International journal of chronic obstructive pulmonary disease, 2017-01, Vol.12, p.3329-3339
2017
Details
- Autor(en) / Beteiligte
- Titel
- Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease
- Ist Teil von
- International journal of chronic obstructive pulmonary disease, 2017-01, Vol.12, p.3329-3339
- Ort / Verlag
- New Zealand: Dove Medical Press Limited
- Erscheinungsjahr
- 2017
- Link zum Volltext
- Quelle
- Taylor & Francis Journals Auto-Holdings Collection
- Beschreibungen/Notizen
- While the efficacy and safety of combined tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO trials. In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received tiotropium/olodaterol, tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV ) area under the curve from 0 to 3 hours (AUC ) response and trough FEV response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 μg, tiotropium 5 μg, and olodaterol 5 μg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days after study medication. In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV AUC and trough FEV responses were greater ( <0.0001) with tiotropium/olodaterol 5/5 μg in both populations versus tiotropium or olodaterol. The East Asian population showed slightly greater trough FEV treatment differences between tiotropium/olodaterol 5/5 μg and tiotropium compared to the overall population. Generally, no increase in adverse events was seen with tiotropium/olodaterol 5/5 μg compared to tiotropium and olodaterol in either population. The efficacy and safety profile of tiotropium/olodaterol 5/5 μg has been demonstrated for both East Asian and global populations.
- Sprache
- Englisch
- Identifikatoren
- ISSN: 1178-2005, 1176-9106eISSN: 1178-2005DOI: 10.2147/COPD.S137719Titel-ID: cdi_doaj_primary_oai_doaj_org_article_2139c0cb15524f88a00cf097432dcd54
- Format
- –
- Schlagworte
- Adrenergic beta-2 Receptor Agonists - adverse effects, Adrenergic beta-2 Receptor Agonists - therapeutic use, adverse effects, Aged, Area Under Curve, Asian people, Asians, Benzoxazines - adverse effects, Benzoxazines - therapeutic use, Bronchodilator Agents - adverse effects, Bronchodilator Agents - therapeutic use, Chemotherapy, China - epidemiology, Cholinergic Antagonists - adverse effects, Cholinergic Antagonists - therapeutic use, Chronic obstructive lung disease, Chronic obstructive pulmonary disease, Clinical trials, Complications and side effects, COPD, Dosage and administration, Double-Blind Method, Drug Combinations, Drug dosages, Drug therapy, Dyspnea, Female, Forced Expiratory Volume, Health Status, Humans, Inhalers, Lung - drug effects, Lung - physiopathology, Lung diseases, Obstructive, Male, Middle Aged, Olodaterol, Original Research, Patients, Pulmonary Disease, Chronic Obstructive - diagnosis, Pulmonary Disease, Chronic Obstructive - drug therapy, Pulmonary Disease, Chronic Obstructive - ethnology, Pulmonary Disease, Chronic Obstructive - physiopathology, pulmonary function, Quality of Life, Recovery of Function, Time Factors, Tiotropium, Tiotropium Bromide - adverse effects, Tiotropium Bromide - therapeutic use, Treatment Outcome, Vital Capacity