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Risk of Exacerbation and Pneumonia with Single-Inhaler Triple versus Dual Therapy in IMPACT

Authors :
Dransfield, Mark T.
Crim, Courtney
Criner, Gerard J.
Day, Nicola C.
Halpin, David M. G.
Han, MeiLan K.
Jones, C. Elaine
Kilbride, Sally
LaFon, David
Lipson, David A.
Lomas, David A.
Martin, Neil
Martinez, Fernando J.
Singh, Dave
Wise, Robert A.
Lange, Peter
Dransfield, Mark T.
Crim, Courtney
Criner, Gerard J.
Day, Nicola C.
Halpin, David M. G.
Han, MeiLan K.
Jones, C. Elaine
Kilbride, Sally
LaFon, David
Lipson, David A.
Lomas, David A.
Martin, Neil
Martinez, Fernando J.
Singh, Dave
Wise, Robert A.
Lange, Peter
Source :
Dransfield , M T , Crim , C , Criner , G J , Day , N C , Halpin , D M G , Han , M K , Jones , C E , Kilbride , S , LaFon , D , Lipson , D A , Lomas , D A , Martin , N , Martinez , F J , Singh , D , Wise , R A & Lange , P 2021 , ' Risk of Exacerbation and Pneumonia with Single-Inhaler Triple versus Dual Therapy in IMPACT ' , Annals of the American Thoracic Society , vol. 18 , no. 5 , pp. 788-798 .
Publication Year :
2021

Abstract

Rationale: In the IMPACT (Informing the Pathway of COPD Treatment) trial, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy reduced exacerbation risk versus FF/VI and UMEC/VI and mortality risk versus UMEC/VI. However, pneumonia incidence was higher in the inhaled corticosteroid (FF)containing arms, raising questions about the relative benefit of exacerbation reduction compared with the increased risk of pneumonia.Objectives: Determine benefit-risk of the three treatments by evaluating time-to-first and rates of composite exacerbation or pneumonia outcomes.Methods: We evaluated time-to-first (prespecified) and rates (post hoc) of investigator-reported pneumonia, serious pneumonia leading to hospitalization or death, and the composite endpoints of 1) moderate (required antibiotics/corticosteroids)/severe (hospitalized) exacerbation or pneumonia and 2) severe exacerbation or serious (hospitalized) pneumonia. Analyses were repeated for radiographically confirmed pneumonia (post hoc).Results: Moderate/severe exacerbations occurred in 47%, 49%, and 50% of patients randomized to FF/UMEC/VI, FF/VI andUMEC/VI, and pneumonias in 8%, 7%, and 5%, respectively. FF/UMEC/VI reduced the risk of combined moderate/severe exacerbation or pneumonia (time-to-first) versus FF/VI (hazard ratio, 0.87 [95% confidence interval (CI), 0.82-0.92]) and UMEC/VI (0.87 [0.81-0.94]), as well as the risk of combined severe exacerbation or serious pneumonia versus UMEC/VI (0.83 [0.72-0.96]). FF/UMEC/VI reduced the rate of combined moderate/severe exacerbation or pneumonia (rate ratio, 0.78 [0.72-0.84]) and combined severe exacerbation or serious pneumonia (rate ratio, 0.76 [0.65-0.89]) versus UMEC/VI. Results were similar for radiographically confirmed pneumonia endpoints.Conclusions: Despite higher incidence of pneumonia in FF-containing arms, these composite exacerbation/pneumonia outcomes support a favorable benefit-risk profile o

Details

Database :
OAIster
Journal :
Dransfield , M T , Crim , C , Criner , G J , Day , N C , Halpin , D M G , Han , M K , Jones , C E , Kilbride , S , LaFon , D , Lipson , D A , Lomas , D A , Martin , N , Martinez , F J , Singh , D , Wise , R A & Lange , P 2021 , ' Risk of Exacerbation and Pneumonia with Single-Inhaler Triple versus Dual Therapy in IMPACT ' , Annals of the American Thoracic Society , vol. 18 , no. 5 , pp. 788-798 .
Notes :
application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1322761407
Document Type :
Electronic Resource

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