Mortality risk reduction with budesonide/glycopyrrolate/formoterol fumarate versus fluticasone furoate/umeclidinium/vilanterol in COPD: a matching-adjusted indirect comparison based on ETHOS and IMPACT.

All-cause mortality budesonide/glycopyrrolate/formoterol fumarate chronic obstructive pulmonary disease fixed-dose fluticasone furoate/umeclidinium/vilanterol inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist matching-adjusted indirect comparison single-inhaler triple therapy

Journal

Current medical research and opinion
ISSN: 1473-4877
Titre abrégé: Curr Med Res Opin
Pays: England
ID NLM: 0351014

Informations de publication

Date de publication:
Oct 2023
Historique:
pubmed: 16 8 2023
medline: 16 8 2023
entrez: 16 8 2023
Statut: ppublish

Résumé

Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. While two approved fixed-dose inhaled corticosteroid/long-acting muscarinic antagonist (LAMA)/long-acting β A systematic literature review identified two studies (ETHOS [NCT02465567]; IMPACT [NCT02164513]) of ≥52 weeks reporting ACM as an efficacy endpoint in patients receiving triple therapy. As ETHOS and IMPACT lack a common comparator, an unanchored MAIC compared ACM between licensed doses of BGF (320/18/9.6 μg) from ETHOS and FF/UMEC/VI (100/62.5/25 μg) from IMPACT in patients with moderate-to-very severe COPD. Using on- and off-treatment data from the final retrieved datasets of the intention-to-treat populations, BGF data were adjusted according to aggregate FF/UMEC/VI data using 11 baseline covariates; a supplementary unadjusted indirect treatment comparison was also conducted. ACM over 52 weeks was statistically significantly reduced by 39% for BGF versus FF/UMEC/VI in the MAIC (hazard ratio [HR] [95% CI]: 0.61 [0.38, 0.95], In this MAIC, which adjusted for population heterogeneity between ETHOS and IMPACT, ACM was significantly reduced with BGF versus FF/UMEC/VI in patients with moderate-to-very severe COPD. Chronic obstructive pulmonary disease (known as COPD) is a leading cause of death worldwide, being responsible for over 3 million deaths in 2019. People living with COPD are more likely to die. Importantly, a sudden worsening of COPD symptoms (known as an exacerbation) is associated with a higher chance of death from heart-related and breathing-related problems. Therefore, reducing risk of death is an important treatment goal for COPD. Of the three medications approved for treating COPD that combine three drugs in a single-inhaler device, there are two—referred to generically as budesonide/glycopyrrolate/formoterol fumarate (BGF) and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)—that can reduce the risk of death in people living with COPD compared with treatments that combine two drugs. However, no studies have directly compared the risk of death in people living with COPD treated with these medicines. We compared the risk of death in people living with moderate-to-very severe COPD who received either BGF during a clinical trial called ETHOS or FF/UMEC/VI during a clinical trial called IMPACT. To make this comparison, we used a method called “matching-adjusted indirect comparison”, which used specific features (such as sex, breathing difficulty, and whether they were current smokers) to match patients from the two studies to ensure similar groups were examined. Our analysis showed a 39% decrease in the chance of death in patients who received BGF compared with patients who received FF/UMEC/VI. This finding may be important for doctors to improve patient health and reduce the risk of death in people living with COPD.

Autres résumés

Type: plain-language-summary (eng)
Chronic obstructive pulmonary disease (known as COPD) is a leading cause of death worldwide, being responsible for over 3 million deaths in 2019. People living with COPD are more likely to die. Importantly, a sudden worsening of COPD symptoms (known as an exacerbation) is associated with a higher chance of death from heart-related and breathing-related problems. Therefore, reducing risk of death is an important treatment goal for COPD. Of the three medications approved for treating COPD that combine three drugs in a single-inhaler device, there are two—referred to generically as budesonide/glycopyrrolate/formoterol fumarate (BGF) and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)—that can reduce the risk of death in people living with COPD compared with treatments that combine two drugs. However, no studies have directly compared the risk of death in people living with COPD treated with these medicines. We compared the risk of death in people living with moderate-to-very severe COPD who received either BGF during a clinical trial called ETHOS or FF/UMEC/VI during a clinical trial called IMPACT. To make this comparison, we used a method called “matching-adjusted indirect comparison”, which used specific features (such as sex, breathing difficulty, and whether they were current smokers) to match patients from the two studies to ensure similar groups were examined. Our analysis showed a 39% decrease in the chance of death in patients who received BGF compared with patients who received FF/UMEC/VI. This finding may be important for doctors to improve patient health and reduce the risk of death in people living with COPD.

Identifiants

pubmed: 37583267
doi: 10.1080/03007995.2023.2247969
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1395-1405

Auteurs

Daiana Stolz (D)

Clinic of Respiratory Medicine, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg, Germany.

Erik Hermansson (E)

AstraZeneca, Gothenburg, Sweden.

Mario Ouwens (M)

AstraZeneca, Gothenburg, Sweden.

Barinder Singh (B)

Pharmacoevidence, Mohali, India.

Akanksha Sharma (A)

Pharmacoevidence, Mohali, India.

Dan Jackson (D)

AstraZeneca, Cambridge, UK.

Patrick Darken (P)

AstraZeneca, Gaithersburg, MD, USA.

Jonathan Marshall (J)

AstraZeneca, Cambridge, UK.

Karin Bowen (K)

AstraZeneca, Gaithersburg, MD, USA.

Hana Müllerová (H)

AstraZeneca, Cambridge, UK.

Bernardino Alcázar Navarrete (B)

Respiratory Department, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Instituto Biosanitario de Granada, IBS-Granada, Granada, Spain.

Richard Russell (R)

King's Centre for Lung Health, Department of Immunobiology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.

MeiLan K Han (MK)

Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, MI, USA.

Deniz Tansey-Dwyer (D)

AstraZeneca, Cambridge, UK.

Classifications MeSH