Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease.
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ABSTRACT: Background and purpose: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. Materials and methods: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 (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response and trough FEV1 response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 ?g, tiotropium 5 ?g, and olodaterol 5 ?g. Treatment-emergent adverse events were recorded throughout treatment and ?21 days after study medication. Results:In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV1 AUC0-3 and trough FEV1 responses were greater (P<0.0001) with tiotropium/olodaterol 5/5 ?g in both populations versus tiotropium or olodaterol. The East Asian population showed slightly greater trough FEV1 treatment differences between tiotropium/olodaterol 5/5 ?g and tiotropium compared to the overall population. Generally, no increase in adverse events was seen with tiotropium/olodaterol 5/5 ?g compared to tiotropium and olodaterol in either population. Conclusion:The efficacy and safety profile of tiotropium/olodaterol 5/5 ?g has been demonstrated for both East Asian and global populations.
SUBMITTER: Bai C
PROVIDER: S-EPMC5701005 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
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