Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety

Samy Suissa,1,2 Sophie Dell’Aniello,1 Pierre Ernst1,2 1Centre for Clinical Epidemiology, Lady Davis Institute-Jewish General Hospital, Montreal, Quebec, Canada; 2Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, CanadaCorrespondence: Samy Suissa, Centre for Clinical...

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Main Authors: Suissa S, Dell'Aniello S, Ernst P
Format: Article
Language:English
Published: Dove Medical Press 2022-08-01
Series:International Journal of COPD
Subjects:
Online Access:https://www.dovepress.com/single-inhaler-triple-versus-dual-bronchodilator-therapy-in-copd-real--peer-reviewed-fulltext-article-COPD
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author Suissa S
Dell'Aniello S
Ernst P
author_facet Suissa S
Dell'Aniello S
Ernst P
author_sort Suissa S
collection DOAJ
description Samy Suissa,1,2 Sophie Dell’Aniello,1 Pierre Ernst1,2 1Centre for Clinical Epidemiology, Lady Davis Institute-Jewish General Hospital, Montreal, Quebec, Canada; 2Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, CanadaCorrespondence: Samy Suissa, Centre for Clinical Epidemiology, Lady Davis Institute-Jewish General Hospital, 3755 Cote Ste-Catherine, H-461, Montreal, Québec, H3T 1E2, Canada, Tel +1 514-340-7593, Fax +1 514-340-7564, Email samy.suissa@mcgill.caPurpose: Randomized trials report that single-inhaler triple therapy is more effective than dual bronchodilators at reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this effect may have been influenced by the forced withdrawal of inhaled corticosteroids (ICS) at randomization. We used an adaptive selection new-user design to compare single-inhaler triple therapy with dual bronchodilators in real-world clinical practice.Patients and Methods: We identified a cohort of COPD patients, 40 years or older, treated during 2017– 2020, from the United Kingdom’s Clinical Practice Research Datalink, a real-world practice setting. ICS-naïve patients initiating single-inhaler triple therapy or dual bronchodilators were compared on the incidence of COPD exacerbation and pneumonia over one year, after adjustment by propensity score weighting.Results: The cohort included 4106 new users of single-inhaler triple therapy and 29,702 of dual bronchodilators. Single-inhaler triple therapy was the first maintenance treatment in 44% of the users and 43% had no COPD exacerbations in the prior year. The adjusted hazard ratio (HR) of a first moderate or severe exacerbation with triple therapy relative to dual bronchodilators was 1.08 (95% confidence interval (CI): 1.00– 1.16). Among patients with two or more prior exacerbations the HR was 0.83 (95% CI: 0.74– 0.92), while for those with prior asthma diagnosis it was 0.86 (95% CI: 0.70– 1.06) and with blood eosinophil count > 300 cells/μL it was 0.89 (95% CI: 0.76– 1.05). The incidence of severe pneumonia was increased with triple therapy (HR 1.50; 95% CI: 1.29– 1.75).Conclusion: In a real-world setting of COPD treatment among ICS-naïve patients, thus unaffected by ICS withdrawal, single-inhaler triple therapy was not more effective than dual bronchodilators at reducing the incidence of exacerbation, except among patients with multiple exacerbations. Single-inhaler triple therapy should be initiated mainly in patients with multiple exacerbations while, for most others, dual bronchodilators are just as effective whilst avoiding the excess risk of severe pneumonias.Keywords: cohort studies, COPD exacerbation, pneumonia, propensity scores, real-world evidence
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spelling doaj.art-546980b670da4ca5a19f4378c623be5a2022-12-22T04:28:43ZengDove Medical PressInternational Journal of COPD1178-20052022-08-01Volume 171975198677794Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and SafetySuissa SDell'Aniello SErnst PSamy Suissa,1,2 Sophie Dell’Aniello,1 Pierre Ernst1,2 1Centre for Clinical Epidemiology, Lady Davis Institute-Jewish General Hospital, Montreal, Quebec, Canada; 2Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, CanadaCorrespondence: Samy Suissa, Centre for Clinical Epidemiology, Lady Davis Institute-Jewish General Hospital, 3755 Cote Ste-Catherine, H-461, Montreal, Québec, H3T 1E2, Canada, Tel +1 514-340-7593, Fax +1 514-340-7564, Email samy.suissa@mcgill.caPurpose: Randomized trials report that single-inhaler triple therapy is more effective than dual bronchodilators at reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this effect may have been influenced by the forced withdrawal of inhaled corticosteroids (ICS) at randomization. We used an adaptive selection new-user design to compare single-inhaler triple therapy with dual bronchodilators in real-world clinical practice.Patients and Methods: We identified a cohort of COPD patients, 40 years or older, treated during 2017– 2020, from the United Kingdom’s Clinical Practice Research Datalink, a real-world practice setting. ICS-naïve patients initiating single-inhaler triple therapy or dual bronchodilators were compared on the incidence of COPD exacerbation and pneumonia over one year, after adjustment by propensity score weighting.Results: The cohort included 4106 new users of single-inhaler triple therapy and 29,702 of dual bronchodilators. Single-inhaler triple therapy was the first maintenance treatment in 44% of the users and 43% had no COPD exacerbations in the prior year. The adjusted hazard ratio (HR) of a first moderate or severe exacerbation with triple therapy relative to dual bronchodilators was 1.08 (95% confidence interval (CI): 1.00– 1.16). Among patients with two or more prior exacerbations the HR was 0.83 (95% CI: 0.74– 0.92), while for those with prior asthma diagnosis it was 0.86 (95% CI: 0.70– 1.06) and with blood eosinophil count > 300 cells/μL it was 0.89 (95% CI: 0.76– 1.05). The incidence of severe pneumonia was increased with triple therapy (HR 1.50; 95% CI: 1.29– 1.75).Conclusion: In a real-world setting of COPD treatment among ICS-naïve patients, thus unaffected by ICS withdrawal, single-inhaler triple therapy was not more effective than dual bronchodilators at reducing the incidence of exacerbation, except among patients with multiple exacerbations. Single-inhaler triple therapy should be initiated mainly in patients with multiple exacerbations while, for most others, dual bronchodilators are just as effective whilst avoiding the excess risk of severe pneumonias.Keywords: cohort studies, COPD exacerbation, pneumonia, propensity scores, real-world evidencehttps://www.dovepress.com/single-inhaler-triple-versus-dual-bronchodilator-therapy-in-copd-real--peer-reviewed-fulltext-article-COPDcohort studiescopd exacerbationpneumoniapropensity scoresreal-world evidence.
spellingShingle Suissa S
Dell'Aniello S
Ernst P
Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety
International Journal of COPD
cohort studies
copd exacerbation
pneumonia
propensity scores
real-world evidence.
title Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety
title_full Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety
title_fullStr Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety
title_full_unstemmed Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety
title_short Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety
title_sort single inhaler triple versus dual bronchodilator therapy in copd real world comparative effectiveness and safety
topic cohort studies
copd exacerbation
pneumonia
propensity scores
real-world evidence.
url https://www.dovepress.com/single-inhaler-triple-versus-dual-bronchodilator-therapy-in-copd-real--peer-reviewed-fulltext-article-COPD
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AT dellaniellos singleinhalertripleversusdualbronchodilatortherapyincopdrealworldcomparativeeffectivenessandsafety
AT ernstp singleinhalertripleversusdualbronchodilatortherapyincopdrealworldcomparativeeffectivenessandsafety