Abstract
Background: Limited information is available on the impact of roflumilast in a “real-life” population of severe COPD patients that may be receiving combination therapies. This study aimed to evaluate the efficacy and safety of roflumilast in COPD patients already receiving long-acting β-agonist/inhaled corticosteroids and long-acting muscarinic antagonist.
Methods: Prospective registry that included severe COPD patients with frequent exacerbations who were prescribed roflumilast on top of triple therapy. The primary endpoint was the yearly rate of all COPD exacerbations before and after roflumilast treatment. Efficacy comparisons between patients that completed 1 year of therapy and those with early withdrawal in <12weeks were performed. Side effects were also registered.
Results: Among 55 patients prescribed roflumilast, 1 year of follow-up was achieved in 51: 54.9% (n=28) completed 1 year of therapy (roflumilast group) and 21.6% (n=11) had early withdrawal. A reduction of all exacerbations with roflumilast was observed (2.75±0.29 vs. 3.57±0.26; P=0.022), with a particular benefit in patients with ≥4 exacerbations prior to initiating therapy (3.55±0.51 vs. 5.00±0.30; P=0.034). A numerical reduction in exacerbations was observed when comparing to early withdrawal group (2.75±0.29 vs. 3.55±0.46; P=0.182). Side effects (mainly gastrointestinal) and treatment discontinuation occurred in 54.5% and 43.6% of the overall population, respectively.
Conclusions: Roflumilast, when added to triple therapy, reduces exacerbations in severe COPD patients. However, side effects are more common and lead more frequently to discontinuation of therapy than has been reported in trials.
- © 2014 ERS
