Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD
| Autor: | Matjaz Fležar, Stefan Andreas, Alberto de la Hoz, Matthias Trampisch, Ulrich Bothner, Roland Buhl, Peter Alter, Lorcan McGarvey |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
srčna frekvenca
medicine.medical_specialty medicine.drug_class Diastole Blood Pressure International Journal of Chronic Obstructive Pulmonary Disease chronic obstructive -- drug therapy chronic obstructive pulmonary disease 03 medical and health sciences chemistry.chemical_compound Pulmonary Disease Chronic Obstructive 0302 clinical medicine tiotropium Double-Blind Method Heart Rate Internal medicine Bronchodilator Forced Expiratory Volume Heart rate Post-hoc analysis heart rate medicine Humans 030212 general & internal medicine Tiotropium Bromide Adverse effect udc:616.2 pulmonary disease krvni tlakt Original Research tiotropij COPD business.industry olodaterol kronična obstruktivna pljučna bolezen -- terapija z zdravili Olodaterol blood pressure General Medicine medicine.disease humanities 3. Good health Benzoxazines Bronchodilator Agents Blood pressure Treatment Outcome 030228 respiratory system chemistry Cardiology business |
| Zdroj: | International Journal of Chronic Obstructive Pulmonary Disease Andreas, S, McGarvey, L, Bothner, U, Trampisch, M, de la Hoz, A, Fležar, M, Buhl, R & Alter, P 2020, ' Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD ', International journal of chronic obstructive pulmonary disease, vol. 15, pp. 1935-1944 . https://doi.org/10.2147/COPD.S246348 International journal of COPD, vol. 15, pp. 1935-1944, 2020. |
| ISSN: | 1178-2005 |
| DOI: | 10.2147/COPD.S246348 |
| Popis: | Stefan Andreas,1,2 Lorcan McGarvey,3 Ulrich Bothner,4 Matthias Trampisch,4 Alberto de la Hoz,4 Matjaz Fležar,5 Roland Buhl,6 Peter Alter7 1Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany; 2LungClinic Immenhausen, Immenhausen, Germany, Member of the German Center for Lung Research (DZL); 3Queen’s University Belfast, Belfast, UK; 4Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 5Klinika Golnik, Golnik, Slovenia; 6Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany; 7Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR); Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence: Stefan AndreasDepartment of Cardiology and Pneumology, University Medical Center Göttingen, Robert-Koch-Str. 40, Göttingen, GermanyTel +49 05673 501 1112Fax +49 05673-501-1101Email stefan.andreas@med.uni-goettingen.deIntroduction: Long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are established maintenance bronchodilator treatments for chronic obstructive pulmonary disease (COPD) with the potential to increase heart rate (HR) and impact blood pressure (BP). While previous studies indicate that HR and BP are not negatively influenced by tiotropium or olodaterol monotherapy, the effect of tiotropium/olodaterol has not been evaluated. We report a post hoc analysis of the effect of dual bronchodilation with tiotropium/olodaterol versus monocomponents on HR and BP in patients with moderate-to-very-severe COPD included in the large TONADO® study.Methods: The TONADO® trials (1237.5 [NCT01431274] and 1237.6 [NCT01431287]) were two replicate, randomized, double-blind, parallel-group, 52-week, Phase III trials that compared tiotropium/olodaterol (5/5 μg and 2.5/5 μg) with tiotropium (5 μg and 2.5 μg) and olodaterol (5 μg) in patients with moderate-to-very-severe COPD. Patients with cardiovascular comorbidities were included. Changes in HR and systolic/diastolic BP were measured before and after dosing with the study medication at each visit (baseline, Week 12, Week 24 and Week 52).Results: Overall, 3,100 patients were included in this analysis. Over 52 weeks, small changes from baseline in mean HR (< 2 beats per minute [bpm]) and small changes from pre- to post-dose (< 1 bpm) were evident at different time points. There was a non-significant increase from baseline in mean diastolic and systolic BP (< 2 mmHg) observed over 52 weeks of treatment. The short-term (1 hour pre- to 1 hour post-dose) mean changes in systolic and diastolic BP over 52 weeks in the tiotropium/olodaterol 5/5 μg group were comparable with those observed for the monocomponents at all time points.Conclusion: There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents. This supports the already demonstrated cardiovascular safety profile of tiotropium/olodaterol as long-acting maintenance bronchodilator treatment for COPD, including patients with cardiovascular comorbidities.Keywords: chronic obstructive pulmonary disease, tiotropium, olodaterol, heart rate, blood pressure |
| Databáze: | OpenAIRE |
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