RT Journal Article
SR Electronic
T1 Roflumilast added to triple therapy in severe COPD patients with frequent exacerbations: Efficacy and tolerability
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P560
VO 44
IS Suppl 58
A1 Mariana Muñoz-Esquerre
A1 Marta Diez-Ferrer
A1 Concepción Montón
A1 Xavier Pomares
A1 Marta López-Sánchez
A1 Daniel Huertas
A1 Frederic Manresa
A1 Jordi Dorca
A1 Salud Santos
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P560.abstract
AB 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.