ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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A Pooled Analysis of Mortality in Patients with COPD Receiving Triple Therapy versus Dual Bronchodilation
Session Title
TP40 - TP040 COPD CLINICAL TRIALS AND THERAPIES
Abstract
A2251 - A Pooled Analysis of Mortality in Patients with COPD Receiving Triple Therapy versus Dual Bronchodilation
Author Block: M. Miravitlles1, P. M. A. Calverley2, K. Verhamme3, M. Dreher4, V. Bayer5, A. Gardev6, A. de la Hoz6, J. A. Wedzicha7, D. Price8; 1Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain, 2Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom, 3Department of Medical Informatics, Erasmus MC, Rotterdam, Netherlands, 4Department of Pneumology and Intensive Care Medicine, University of Aachen, Aachen, Germany, 5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States, 6Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 7Airways Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom, 8Observational and Pragmatic Research Institute, Singapore, Singapore.
Rationale: Recent studies report a possible mortality benefit of treatment with long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) versus LAMA/LABA combinations in patients with highly symptomatic COPD and a history of exacerbations (≥1 moderate or severe exacerbation in the previous year). We compared the time to all-cause mortality with LAMA/LABA/ICS versus LAMA+LABA in a population of patients with predominantly moderate-to-severe COPD and a predominantly lower exacerbation risk. Methods: Data were pooled from patients who participated in six phase 3/4 randomized controlled trials (TONADO 1/2, DYNAGITO, WISDOM, UPLIFT and TIOSPIR) and received treatment with either LAMA/LABA/ICS (n=11,891) or LAMA+LABA (n=3,156). There was no withdrawal of prior treatment at randomization in either arm, and the LAMA/LABA/ICS group were receiving ICS prior to study entry. The analysis was on-treatment and all data were censored at 52 weeks. To address any imbalance in characteristics between treatment arms, analyses were performed in a propensity score (PS)-matched cohort with age, sex, geographical region, smoking status, post-bronchodilator forced expiratory volume in 1 second (FEV1) percent predicted, exacerbation history, body mass index and time since diagnosis as covariates. Patients were PS-matched to those who received LAMA+LABA during the treatment period and had not previously received ICS. Cox proportional hazard regression models adjusting for covariates (see Figure) were used to assess time to all-cause mortality. Results: After propensity score matching, there were 3,133 patients in both the LAMA+LABA and LAMA/LABA/ICS treatment groups. Baseline characteristics and comorbidities were well balanced between groups (LAMA+LABA vs. LAMA/LABA/ICS: male: 71.7% vs. 72.0%; age, mean±SD: 65.5±8.8 years vs. 65.5±8.7 years; FEV1% predicted [post-bronchodilator], mean±SD: 48.6±13.2% vs. 48.4±13.3%). Groups were composed mostly of infrequent exacerbators (patients with ≥2 COPD exacerbation in prior year: 19.1% vs. 19.0%). Overall, there were 41 (1.3%) deaths in the LAMA+LABA group and 45 (1.4%) in the LAMA/LABA/ICS group. No statistically significant difference in the time to death was observed between treatment groups (Figure; hazard ratio 1.06; 95% confidence intervals 0.68, 1.64; P=0.806). Sensitivity analyses using three additional models with different covariates showed similar results (Figure). Conclusions: This pooled analysis of over 6,000 PS-matched patients showed no differences in mortality between LAMA+LABA and triple therapy in patients with moderate-to-very severe COPD and predominantly low risk of exacerbations.
Author Block: M. Miravitlles1, P. M. A. Calverley2, K. Verhamme3, M. Dreher4, V. Bayer5, A. Gardev6, A. de la Hoz6, J. A. Wedzicha7, D. Price8; 1Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d’Hebron Research Institute (VHIR), Barcelona, Spain, 2Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom, 3Department of Medical Informatics, Erasmus MC, Rotterdam, Netherlands, 4Department of Pneumology and Intensive Care Medicine, University of Aachen, Aachen, Germany, 5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States, 6Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 7Airways Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom, 8Observational and Pragmatic Research Institute, Singapore, Singapore.
Rationale: Recent studies report a possible mortality benefit of treatment with long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) versus LAMA/LABA combinations in patients with highly symptomatic COPD and a history of exacerbations (≥1 moderate or severe exacerbation in the previous year). We compared the time to all-cause mortality with LAMA/LABA/ICS versus LAMA+LABA in a population of patients with predominantly moderate-to-severe COPD and a predominantly lower exacerbation risk. Methods: Data were pooled from patients who participated in six phase 3/4 randomized controlled trials (TONADO 1/2, DYNAGITO, WISDOM, UPLIFT and TIOSPIR) and received treatment with either LAMA/LABA/ICS (n=11,891) or LAMA+LABA (n=3,156). There was no withdrawal of prior treatment at randomization in either arm, and the LAMA/LABA/ICS group were receiving ICS prior to study entry. The analysis was on-treatment and all data were censored at 52 weeks. To address any imbalance in characteristics between treatment arms, analyses were performed in a propensity score (PS)-matched cohort with age, sex, geographical region, smoking status, post-bronchodilator forced expiratory volume in 1 second (FEV1) percent predicted, exacerbation history, body mass index and time since diagnosis as covariates. Patients were PS-matched to those who received LAMA+LABA during the treatment period and had not previously received ICS. Cox proportional hazard regression models adjusting for covariates (see Figure) were used to assess time to all-cause mortality. Results: After propensity score matching, there were 3,133 patients in both the LAMA+LABA and LAMA/LABA/ICS treatment groups. Baseline characteristics and comorbidities were well balanced between groups (LAMA+LABA vs. LAMA/LABA/ICS: male: 71.7% vs. 72.0%; age, mean±SD: 65.5±8.8 years vs. 65.5±8.7 years; FEV1% predicted [post-bronchodilator], mean±SD: 48.6±13.2% vs. 48.4±13.3%). Groups were composed mostly of infrequent exacerbators (patients with ≥2 COPD exacerbation in prior year: 19.1% vs. 19.0%). Overall, there were 41 (1.3%) deaths in the LAMA+LABA group and 45 (1.4%) in the LAMA/LABA/ICS group. No statistically significant difference in the time to death was observed between treatment groups (Figure; hazard ratio 1.06; 95% confidence intervals 0.68, 1.64; P=0.806). Sensitivity analyses using three additional models with different covariates showed similar results (Figure). Conclusions: This pooled analysis of over 6,000 PS-matched patients showed no differences in mortality between LAMA+LABA and triple therapy in patients with moderate-to-very severe COPD and predominantly low risk of exacerbations.
