Once-daily QVA149 improves lung function and health status versus twice-daily salmeterol/fluticasone (SFC) in symptomatic GOLD B and GOLD D COPD patients: LANTERN/ILLUMINATE pooled analysis

Abstract

Introduction: To further assess the efficacy of QVA149 compared with SFC in LANTERN and ILLUMINATE studies, we performed a pooled analysis of the overall data and also in the GOLD B and D patient (pt) subgroups. Methods: Data was pooled from two 26-week (wk) double-blind studies in symptomatic COPD pts randomised to QVA149 110/50μg od or SFC 50/500μg bid. Endpoints were FEV1 AUC0–12h, peak FEV1, peak FVC, pre-dose trough FEV1, pre-dose trough FVC, TDI, SGRQ, rescue medication use and safety. Results: In total, 1263 pts were divided into GOLD B (n=809) and GOLD D (n=454) subgroups (GOLD 2014). QVA149 demonstrated statistically significant improvement in lung function vs. SFC (Table) at Wk 26. Changes from baseline in TDI and rescue medication use were statistically significant with QVA149 vs. SFC in overall population and in GOLD B (TDI only) and in GOLD D (rescue medication only) subgroups (Table). QVA149 also reduced exacerbations in the pooled analysis. Adverse events were similar between QVA149 (295) and SFC (335), with a lower incidence of pneumonia with QVA149 (14 vs 3). Conclusion: In this pooled analysis, QVA149 demonstrated better efficacy than SFC in overall population and in GOLD B and GOLD D patients in all lung function parameters tested. This supports the use of QVA149 over SFC in symptomatic patients with COPD.