Indacaterol/glycopyrronium (IND/GLY) delays clinically important deterioration (CID) versus salmeterol/fluticasone (SFC) in symptomatic COPD patients: LANTERN/ILLUMINATE pooled analysis

Introduction COPD is marked by progressive decline in lung function and quality of life, and exacerbations. A composite endpoint like CID can be an indicator of the treatment effect on COPD worsening. This was a post hoc analysis of IND/GLY vs. SFC on CID in symptomatic moderate-to-severe COPD patients (pts) without frequent exacerbations from the LANTERN and ILLUMINATE studies. Methods Data was pooled from two 26-week studies in symptomatic COPD pts randomised to IND/GLY 110/50μg o.d. or SFC 50/500μg b.i.d. We assessed risk of CID and sustained CID using 2 definitions based on minimum clinically important differences. Definition 1 (D1): CID defined as ≥100mL decrease in FEV 1 or ≥4unit increase in SGRQ total score or a moderate-severe COPD exacerbation; sustained CID defined as ≥100mL decrease in FEV 1 or ≥4unit increase in SGRQ total score on 2 consecutive visits ≥4weeks apart or ≥50% of all subsequent visits or a moderate-severe COPD exacerbation. Definition 2 (D2): same as D1 except FEV 1 criteria replaced with ≥1unit decrease in TDI. A subgroup analysis was done by gender, COPD severity, age, smoking status and serum eosinophil count. Results In total, 1263 pts (IND/GLY n=630, SFC n=633) were included. IND/GLY significantly delayed time to first and sustained CID vs. SFC in D1 [HR(95%CI):0.67(0.57–0.80), 0.63(0.52–0.77), respectively; p Conclusion IND/GLY reduced the risk of CID versus SFC, supporting its use over SFC in symptomatic COPD patients.