Efficacy and safety of QVA149 compared with salmeterol/fluticasone combination (SFC) in Chinese patients with moderate-to-severe COPD: A subgroup analysis from the LANTERN study

Introduction: The LANTERN study demonstrated better efficacy of QVA149 (LABA/LAMA) vs SFC (LABA/ICS) in moderate-to-severe COPD patients (pts) with a history of ≤1 exacerbation in the previous year (Zhong et al, Eur Respir J. 2014;44,58S;P2815. Here, we present the efficacy and safety of QVA149 vs SFC in the subgroup of Chinese pts from the LANTERN study. Methods: The 26-wk, double-blind study randomised pts (1:1) to QVA149 (110/50μg) od or SFC (50/500μg) bid. The primary endpoint was non-inferiority of QVA149 to SFC in terms of post-dose trough FEV 1 . Other endpoints included FVC, FEV 1 AUC 0-4h , TDI, SGRQ, COPD exacerbations and safety. Results: A total of 598 (80.4%) pts were from mainland China who were randomised to either QVA149 (n=298) or SFC (n=300). The primary endpoint was met and QVA149 showed superiority vs SFC with a statistically significant and clinically meaningful increase in trough FEV 1 , FEV 1 AUC 0-4h and FVC. Similar improvement in TDI and SGRQ scores was observed in both groups (Table). QVA149 significantly reduced the annualised rate of moderate or severe, and severe exacerbations vs SFC (rate ratio: 0.57 and 0.32, respectively).Adverse events were low in QVA149 (34.6%) vs SFC (43.1%) with a lower incidence of pneumonia (1 vs 6). Conclusion: These findings support the use of the QVA149 over SFC in Chinese patients with none or one COPD exacerbation in the previous year.