Rationale Tiotropium plus olodaterol (T+O) is a novel once-daily combination of the long-acting muscarinic antagonist (LAMA) tiotropium (T) and the recently approved long-acting β2-agonist (LABA) olodaterol, for use as maintenance treatment in chronic obstructive pulmonary disease (COPD). These post hoc analyses of data from the two pivotal 1-year TONADO studies determined whether treatment with a long-acting bronchodilator (LABD) prior to randomisation affected the lung-function benefits of T+O 5/5 µg (via Respimat®) compared to T 5 µg (via Respimat®).
Methods In the studies, 2124 patients had not received prior LABD treatment (T+O n = 426; T n = 454) and 3038 patients had (T+O n = 603, T n = 579; 60.6% LAMA, 78.8% LABA). Baseline characteristics for all patients and a sub-group with Global initiative for chronic Obstructive Lung Disease (GOLD) 2 lung-function impairment are presented in the Table 1. Forced expiratory volume in 1 s (FEV1) area under the curve from 0–3 h (AUC0–3) response (change from baseline) and trough FEV1 response were primary end points in the studies.
Results Comparable responses for both FEV1 AUC0–3 and trough FEV1 were observed in patients previously treated and untreated with LABD (see Table 1). The between-treatment differences (adjusted mean response [SE]; mL) for no prior LABD and prior LABD treatment, respectively, were: 116 (13) and 105 (11) for FEV1 AUC0–3, and 76 (14) and 49 (11) for trough FEV1. In the GOLD 2 subgroup, the between-treatment differences (adjusted mean response [SE]; mL) for no prior LABD and prior LABD treatment, respectively, were: 114 (19) and 123 (17) for FEV1 AUC0–3, and 79 (20) and 61 (18) for trough FEV1.
Conclusions Our analyses demonstrate the robust lung-function efficacy of T+O, compared to T alone, independent of the requirement for, or prior use of, LABD. These findings suggest a benefit of combination therapy over the mono-product as a first-line maintenance treatment.
Funding Boehringer Ingelheim.
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