GSK573719/vilanterol: Phase IIIa data
A 24-week, double-blind, international Phase IIIa trial in 872 COPD patients showed that once-daily 125/25 µg GSK573719/vilanterol met the co-primary endpoint of improving trough FEV1 from baseline to the end of treatment on day 169 vs. Spiriva HandiHaler tiotropium, but missed the co-primary endpoint of improving trough FEV1 from baseline to day 169 vs. 125 µg GSK573719 alone. Specifically, high-dose GSK573719/vilanterol improved trough FEV1 at day 169 by 74 mL compared to Spiriva (p=0.003) and by 37 mL compared to GSK573719 alone (p=0.142). The 62.5/25 µg dose of GSK573719/vilanterol missed both co-primary endpoints. Specifically, low-dose GSK573719/vilanterol improved trough FEV1 at day 169 by 60 mL compared to Spiriva (p=0.018) and by 22 mL compared to GSK573719 alone (p=0.377). Theravance said that it could not draw a statistical inference from the 0.018 p-value. The most common adverse events reported in all treatment arms were headache, nasopharyngitis, upper respiratory tract infection, cough, oropharyngeal pain and back pain. The incidence of cardiovascular and serious adverse events was similar across all treatment arms. ...