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在日本,接受氟替卡松乌美溴铵维兰特罗单吸入器三联疗法治疗的哮喘患者的真实世界特征。

Real-world characteristics of patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol single-inhaler triple therapy in Japan.

机构信息

Department of Respiratory Medicine, Kawasaki Medical School, 577, Matsushima, Kurashiki, Okayama, 701-0192, Japan.

Value Evidence and Outcomes, Japan Medical and Development, GSK, 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan.

出版信息

Respir Investig. 2024 Jul;62(4):685-694. doi: 10.1016/j.resinv.2024.05.011. Epub 2024 May 24.

Abstract

BACKGROUND

Real-world data assessing characteristics of patients with asthma initiating inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β-agonist (ICS/LAMA/LABA) triple therapy in Japan are limited.

METHODS

Descriptive, observational study of patients with asthma aged ≥15 years newly initiating single- or multiple-inhaler triple therapy (SITT: fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI], SITT: indacaterol/glycopyrronium bromide/mometasone furoate [IND/GLY/MF] or MITT) or ICS/LABA using JMDC/Medical Data Vision (MDV) health insurance databases from February 2021-February 2022 (first prescription date: index date). Patients were assigned to three non-mutually exclusive cohorts: A) new FF/UMEC/VI initiators; B) new FF/UMEC/VI, IND/GLY/MF, or MITT initiators; C) new FF/UMEC/VI, IND/GLY/MF, MITT or ICS/LABA initiators as initial maintenance therapy (IMT). Patient characteristics were assessed descriptively for 12-months pre-treatment initiation (baseline period).

RESULTS

Cohort A: among new FF/UMEC/VI initiators, 12.8% and 0.1% (JMDC) and 21.7% and 0.9% (MDV) of patients had ≥1 moderate and severe exacerbation; 52.0% (JMDC) and 79.2% (MDV) had ICS/LABA use. Cohort B: most patients initiated FF/UMEC/VI and IND/GLY/MF over MITT (JMDC: 91.3% vs 8.7%; MDV: 67.8% vs 32.2%), with fewer exacerbations and lower rescue medication use. Cohort C: a greater proportion of FF/UMEC/VI initiators as IMT experienced a moderate exacerbation at index versus ICS/LABA initiators as IMT (JMDC: 17.8% vs 10.7%; MDV: 8.0% vs 5.1%).

CONCLUSIONS

Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation.

摘要

背景

评估日本哮喘患者起始吸入皮质类固醇/长效毒蕈碱拮抗剂/长效β-激动剂(ICS/LAMA/LABA)三联疗法的患者特征的真实世界数据有限。

方法

描述性、观察性研究,纳入 2021 年 2 月至 2022 年 2 月(首次处方日期:索引日期)期间使用 JMDC/Medical Data Vision(MDV)健康保险数据库的新起始单一或多吸入器三联疗法(SITT:糠酸氟替卡松/乌美溴铵/维兰特罗[FF/UMEC/VI]、SITT:茚达特罗/格隆溴铵/糠酸莫米松[IND/GLY/MF]或 MITT)或 ICS/LABA 的哮喘患者。患者被分配到三个非互斥队列:A)新起始 FF/UMEC/VI 患者;B)新起始 FF/UMEC/VI、IND/GLY/MF 或 MITT 患者;C)新起始 FF/UMEC/VI、IND/GLY/MF、MITT 或 ICS/LABA 作为初始维持治疗(IMT)的患者。在治疗前起始前(基线期) 12 个月对患者特征进行描述性评估。

结果

队列 A:在新起始 FF/UMEC/VI 患者中,JMDC 中 12.8%和 0.1%的患者和 MDV 中 21.7%和 0.9%的患者有≥1 次中度和重度加重;JMDC 中 52.0%和 MDV 中 79.2%的患者使用 ICS/LABA。队列 B:大多数患者起始 FF/UMEC/VI 和 IND/GLY/MF 而非 MITT(JMDC:91.3% vs 8.7%;MDV:67.8% vs 32.2%),且有更少的加重和更低的急救药物使用。队列 C:与 ICS/LABA 起始 IMT 相比,更多的 FF/UMEC/VI 起始 IMT 患者发生中度加重(JMDC:17.8% vs 10.7%;MDV:8.0% vs 5.1%)。

结论

治疗组患者特征总体相似;与 MITT 起始患者相比,SITT 起始患者的加重和急救药物使用更少,SITT 起始患者的 IMT 比例高于 MITT 起始患者。医生可能根据加重情况将三联治疗作为 IMT 处方,而非双联治疗。

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