Jacques Loretta, Bakerly Nawar Diar, New John P, Svedsater Henrik, Lay-Flurrie James, Leather David A
a Respiratory Research & Development, GSK , Uxbridge , Middlesex , UK.
b Salford Royal NHS Foundation Trust , Salford , UK.
J Asthma. 2019 Jul;56(7):748-757. doi: 10.1080/02770903.2018.1490751. Epub 2018 Oct 16.
The Asthma Salford Lung Study demonstrated the effectiveness of initiating once-daily fluticasone furoate/vilanterol (FF/VI) versus continuing usual care in asthma patients in UK primary care [ 1 ]. Here, we report a secondary analysis in a subset of patients with fluticasone propionate/salmeterol (FP/Salm) as their baseline intended maintenance therapy, to evaluate the relative effectiveness of initiating FF/VI versus continuing FP/Salm.
Adults with symptomatic asthma were randomised to initiate FF/VI 100[200]/25 µg or continue FP/Salm. The Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), Work Productivity and Activity Impairment Asthma questionnaire, severe exacerbations, salbutamol inhaler prescriptions and serious adverse events (SAEs) were recorded throughout the 12-month treatment period.
One thousand two hundred and sixty-four patients (FF/VI 646; FP/Salm 618) were included in this subset analysis; 978 had baseline ACT score <20 and were included in the primary effectiveness analysis (PEA) population. At week 24, odds of patients being ACT responders (total score ≥20 and/or improvement from baseline ≥3) were significantly higher with FF/VI versus FP/Salm (71% vs. 56%; odds ratio 2.03 [95% CI: 1.53, 2.68]; p < 0.001 [PEA]). Significant benefit with FF/VI versus FP/Salm was also observed for AQLQ responders, activity impairment due to asthma, exacerbation rates, and salbutamol inhalers prescribed. No significant between-group differences were observed for impairment while working or work absenteeism due to asthma.
For patients in primary care, initiating FF/VI was significantly better than continuing with FP/Salm for improving asthma control and quality of life, and reducing asthma exacerbations, with no notable difference in SAEs. ClinicalTrials.gov: NCT01706198.
索尔福德哮喘肺部研究证明,在英国初级医疗中,哮喘患者起始每日一次的糠酸氟替卡松/维兰特罗(FF/VI)治疗相较于继续常规治疗具有有效性[1]。在此,我们报告一项针对以丙酸氟替卡松/沙美特罗(FP/Salm)作为基线预期维持治疗的患者亚组的二次分析,以评估起始FF/VI相较于继续使用FP/Salm的相对有效性。
有症状的成年哮喘患者被随机分组,分别起始100[200]/25μg的FF/VI治疗或继续使用FP/Salm治疗。在整个12个月的治疗期间,记录哮喘控制测试(ACT)、哮喘生活质量问卷(AQLQ)、工作生产力和活动受限哮喘问卷、严重加重情况、沙丁胺醇吸入剂处方以及严重不良事件(SAE)。
该亚组分析纳入了1264例患者(FF/VI组646例;FP/Salm组618例);978例患者基线ACT评分<20,被纳入主要有效性分析(PEA)人群。在第24周时,FF/VI组患者成为ACT应答者(总分≥20分和/或较基线改善≥3分)的几率显著高于FP/Salm组(71%对56%;优势比2.03[95%CI:1.53,2.68];p<0.001[PEA])。在AQLQ应答者、因哮喘导致的活动受限、加重率以及沙丁胺醇吸入剂处方方面,也观察到FF/VI组相较于FP/Salm组有显著益处。在因哮喘导致的工作受损或旷工方面,未观察到组间有显著差异。
对于初级医疗中的患者,起始FF/VI在改善哮喘控制和生活质量、减少哮喘加重方面显著优于继续使用FP/Salm,严重不良事件方面无显著差异。ClinicalTrials.gov:NCT01706198。