Symptom control in patients with asthma using inhaled corticosteroids/long-acting β2-agonists (fluticasone furoate/vilanterol or budesonide/formoterol) in the US: a retrospective matched cohort study

Treatment with fluticasone furoate/vilanterol (FF/VI), an inhaled corticosteroid/long-acting β2-agonist therapy, reduces the risk of severe asthma exacerbations and improves lung function and symptom control in patients with asthma. However, real-world data remain limited among asthma patients in the United States (US). This retrospective cohort study propensity score (PS) matched adult asthma patients initiating once-daily FF/VI 100/25 mcg with patients initiating twice-daily budesonide/formoterol (B/F) 160/4.5 mcg using a US claims database (January 1, 2015–December 31, 2018). Asthma control was measured by the mean number of short-acting β2-agonist (SABA) canisters dispensed per patient-year (PPY) during follow-up. Time to first, and rates of, overall and severe asthma exacerbations were also measured. After PS matching, 18,531 patients receiving FF/VI were matched to 18,531 patients receiving B/F. Mean SABA canisters dispensed PPY was significantly lower for FF/VI users compared with B/F users (FF/VI: 1.47, B/F: 1.64; p < 0.001). FF/VI use resulted in 13% significantly lower risk of having an overall asthma-related exacerbation and 22% lower risk of a severe exacerbation versus B/F use (overall exacerbation hazard ratio [HR] [95% confidence interval (CI)]: 0.87 [0.82–0.92], p < 0.001; severe exacerbation HR [95% CI]: 0.78 [0.63–0.97], p = 0.027). Asthma-related exacerbation rates per 100 patient-days were also significantly lower for the FF/VI group compared with the B/F group (overall: 0.0475 vs. 0.0558, p < 0.001; severe: 0.0026 vs. 0.0033, p = 0.020). In real-world practice, initiation of once-daily FF/VI 100/25 mcg in adults with asthma was associated with lower use of SABA and fewer asthma-related exacerbations, which may indicate better asthma control, when compared with use of twice-daily B/F 160/4.5 mcg.糠酸氟替卡松/维兰特罗（fluticasone furoate/vilanterol, FF/VI）属于吸入性糖皮质激素/长效β₂受体激动剂类治疗方案，可降低哮喘患者严重哮喘急性加重风险，改善肺功能与症状控制水平。然而，美国哮喘患者群体的真实世界相关研究数据仍相对有限。 本研究依托美国医保索赔数据库（2015年1月1日—2018年12月31日）开展倾向得分匹配（propensity score, PS）的回顾性队列研究，将初始接受每日一次100/25 μg FF/VI治疗的成年哮喘患者，与初始接受每日两次160/4.5 μg布地奈德/福莫特罗（budesonide/formoterol, B/F）治疗的患者进行匹配对照。 哮喘控制水平以随访期间每位患者-年（patient-year, PPY）配发的短效β₂受体激动剂（short-acting β₂-agonist, SABA）处方罐数的均值进行评估。同时统计首次哮喘急性加重的发生时间、总体及严重哮喘急性加重的发生率。 经倾向得分匹配后，共纳入18531例接受FF/VI治疗的患者，与18531例接受B/F治疗的患者完成匹配。结果显示，FF/VI使用者的患者-年平均配发SABA罐数显著低于B/F使用者（FF/VI组：1.47罐，B/F组：1.64罐；p<0.001）。 与B/F治疗相比，FF/VI治疗可使总体哮喘相关急性加重风险显著降低13%，严重急性加重风险降低22%（总体急性加重风险比（hazard ratio, HR）[95%置信区间（confidence interval, CI）]：0.87[0.82–0.92]，p<0.001；严重急性加重HR[95%CI]：0.78[0.63–0.97]，p=0.027）。FF/VI组每100患者日的哮喘相关急性加重率同样显著低于B/F组（总体：0.0475 vs 0.0558，p<0.001；严重：0.0026 vs 0.0033，p=0.020）。 在真实世界临床实践中，成年哮喘患者初始接受每日一次100/25 μg FF/VI治疗，相较于每日两次160/4.5 μg B/F治疗，其SABA使用量更低、哮喘相关急性加重次数更少，提示哮喘控制水平更优。