Global Respiratory Franchise, GlaxoSmithKline plc., Brentford, Middlesex, UK.
Value Evidence & Outcomes, GlaxoSmithKline plc., Brentford, Middlesex, UK.
Respir Res. 2019 Aug 2;20(1):173. doi: 10.1186/s12931-019-1127-6.
Despite the availability of treatment guidelines and inhaled medications for asthma and chronic obstructive pulmonary disease (COPD), much remains to be done to lessen the burden of these respiratory diseases for patients. The challenge of selecting effective and efficacious drugs for patients is a key focus area for healthcare professionals. Here we discuss the concept of "drivers of effectiveness"- features of a medicine which may increase or decrease its effectiveness in the presence of real-world factors - and highlight the importance of considering these drivers in the early stages of drug development, and exploring their impact in carefully designed pragmatic trials. Using the Salford Lung Studies (SLS) in asthma and COPD as an illustrative example, we discuss various features of the inhaled corticosteroid/long-acting β-agonist combination, fluticasone furoate/vilanterol (FF/VI), as potential drivers of effectiveness that may have contributed to the improved patient outcomes observed with initiation of FF/VI versus continuation of usual care in the UK primary care setting.
尽管有哮喘和慢性阻塞性肺疾病 (COPD) 的治疗指南和吸入药物，但为了减轻这些呼吸道疾病对患者的负担，仍有许多工作要做。为患者选择有效和高效药物的挑战是医疗保健专业人员的一个重点关注领域。在这里，我们讨论了“有效性驱动因素”的概念——药物的某些特征可能会增加或降低其在现实因素存在下的有效性——并强调了在药物开发的早期阶段考虑这些驱动因素的重要性，并探索它们在精心设计的实用试验中的影响。我们使用哮喘和 COPD 的索尔福德肺部研究 (SLS) 作为说明性示例，讨论了吸入皮质类固醇/长效β激动剂联合制剂糠酸氟替卡松/维兰特罗 (FF/VI) 的各种特性，这些特性可能是有效性的驱动因素，这有助于改善 UK 初级保健环境中开始使用 FF/VI 与继续常规护理相比观察到的患者结局。
