preserved exercise capacity. We conclude that in hypoxemic chronic obstructive lung disease, continuous O2 therapy is associated with a lower mortality than is nocturnal O2 therapy. The reason for this difference is not clear.
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              Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party.

              Research Medical (1981)
              A controlled trial of long term domiciliary oxygen therapy has been carried out in three centres in the U.K. The 87 patients, all under 70 years of age, who took part had chronic bronchitis or emphysema with irreversible airways obstruction, severe arterial hypoxaemia, carbon dioxide retention, and a history of congestive heart failure. The patients were randomised to oxygen therapy (treated) or no oxygen (controls). Oxygen was given by nasal prongs for at least 15 h daily, usually at 2 1/min. The two groups were well matched, both clinically and in terms of lung function and other laboratory findings. 19 of the 42 oxygen treated patients died in the five years of survival follow-up compared with 30 out of 45 controls: in the 66 men in this trial the survival advantage of oxygen did not emerge until 500 days had elapsed. Survival for the 12 female controls was surprisingly poor, 8 of them being dead at 3 years. Mortality was not easy to predict, though a summation of arterial carbon dioxide tension and red cell mass was helpful. Neither time spent in hospital because of exacerbations of respiratory failure nor work attendance were affected by oxygen therapy, but these patients were very ill at the start of the trial and many had already retired on grounds of age or ill-health. Physiological measurements suggested that oxygen did not slow the progress of respiratory failure in those who died early. However, in longer term survivors on oxygen, arterial oxygenation did seem to stop deterioration.
              Article 0 comments Cited 131 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Am J Respir Crit Care Med
                Journal ID (iso-abbrev): Am. J. Respir. Crit. Care Med
                Journal ID (publisher-id): ajrccm
                Title: American Journal of Respiratory and Critical Care Medicine
                Publisher: American Thoracic Society
                ISSN (Print): 1073-449X
                ISSN (Electronic): 1535-4970
                Publication date (Print and electronic): 15 June 2020
                Publication date (Electronic): 15 June 2020
                Publication date (Print): 15 June 2020
                Publication date PMC-release: 15 June 2020
                Volume: 201
                Issue: 12
                Pages: 1508-1516
                Affiliations
                [ 1 ]Clinical Sciences
                [ 9 ]Development, R&D, and
                [ 14 ]Global Clinical Science and Delivery, GlaxoSmithKline, Collegeville, Pennsylvania
                [ 2 ]Pulmonary, Allergy and Critical Care Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
                [ 3 ]Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina
                [ 4 ]Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
                [ 5 ]Safety and Medical Governance and
                [ 10 ]Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom
                [ 6 ]Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama
                [ 7 ]University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom
                [ 8 ]University of Michigan, Pulmonary and Critical Care, Ann Arbor, Michigan
                [ 11 ]Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
                [ 12 ]Medical Department, Pulmonary Section, Herlev–Gentofte Hospital, Herlev, Denmark
                [ 13 ]UCL Respiratory, University College London, London, United Kingdom
                [ 15 ]Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom
                [ 16 ]Institute for Lung Health, University of Leicester, Leicester, United Kingdom
                [ 17 ]Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom
                [ 18 ]Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; and
                [ 19 ]New York–Presbyterian Hospital/Weill Cornell Medical Center, New York, New York
                Author notes
                Correspondence and requests for reprints should be addressed to David A. Lipson, M.D., GSK, 1250 South Collegeville Road, Collegeville, PA 19426. E-mail: david.a.lipson@ 123456gsk.com .
                [*]

                G.J.C. is Associate Editor, M.K.H. is Associate Editor, and F.J.M. is Deputy Editor of AJRCCM. Their participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.

                Author information
                http://orcid.org/0000-0001-6732-4593
                http://orcid.org/0000-0003-1267-3483
                http://orcid.org/0000-0003-2009-4406
                http://orcid.org/0000-0003-0176-7273
                http://orcid.org/0000-0003-0401-0081
                http://orcid.org/0000-0002-2238-8144
                http://orcid.org/0000-0003-2434-1152
                Article
                Publisher-manuscript ID: 201911-2207OC
                DOI: 10.1164/rccm.201911-2207OC
                PMC ID: 7301738
                PubMed ID: 32162970
                SO-VID: 94d1813a-e74b-4272-a4e9-81bf3bfdd2d2
                Copyright © Copyright © 2020 by the American Thoracic Society
                License:

                This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 15 November 2019
                Date accepted : 09 March 2020
                Related
                Page count
                Figures: 3, Tables: 3, Pages: 9
                Categories
                Subject: Original Articles
                Subject: Chronic Obstructive Pulmonary Disease

                Keywords: copd,triple therapy,mortality,survival
                Data availability:
                Keywords: copd, triple therapy, mortality, survival

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