中度重度哮喘患者的基线特征和维持疗法选择对症状控制、缓解剂使用和恶化风险的影响:临床建模与模拟研究》。

IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Pierluigi Paggiaro, Gabriel Garcia, Nicolas Roche, Manish Verma, Maximilian Plank, Sean Oosterholt, Janna K. Duong, Anurita Majumdar, Oscar Della Pasqua
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引用次数: 0

摘要

简介尽管已经确定了一些与哮喘症状恶化和病情加重风险相关的因素,但这些因素的特征尚未完全确定。我们开展了一项临床建模和模拟研究,以了解中度重度哮喘患者在接受常规剂量吸入式皮质类固醇(ICS)单药治疗或ICS/长效β2-激动剂(LABA)联合治疗的随访期间,影响症状控制、缓解剂使用和病情恶化风险的基线因素:采用随机临床试验(2001 年至 2019 年间进行)中的患者个体数据,对症状时间进程(n = 7593)、缓解药物使用模式(n = 3768)和首次加重时间(n = 6763)进行建模,同时考虑患者特异性和外在因素,包括治疗。模型验证采用标准图形和统计标准。然后在具有不同基线特征和治疗设置的患者队列中模拟症状控制评分(哮喘控制问卷 5 [ACQ-5])的变化、缓解剂使用量的减少和年化加重率:结果:吸烟者、基线 ACQ-5 和体重指数较高者会影响症状控制评分、缓解剂使用量和病情加重风险(P这项研究进一步揭示了个体基线特征对治疗反应的影响,并强调了 ICS/LABA 联合疗法在症状控制、缓解剂使用和病情加重风险方面的显著差异。这些因素应纳入临床实践,作为对中重度哮喘患者进行量身定制管理的基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Baseline Characteristics and Maintenance Therapy Choice on Symptom Control, Reliever Use, Exacerbation Risk in Moderate–Severe Asthma: A Clinical Modelling and Simulation Study

Baseline Characteristics and Maintenance Therapy Choice on Symptom Control, Reliever Use, Exacerbation Risk in Moderate–Severe Asthma: A Clinical Modelling and Simulation Study

Introduction

Although some factors associated with asthma symptom deterioration and risk of exacerbation have been identified, these are not yet fully characterised. We conducted a clinical modelling and simulation study to understand baseline factors affecting symptom control, reliever use and exacerbation risk in patients with moderate–severe asthma during follow-up on regularly dosed inhaled corticosteroid (ICS) monotherapy, or ICS/long-acting beta2-agonist (LABA) combination therapy.

Methods

Individual patient data from randomised clinical trials (undertaken between 2001 and 2019) were used to model the time course of symptoms (n = 7593), patterns of reliever medication use (n = 3768) and time-to-first exacerbation (n = 6763), considering patient-specific and extrinsic factors, including treatment. Model validation used standard graphical and statistical criteria. Change in symptom control scores (Asthma Control Questionnaire 5 [ACQ-5]), reduction in reliever use and annualised exacerbation rate were then simulated in patient cohorts with different baseline characteristics and treatment settings.

Results

Being a smoker, having higher baseline ACQ-5 and body mass index affected symptom control scores, reliever use and exacerbation risk (p < 0.01). In addition, low forced expiratory volume in 1 s percent predicted, female sex, season and previous exacerbations were found to contribute to a further increase in exacerbation risk (p < 0.01), whereas long asthma history was associated with more frequent reliever use (p < 0.01). These effects were independent from the underlying maintenance therapy. In different scenarios, fluticasone furoate (FF)/vilanterol was associated with greater reductions in reliever use and exacerbation rates compared with FF or fluticasone propionate (FP) alone or budesonide/formoterol, independently from other factors (p < 0.01).

Conclusions

This study provided further insight into the effects of individual baseline characteristics on treatment response and highlighted significant differences in the performance of ICS/LABA combination therapy on symptom control, reliever use and exacerbation risk. These factors should be incorporated into clinical practice as the basis for tailored management of patients with moderate–severe asthma.

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来源期刊
Advances in Therapy
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.
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