Efficacy of Tegoprazan in Patients With Functional Dyspepsia: A Prospective, Multicenter, Single-arm Study.

IF 3.3 3区医学 Q2 CLINICAL NEUROLOGY

Journal of Neurogastroenterology and Motility Pub Date : 2024-07-30 Epub Date: 2024-05-04 DOI:10.5056/jnm23150

Cheal Wung Huh, Young Hoon Youn, Da Hyun Jung, Ra Ri Cha, Yeon Ji Kim, Kyoungwon Jung, Kyung Ho Song, Ki Bae Bang, Chung Hyun Tae, Soo In Choi, Cheol Min Shin

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引用次数: 0

Abstract

Background/aims: Acid-suppressive drugs, such as proton pump inhibitors (PPIs), are treatment options for functional dyspepsia (FD). However, the efficacy of potassium-competitive acid blockers (P-CABs) in treating FD has not yet been established. This prospective multicenter clinical trial-based study aimed to assess the efficacy and safety of tegoprazan as a P-CAB treatment in patients with FD.

Methods: FD was diagnosed using the Rome IV criteria. All patients received tegoprazan 50 mg once daily for 8 weeks. Dyspeptic symptoms were assessed using a dyspepsia symptom questionnaire (5-point Likert scale, Nepean Dyspepsia Index-Korean [NDI-K], and gastroesophageal reflux disease-health-related quality of life [GERD-HRQL]). The main outcome was satisfactory symptom relief rates at 8 weeks.

Results: In this study, from the initial screening of 209 patients, 173 were included in the per-protocol set analysis. Satisfactory symptom relief rates at 8 and 4 weeks were 86.7% and 74.6%, respectively. In addition, the NDI-K and GERD-HRQL scores significantly improved at 8 and 4 weeks compared with the baseline scores. The efficacy of tegoprazan was not influenced by the FD subtype or Helicobacter pylori status. In patients with overlapping FD and GERD, there was a greater improvement in the NDI-K and GERD-HRQL scores than in patients with FD symptoms only. No serious drug-related adverse events occurred during this study.

Conclusion: Tegoprazan (50 mg) administered once daily provided satisfactory symptom relief for FD.

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Tegoprazan 对功能性消化不良患者的疗效：一项前瞻性、多中心、单臂研究。

背景/目的：质子泵抑制剂（PPI）等抑酸药物是治疗功能性消化不良（FD）的选择。然而，钾竞争性酸阻滞剂（P-CABs）治疗功能性消化不良的疗效尚未确定。这项基于多中心临床试验的前瞻性研究旨在评估替戈普拉赞作为 P-CAB 治疗 FD 患者的疗效和安全性：方法：根据罗马IV标准诊断FD。所有患者均接受特戈普拉赞治疗，每天一次，每次50毫克，疗程8周。消化不良症状采用消化不良症状调查表（5点李克特量表）、韩国尼氏消化不良指数（NDI-K）和胃食管反流病-健康相关生活质量（GERD-HRQL）进行评估。主要结果是8周后的症状缓解满意率：在这项研究中，从最初筛选出的 209 名患者中，有 173 人被纳入按方案设置的分析。8周和4周时的症状缓解满意率分别为86.7%和74.6%。此外，与基线分数相比，8 周和 4 周时的 NDI-K 和 GERD-HRQL 分数均有显著改善。替戈普拉赞的疗效不受FD亚型或幽门螺旋杆菌状态的影响。与仅有FD症状的患者相比，有FD和胃食管反流重叠症状的患者的NDI-K和胃食管反流-HRQL评分改善幅度更大。本研究期间未发生严重的药物相关不良事件：结论：每日一次服用替戈普拉赞（50 毫克）可令人满意地缓解 FD 的症状。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Neurogastroenterology and Motility GASTROENTEROLOGY & HEPATOLOGY-CLINICAL NEUROLOGY

CiteScore

6.30

自引率

8.80%

发文量

期刊介绍： Journal of Neurogastroenterology and Motility (J Neurogastroenterol Motil) is a joint official journal of the Korean Society of Neurogastroenterology and Motility, the Thai Neurogastroenterology and Motility Society, the Japanese Society of Neurogastroenterology and Motility, the Indian Motility and Functional Disease Association, the Chinese Society of Gastrointestinal Motility, the South East Asia Gastro-Neuro Motility Association, the Taiwan Neurogastroenterology and Motility Society and the Asian Neurogastroenterology and Motility Association, launched in January 2010 after the title change from the Korean Journal of Neurogastroenterology and Motility, published from 1994 to 2009.