Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome "Tor Vergata", Rome, Italy.
Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Parma, Italy.
Expert Opin Pharmacother. 2021 Apr;22(5):611-620. doi: 10.1080/14656566.2020.1845314. Epub 2020 Nov 11.
: The current recommendations of chronic obstructive pulmonary disease (COPD) suggest to escalate from inhaled corticosteroid/long-acting β-adrenoceptor agonist (ICS/LABA) treatment to triple therapy in patients experiencing persistent breathlessness, exercise limitation, or exacerbation. The addition of an ICS to LABA/long-acting muscarinic antagonist (LAMA) combination is recommended for frequently exacerbating patients with high levels of blood eosinophils. Nowadays, three triple therapies have been approved as fixed-dose combinations (FDCs) for the treatment of COPD: beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FOR/GLY), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR).: This narrative review evaluates the efficacy and safety profile of triple FDC therapy for the treatment of COPD, by evaluating the data originating from pivotal randomized-controlled trials (RCTs).: The currently approved triple FDCs exert a protective effect against the risk of COPD exacerbation compared to ICS/LABA and LABA/LAMA, with some concerns regarding the risk of pneumonia for some specific FDCs. Since the assessed RCTs were characterized by important confounders, the obtained results should be interpreted with caution. Indeed, FDCs provide advantages in terms of improved adherence to treatment and lower errors in COPD management; however, direct head-to-head comparisons are needed to establish real differences between the currently approved triple FDCs.
目前，慢性阻塞性肺疾病（COPD）的治疗建议是，对于持续性呼吸困难、运动受限或病情恶化的患者，将吸入性皮质类固醇/长效β-受体激动剂（ICS/LABA）治疗升级为三联疗法。对于血嗜酸性粒细胞水平较高、频繁恶化的患者，建议在 LABA/长效毒蕈碱拮抗剂（LAMA）联合治疗的基础上再添加 ICS。目前，三种三联疗法已被批准为 COPD 的固定剂量组合（FDC）：丙酸倍氯米松/福莫特罗富马酸盐/格隆溴铵（BDP/FOR/GLY）、糠酸氟替卡松/乌美溴铵/维兰特罗（FF/UMEC/VI）和布地奈德/格隆溴铵/福莫特罗富马酸盐（BUD/GLY/FOR）。本文综述性评价了关键随机对照试验（RCT）的数据，评估了三联 FDC 疗法治疗 COPD 的疗效和安全性。目前批准的三联 FDC 与 ICS/LABA 和 LABA/LAMA 相比，能降低 COPD 恶化风险，但某些特定 FDC 存在肺炎风险。由于评估的 RCT 存在重要混杂因素，因此应谨慎解读研究结果。实际上，FDC 在改善治疗依从性和降低 COPD 管理错误方面具有优势；然而，需要直接进行头对头比较，才能确定目前批准的三种三联 FDC 之间的实际差异。
