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DOI: 10.1055/s-0035-1544638
Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat in chronic obstructive pulmonary disease in two 1-year studies
Introduction: The fixed-dose combination (FDC) of tiotropium (T), a once-daily long-acting muscarinic antagonist, and olodaterol (O), a once-daily long-acting ß2-agonist, is currently being evaluated in chronic obstructive pulmonary disease (COPD). Two 52-week, Phase III replicate pivotal studies were conducted to assess the efficacy and safety of FDCs of T and O (T+O) delivered via Respimat Soft Mist inhaler in patients (pts) with GOLD Stage 2 – 4 COPD. Pooled safety data from the two studies are presented here.
Methods: These were double-blind, randomised, parallel-group studies with 5 arms: O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg, T+O 5/5 µg. Key inclusion criteria were: age= 40 years, diagnosis of COPD, smoking history > 10 pack-years. Pts with a history of asthma or significant disease other than COPD were excluded. Adverse events (AEs) were reported throughout the studies.
Results: A total of 5162 pts were randomised and treated.
*MedDRA SOC |
|||||
Pts with AE, % |
|||||
O5 µg |
T |
T5 µg |
T+O |
T+O |
|
n = 1038 |
2.5 µg |
n = 1033 |
2.5/5 µg |
5/5 µg |
|
n = 1032 |
n = 1030 |
n = 1029 |
|||
Total AEs |
76.6 |
73.4 |
73.3 |
74.7 |
74.0 |
Serious AEs |
17.4 |
15.1 |
16.7 |
16.3 |
16.4 |
Fatal AEs |
1.3 |
1.2 |
1.6 |
1.4 |
1.7 |
Cardiac disorders* |
5.7 |
5.8 |
5.3 |
5.8 |
4.5 |
Respiratory, thoracic and mediastinal disorders* |
45.3 |
43.9 |
42.7 |
38.2 |
39.4 |
In general, AEs, serious AEs and fatal AEs were balanced across treatment groups. In particular, frequencies of AEs in the cardiac disorders System Organ Class (SOC) and respiratory disorders SOC were similar.
Conclusions: T+O FDCs were safe and well tolerated. In comparison to the individual components, there was no notable increase in AEs with T+O FDCs.
Funding: Boehringer Ingelheim.
Presented at ERS congress meeting 2014