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The relationship between eosinophils and reduction in major adverse cardiac events in ETHOS

Mona Bafadhel, Klaus F Rabe, Dave Singh, Martin Jenkins, Paul Dorinsky, Mehul Patel
European Respiratory Journal 2021 58: RCT208; DOI: 10.1183/13993003.congress-2021.RCT208
Mona Bafadhel
1Respiratory Medicine Unit, Nuffield Department of Medicine, Old Road Campus, University of Oxford, Oxford, United Kingdom
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  • For correspondence: mona.bafadhel@ndm.ox.ac.uk
Klaus F Rabe
2LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany
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Dave Singh
3University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom
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Martin Jenkins
4AstraZeneca, Cambridge, United Kingdom
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Paul Dorinsky
5AstraZeneca, Durham, NC, United States of America
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Mehul Patel
4AstraZeneca, Cambridge, United Kingdom
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Abstract

Background: In the Phase III, 52-wk ETHOS trial (NCT02465567) in COPD, budesonide/glycopyrronium/formoterol (BGF) triple therapy significantly reduced all-cause mortality risk (ACM, HR 0.51; unadjusted p=0.0035) vs glycopyrronium/formoterol (GFF) dual therapy.

Aim: As cardiovascular (CV) death was the most common cause of ACM and benefits of inhaled corticosteroids (ICS) on COPD outcomes are related to eosinophils (EOS), we performed a post-hoc analysis and examined this for major adverse cardiac events (MACE) in ETHOS.

Methods: The effect of BGF 320/14.4/10μg vs GFF 14.4/10µg on fatal and non-fatal MACE and their relationship to EOS was assessed in patients with moderate-to-very severe COPD. Potential MACE were adjudicated by an external committee.

Results: Incidence of MACE were numerically lower with ICS-containing therapies (BGF 320: 1.4%; BGF 160: 1.4%; BFF: 1.1%) vs GFF (2.1%). The difference in MACE rates between BGF 320 and GFF on fatal CV events and non-fatal MI was more pronounced as EOS increased (Table). This effect was not seen for non-fatal stroke.

Conclusion: Overall, there were fewer MACE in ICS-containing therapy groups than GFF. While event numbers were low, benefits of BGF vs GFF on CV death and non-fatal MI related to higher baseline EOS were consistent with the reduction in ACM with increasing EOS previously observed (Martinez, F.J. et al. Am J Respir Crit Care Med 2020. Epub ahead of print).

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Footnotes

Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, RCT208.

This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

  • Copyright ©the authors 2021
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The relationship between eosinophils and reduction in major adverse cardiac events in ETHOS
Mona Bafadhel, Klaus F Rabe, Dave Singh, Martin Jenkins, Paul Dorinsky, Mehul Patel
European Respiratory Journal Sep 2021, 58 (suppl 65) RCT208; DOI: 10.1183/13993003.congress-2021.RCT208

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The relationship between eosinophils and reduction in major adverse cardiac events in ETHOS
Mona Bafadhel, Klaus F Rabe, Dave Singh, Martin Jenkins, Paul Dorinsky, Mehul Patel
European Respiratory Journal Sep 2021, 58 (suppl 65) RCT208; DOI: 10.1183/13993003.congress-2021.RCT208
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