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DOI: 10.1055/s-0037-1598309
Tiotropium + olodaterol provides significant lung-function benefits compared to flucticasone + salmeterol regardless of prior bronchodilator use
Publication History
Publication Date:
23 February 2017 (online)
Introduction:
The ENERGITO® study demonstrated superior lung function with long-acting muscarinic antagonist (LAMA) tiotropium + long-acting β2-agonist (LABA) olodaterol (T+O) compared to inhaled corticosteroid (ICS) fluticasone + LABA salmeterol (F+S) in patients with COPD.
Aim:
To investigate if lung-function benefits of T+O compared to F+S were affected by prior ICS, LAMA or LABA treatment in ENERGITO®.
Methods:
In ENERGITO® (1237.11, NCT01969721; Phase IIIb, randomised, double-blind), patients with moderate to severe COPD received once-daily T+O 2.5/5 or 5/5 µg and twice-daily F+S 250/50 or 500/50 µg for 6 weeks. A post hoc analysis evaluated FEV1 AUC0 – 12 and AUC0 – 24 responses in patients with or without LAMA, LABA or ICS therapy at screening.
Results:
229 patients were enrolled and treated: 123 received prior LAMA, 141 LABA, 109 ICS. T+O significantly improved FEV1 AUC0 – 12 and AUC0 – 24 responses in patients with or without prior LAMA, LABA or ICS therapy compared to F+S (Table).
Conclusions:
In ENERGITO®, patients with moderate or severe COPD showed improved lung function with T+O compared to F+S regardless of prior treatment. T+O is a better choice than LABA/ICS to optimise lung function when initiating maintenance treatment.
Funding:
Boehringer Ingelheim
Treatment difference |
||||||
Adjusted mean FEV1 AUC0 – 12 response, L (SE) |
||||||
Prior LAMA |
No LAMA |
Prior LABA |
No LABA |
Prior ICS |
No ICS |
|
T+O 5/5 µg vs. F+S 250/50 µg T+O 5/5 µg vs. F+S 500/50 µg |
0.121a (0.016) 0.130a (0.016) |
0.129a (0.016) 0.127a (0.016) |
0.123a (0.012) 0.137a (0.012) |
0.128a (0.021) 0.118a (0.021) |
0.129a (0.013) 0.139a (0.013) |
0.123a (0.017) 0.120a (0.017) |
Adjusted mean FEV1 AUC0 – 24 response, L (SE) |
||||||
Prior LAMA |
No LAMA |
Prior LABA |
No LABA |
Prior ICS |
No ICS |
|
T+O 5/5 µg vs. F+S 250/50 µg T+O 5/5 µg vs. F+S 500/50 µg |
0.083a (0.015) 0.092a (0.015) |
0.081a (0.016) 0.079a (0.015) |
0.083a (0.012) 0.096a (0.012) |
0.082a (0.020) 0.072a (0.020) |
0.084a (0.013) 0.099a (0.012) |
0.081a (0.017) 0.076a (0.017) |
ap < 0.001 SE, standard error |
Content already presented at ERS congress 2016
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No conflict of interest has been declared by the author(s).