Combination of vonoprazan and amoxicillin as the first-line Helicobacter pylori eradication therapy: a multicenter, prospective, randomized, parallel-controlled study

Abstract

Background The eradication rate of Helicobacter pylori (H. pylori) decreased gradually. This study aimed to analyze the efficacy and safety of a 14-day combination of vonoprazan and amoxicillin as the first-line eradication therapy for H. pylori infection, and compared them with those of the bismuth quadruple therapy. Methods A prospective randomized clinical trial (RCT) was designed, involving patients with H. pylori infection in 6 institutions who did not receive any treatment yet. They were randomly assigned into VA-dual group (vonprazan 20mg b.i.d + amoxicillin 750mg q.i.d) or EACP-quadruple group (esomeprazole 20mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth subcitrate 220mg b.i.d) for 14 days in ratio of 1:1. At least 28 days later, the eradication rate were detected by the 13C-urea breath test (UBT). Results A total of 562 patients from February 2022 to September 2022 were enrolled and 316 were randomly. In the ITT analysis, the eradication rates of H. pylori in VA-dual group and EACP-quadruple group were 89.9% and 81.0% respectively, p = 0.037. In the PP analysis were 97.9% and 90.8%, p = 0.009. The different eradication rate was 8.9% (95%CI, 1.2–16.5%) and 7.2% (95%CI, 1.8–12.4%) in ITT and PP analysis, both lower limit of the 95%CI was still higher than the prespecified margin. In addition, the incidence of adverse events in VA-dual group was significantly lower than that in EACP-quadruple group (19.0% vs. 43.0%, P < 0.001). Conclusion The efficacy and safety of a 14-day combination therapy of vonoprazan and amoxicillin in eradicating H. pylori are superior to bismuth quadruple therapy, and this combination significantly reduces the use of antibiotics.

Vonoprazan‐amoxicillin dual therapy versus bismuth‐containing quadruple therapy for Helicobacter pylori eradication: A systematic review and meta‐analysis

“…All studies, with the exception of the one in Thailand, 22 were conducted in China. Among these studies, there were two multicenter RCTs 18,20 and four single-center RCTs. 19,[21][22][23] The sample size spanned from 47 to 375.…”

“…Recently, several randomized controlled trials (RCTs) [18][19][20][21][22][23] regarding VA dual therapy versus BQT for H. pylori eradication have been published in 2023, but the results were inconsistent and controversial. Hence, we performed a systematic review and meta-analysis of RCTs to compare the effects of VA dual therapy with BQT for H. pylori eradication.…”

Vonoprazan and amoxicillin dual therapy as the first‐line treatment of Helicobacter pylori infection: A systematic review and meta‐analysis

“…Similar observations also pertain to VPZ triple therapy comparisons. As for the comparison between VA dual therapy and bismuth‐containing quadruple therapy, no significant difference was observed as well 12,25,26,28 …”

“…As for the comparison between VA dual therapy and bismuth-containing quadruple therapy, no significant difference was observed as well. 12,25,26,28 The adverse events rate of VA dual therapy was lower than VPZ triple therapy and bismuth-containing quadruple therapy, which In contrast to the four previous systematic reviews and meta-analysis, 8,[35][36][37] our study incorporates nine articles. 12,[24][25][26][27][28]34,38 Compared with previous meta-analysis, we made a comprehensive analysis to compare the efficacy and safety of VA dual ther- This meta-analysis had several limitations that should be considered.…”

“…12,25,26,28 The adverse events rate of VA dual therapy was lower than VPZ triple therapy and bismuth-containing quadruple therapy, which In contrast to the four previous systematic reviews and meta-analysis, 8,[35][36][37] our study incorporates nine articles. 12,[24][25][26][27][28]34,38 Compared with previous meta-analysis, we made a comprehensive analysis to compare the efficacy and safety of VA dual ther- This meta-analysis had several limitations that should be considered. First, the number of studies evaluating the efficacy and safety of VPZ-containing quadruple therapy, PPIs-based dual therapy and PPIs-based triple therapy was limited (only two studies in each subgroup), which might result in ungeneralizable findings.…”