Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Ana
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ORIGINAL RESEARCH
Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADOÒ/ DYNAGITOÒ Trials Jadwiga A. Wedzicha . Roland Buhl . Dave Singh . Claus F. Vogelmeier . Alberto de la Hoz . Wenqiong Xue . Antonio Anzueto . Peter M. A. Calverley Received: May 20, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Previous studies demonstrated that tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. Methods: This post hoc analysis pooled data from TONADOÒ 1 ? 2 and DYNAGITOÒ, three Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12619259. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12325020-01438-3) contains supplementary material, which is available to authorized users. J. A. Wedzicha (&) Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK e-mail: [email protected] R. Buhl Johannes Gutenberg University Mainz, Mainz, Germany D. Singh Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK C. F. Vogelmeier Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany
52-week, parallel-group, randomised, doubleblind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received tiotropium/olodaterol 5/5 lg or tiotropium 5 lg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2–4 disease severity and baseline inhaled corticosteroid (ICS) use. Results: In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95;
A. de la Hoz Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany W. Xue Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA A. Anzueto Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans Health Care System, San Antonio, TX, USA P. M. A. Calverley Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK
Adv Ther
P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium. Lower rates of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium were evident in patients with 0–1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least tw
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