噻托溴铵附加疗法安全,并可减少儿科哮喘患者的季节性恶化。

Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients.

机构信息

Dept of Pediatric Pulmonology and Allergy, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany

Children's Hospital of Colorado and the University of Colorado Denver School of Medicine, Aurora, CO, USA.

出版信息

Eur Respir J. 2019 Jun 13;53(6). doi: 10.1183/13993003.01824-2018. Print 2019 Jun.

Abstract

There remains an unmet need for effective, well-tolerated therapeutic options in paediatric patients with not fully controlled asthma, for whom safety is of paramount importance.Data were pooled from five randomised, double-blind, placebo-controlled studies evaluating tiotropium 5 or 2.5 µg placebo add-on therapy in patients with symptomatic asthma aged 1-17 years. Analysis included adverse events (AEs) and serious AEs (SAEs) reported throughout and for 30 days following treatment.Of 1691 patients treated, 1119 received tiotropium. Reporting of AEs was low and comparable across all groups: tiotropium 5 µg (51%), tiotropium 2.5 µg (51%) and placebo (54%). Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex. The number of AEs related to asthma symptoms and exacerbations was lower with tiotropium (5 µg) than with placebo, particularly during the seasonal peaks of these AEs.This comprehensive analysis of a large safety database allowed subgroup analyses that are often impractical with individual trials and provides further support for the safety of once-daily tiotropium Respimat add-on therapy in paediatric patients with symptomatic asthma.

摘要

在未完全控制的哮喘的儿科患者中,仍然需要有效的、耐受性良好的治疗选择,安全性至关重要。本数据来自五项随机、双盲、安慰剂对照研究,评估了噻托溴铵 5 或 2.5μg 与安慰剂联合治疗有症状的 1-17 岁哮喘患者。分析包括治疗期间和治疗后 30 天内报告的不良事件(AE)和严重不良事件(SAE)。1691 例接受治疗的患者中,有 1119 例接受了噻托溴铵治疗。所有组的 AE 报告均较低且相似:噻托溴铵 5μg(51%)、噻托溴铵 2.5μg(51%)和安慰剂(54%)。药物相关 AE、导致停药和 SAE 的报告也较低,且在治疗组之间平衡,与年龄、疾病严重程度或性别无关。与噻托溴铵(5μg)相比,与安慰剂相比,与哮喘症状和恶化相关的 AE 数量更少,尤其是在这些 AE 的季节性高峰期间。这一大规模安全性数据库的综合分析允许进行亚组分析,这在个别试验中往往是不切实际的,并进一步支持噻托溴铵 Respimat 每日一次附加疗法在有症状的哮喘儿科患者中的安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c05/6581158/7a544d4a8ba8/ERJ-01824-2018.01.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索