Kang Noeul, Kang Min-Gyu, Lee Seung Eun, Kang Sung-Yoon, Jo Eun-Jung, Lee Ji Ho, Kim Sae-Hoon, Bahn Joon-Woo, Lee Byung-Jae, Song Woo-Jung
Division of Allergy, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Departmemt of Internal Medicine, Chungbuk National University Hospital, Chungbuk National College of Medicine, Cheongju, Korea.
Lung. 2025 Apr 29;203(1):59. doi: 10.1007/s00408-025-00815-5.
Potassium-competitive acid blockers (P-CABs) are a newer class of acid suppressants with convenient dosing and a rapid onset of action, while showing efficacy comparable to proton pump inhibitors (PPIs) in treating peptic symptoms of gastroesophageal reflux disease (GERD). This study aimed to assess the effect of P-CABs on GERD-related chronic cough.
This randomized, double-blind, active-controlled, exploratory trial evaluated adults with chronic cough (≥ 8 weeks) and a recent physician diagnosis of GERD or peptic symptoms (< 1 month). Participants were randomized (1:1) to receive either fexuprazan 40 mg or esomeprazole 40 mg (PPI) once daily for eight weeks, along with matched placebos. The primary endpoint was the change in Leicester Cough Questionnaire (LCQ) score from baseline. Secondary endpoints included changes in the cough severity Numerical Rating Scale (NRS) and Reflux Disease Questionnaire (RDQ) scores. Safety was evaluated through monitoring adverse events.
Of the 190 subjects recruited, 161 met the selection criteria and were randomized, and 146 completed the trial. The participants were predominantly female (74.3%, mean age 39 ± 12 years). After 8 weeks of treatment, cough-related quality of life improved significantly, with comparable LCQ scores change between the groups (fexuprazan: 4.9 ± 4.0 vs. esomeprazole: 5.3 ± 3.8, p = 0.558). Changes in cough severity NRS and RDQ scores were also similar between the groups. Adverse events were comparable and consisted mostly of mild symptoms.
These findings support the potential of P-CABs as a promising alternative to PPIs for patients with chronic cough requiring acid-suppressive therapy.
钾离子竞争性酸阻滞剂（P-CABs）是一类新型的抑酸剂，给药方便且起效迅速，在治疗胃食管反流病（GERD）的消化症状方面，其疗效与质子泵抑制剂（PPIs）相当。本研究旨在评估P-CABs对GERD相关慢性咳嗽的影响。
本项随机、双盲、活性对照、探索性试验评估了患有慢性咳嗽（≥8周）且近期经医生诊断为GERD或有消化症状（<1个月）的成年人。参与者被随机（1:1）分配，每天服用一次40mg的富马酸伏诺拉生或40mg的埃索美拉唑（PPI），持续8周，并同时服用匹配的安慰剂。主要终点是莱斯特咳嗽问卷（LCQ）评分相对于基线的变化。次要终点包括咳嗽严重程度数字评定量表（NRS）和反流病问卷（RDQ）评分的变化。通过监测不良事件来评估安全性。
在招募的190名受试者中，161名符合入选标准并被随机分组，146名完成了试验。参与者以女性为主（74.3%，平均年龄39±12岁）。治疗8周后，咳嗽相关的生活质量显著改善，两组之间的LCQ评分变化相当（富马酸伏诺拉生组：4.9±4.0 vs. 埃索美拉唑组：5.3±3.8，p = 0.558）。两组之间咳嗽严重程度NRS和RDQ评分的变化也相似。不良事件相当，主要为轻度症状。
这些研究结果支持了P-CABs对于需要抑酸治疗的慢性咳嗽患者而言，有望成为PPIs的一种有前景的替代药物。
