糠酸氟替卡松/乌美溴铵/维兰特罗起始治疗对既往接受吸入性糖皮质激素/长效β受体激动剂治疗的日本哮喘患者的真实世界有效性:一项回顾性队列研究

Real-World Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol Initiation in Japanese Patients with Asthma Previously on Inhaled Corticosteroid/Long-Acting β-Agonist Therapy: A Retrospective Cohort Study.

作者信息

Oga Toru, Gon Yasuhiro, Takano Masashi, Ito Risako, Mita Chifuku, Mukai Isao, Noorduyn Stephen G, Requena Gema, Yarita Masao

机构信息

Department of Respiratory Medicine, Kawasaki Medical School, Kurashiki 701-0192, Japan.

Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Toyko 173-8610, Japan.

出版信息

J Clin Med. 2025 Apr 9;14(8):2566. doi: 10.3390/jcm14082566.

Abstract

: Japanese guidelines recommend the addition of a long-acting muscarinic antagonist for patients with asthma uncontrolled on inhaled corticosteroid/long-acting β-agonist (ICS/LABA) therapy, the effectiveness of which is evaluated here. : Retrospective, observational, single-arm cohort study in patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following ICS/LABA, using independently analyzed data from Japanese claims databases: JMDC and Medical Data Vision (MDV). The index date was that of the first FF/UMEC/VI prescription. Outcomes were assessed during a 12-month follow-up versus a 12-month pre-index period (baseline) and included asthma exacerbations, oral corticosteroid (OCS) use, and short-acting β-agonist (SABA) use. P-values associated with rate ratios (RRs) were estimated using Conditional Poisson regression. : Overall, 3229 patients in the JMDC database and 1135 in the MDV database were included. Following FF/UMEC/VI initiation, the total annualized moderate-severe asthma exacerbation rate in the JMDC database reduced from 0.50 to 0.40 per-person-per-year (PPPY) (RR [95% confidence interval]: 0.78 [0.73, 0.84]; < 0.001), with similar reductions in the MDV database: 0.53 to 0.42 PPPY (0.79 [0.70, 0.89]; < 0.001). In both databases, there was a 20% reduction (JMDC: 0.80 [0.73, 0.88]; < 0.001; MDV: 0.80 [0.68, 0.94]; = 0.005) in patients with ≥1 OCS prescription after FF/UMEC/VI initiation. The proportion of patients with ≥1 SABA canister prescription dropped by 31% 0.69 [0.57, 0.84]; < 0.001) in the JMDC database and 23% (0.77 [0.66, 0.90]; < 0.001) in the MDV database. : This suggests FF/UMEC/VI is effective in improving asthma exacerbations and reducing OCS and SABA use in Japanese patients previously using ICS/LABA in real-world clinical practice.

摘要

日本指南建议,对于接受吸入性糖皮质激素/长效β受体激动剂(ICS/LABA)治疗但哮喘仍未得到控制的患者,加用长效毒蕈碱拮抗剂,本文对其有效性进行了评估。

对在ICS/LABA治疗后开始使用糠酸氟替卡松/乌美溴铵/维兰特罗(FF/UMEC/VI)的哮喘患者进行回顾性、观察性单臂队列研究,使用来自日本索赔数据库JMDC和Medical Data Vision(MDV)的独立分析数据。索引日期为首次开具FF/UMEC/VI处方的日期。在12个月的随访期间与索引前12个月(基线)期间对结局进行评估,包括哮喘加重、口服糖皮质激素(OCS)使用情况和短效β受体激动剂(SABA)使用情况。使用条件泊松回归估计与率比(RRs)相关的P值。

总体而言,JMDC数据库纳入了3229例患者,MDV数据库纳入了1135例患者。开始使用FF/UMEC/VI后,JMDC数据库中每年中度至重度哮喘加重的总发生率从每人每年0.50降至0.40(RR[95%置信区间]:0.78[0.73,0.84];P<0.001),MDV数据库中也有类似的下降:从每人每年0.53降至0.42(0.79[0.70,0.89];P<0.001)。在两个数据库中,开始使用FF/UMEC/VI后,有≥1次OCS处方的患者减少了20%(JMDC:0.80[0.73,0.88];P<0.001;MDV:0.80[0.68,0.94];P=0.005)。在JMDC数据库中,有≥1个SABA吸入器处方的患者比例下降了31%(0.69[0.57,0.84];P<0.001),在MDV数据库中下降了23%(0.77[0.66,0.90];P<0.001)。

这表明在现实临床实践中,FF/UMEC/VI对于改善日本此前使用ICS/LABA的患者的哮喘加重情况以及减少OCS和SABA的使用是有效的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e54/12028120/eaf96707fa79/jcm-14-02566-g001.jpg

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