Abstract
Introduction
Once-daily (OD) QVA149 is a dual bronchodilator combining the long-acting β2-agonist indacaterol (IND) and long-acting muscarinic antagonist glycopyrronium (GLY) for the treatment of COPD. Here we evaluated the safety profile of QVA149 compared with its monocomponents (IND and GLY), open-label tiotropium and salmeterol/fluticasone.
Methods
This evaluation of 6-month safety data for QVA149 consisted of data from three pivotal Phase III studies (SHINE, ILLUMINATE and ENLIGHTEN) and a safety study in Japanese patients (ARISE). Safety was assessed by recording adverse events (AEs) and serious AEs (SAEs), electrocardiograms, hematology, clinical chemistry, urinalysis, physical condition, and vital signs (pulse and blood pressure).
Results
The table shows the summary of safety results. The overall safety profile was similar across all groups.
Conclusion
Once-daily QVA149 had a good safety profile with no safety signals compared with its monocomponents IND and GLY, tiotropium, and salmeterol/fluticasone.
- © 2013 ERS