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DOI: 10.1055/s-0036-1572057
Tiotropium + Olodaterol Fixed-Dose Combination Therapy Provides Lung-Function Benefits Compared With Tiotropium Alone In Patients With GOLD A/B And C/D Chronic Obstructive Pulmonary Disease: Post Hoc Analyses Of Two 1-Year Studies
Rationale: Tiotropium plus olodaterol (T+O) fixed-dose combination therapy combines the long-acting muscarinic antagonist tiotropium and the recently approved long-acting β2-agonist olodaterol as once-daily maintenance treatment in chronic obstructive pulmonary disease (COPD). We present post hoc analyses of data from the two pivotal 1-year TONADO studies that examined the lung-function benefits of T+O 5/5 µg (via Respimat®) compared with T 5 µg (Respimat®) in patients with COPD classified by the Global initiative for chronic Obstructive Lung Disease (GOLD) as A/B and C/D.
Methods: Classification as GOLD A/B and C/D was based on self-reported COPD exacerbation history and lung-function measurements. Forced expiratory volume in 1 second (FEV1) area under the curve from 0 – 3 hours of dosing (AUC0 – 3) and trough FEV1 were primary and secondary end points, respectively, in the studies.
Results: 875 patients were classified as GOLD A/B (T+O n = 428; T n = 447) and 1187 were classified as GOLD C/D (T+O n = 601; T n = 586). Baseline characteristics are presented in the Table. Patients with COPD classified as GOLD A/B demonstrated a numerically higher response in both FEV1 AUC0 – 3 and trough FEV1 when compared with patients classified as GOLD C/D (see Table). The between-treatment differences (adjusted mean response [95% confidence interval]; mL) were comparable in both subgroups, with treatment differences for GOLD A/B and C/D, respectively, of 105 (79, 132) and 115 (94, 136) for FEV1 AUC0 – 3 and 60 (33, 88) and 61 (40, 82) for trough FEV1.
Conclusions: Our analyses demonstrate robust lung-function efficacy for T+O, compared with T alone, in all GOLD COPD groups. Higher responses were observed in the GOLD A/B group compared to the GOLD C/D group for both treatment arms.
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GOLD A/B |
GOLD C/D |
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|
T+O |
T |
T+O |
T |
|
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Baseline characteristics |
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n |
428 |
447 |
601 |
586 |
|
Age (years), mean ± SD |
63.9 ± 8.4 |
63.7 ± 9.1 |
63.7 ± 8.3 |
64.0 ± 8.2 |
|
Male, n (%) |
302 (70.6) |
298 (66.7) |
431 (71.7) |
457 (78.0) |
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Ex-smoker, n (%) |
244 (57.0) |
263 (58.8) |
385 (64.1) |
400 (68.3) |
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Post-bronchodilator FEV1 (L), mean ± SD |
1.72 ± 0.44 |
1.73 ± 0.46 |
1.08 ± 0.36 |
1.10 ± 0.38 |
|
Post-bronchodilator FEV1 (% predicted), mean ± SD |
62.7 ± 8.2 |
63.0 ± 8.2 |
39.8 ± 11.5 |
39.5 ± 12.0 |
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Reversibility (mL), mean ± SD |
187 ± 158 |
192 ± 164 |
148 ± 138 |
155 ± 129 |
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Lung function following 24 weeks' treatment |
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Adjusted mean FEV1 AUCO-3 (mL)± SE |
288 ± 10 |
183 ± 9 |
243 ± 8 |
128 ± 8 |
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Adjusted mean trough FEV1 (mL)± SE |
148 ± 10 |
88 ± 10 |
135 ± 8 |
74 ± 8 |
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SD, standard deviation; SE, standard error |
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Funding: Boehringer Ingelheim.