• Mariana Muñoz-Esquerre, Marta Diez-Ferrer, Concepción Montón, Xavier Pomares, Marta López-Sánchez, Daniel Huertas, Frederic Manresa, Jordi Dorca, and Salud Santos.
• Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
• Pulm Pharmacol Ther. 2015 Feb 1; 30: 16-21.

BackgroundRoflumilast is used in severe chronic obstructive pulmonary disease (COPD) patients with frequent exacerbations. However, limited information is available on its impact in a "real-life" population that may be receiving triple therapy.ObjectiveThis study aimed to evaluate the effectiveness and safety of roflumilast in COPD patients already receiving triple therapy (long-acting β-agonist/inhaled corticosteroids and long-acting muscarinic antagonist).MethodsProspective registry that included COPD patients who were prescribed roflumilast added to triple therapy. The yearly rate of all COPD exacerbations before and after roflumilast and side effects related to the drug were registered.ResultsAmong 55 patients prescribed 500 mg of roflumilast. Only 50.9% (n = 28) completed 1 year of therapy (roflumilast group). 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). Side effects (mainly gastrointestinal) and treatment discontinuation occurred in 69.1% and 49.1% of the overall population, respectively.ConclusionsRoflumilast, when added to triple therapy, reduces exacerbations in a "real-life" population of severe COPD patients with frequent exacerbations. However, side effects are more common and lead more frequently to discontinuation of therapy than has been reported in trials.Copyright © 2014 Elsevier Ltd. All rights reserved.

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