Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD W
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ORIGINAL RESEARCH
Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naı¨ve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials Roland Buhl . Alberto de la Hoz . Wenqiong Xue . Dave Singh . Gary T. Ferguson Received: March 27, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: The efficacy of tiotropium/olodaterol compared with tiotropium in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated in a large clinical programme. Currently, randomised controlled trial (RCT) data on dual bronchodilation as firstline maintenance therapy are limited. In this post hoc analysis of pooled data from four RCTs, we compared the efficacy of tiotropium/olodaterol versus tiotropium as maintenance therapy in patients with COPD who were not Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12458273. R. Buhl (&) Pulmonary Department, Johannes Gutenberg Universitat Mainz, Mainz, Germany e-mail: [email protected] A. de la Hoz Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany W. Xue Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA D. Singh Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK G. T. Ferguson Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA
receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting b2-agonists (LABAs) or inhaled corticosteroids (ICS) (‘‘maintenance naı¨ve’’) at study entry. Methods: TONADOÒ 1/2 (52 weeks) and OTEMTOÒ 1/2 (12 weeks) were phase III RCTs in patients with COPD. TONADO 1/2 and OTEMTO 1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1 s (FEV1) \ 80% predicted (lower limit FEV1 C 30% in OTEMTO 1/2 only). We examined the effect of tiotropium/olodaterol 5/5 lg versus tiotropium 5 lg on trough FEV1 response, St. George’s Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score at 12 weeks in four pooled studies. Results: The pooled analysis included 1078 maintenance-naı¨ve patients. There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV1 [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P \ 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12. For patients receiving tiotropium/olodaterol, the odds of achieving a minimal clinically important difference from baseline in any of the analysed outcomes (FEV1 C 0.1 L, SGRQ C 4.0 points or TDI C 1.0 point) were higher versus tiotropium. Conclusions: In patients who were maintenance naı¨ve at baseline, treatment initiation with tiotropium/olodaterol resulted in greater
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improvements in lung function, health status and dyspnoea severity compared with tiotropium alone, without compromising patient safety. These results support the use of
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