Vonoprazan-amoxicillin dual therapy improves 14-day eradication and reduces adverse events in patients with <i>Helicobacter pylori</i> infection: an updated landmark systematic review and meta-analysis of 11 randomized trials with subgroup analysis.

Abstract

Vonoprazan, a potassium-competitive acid blocker (P-CAB), may enhance <i>Helicobacter pylori</i> (<i>H. pylori</i>) eradication in combination with amoxicillin. With increasing drug resistance, dual therapy is a potential alternative to standard triple and quadruple regimens. This systematic review and meta-analysis evaluated the efficacy and safety of vonoprazan dual therapy (VDT) as first-line treatment for <i>H. pylori</i> infection. A comprehensive systematic search on PubMed, Embase, Scopus and Cochrane Library identified 11 randomized controlled trials (RCTs) involving 2877 patients (1439 VDT; 1438 control), comparing VDT with standard triple therapy, quadruple therapy or individualized treatment regimens for <i>H. pylori</i> eradication, up to March 2025. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel method for dichotomous outcomes. Random or fixed-effects models were applied based on heterogeneity, assessed using the Higgins <i>I</i>2 statistic. A P-value &lt;0.05 was considered statistically significant. VDT significantly improved eradication rates compared to standard therapy (RR 1.06, 95%CI 1.00-1.12; P&lt;0.001), driven primarily by 14-day regimens (RR 1.08, 95%CI 1.01-1.15; P=0.0001); no benefit was seen for 7-day regimens (RR 0.97, 95%CI 0.91-1.04; P=0.30), with low heterogeneity (8.6%). There was no significant difference in drug compliance (RR 1.02, 95%CI 0.99-1.05; P=0.03), with moderate heterogeneity (50.3%). VDT demonstrated significantly fewer adverse events (RR 0.66, 95%CI 0.52-0.84; P&lt;0.001). VDT is as effective as standard therapies overall, but shows clear superiority in 14-day regimens, with no advantage in 7-day durations. The observed heterogeneity was probably due to differences in treatment duration and regional variability in resistance.