Cargando…
Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database
INTRODUCTION: In patients with chronic obstructive pulmonary disease (COPD), treatment with long-acting muscarinic antagonist (LAMA)/long-acting β(2)-agonist (LABA) combination therapy significantly improves lung function versus LABA/inhaled corticosteroid (ICS). To investigate whether LAMA/LABA cou...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8107175/ https://www.ncbi.nlm.nih.gov/pubmed/33721209 http://dx.doi.org/10.1007/s12325-021-01646-5 |
_version_ | 1783689904579936256 |
---|---|
author | Quint, Jennifer K. Montonen, Jukka Esposito, Daina B. He, Xintong Koerner, Leslie Wallace, Laura de la Hoz, Alberto Miravitlles, Marc |
author_facet | Quint, Jennifer K. Montonen, Jukka Esposito, Daina B. He, Xintong Koerner, Leslie Wallace, Laura de la Hoz, Alberto Miravitlles, Marc |
author_sort | Quint, Jennifer K. |
collection | PubMed |
description | INTRODUCTION: In patients with chronic obstructive pulmonary disease (COPD), treatment with long-acting muscarinic antagonist (LAMA)/long-acting β(2)-agonist (LABA) combination therapy significantly improves lung function versus LABA/inhaled corticosteroid (ICS). To investigate whether LAMA/LABA could provide better clinical outcomes than LABA/ICS, this non-interventional database study assessed the risk of COPD exacerbations, pneumonia, and escalation to triple therapy in patients with COPD initiating maintenance therapy with tiotropium/olodaterol versus any LABA/ICS combination. METHODS: Administrative healthcare claims and laboratory results data from the US HealthCore Integrated Research Database(sm) were evaluated for patients with COPD initiating tiotropium/olodaterol versus LABA/ICS treatment (January 2013–March 2019). Patients were aged at least 40 years with a diagnosis of COPD (but not asthma) at cohort entry. A Cox proportional hazard regression model was used (as-treated analysis) to assess risk of COPD exacerbation, community-acquired pneumonia, and escalation to triple therapy, both individually and as a combined risk of any one of these events. Potential imbalance of confounding factors between cohorts was handled using fine stratification, reweighting, and trimming by exposure propensity score (high-dimensional); subgroup analyses were conducted on the basis of blood eosinophil levels and exacerbation history. RESULTS: The total population consisted of 61,985 patients (tiotropium/olodaterol n = 2684; LABA/ICS n = 59,301); after reweighting, the total was 42,953 patients (tiotropium/olodaterol n = 2600; LABA/ICS n = 40,353; mean age 65 years; female 54.5%). Patients treated with tiotropium/olodaterol versus LABA/ICS experienced a reduction in the risk of COPD exacerbations (adjusted hazard ratio 0.76 [95% confidence interval 0.68, 0.85]), pneumonia (0.74 [0.57, 0.97]), escalation to triple therapy (0.22 [0.19, 0.26]), and any one of these events (0.45 [0.41, 0.49]); the combined risk was similar irrespective of baseline eosinophils and exacerbation history. CONCLUSIONS: In patients with COPD, tiotropium/olodaterol was associated with a lower risk of COPD exacerbations, pneumonia, and escalation to triple therapy versus LABA/ICS, both individually and in combination; the combined risk was reduced irrespective of baseline eosinophils or exacerbation history. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04138758 (registered 23 October 2019). GRAPHIC ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-021-01646-5. |
format | Online Article Text |
id | pubmed-8107175 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-81071752021-05-24 Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database Quint, Jennifer K. Montonen, Jukka Esposito, Daina B. He, Xintong Koerner, Leslie Wallace, Laura de la Hoz, Alberto Miravitlles, Marc Adv Ther Original Research INTRODUCTION: In patients with chronic obstructive pulmonary disease (COPD), treatment with long-acting muscarinic antagonist (LAMA)/long-acting β(2)-agonist (LABA) combination therapy significantly improves lung function versus LABA/inhaled corticosteroid (ICS). To investigate whether LAMA/LABA could provide better clinical outcomes than LABA/ICS, this non-interventional database study assessed the risk of COPD exacerbations, pneumonia, and escalation to triple therapy in patients with COPD initiating maintenance therapy with tiotropium/olodaterol versus any LABA/ICS combination. METHODS: Administrative healthcare claims and laboratory results data from the US HealthCore Integrated Research Database(sm) were evaluated for patients with COPD initiating tiotropium/olodaterol versus LABA/ICS treatment (January 2013–March 2019). Patients were aged at least 40 years with a diagnosis of COPD (but not asthma) at cohort entry. A Cox proportional hazard regression model was used (as-treated analysis) to assess risk of COPD exacerbation, community-acquired pneumonia, and escalation to triple therapy, both individually and as a combined risk of any one of these events. Potential imbalance of confounding factors between cohorts was handled using fine stratification, reweighting, and trimming by exposure propensity score (high-dimensional); subgroup analyses were conducted on the basis of blood eosinophil levels and exacerbation history. RESULTS: The total population consisted of 61,985 patients (tiotropium/olodaterol n = 2684; LABA/ICS n = 59,301); after reweighting, the total was 42,953 patients (tiotropium/olodaterol n = 2600; LABA/ICS n = 40,353; mean age 65 years; female 54.5%). Patients treated with tiotropium/olodaterol versus LABA/ICS experienced a reduction in the risk of COPD exacerbations (adjusted hazard ratio 0.76 [95% confidence interval 0.68, 0.85]), pneumonia (0.74 [0.57, 0.97]), escalation to triple therapy (0.22 [0.19, 0.26]), and any one of these events (0.45 [0.41, 0.49]); the combined risk was similar irrespective of baseline eosinophils and exacerbation history. CONCLUSIONS: In patients with COPD, tiotropium/olodaterol was associated with a lower risk of COPD exacerbations, pneumonia, and escalation to triple therapy versus LABA/ICS, both individually and in combination; the combined risk was reduced irrespective of baseline eosinophils or exacerbation history. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04138758 (registered 23 October 2019). GRAPHIC ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-021-01646-5. Springer Healthcare 2021-03-15 2021 /pmc/articles/PMC8107175/ /pubmed/33721209 http://dx.doi.org/10.1007/s12325-021-01646-5 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Quint, Jennifer K. Montonen, Jukka Esposito, Daina B. He, Xintong Koerner, Leslie Wallace, Laura de la Hoz, Alberto Miravitlles, Marc Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database |
title | Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database |
title_full | Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database |
title_fullStr | Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database |
title_full_unstemmed | Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database |
title_short | Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database |
title_sort | effectiveness and safety of copd maintenance therapy with tiotropium/olodaterol versus laba/ics in a us claims database |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8107175/ https://www.ncbi.nlm.nih.gov/pubmed/33721209 http://dx.doi.org/10.1007/s12325-021-01646-5 |
work_keys_str_mv | AT quintjenniferk effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase AT montonenjukka effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase AT espositodainab effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase AT hexintong effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase AT koernerleslie effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase AT wallacelaura effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase AT delahozalberto effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase AT miravitllesmarc effectivenessandsafetyofcopdmaintenancetherapywithtiotropiumolodaterolversuslabaicsinausclaimsdatabase |