Western Sky Medical Research, El Paso, TX, USA.
Bio-Medical Research Center, Lam Dong Medical College, Da Lat, Vietnam.
Adv Ther. 2019 Oct;36(10):2587-2599. doi: 10.1007/s12325-019-01062-w. Epub 2019 Aug 21.
Tiotropium, a long-acting muscarinic antagonist, is approved for maintenance treatment of asthma in patients at least 6 years of age in the USA. We systematically reviewed published evidence on the efficacy and safety of 2.5 µg tiotropium Respimat add-on therapy to inhaled corticosteroid (ICS) with or without additional controller medication(s) in children, adolescents, and adults with asthma.
We searched PubMed from inception until October 3, 2018, for phase 2 and 3 randomized controlled trials (RCTs) evaluating the effects of 2.5 µg tiotropium Respimat on lung function parameters in patients with asthma. We extracted adjusted mean differences for lung function data and adverse events (AEs) from relevant articles.
Overall, 11 RCTs (three phase 2 and eight phase 3 studies) including 3244 patients (2.5 µg tiotropium Respimat, n = 1642; placebo, n = 1602) met the predefined inclusion criteria. Once-daily 2.5 µg tiotropium Respimat improved lung function parameters, including peak and trough forced expiratory volume in 1 s and peak and trough forced vital capacity, versus placebo. Overall, the safety profile of 2.5 µg tiotropium Respimat was comparable to that of placebo, with the most commonly reported AEs being asthma worsening, reduction in peak expiratory rate, nasopharyngitis, and respiratory tract infections.
On the basis of the results of phase 2 and 3 studies, 2.5 µg tiotropium Respimat as add-on to ICS therapy was safe and associated with consistent improvements in lung function in patients with asthma of varying severities across different age groups.
Development of the manuscript was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).
噻托溴铵是一种长效毒蕈碱拮抗剂，已获批准用于美国至少 6 岁以上哮喘患者的维持治疗。我们系统地回顾了已发表的关于噻托溴铵 2.5μg 定量吸入器附加治疗在伴有或不伴有附加控制药物的吸入性皮质类固醇（ICS）治疗的儿童、青少年和成人哮喘患者中的疗效和安全性的证据。
我们从文献建立伊始至 2018 年 10 月 3 日在 PubMed 上搜索了评估噻托溴铵 2.5μg 定量吸入器对哮喘患者肺功能参数影响的 2 期和 3 期随机对照试验（RCT）。我们从相关文章中提取了肺功能数据和不良反应（AE）的调整平均差异。
总体而言，11 项 RCT（3 项 2 期和 8 项 3 期研究）纳入了 3244 名患者（噻托溴铵 2.5μg 定量吸入器组 n=1642；安慰剂组 n=1602），符合预定的纳入标准。与安慰剂相比，每日一次的噻托溴铵 2.5μg 定量吸入器改善了肺功能参数，包括峰值和谷值 1 秒用力呼气量以及峰值和谷值用力肺活量。总体而言，噻托溴铵 2.5μg 定量吸入器的安全性与安慰剂相当，最常见的不良反应为哮喘恶化、呼气峰流速降低、鼻咽炎和呼吸道感染。
基于 2 期和 3 期研究的结果，噻托溴铵 2.5μg 定量吸入器作为 ICS 治疗的附加药物在不同年龄段、不同严重程度的哮喘患者中是安全的，且与肺功能的持续改善相关。
本文的撰写得到了勃林格殷格翰制药公司（BIPI）的资助。
