François Maltais1, Roland Buhl2, Andrea Koch3, Valeria C Amatto4, Jim Reid5, Lars Grönke4, Ulrich Bothner4, Florian Voß6, Lorcan McGarvey7, Gary T Ferguson8. 1. Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, QC, Canada. Electronic address: Francois.Maltais@fmed.ulaval.ca. 2. Pulmonary Department, Mainz University Hospital, Mainz, Germany. 3. Medizinische Klinik und Poliklinik V, Klinikum der Ludwig-Maximilians-Universität, and the German Center for Lung Research (DZL), Klinikum der Ludwig-Maximilians-Universität, Munich, Germany. 4. Boehringer Ingelheim International GmbH, Ingelheim, Germany. 5. Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. 6. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. 7. Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland. 8. Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI.
Abstract
BACKGROUND: Cardiovascular disease is a frequent comorbidity in patients with COPD. Many physicians, particularly pulmonologists, are reluctant to use β-adrenoceptor blocking agents (β-blockers) in patients with COPD, despite their proven effectiveness in preventing cardiovascular events. METHODS: The large (5,162 patients) phase III TONADO 1 and 2 studies assessed lung function and patient-reported outcomes in patients with moderate to very severe COPD receiving long-acting bronchodilator treatment across 1 year. This post hoc analysis characterized lung-function changes, patient-reported outcomes, and safety in the subgroup of patients receiving β-blockers in the studies. RESULTS: In total, 557 of 5,162 patients (11%) received β-blockers at baseline. Postbronchodilator FEV1 at baseline was higher in the β-blocker group (1.470 L) compared with that in the no β-blocker group (1.362 L). As expected, patients receiving β-blockers had a more frequent history of cardiovascular comorbidities and medications. Lung function improved from baseline in patients with or those without β-blocker treatment, and no relevant between-group differences were observed in trough FEV1 or trough FVC at 24 or 52 weeks. No relevant differences were observed for St. George's Respiratory Questionnaire results and Transition Dyspnea Index in patients with β-blockers compared with those in patients without. Safety findings were comparable between groups. CONCLUSIONS:Lung function, overall respiratory status, and safety of tiotropium/olodaterol were not influenced by baseline β-blocker treatment in patients with moderate to very severe COPD. Results from this large patient cohort support the cautious and appropriate use of β-blockers in patients with COPD and cardiovascular comorbidity. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01431274 and No. NCT01431287; URL: www.clinicaltrials.gov.
RCT Entities:
BACKGROUND:Cardiovascular disease is a frequent comorbidity in patients with COPD. Many physicians, particularly pulmonologists, are reluctant to use β-adrenoceptor blocking agents (β-blockers) in patients with COPD, despite their proven effectiveness in preventing cardiovascular events. METHODS: The large (5,162 patients) phase III TONADO 1 and 2 studies assessed lung function and patient-reported outcomes in patients with moderate to very severe COPD receiving long-acting bronchodilator treatment across 1 year. This post hoc analysis characterized lung-function changes, patient-reported outcomes, and safety in the subgroup of patients receiving β-blockers in the studies. RESULTS: In total, 557 of 5,162 patients (11%) received β-blockers at baseline. Postbronchodilator FEV1 at baseline was higher in the β-blocker group (1.470 L) compared with that in the no β-blocker group (1.362 L). As expected, patients receiving β-blockers had a more frequent history of cardiovascular comorbidities and medications. Lung function improved from baseline in patients with or those without β-blocker treatment, and no relevant between-group differences were observed in trough FEV1 or trough FVC at 24 or 52 weeks. No relevant differences were observed for St. George's Respiratory Questionnaire results and Transition Dyspnea Index in patients with β-blockers compared with those in patients without. Safety findings were comparable between groups. CONCLUSIONS: Lung function, overall respiratory status, and safety of tiotropium/olodaterol were not influenced by baseline β-blocker treatment in patients with moderate to very severe COPD. Results from this large patient cohort support the cautious and appropriate use of β-blockers in patients with COPD and cardiovascular comorbidity. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01431274 and No. NCT01431287; URL: www.clinicaltrials.gov.
Authors: Gary T Ferguson; François Maltais; Jill Karpel; Ulrich Bothner; Isabel Kloer; Matthias Trampisch; Roland Buhl Journal: NPJ Prim Care Respir Med Date: 2020-12-04 Impact factor: 2.871
Authors: Kenneth R Chapman; Robert A Wise; Benjamin M Scirica; Deepak L Bhatt; Sami Z Daoud; Dan Lythgoe; Esther Garcia Gil Journal: Respir Res Date: 2021-10-22