Ramadan Wijdan H, Al Masri Sarah, Rizk John
Department of Pharmacy Practice, School of Pharmacy, Lebanese American University, Byblos, Lebanon.
GlaxoSmith Kline, Beirut, Lebanon.
Clin Respir J. 2019 Nov;13(11):663-673. doi: 10.1111/crj.13073. Epub 2019 Sep 2.
Chronic obstructive pulmonary disease (COPD) is a common respiratory disease that is predicted to be one of the leading causes of death worldwide. Pharmacologic treatment options of COPD are bronchodilators, using either long-acting β2-agonists (LABAs), or long-acting muscarinic antagonists (LAMAs), or a combination of two. Anoro Ellipta (umeclidinium + vilanterol) dry powder inhaler, a fixed-dose combination of LAMA and LABA, was Food and Drug Administration (FDA) approved in 2013 for COPD. The objective of this study is to evaluate the efficacy and safety of once daily umeclidinium/vilanterol (62.5 mcg/25 mcg) in COPD patients, focusing on pharmacodynamic and pharmacokinetic characteristics, efficacy and safety in clinical studies and cost. Literature search was done through PubMed (2004-2017) using the terms umeclidinium, vilanterol, COPD, LABA and LAMA. Recent and significant clinical trials about the monocomponents and their combination were identified, in addition to reviews, guidelines for COPD, data from manufacturer and FDA product labels. The search was limited to English language studies on human subjects. Clinical data published on the combination of umeclidinium/vilanterol in patients with COPD have shown greater improvements in lung function compared to monotherapies. However, further studies comparing umeclidinium/vilanterol FDC (ANORO) to other LABA/LAMA combinations are needed.
慢性阻塞性肺疾病(COPD)是一种常见的呼吸系统疾病,预计将成为全球主要死因之一。COPD的药物治疗选择包括支气管扩张剂,可使用长效β2受体激动剂(LABAs)、长效毒蕈碱拮抗剂(LAMAs)或两者联合使用。Anoro Ellipta(乌美溴铵+维兰特罗)干粉吸入器,一种LAMA和LABA的固定剂量组合,于2013年获得美国食品药品监督管理局(FDA)批准用于治疗COPD。本研究的目的是评估每日一次使用乌美溴铵/维兰特罗(62.5微克/25微克)对COPD患者的疗效和安全性,重点关注药效学和药代动力学特征、临床研究中的疗效和安全性以及成本。通过PubMed(2004 - 2017年)使用乌美溴铵、维兰特罗、COPD、LABA和LAMA等关键词进行文献检索。除了综述、COPD指南、制造商数据和FDA产品标签外,还确定了关于单一组分及其组合的近期重要临床试验。检索仅限于关于人类受试者的英文研究。已发表的关于COPD患者使用乌美溴铵/维兰特罗组合的临床数据显示,与单一疗法相比,肺功能有更大改善。然而,需要进一步研究将乌美溴铵/维兰特罗固定剂量复方制剂(ANORO)与其他LABA/LAMA组合进行比较。