Comparison of Keverprazan-based versus esomeprazole-based dual therapy for initial treatment of <i>Helicobacter pylori</i> infection: a prospective, multicenter, randomized controlled trial.
Keverprazan-amoxicillin therapy is non-inferior to esomeprazole-amoxicillin therapy for H. pylori eradication, but the differences in efficacy are not statistically significant.
Where it sits
this study against the rest of the survodutide (bi 456906) corpusSummary and findings
This study compared the efficacy of 14-day keverprazan-amoxicillin therapy versus esomeprazole-amoxicillin therapy in adults with treatment-naive Helicobacter pylori infection. The primary outcome measured was the H. pylori eradication rate. The results indicated non-inferiority of the keverprazan-based therapy compared to the esomeprazole-based therapy.
Abstract
<h4>Background</h4>Keverprazan offers a new perspective for <i>Helicobacter pylori</i> eradication. This study compared 14-day keverprazan-amoxicillin therapy with esomeprazole-amoxicillin therapy to explore a superior treatment strategy.<h4>Methods</h4>This was a prospective, open-label, multicenter, randomized controlled trial in adult patients with treatment-naive <i>H. pylori</i> infection. Participants were randomly assigned to receive either 14-day of KA therapy (Keverprazan 20 mg b.i.d plus amoxicillin 1 g t.i.d) or 14-day of EA therapy (Esomeprazole 40 mg b.i.d plus amoxicillin 1 g t.i.d). The primary outcome was the <i>H. pylori</i> eradication rate. Secondary outcomes were the incidence of adverse events and patient adherence.<h4>Results</h4>A total of 264 patients were enrolled in the study. In the intention-to-treat (ITT) analysis, the eradication rates for the 14-day KA group and the 14-day EA group were 87.9% and 80.3%, respectively (<i>p</i> = 0.092); in the modified intention-to-treat (mITT) analysis, the eradication rates were 92.1% and 86.2%, respectively (<i>p</i> = 0.135); and in the per-protocol (PP) analysis, the eradication rates were 93.5% and 88.3%, respectively (<i>p</i> = 0.155). Non-inferiority was confirmed between the two groups (all <i>p</i> < 0.001). Adverse events and patient adherence were similar between the two groups.<h4>Conclusion</h4>For treatment-naive <i>H. pylori</i> infection, the 14-day KA therapy is non-inferior to EA therapy. Given its good tolerability, pharmacogenomic independence, and potent acid suppression, KA is a rational first-line alternative to EA in the Chinese population.