Rodrigo Gustavo J, Neffen Hugo
Departamento de Emergencia, Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay.
Unidad de Medicina Respiratoria, Hospital de Niños "O. Santa Fe, Argentina.
Chest. 2015 Aug;148(2):397-407. doi: 10.1378/chest.15-0084.
COPD guidelines recommend the combined use of inhaled long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) if symptoms are not improved by a single agent. This systematic review tested the hypothesis that the bronchodilator effect of the LABA/LAMA combination, umeclidinium (UMEC)/vilanterol (VIL), would translate into better outcomes without incurring increased adverse events (AEs).
This was a systematic review of randomized, placebo-controlled or crossover trials (> 4 weeks) involving UMEC/VIL compared with its monocomponents, tiotropium, or fluticasone/salmeterol. Primary outcomes were trough FEV1, serious adverse events (SAEs), and serious cardiovascular events (SCVEs).
Eleven trials from 10 studies (9,609 patients) showed that UMEV/VIL provided superior improvements in lung function compared with UMEC, VIL, tiotropium, and fluticasone propionate/salmeterol (mean trough FEV1, 60, 110, 90, and 90 mL, respectively; P < .0001). Also, UMEC/VIL had a greater likelihood of demonstrating a minimal clinically important difference on the Transition Dyspnea Index compared with UMEC and VIL (number needed to treat for benefit [NNTB] = 14 and 10, respectively). UMEC/VIL therapy significantly reduced the risk of COPD exacerbations compared with UMEC and VIL (NNTB = 42 and 41, respectively). On the contrary, we noted no significant differences between UMEC/VIL and tiotropium with respect to dyspnea, health status, or risk of COPD exacerbation. Regarding safety issues, the incidence of AEs, SAEs, SCVEs, and mortality on treatment was similar across treatments, suggesting reduced safety concerns with the use of the UMEC/VIL combination.
Once-daily inhaled UMEC/VIL showed superior efficacy compared with its monocomponents, tiotropium, and fluticasone/combination in patients with moderate to severe COPD.
慢性阻塞性肺疾病（COPD）指南建议，如果单一药物不能改善症状，则联合使用吸入长效β2受体激动剂（LABA）和长效毒蕈碱拮抗剂（LAMA）。本系统评价检验了以下假设：LABA/LAMA组合药物乌美溴铵（UMEC）/维兰特罗（VIL）的支气管扩张作用能转化为更好的治疗效果，且不会增加不良事件（AE）的发生。
这是一项对随机、安慰剂对照或交叉试验（>4周）的系统评价，试验涉及UMEC/VIL与其单一组分、噻托溴铵或氟替卡松/沙美特罗的比较。主要结局指标为谷值第一秒用力呼气容积（FEV1）、严重不良事件（SAE）和严重心血管事件（SCVE）。
来自10项研究的11项试验（9609例患者）表明，与UMEC、VIL、噻托溴铵和丙酸氟替卡松/沙美特罗相比，UMEV/VIL在肺功能改善方面更优（平均谷值FEV1分别为60、110、90和90 mL；P <.0001）。此外，与UMEC和VIL相比（获益所需治疗人数[NNTB]分别为14和10），UMEC/VIL在过渡性呼吸困难指数上更有可能显示出最小临床重要差异。与UMEC和VIL相比，UMEC/VIL治疗显著降低了COPD急性加重的风险（NNTB分别为42和41）。相反，我们注意到在呼吸困难、健康状况或COPD急性加重风险方面，UMEC/VIL与噻托溴铵之间无显著差异。关于安全性问题，各治疗组治疗期间AE、SAE、SCVE和死亡率的发生率相似，这表明使用UMEC/VIL组合药物时安全性顾虑较少。
对于中度至重度COPD患者，每日一次吸入UMEC/VIL与其单一组分、噻托溴铵及氟替卡松/联合用药相比显示出更优的疗效。
