Spyratos Dionisios, Sichletidis Lazaros
Pulmonary Department, "G Papanikolaou" Hospital, Aristotle University of Thessaloniki, Exohi, Thessaloniki, Greece.
Ther Clin Risk Manag. 2015 Mar 25;11:481-7. doi: 10.2147/TCRM.S67491. eCollection 2015.
Chronic obstructive pulmonary disease (COPD) is a common disease among the elderly that could be prevented by smoking cessation. As it is characterized by airflow limitation that is not fully reversible, bronchodilator therapy is the first choice of treatment. Symptomatic COPD patients with or without risk for future exacerbations have a strong indication for the permanent use of long- and ultralong-acting β2-agonists and/or long-acting muscarinic antagonists. Combining bronchodilators is an effective approach, as they demonstrate synergic action at a cellular level and have additive clinical benefits and fewer adverse events compared with increased doses of the monocomponents. Novel fixed-dose combinations of long-acting β2-agonists/long-acting muscarinic antagonists in one inhaler have been approved for clinical use by the US Food and Drug Administration and the European Medicines Agency. This review focuses on published clinical trials about the fixed-dose combination of umeclidinium/vilanterol trifenatate in patients with COPD. Results from six studies (five of them of 12 weeks' duration and one that lasted 1 year, including more than 6,000 patients in total) showed that umeclidinium/vilanterol trifenatate improved lung function, dyspnea, and health-related quality of life and decreased the exacerbation rate with no serious adverse events. More longstanding trials are needed to evaluate the effect of the drug on disease progression and compare it directly with other fixed-dose combinations.
慢性阻塞性肺疾病(COPD)是老年人中的常见疾病,戒烟可预防该病。由于其特征为气流受限且不完全可逆,支气管扩张剂治疗是首选治疗方法。有或无未来加重风险的症状性COPD患者强烈指征长期使用长效和超长效β2受体激动剂和/或长效毒蕈碱拮抗剂。联合使用支气管扩张剂是一种有效方法,因为它们在细胞水平上显示协同作用,与增加单一组分剂量相比,具有相加的临床益处且不良事件更少。长效β2受体激动剂/长效毒蕈碱拮抗剂的新型固定剂量组合吸入剂已获美国食品药品监督管理局和欧洲药品管理局批准用于临床。本综述重点关注已发表的关于COPD患者使用乌美溴铵/三苯乙酸维兰特罗固定剂量组合的临床试验。六项研究(其中五项为期12周,一项为期1年,总共纳入超过6000名患者)结果显示,乌美溴铵/三苯乙酸维兰特罗改善了肺功能、呼吸困难和健康相关生活质量,并降低了加重率,且无严重不良事件。需要更多长期试验来评估该药物对疾病进展的影响,并将其与其他固定剂量组合直接比较。