Mariana Muñoz-Esquerre1, Marta Diez-Ferrer1, Concepción Montón2, Xavier Pomares3, Marta López-Sánchez1, Daniel Huertas1, Frederic Manresa1, Jordi Dorca4, Salud Santos5. 1. Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain. 2. Department of Pulmonary Medicine, Hospital de Sabadell, Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain. 3. 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. 4. 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. 5. 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.
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.
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 COPDpatients already receiving triple therapy (long-acting β-agonist/inhaled corticosteroids and long-acting muscarinic antagonist). METHODS: Prospective registry that included COPDpatients 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 COPDpatients with frequent exacerbations. However, side effects are more common and lead more frequently to discontinuation of therapy than has been reported in trials.
Authors: Henrik Watz; Nitin Bagul; Klaus F Rabe; Stephen Rennard; Vijay Kt Alagappan; Jonas Román; Axel Facius; Peter Ma Calverley Journal: Int J Chron Obstruct Pulmon Dis Date: 2018-03-06
Authors: Salud Santos; Alicia Marin; Joan Serra-Batlles; David de la Rosa; Ingrid Solanes; Xavier Pomares; Marta López-Sánchez; Mariana Muñoz-Esquerre; Marc Miravitlles Journal: Int J Chron Obstruct Pulmon Dis Date: 2016-03-11