吉法替尼改善慢性咳嗽的客观和主观指标：预先设定亚组的 3 期疗效汇总分析。
Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups.
机构信息
Division of Infection, Immunity & Respiratory Medicine, University of Manchester & Manchester University NHS Trust, 2nd Floor Education & Research Centre, Southmoor Rd, Wythenshawe, Manchester, M23 9LT, UK.
Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
出版信息
Lung. 2022 Aug;200(4):423-429. doi: 10.1007/s00408-022-00553-y. Epub 2022 Jul 27.
INTRODUCTION
In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC).
METHODS
Here, the efficacy of gefapixant 45 mg vs placebo was evaluated across COUGH-1/COUGH-2 in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis (RCC, UCC). Awake cough frequency reductions at Week 12 and LCQ response rates (i.e., ≥ 1.3-point improvement) at Week 24 were assessed.
RESULTS
Among 1360 participants analyzed, gefapixant 45 mg resulted in consistent awake cough frequency reductions overall and across predefined subgroups at Week 12. Gefapixant also resulted in improved LCQ scores across subgroups at Week 24; ≥ 70% of participants in each subgroup treated with gefapixant 45 mg had an LCQ response.
CONCLUSION
These data suggest gefapixant 45 mg provides consistent objective and subjective efficacy across subgroups of individuals with RCC or UCC.
简介
在第 3 阶段试验（COUGH-1/COUGH-2）中，每日两次服用 gefapixant 45 毫克与安慰剂相比，可显著降低难治性或不明原因的慢性咳嗽（RCC 或 UCC）患者 24 小时咳嗽频率。
方法
在此，根据性别、地区、年龄、咳嗽持续时间、咳嗽严重程度、咳嗽频率和诊断（RCC、UCC），对 COUGH-1/COUGH-2 中 gefapixant 45 毫克与安慰剂的疗效进行了预定义亚组评估。评估了第 12 周时清醒咳嗽频率的降低和第 24 周时 LCQ 应答率（即≥1.3 分的改善）。
结果
在分析的 1360 名参与者中，gefapixant 45 毫克在第 12 周时总体上和在预定义亚组中均一致地降低了清醒咳嗽频率。gefapixant 还在第 24 周时改善了各亚组的 LCQ 评分；接受 gefapixant 45 毫克治疗的每个亚组中≥70%的参与者出现了 LCQ 应答。
结论
这些数据表明，gefapixant 45 毫克在 RCC 或 UCC 患者的亚组中提供了一致的客观和主观疗效。
Zotero 插件