Efficacy and safety of tiotropium + olodaterol maintenance treatment in patients with COPD in the TONADO® and OTEMTO® studies: a subgroup analysis by age
Authors Ferguson GT, Karpel JP, Clerisme-Beaty E, Grönke L, Voß F, Buhl R
Received 18 March 2016
Accepted for publication 10 June 2016
Published 31 October 2016 Volume 2016:11(1) Pages 2701—2710
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Professor Hsiao-Chi Chuang
Peer reviewer comments 2
Editor who approved publication: Dr Richard Russell
Gary T Ferguson,1 Jill P Karpel,2 Emmanuelle Clerisme-Beaty,3 Lars Grönke,4 Florian Voß,4 Roland Buhl5
1Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, 2North Shore Medical Arts LLP, Great Neck, NY, 3Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA; 4Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, 5Pulmonary Department, Mainz University Hospital, Mainz, Germany
Background: Increasing age is associated with poor prognosis in patients with COPD.
Objective: This analysis from the replicate Phase III OTEMTO® and TONADO® studies examined the efficacy and safety of tiotropium, a long-acting anticholinergic, combined with olodaterol, a long-acting β2-agonist, compared to monotherapies and placebo in patients with COPD aged 40 years to <65 years, 65 years to <75 years, 75 years to <85 years, and ≥85 years.
Methods: In these double-blind, parallel-group, active-controlled, multicenter, randomized studies, patients received tiotropium + olodaterol 2.5/5 µg or 5/5 µg, tiotropium 5 µg or 2.5 µg (TONADO only), olodaterol 5 µg (TONADO only), or placebo (OTEMTO only). This analysis used the approved doses of tiotropium + olodaterol 5/5 µg, tiotropium 5 µg, and olodaterol 5 µg. Primary end points at 12 weeks (OTEMTO) or 24 weeks (TONADO) included St George’s Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in 1 second (FEV1) area under the curve from 0 hour to 3 hours (AUC0–3) response, and trough FEV1 response.
Results: A total of 1,621 patients were randomized (40 years to <65 years, n=749; 65 years to <75 years, n=674; 75 years to <85 years, n=186; ≥85 years, n=12) in OTEMTO and 5,162 patients (40 years to <65 years, n=2,654; 65 years to <75 years, n=1,967; 75 to <85 years, n=528; ≥85 years, n=13) in TONADO. FEV1 AUC0–3 and trough FEV1 responses improved with tiotropium + olodaterol 5/5 µg at 12 weeks and 24 weeks compared to monotherapies or placebo for all age groups. SGRQ scores generally improved with tiotropium + olodaterol 5/5 µg after 12 weeks in OTEMTO and improved after 24 weeks in all age groups in TONADO. In all age groups receiving tiotropium + olodaterol 5/5 µg compared to monotherapies or placebo, transition dyspnea index scores generally improved, while rescue medication usage improved.
Conclusion: No differences were noted in relative responses to treatment or safety when using tiotropium + olodaterol 5/5 µg compared to monotherapies or placebo across all age groups.
Keywords: FEV1, SGRQ, lung function, TDI, rescue medication
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]