LAUSR

Introduction: The FLAME study demonstrated that indacaterol/glycopyrronium (IND/GLY) is superior to salmeterol/fluticasone (SFC) in reducing the rate and risk of exacerbations 1 . Here, we determined the NNT for IND/GLY to prevent 1 COPD exacerbation, to prevent 1 case of repeat exacerbation, and to prevent a patient from having an exacerbation during 1 year vs SFC. Methods: FLAME was a 52-week multicentre, randomised (1:1), double-blind, double-dummy, parallel-group study which compared IND/GLY 110/50 µg o.d. and SFC 50/500 µg b.i.d. Annualised and Kaplan-Meier (KM) event rates of exacerbation during the 52-week treatment period from the FLAME study were used to estimate the NNT for IND/GLY vs SFC. Results: Based on the annualised exacerbation event rates, the NNT for IND/GLY vs SFC was 4.76 to prevent 1 moderate or severe exacerbation. The NNT with IND/GLY vs SFC was 50 to prevent 1 severe exacerbation requiring hospitalisation. To prevent 1 incidence of repeat exacerbations (≥ 3 exacerbations of any severity: mild, moderate or severe) for 1 year, NNT with IND/GLY was estimated to be 31.58 vs SFC. Furthermore, the NNT with IND/GLY vs SFC was 15 to maintain a patient free from moderate or severe exacerbation for 1 year, as calculated from KM event rates. Conclusion: NNT calculations confirm the clear efficacy advantage of IND/GLY compared with SFC in preventing COPD exacerbations in patients with moderate-to-very severe airflow limitation. Reference: 1. Wedzicha JA et al. N Engl J Med 2016; 374:2222-2234.