Vonoprazan-tetracycline dual regimen as rescue therapy for Helicobacter pylori infection: randomized controlled trial
Abstract
BACKGROUND & AIMS: Treatment of Helicobacter pylori infection after previous eradication failure remains challenging. This study evaluated the efficacy and safety of a vonoprazan-tetracycline (VT) dual regimen as a potential rescue therapy.
METHODS: In this prospective, open-label, randomized controlled trial, H pylori-positive adults with at least 1 prior eradication failure were allocated 1:1 to VT dual therapy (vonoprazan [20 mg, twice a day] and tetracycline [500 mg, 3 times a day]), or bismuth quadruple therapy (BQT; lansoprazole [30 mg, twice a day], colloidal bismuth [150 mg, 3 times a day], tetracycline [500 mg, 3 times a day], and metronidazole [400 mg, 3 times a day]) for 14 days. The primary outcome was noninferiority in eradication rates between VT and BQT groups. Secondary outcomes assessed adverse effects in both groups.
RESULTS: Of 350 randomized patients (175 per group), the eradication rates in the VT dual-therapy group and the BQT group were, respectively, 90.6% (154 of 170; 95% confidence interval [CI], 84.9%-94.4%) and 89.3% (151 of 169; 95% CI, 83.5%-93.4%) in modified intention-to-treat analysis (difference, 1.2%; 95% CI,-5.7% to 8.2%; noninferiority P = .0003), 91.1% (153 of 168; 95% CI, 85.4%-94.7%) and 92.2% (141 of 153; 95% CI, 86.4%-95.7%) in per-protocol analysis (difference, -1.1%; 95% CI, -7.8% to 5.6%; noninferiority P = .002), meeting the noninferiority criterion (P < .0125). Treatment-emergent adverse events were less frequent with dual…
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: 350 participants or records.
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