慢性阻塞性肺疾病治疗路径信息研究（IMPACT试验）：单吸入器三联疗法（糠酸氟替卡松/乌美溴铵/维兰特罗）与糠酸氟替卡松/维兰特罗及乌美溴铵/维兰特罗用于慢性阻塞性肺疾病患者的疗效比较：西欧和北美地区分析
InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions.
作者信息
Bourdin Arnaud, Criner Gerard, Devouassoux Gilles, Dransfield Mark, Halpin David M G, Han MeiLan K, Jones C Elaine, Kalhan Ravi, Lange Peter, Lettis Sally, Lipson David A, Lomas David A, Echave-Sustaeta María-Tomé José M, Martin Neil, Martinez Fernando J, Quasny Holly, Sail Lynda, Siler Thomas M, Singh Dave, Thomashow Byron, Watz Henrik, Wise Robert, Hanania Nicola A
机构信息
Department of Pneumology and Addictology, University of Montpellier, CHU Montpellier, Montpellier, France.
Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States.
出版信息
Chronic Obstr Pulm Dis. 2021 Jan;8(1):76-90. doi: 10.15326/jcopdf.2020.0158.
BACKGROUND
The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.
METHODS
IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed.
RESULTS
Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], <.001 and 0.76 [0.67-0.87], <.001) and in North America (0.87 [0.77-0.97], =.014 and 0.69 [0.60-0.80], <.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe.
CONCLUSION
Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.
CLINICAL TRIAL REGISTRATION
NCT02164513.
背景
慢性阻塞性肺疾病（COPD）治疗信息通路（IMPACT）试验表明，对于有加重病史的COPD患者，糠酸氟替卡松/乌美溴铵/维兰特罗（FF/UMEC/VI）相比FF/VI或UMEC/VI可降低中重度加重率。由于IMPACT是一项全球性研究，因此按地理区域进行了事后分析，以调查总体研究结果中的潜在差异。
方法
IMPACT是一项为期52周的随机双盲试验。有症状的COPD患者且前一年有≥1次中重度加重，按2:2:1随机分组，分别接受每日一次的FF/UMEC/VI 100/62.5/25μg、FF/VI 100/25μg或UMEC/VI 62.5/25μg治疗。在总体、西欧和北美人群中评估的终点包括治疗期间的中重度加重（发生率和首次加重时间）、1秒用力呼气容积谷值和圣乔治呼吸问卷（SGRQ）总分。评估了安全性。
结果
总体上，共纳入10355例患者，其中3164例来自西欧，2639例来自北美。在西欧，FF/UMEC/VI相比FF/VI和UMEC/VI显著降低了治疗期间的中重度加重率（率比分别为0.82[95%CI 0.74 - 0.91]，P<0.001和0.76[0.67 - 0.87]，P<0.001）；在北美，FF/UMEC/VI相比FF/VI和UMEC/VI也显著降低了治疗期间的中重度加重率（率比分别为0.87[0.77 - 0.97]，P = 0.014和0.69[0.60 - 0.80]，P<0.001）。在两个地区，FF/UMEC/VI相比FF/VI和UMEC/VI均降低了首次中重度加重时间并改善了肺功能，在西欧改善了SGRQ总分，但在北美未改善。各治疗组/地区之间的安全性概况总体相似；在北美观察到吸入性糖皮质激素类药物增加肺炎发生率的效应，但在西欧未观察到。
结论
与意向性治疗结果一致，FF/UMEC/VI降低了西欧和北美的中重度加重率及风险，并改善了肺功能；然而，在SGRQ总分和肺炎发生率方面存在地区间差异。
临床试验注册
NCT02164513
Zotero 插件