Muñoz-Esquerre Mariana, Diez-Ferrer Marta, Montón Concepción, Pomares Xavier, López-Sánchez Marta, Huertas Daniel, Manresa Frederic, Dorca Jordi, Santos Salud
Department of Pulmonary Medicine, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
Department of Pulmonary Medicine, Hospital de Sabadell, Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain.
Pulm Pharmacol Ther. 2015 Feb;30:16-21. doi: 10.1016/j.pupt.2014.10.002. Epub 2014 Oct 30.
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.
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).
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.
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.
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.
罗氟司特用于治疗频繁急性加重的重度慢性阻塞性肺疾病（COPD）患者。然而，关于其在可能接受三联疗法的“真实生活”人群中的影响，可用信息有限。
本研究旨在评估罗氟司特在已接受三联疗法（长效β受体激动剂/吸入性糖皮质激素和长效毒蕈碱拮抗剂）的COPD患者中的有效性和安全性。
前瞻性登记研究纳入了在三联疗法基础上加用罗氟司特的COPD患者。记录罗氟司特治疗前后所有COPD急性加重的年发生率以及与药物相关的副作用。
在55例处方剂量为500mg罗氟司特的患者中，只有50.9%（n = 28）完成了1年的治疗（罗氟司特组）。观察到罗氟司特可减少所有急性加重事件（2.75±0.29 vs. 3.57±0.26；P = 0.022），对于治疗开始前急性加重≥4次的患者有特别益处（3.55±0.51 vs. 5.00±0.30；P = 0.034）。副作用（主要为胃肠道副作用）和治疗中断分别发生在总体人群的69.1%和49.1%中。
在三联疗法基础上加用罗氟司特，可减少频繁急性加重的重度COPD“真实生活”人群的急性加重事件。然而，副作用比试验报道的更常见，且更常导致治疗中断。
