Identification of factors associated with exacerbation risk in severe COPD: multivariate analysis of the WISDOM study

Introduction: Treatment management and patient outcomes could be improved by identifying patients with severe COPD who are at increased risk of exacerbations. Aim: To identify factors associated with exacerbation risk using a multivariate analysis of data from the WISDOM study. Methods: In WISDOM (NCT00975195; 12-month, randomised, parallel-group study), patients with severe to very severe COPD and a history of exacerbations received 18 µg tiotropium, 100 µg salmeterol and 1000 µg fluticasone propionate daily for 6 weeks, then continued or reduced inhaled corticosteroids (ICS) for 12 weeks. This post hoc multivariate analysis of time to first moderate or severe exacerbation used a stepwise selection process for candidate variables. Results: For the overall study period, the analysis was based on 2291 patients. Factors associated with a significantly increased risk of exacerbation were taking ICS at screening and ≥2 previous courses of antibiotics or steroids (Figure). Higher baseline FEV 1 , GOLD C vs GOLD D and taking xanthines at screening were associated with a significantly decreased risk of exacerbation. A backwards elimination variable selection process confirmed these results. Conclusions: Several factors were significantly associated with exacerbation risk in WISDOM. An increased risk was found in patients with prior ICS treatment and an exacerbation history. Funding: Boehringer Ingelheim.