Indacaterol/glycopyrronium (IND/GLY) improves lung function irrespective of gender baseline differences in patients with COPD: A pooled analysis from the IGNITE Program

Introduction In the past years, there is evidence of increasing prevalence and mortality rates in women diagnosed with COPD. Data on response to long-acting bronchodilators for COPD management are needed in order to identify optimal treatment according to gender variances. Here we report improvement in lung function with IND/GLY in men and women from randomised trials of IGNITE program. Methods Data were pooled from 6 trials of ≥6 months duration (SHINE [n=2144], SPARK [n=2224], ILLUMINATE [n=523], ENLIGHTEN [n=339], ARISE [n=160], and LANTERN [n=744]). Efficacy of IND/GLY was assessed in terms of improvement in FEV 1 and FVC vs. placebo (PBO), tiotropium (TIO), and salmeterol/fluticasone (SFC) in men and women with moderate to very severe COPD (FEV 1 Results Data of 6108 patients were pooled and analysed (men [n=4719] and women [n=1389]). There were significant differences in COPD baseline characteristics, with women being younger and more likely to have prior exacerbation. At Week 26, change from baseline in trough FEV 1 and FVC with IND/GLY was significantly better vs. all comparators in both men and women (Table). Conclusion Irrespective of gender differences in baseline characteristics, improvement in lung function with IND/GLY versus PBO, TIO and SFC was significantly better and comparable in both men and women with COPD.