Reassessing Vonoprazan for Endoscopy-Negative Reflux Disease: A Systematic Review and Meta-Analysis.

IF 2.5 4区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Digestive Diseases and Sciences Pub Date : 2025-09-18 DOI:10.1007/s10620-025-09399-9

Minahil Iqbal, Muhammad Ahsan Asif, Asma Tahir, Humza Saeed, Sufyan Shahid, Mariam Shahabi, Arfa Ahmed Assad, Muhammad Ahmad, Azeem Khalid, Hassam Ali, Douglas G Adler

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引用次数: 0

Abstract

Background: Non-erosive reflux disease (NERD) is characterized by reflux without esophageal erosions. Vonoprazan, a potassium-competitive acid blocker, is recommended for patients with erosive esophagitis (EE). However, its role in NERD, remains limited. We conducted a systematic review and meta-analysis to assess its efficacy in patients with NERD.

Methods: A systematic literature search was conducted, on MEDLINE, Embase and Cochrane Library until January 25, 2025, to identify all randomized controlled trials (RCTs) comparing Vonoprazan to placebo in patients with NERD. Binary and continuous outcomes were pooled using risk ratios (RRs), and standardized mean differences (SMDs), respectively, along with their 95% confidence intervals (CIs).

Results: Four RCTs with a total of 2540 patients (50.3% females) were included. Vonoprazan 10 mg was comparable to placebo in terms of mean proportion of days without heartburn (SMD: 0.12; 95% CI - 0.04-0.29, p = 0.14), mean severity score of heartburn (SMD: 0.01; 95% CI - 0.15-0.17, p = 0.94), treatment-related adverse events (RR: 0.93; 95% CI: 0.71-1.20, p = 0.568), and serious adverse events (RR: 1.46; 95% CI 0.23-9.23, p = 0.689). Vonoprazan 20 mg was superior to placebo in terms of mean proportion of days without heartburn (SMD: 0.13; 95% CI 0.01-0.24 p = 0.03), with comparable results for mean severity score of heartburn (SMD: - 0.03; 95% CI - 0.15-0.08 p = 0.56), treatment-related adverse events (RR: 1.11; 95% CI 0.52-2.36 p = 0.785), and serious adverse events (RR: 6.03; 95% CI 0.73-50.10 p = 0.096).

Conclusion: Vonoprazan 10 mg showed no benefit over placebo in NERD. The 20 mg dose modestly increased heartburn-free days with similar safety, suggesting potential efficacy.

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重新评估伏诺哌嗪治疗内窥镜阴性反流病：系统回顾和荟萃分析。

背景：非糜烂性反流病（NERD）以无食管糜烂的反流为特征。Vonoprazan是一种钾竞争性酸阻滞剂，推荐用于糜烂性食管炎（EE）患者。然而，它在NERD中的作用仍然有限。我们进行了系统回顾和荟萃分析，以评估其对NERD患者的疗效。方法：到2025年1月25日，在MEDLINE、Embase和Cochrane Library上进行了系统的文献检索，以确定所有比较Vonoprazan与安慰剂治疗NERD患者的随机对照试验（rct）。分别使用风险比（rr）和标准化平均差异（SMDs）及其95%置信区间（ci）对二元和连续结果进行汇总。结果：纳入4项随机对照试验，共2540例患者（女性50.3%）。Vonoprazan 10 mg在无烧心天数的平均比例（SMD: 0.12; 95% CI - 0.04-0.29, p = 0.14）、烧心严重程度的平均评分（SMD: 0.01; 95% CI - 0.15-0.17, p = 0.94）、治疗相关不良事件（RR: 0.93; 95% CI: 0.71-1.20, p = 0.568）和严重不良事件（RR: 1.46; 95% CI: 0.23-9.23, p = 0.689）方面与安慰剂相当。Vonoprazan 20 mg在没有烧心的平均天数比例（SMD: 0.13; 95% CI 0.01-0.24 p = 0.03）方面优于安慰剂，在烧心的平均严重程度评分（SMD: - 0.03; 95% CI - 0.15-0.08 p = 0.56）、治疗相关不良事件（RR: 1.11; 95% CI 0.52-2.36 p = 0.785）和严重不良事件（RR: 6.03; 95% CI 0.73-50.10 p = 0.096）方面也优于安慰剂。结论：Vonoprazan 10mg对NERD患者无明显疗效。20mg剂量适度增加无烧心天数，安全性相似，提示潜在疗效。

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来源期刊

Digestive Diseases and Sciences 医学-胃肠肝病学

CiteScore

6.40

自引率

3.20%

发文量

420

审稿时长

1 months

期刊介绍： Digestive Diseases and Sciences publishes high-quality, peer-reviewed, original papers addressing aspects of basic/translational and clinical research in gastroenterology, hepatology, and related fields. This well-illustrated journal features comprehensive coverage of basic pathophysiology, new technological advances, and clinical breakthroughs; insights from prominent academicians and practitioners concerning new scientific developments and practical medical issues; and discussions focusing on the latest changes in local and worldwide social, economic, and governmental policies that affect the delivery of care within the disciplines of gastroenterology and hepatology.