日本使用布地奈德/格列吡嗪/福莫特罗或其他三联疗法的慢性阻塞性肺病患者的特征：真实世界医疗索赔数据库研究》（MITOS-AURA）。

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2024-10-16 DOI:10.1007/s12325-024-02994-8

Koichiro Takahashi, Naoyuki Makita, Johann Castañeda-Sanabria, Ramzi Argoubi, Grégoire Nowacki, Seham Issa, Isao Matsumoto, Yuri Yoshida, Hana Müllerová

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引用次数: 0

摘要

简介在日本，慢性阻塞性肺病（COPD）患者可升级为吸入式三联疗法。两种结合了吸入皮质类固醇/长效毒蕈碱拮抗剂/长效β2-受体激动剂（ICS/LAMA/LABA）的单吸入三联疗法已被批准用于慢性阻塞性肺病患者的维持治疗，此外还提供多吸入三联疗法（MITTs）。有关慢性阻塞性肺病患者开始使用三联疗法的实际治疗模式和特点的证据十分有限：这项观察性、回顾性队列研究从行政索赔数据库（2018 年 5 月至 2021 年 12 月）中识别了日本的 COPD 患者。研究评估了开始使用三联疗法的四个队列的人口统计学、临床特征和医疗资源利用率（HCRU）：布地奈德/甘氨酰吡咯铵/富马酸福莫特罗二水合物（BGF）早期使用者（市场批准后[2019年9月1日]12个月内开始使用）、BGF当代使用者（市场批准后12个月内开始使用）、糠酸氟替卡松/优甲乐/维兰特罗（FF/UMEC/VI）使用者和任何MITT使用者：共有 636 名患者为 BGF 早期使用者，2558 名患者为 BGF 当代使用者，11187 名患者使用 FF/UMEC/VI，5931 名患者使用 MITT。各组群中合并哮喘的患者比例分别为：早期 BGF 使用者 73.0%；当代 BGF 使用者 74.2%；FF/UMEC/VI 使用者 75.7%；MITT 使用者 84.5%。在 12 个月的基线期间，中度/重度病情恶化次数≥ 1 次的患者比例为：BGF 早期采用者 18.2%；BGF 当代采用者 14.3%；FF/UMEC/VI 采用者 13.1%；MITT 采用者 14.0%。基线期间的 ICS/LABA 治疗是最常见的三联疗法途径，在各组别中占 38.2% 至 51.7%。各组群的 HCRU 相对较高（12 个月基线期间医院门诊就诊人次/患者，11.0-14.1）。在所有队列中，超过 80% 的患者患有多种疾病；心血管疾病是最常见的疾病之一：结论：许多开始接受三联疗法治疗慢性阻塞性肺疾病的患者同时患有哮喘，并曾接受过 ICS/LABA 维持治疗。与其他队列相比，在启动后初期处方 BGF 的患者更有可能有既往加重病史，这表明患者的病情更为严重。

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Characteristics of Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol or Other Triple Therapies in Japan: A Real-World Healthcare Claims Database Study (MITOS-AURA)

Introduction

In Japan, patients with chronic obstructive pulmonary disease (COPD) can be escalated to treatment with inhaled triple therapy. Two single-inhaler triple therapies combining an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist (ICS/LAMA/LABA) are approved maintenance therapies for patients with COPD, and multiple-inhaler triple therapies (MITTs) are also available. There is limited evidence regarding real-life treatment patterns and characteristics of patients with COPD initiating triple therapies.

Methods

This observational, retrospective cohort study identified patients with COPD in Japan from an administrative claims database (May 2018–December 2021). Demographics, clinical characteristics, and healthcare resource utilization (HCRU) were assessed in four cohorts initiating a triple therapy: budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) early adopters (initiated ≤ 12 months after market approval [September 1, 2019]), contemporary BGF users (initiated > 12 months after market approval), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) users, and any MITT users.

Results

A total of 636 patients were BGF early adopters, 2558 were contemporary BGF users, 11,187 used FF/UMEC/VI, and 5931 used MITT. The percentage of patients with concomitant asthma in each cohort was 73.0%, BGF early adopter; 74.2%, contemporary BGF; 75.7%, FF/UMEC/VI; and 84.5%, MITT. During the 12-month baseline period, the frequency of patients with ≥ 1 moderate/severe exacerbation was 18.2%, BGF early adopter; 14.3%, contemporary BGF; 13.1%, FF/UMEC/VI; and 14.0%, MITT. ICS/LABA treatment during baseline was the most frequent pathway to triple therapy, ranging from 38.2% to 51.7% across cohorts. HCRU was relatively high across cohorts (range of hospital outpatient visits/patient during the 12-month baseline period, 11.0–14.1). Multimorbidity was observed in > 80% of patients in all cohorts; cardiovascular diseases were among the most common.

Conclusion

Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease.

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.