The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial
Robert A Wise,1 Kenneth R Chapman,2 Benjamin M Scirica,3,4 Sami Z Daoud,5 Dan Lythgoe,6 Esther Garcia-Gil7 1Medicine, Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2Department of Medicine, University of Toronto, Toronto, ON, Canada; 3Cardiovascular Div...
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ftdovepress:oai:dovepress.com/63206 2023-05-15T18:13:18+02:00 The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial Wise,Robert A Chapman,Kenneth R Scirica,Benjamin M Daoud,Sami Z Lythgoe,Dan Garcia-Gil,Esther 2021-03-18 text/html https://www.dovepress.com/the-impact-of-exacerbation-history-on-the-safety-and-efficacy-of-aclid-peer-reviewed-fulltext-article-COPD en eng Dove Press info:eu-repo/semantics/altIdentifier/doi/10.2147/COPD.S285068 https://www.dovepress.com/the-impact-of-exacerbation-history-on-the-safety-and-efficacy-of-aclid-peer-reviewed-fulltext-article-COPD info:eu-repo/semantics/openAccess International Journal of Chronic Obstructive Pulmonary Disease Original Research info:eu-repo/semantics/article 2021 ftdovepress https://doi.org/10.2147/COPD.S285068 2022-12-27T23:08:11Z Robert A Wise,1 Kenneth R Chapman,2 Benjamin M Scirica,3,4 Sami Z Daoud,5 Dan Lythgoe,6 Esther Garcia-Gil7 1Medicine, Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2Department of Medicine, University of Toronto, Toronto, ON, Canada; 3Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA, USA; 4Department of Medicine, Harvard Medical School, Boston, MA, USA; 5Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA; 6Statistics, Phastar, Chiswick, London, UK; 7Respiratory & Immunology, BioPharmaceuticals Medical, AstraZeneca, Barcelona, SpainCorrespondence: Robert A WiseMedicine, Pulmonary and Critical Care, Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD, 21224, USAEmail rwise@jhmi.eduPurpose: Chronic obstructive pulmonary disease (COPD) exacerbations are associated with increased risk of major adverse cardiovascular events (MACE) and mortality. Here, we investigate whether the safety and efficacy of aclidinium bromide differ due to exacerbation history in patients with COPD and increased cardiovascular risk.Patients and Methods: ASCENT-COPD was a Phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group study of patients with moderate-to-very severe COPD and increased cardiovascular risk. Patients were randomized 1:1 to receive aclidinium or placebo twice daily for up to 3 years. Outcomes included time to first MACE and all-cause mortality over 3 years, exacerbation rate during the first year on-treatment, and change in baseline pre-dose forced expiratory volume in 1 second (FEV1) over 3 years. This pre-specified subgroup analysis compared outcomes in patients receiving aclidinium vs placebo. The comparison of patients with vs without an exacerbation history was added following a protocol amendment to increase enrollment in the primary study.Results: Of 3589 patients, 2156 (60.1%) had ≥ 1 moderate or severe exacerbations in the prior year, ... Article in Journal/Newspaper sami Dove Medical Press Bayview ENVELOPE(-54.748,-54.748,49.617,49.617) Brigham ENVELOPE(162.300,162.300,-77.117,-77.117) Canada Esther ENVELOPE(-57.700,-57.700,-61.917,-61.917) Mace ENVELOPE(155.883,155.883,-81.417,-81.417) International Journal of Chronic Obstructive Pulmonary Disease Volume 16 689 699 |
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International Journal of Chronic Obstructive Pulmonary Disease |
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International Journal of Chronic Obstructive Pulmonary Disease Wise,Robert A Chapman,Kenneth R Scirica,Benjamin M Daoud,Sami Z Lythgoe,Dan Garcia-Gil,Esther The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial |
topic_facet |
International Journal of Chronic Obstructive Pulmonary Disease |
description |
Robert A Wise,1 Kenneth R Chapman,2 Benjamin M Scirica,3,4 Sami Z Daoud,5 Dan Lythgoe,6 Esther Garcia-Gil7 1Medicine, Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2Department of Medicine, University of Toronto, Toronto, ON, Canada; 3Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA, USA; 4Department of Medicine, Harvard Medical School, Boston, MA, USA; 5Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA; 6Statistics, Phastar, Chiswick, London, UK; 7Respiratory & Immunology, BioPharmaceuticals Medical, AstraZeneca, Barcelona, SpainCorrespondence: Robert A WiseMedicine, Pulmonary and Critical Care, Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD, 21224, USAEmail rwise@jhmi.eduPurpose: Chronic obstructive pulmonary disease (COPD) exacerbations are associated with increased risk of major adverse cardiovascular events (MACE) and mortality. Here, we investigate whether the safety and efficacy of aclidinium bromide differ due to exacerbation history in patients with COPD and increased cardiovascular risk.Patients and Methods: ASCENT-COPD was a Phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group study of patients with moderate-to-very severe COPD and increased cardiovascular risk. Patients were randomized 1:1 to receive aclidinium or placebo twice daily for up to 3 years. Outcomes included time to first MACE and all-cause mortality over 3 years, exacerbation rate during the first year on-treatment, and change in baseline pre-dose forced expiratory volume in 1 second (FEV1) over 3 years. This pre-specified subgroup analysis compared outcomes in patients receiving aclidinium vs placebo. The comparison of patients with vs without an exacerbation history was added following a protocol amendment to increase enrollment in the primary study.Results: Of 3589 patients, 2156 (60.1%) had ≥ 1 moderate or severe exacerbations in the prior year, ... |
format |
Article in Journal/Newspaper |
author |
Wise,Robert A Chapman,Kenneth R Scirica,Benjamin M Daoud,Sami Z Lythgoe,Dan Garcia-Gil,Esther |
author_facet |
Wise,Robert A Chapman,Kenneth R Scirica,Benjamin M Daoud,Sami Z Lythgoe,Dan Garcia-Gil,Esther |
author_sort |
Wise,Robert A |
title |
The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial |
title_short |
The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial |
title_full |
The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial |
title_fullStr |
The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial |
title_full_unstemmed |
The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial |
title_sort |
impact of exacerbation history on the safety and efficacy of aclidinium in patients with chronic obstructive pulmonary disease and increased cardiovascular risk: ascent-copd trial |
publisher |
Dove Press |
publishDate |
2021 |
url |
https://www.dovepress.com/the-impact-of-exacerbation-history-on-the-safety-and-efficacy-of-aclid-peer-reviewed-fulltext-article-COPD |
long_lat |
ENVELOPE(-54.748,-54.748,49.617,49.617) ENVELOPE(162.300,162.300,-77.117,-77.117) ENVELOPE(-57.700,-57.700,-61.917,-61.917) ENVELOPE(155.883,155.883,-81.417,-81.417) |
geographic |
Bayview Brigham Canada Esther Mace |
geographic_facet |
Bayview Brigham Canada Esther Mace |
genre |
sami |
genre_facet |
sami |
op_relation |
info:eu-repo/semantics/altIdentifier/doi/10.2147/COPD.S285068 https://www.dovepress.com/the-impact-of-exacerbation-history-on-the-safety-and-efficacy-of-aclid-peer-reviewed-fulltext-article-COPD |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/10.2147/COPD.S285068 |
container_title |
International Journal of Chronic Obstructive Pulmonary Disease |
container_volume |
Volume 16 |
container_start_page |
689 |
op_container_end_page |
699 |
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1766185814542254080 |