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DOI: 10.1055/s-0036-1572083
Analysis Of The Efficacy And Safety Of The Fixed-Dose Combination Of Tiotropium + Olodaterol In Patients With COPD By Previous Usage Of Inhaled Corticosteroids
Rationale: Tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2-agonist (both administered once-daily), have been studied as a once-daily fixed-dose combination (FDC). Two Phase III studies have demonstrated that T+O FDC significantly improved lung function and symptoms over T and O monotherapy treatments in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).1 During these studies, patients were allowed to continue existing treatment with inhaled corticosteroids (ICS); this analysis was conducted to determine the effects of study treatment on lung function in patients receiving or not receiving ICS as reported at baseline.
Methods: 5162 patients were randomized to treatment with O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg, or T+O 5/5 µg (Respimat® inhaler) in two 52-week, double-blind, parallel-group studies. Primary efficacy end points were trough forced expiratory volume in 1 second (FEV1) response (i.e. change from baseline), FEV1 area under the curve from 0 – 3 hours (AUC0 – 3) response, and St. George's Respiratory Questionnaire (SGRQ) total score after 24 weeks. Pooled data are presented for the patient subgroups either using or not using ICS at baseline.
Results: In the overall population, all treatments resulted in clinically relevant improvements in lung function, with significant increases with both T+O doses over the individual components (p < 0.01).1 These effects on lung function were observed irrespective of whether or not patients had reported concomitant use of ICS at baseline (see Table).
Conclusions: In patients with COPD, T+O 5/5 µg significantly improved lung function over T 5 µg and O 5 µg monotherapy, irrespective of whether patients had reported ICS use at baseline.
Trough FEV1, L |
FEV 1 AUC 0 – 3, L |
|||
n |
Adjusted mean (SE) change |
n |
Adjusted mean (SE) change |
|
ICS usage |
||||
497 |
0.046 (0.009) |
503 |
0.129 (0.009) |
|
O 5 |
||||
471 |
0.084 (0.009) |
476 |
0.142 (0.009) |
|
T 2.5 |
||||
464 |
0.088 (0.009) |
465 |
0.147 (0.009) |
|
T 5 |
||||
489 |
0.114 (0.009) †#* |
492 |
0.246 (0.009) †##** |
|
T+O 2.5/5 |
||||
503 |
0.133 (0.009) †##** |
505 |
0.260 (0.008) †##** |
|
T+O 5/5 |
||||
No ICS usage |
||||
510 0.067 (0.009) |
514 |
0.139 (0.009) |
||
O 5 |
||||
533 0.062 (0.009) |
537 |
0.132 (0.008) |
||
T 2.5 |
||||
536 |
0.073 (0.009) |
543 |
0.155 (0.008) |
|
T 5 |
||||
511 |
0.122 (0.009) †##** |
517 |
0.252 (0.008) †##** |
|
T+O 2.5/5 |
||||
500 0.149 (0.009) †##** |
503 |
0.263 (0.009) †##** |
||
T+O 5/5 |
||||
†p < 0.0001 vs. O 5; ##p < 0.0001 vs. T 2.5; **p < 0.001 vsT 5 SE, standard error a Patients were not recorded as receiving LAMA or LABA at baseline in this study |
Reference
1. Buhl R et al. Eur Respir J 2014; 45(4):969 – 79.
Funding: Boehringer Ingelheim.