title: Roflumilast added to triple therapy in patients with severe COPD: a real life study.
abstract: BACKGROUND
  Roflumilast 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.
  
  
  OBJECTIVE
  This 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).
  
  
  METHODS
  Prospective 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.
  
  
  RESULTS
  Among 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.
  
  
  CONCLUSIONS
  Roflumilast, 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.
authors.affiliation: Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
authors.forename: Mariana
authors.initials: M
authors.lastname: Muñoz-Esquerre
authors.affiliation: Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Diez-Ferrer
authors.affiliation: Department of Pulmonary Medicine, Hospital de Sabadell, Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Concepción
authors.initials: C
authors.lastname: Montón
authors.affiliation: Department of Pulmonary Medicine, Hospital de Sabadell, Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Pomares
authors.affiliation: Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: López-Sánchez
authors.affiliation: Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Huertas
authors.affiliation: Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
authors.forename: Frederic
authors.initials: F
authors.lastname: Manresa
authors.affiliation: Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain; Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Dorca
authors.affiliation: Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain; Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Barcelona, Spain. Electronic address: saludsantos@bellvitgehospital.cat.
authors.forename: Salud
authors.initials: S
authors.lastname: Santos
mesh_terms: D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000368:Aged; D000631:Aminopyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003521:Cyclopropanes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D058988:Phosphodiesterase 4 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D012042:Registries; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000318:Adrenergic beta-Agonists; D000631:Aminopyridines; D001549:Benzamides; D003521:Cyclopropanes; D005938:Glucocorticoids; D018727:Muscarinic Antagonists; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast
keywords: COPD exacerbations; Combination therapy; Phosphodiesterase-4 inhibitors; Side effects