Abstract
Introduction: Roflumilast (ROF) reduces moderate and severe exacerbations in severe COPD patients at risk of exacerbation, despite ICS/LABA +/- LAMA therapy. Its effects on severe exacerbations in these patients with a history of hospitalization for COPD exacerbation have not been described.
Methods: The REACT study included patients with severe COPD, chronic bronchitis, and at least two exacerbations in the previous year. ROF 500µg once daily or placebo (PBO) was added to ICS/LABA +/- LAMA for 52 weeks. In this post-hoc analysis, we used negative binomial regression to estimate severe exacerbation rates (i.e. those leading to hospitalization and/or death) in patients with or without a history of hospitalization for COPD exacerbation.
Results: In the overall population (n=1935), 641 patients had a history of hospitalization for COPD exacerbation (ROF: n=322; PBO: n=319); 647 patients in each arm had no history of hospitalization. Patients with a history of hospitalization had a higher proportion of current smokers than patients with no prior hospitalization; other features were similar between groups. In patients with a history of hospitalization, ROF reduced the rate of severe exacerbations by 34.9% (ROF 0.39 vs PBO 0.60; rate ratio 0.65; 95% CI 0.48–0.89; p<0.01). In patients with no history of hospitalization, the rate reduction was 7.6% (0.17 vs 0.18; 0.92; 0.67–1.28; p=0.63).
Conclusions: ROF reduces the rate of exacerbations leading to re-hospitalization and/or death in patients inadequately controlled with ICS/LABA +/- LAMA with a history of hospitalization for exacerbation. The reduction was higher than in patients with no prior hospitalization.
- Copyright ©ERS 2015