布地奈德/格隆溴铵/福莫特罗:慢性阻塞性肺疾病综述

Budesonide/Glycopyrronium/Formoterol: A Review in COPD.

作者信息

Heo Young-A

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2021 Aug;81(12):1411-1422. doi: 10.1007/s40265-021-01562-6. Epub 2021 Aug 3.

Abstract

Budesonide/glycopyrronium/formoterol (BREZTRI AEROSPHERE™; TRIXEO AEROSPHERE™) is an inhaled fixed-dose combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide and the long-acting β-agonist (LABA) formoterol fumarate approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is delivered via a pressurized metered-dose Aerosphere inhaler and is formulated using co-suspension delivery technology. In two pivotal phase III trials of 24-52 weeks' duration, budesonide/glycopyrronium/formoterol reduced the rates of moderate/severe COPD exacerbations and improved lung function to a greater extent than budesonide/formoterol and/or glycopyrronium/formoterol. Budesonide/glycopyrronium/formoterol also demonstrated beneficial effects on dyspnoea, rescue medication requirements and health-related quality of life (HR-QOL), and reduced the risk of all-cause mortality. Budesonide/glycopyrronium/formoterol was generally well tolerated, with the tolerability profile being generally similar to that of the individual components. Budesonide/glycopyrronium/formoterol provides a useful and convenient option for the maintenance treatment of COPD, including for patients whose disease is inadequately controlled with dual ICS/LABA or LAMA/LABA therapy.

摘要

布地奈德/格隆溴铵/福莫特罗(BREZTRI AEROSPHERE™;TRIXEO AEROSPHERE™)是一种吸入用固定剂量复方制剂,由吸入性糖皮质激素(ICS)布地奈德、长效毒蕈碱拮抗剂(LAMA)格隆溴铵和长效β受体激动剂(LABA)富马酸福莫特罗组成,已获批用于慢性阻塞性肺疾病(COPD)的维持治疗。它通过压力定量气雾剂吸入器给药,并采用共悬浮给药技术配制。在两项为期24 - 52周的关键III期试验中,布地奈德/格隆溴铵/福莫特罗降低中重度COPD急性加重率,且在改善肺功能方面比布地奈德/福莫特罗和/或格隆溴铵/福莫特罗更显著。布地奈德/格隆溴铵/福莫特罗对呼吸困难、急救药物需求及健康相关生活质量(HR - QOL)也显示出有益作用,并降低了全因死亡率风险。布地奈德/格隆溴铵/福莫特罗总体耐受性良好,耐受性特征与各单一成分总体相似。布地奈德/格隆溴铵/福莫特罗为COPD的维持治疗提供了一种有用且方便的选择,包括对疾病未得到ICS/LABA或LAMA/LABA双重疗法充分控制的患者。

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