Efficacy and Safety of Fexuprazan-Based Modified High-Dose Dual Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial
Abstract
Background/aims: The eradication efficacy of proton pump inhibitor (PPI)-based standard triple therapy (STT) for Helicobacter pylori infection has declined in Korea, largely because of increasing clarithromycin resistance. High-dose dual therapy (HDDT) using potent acid suppression represents a promising clarithromycin-sparing strategy. This study evaluated the efficacy and safety of fexuprazan-based modified HDDT (m-HDDT) including bismuth, compared with conventional PPI-based STT as first-line eradication therapy.
Methods: This prospective, multicenter, randomized, open-label, non-inferiority trial was conducted at eight tertiary hospitals in Korea. Treatment-naïve adults with confirmed H. pylori infection were randomized to receive either m-HDDT (fexuprazan 40 mg twice daily, amoxicillin 1000 mg three times daily, and bismuth subcitrate potassium 300 mg three times daily) or STT (lansoprazole 30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, all twice daily) for 14 days. Eradication was assessed by urea breath test 4-8 weeks after therapy. The primary endpoint was the eradication rate in the full analysis set (FAS), with a prespecified non-inferiority margin of -10%. Safety and compliance were evaluated as secondary outcomes.
Results: In total, 196 patients were included in the FAS (m-HDDT, n = 96; STT, n = 100). Helicobacter pylori eradication was achieved in 81.3% of patients in the m-HDDT group and 79.0% in the STT group, demonstrating non-inferiority of m-HDDT…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 196 participants or records.
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