Quadruple therapy with vonoprazan 20 mg daily as a first‐line treatment for Helicobacter pylori infection: A single‐center, open‐label, noninferiority, randomized controlled trial

Abstract

Background Although vonoprazan has been proven to be a highly potent drug for Helicobacter pylori eradication, there have been no randomized trials comparing the effectiveness of regimens containing vonoprazan 20 mg daily with alternative standard strategies. We aimed to assess the efficacy, tolerance, and cost‐effectiveness of quadruple therapy with vonoprazan 20 mg daily as a first‐line therapy for H. pylori eradication. Materials and Methods We conducted a single‐center, open‐label, noninferiority, randomized controlled study in Zhejiang, China. Treatment‐naive H. pylori‐positive participants (n = 234) were randomly assigned to three groups in a 1:1:1 ratio: vonoprazan 20 mg daily with amoxicillin 1000 mg, furazolidone 100 mg and colloidal bismuth 200 mg each given twice a day for 10 days (V10) or 14 days (V14), or esomeprazole 20 mg with amoxicillin 1000 mg, furazolidone 100 mg and colloidal bismuth 200 mg each given twice a day for 14 days (E14). The primary endpoint was the eradication rates in each group. The secondary endpoints were the incidence of adverse events (AEs) and compliance. Results The eradication rates in the V10, V14 and E14 groups were 96.2% (89.2–99.2%), 94.9% (87.4–98.6%), and 93.6% (85.7–97.9%) in the intention‐to‐treat analysis, and 98.6% (92.7–100.0%), 97.4% (90.8–99.7%), and 94.8% (87.2–98.6%) in the per‐protocol analysis, respectively. Quadruple therapy with vonoprazan 20 mg daily was noninferior to the esomeprazole‐based regimen (Farrington and Manning test: margin 10%, significance level 2.5%). The adverse event rates were 12.8% versus 3.8% versus 6.4% in the V10, V14, and E14 groups, respectively. All regimens were well tolerated without significant differences (p = 0.096). The cost‐effectiveness ratio was 1.32, 1.88, and 3.06 for the V10, V14, and E14 groups in the intention‐to‐treat analysis, respectively. (NCT04907747). Conclusions Vonoprazan (20 mg daily) was as effective as esomeprazole (20 mg twice a day) in quadruple therapies for the eradication of H. pylori, was more economical, and was well tolerated. In addition, the 10‐day regimen of vonoprazan (20 mg daily) was comparable to the 14‐day regimen.

Vonoprazan and amoxicillin dual therapy for 14 days as the first‐line treatment of Helicobacter pylori infection: A non‐inferiority, randomized clinical trial

“…7,8 Vonoprazan was used in VBAF to replace PPI to improve the eradication rate. Recent clinical trials [30][31][32] focusing on vonoprazancontaining quadruple therapy proved its high efficacy for eradicating H. pylori in China. Among the 3 studies, furazolidone-containing vonoprazan quadruple therapy showed the highest eradication rate (97.4% in PP analysis), which was similar with the eradication rate achieved by our study (97.7% in PP analysis).…”

Research trends on vonoprazan‐based therapy for Helicobacter pylori eradication: A bibliometric analysis from 2015 to 2023

“…17,18 MNZ is approved as second-line treatment in Japan in combination with VPZ and amoxicillin and Murakami et al 16 Bismuth-containing quadruple therapy has been recommended as the first-line treatment of H. pylori infection in regions with high resistance rate of clarithromycin. 20 Lu et al 21 assessed the efficacy of 10-and 14-day VPZ-containing bismuth amoxicillin, furazolidone quadruple therapy (amoxicillin 1 g bid and furazolidone 100 mg bid) in China. A total of 156 patients were included and randomized to receive the VPZ quadruple therapy, both groups showed high efficacy with eradication rates of 10-and 14-day VPZ-containing quadruple therapy of 98.6% and 97.4% PP.…”

“…The publications, total citations, and H-index of the 10 most productive countries were analyzed in Table S2. Japan had the largest number of publications (45), H-index (21), and citations (1, 143), followed by China with 7 publications. Japan was the region where VPZ-based H. pylori eradication regimens were most widely used, followed by China and the United States.…”

Clinical Study on the Eradication of Helicobacter pylori by Vonoprazan Combined with Amoxicillin for 10‐Day Dual Therapy

“…Endpoint 1 focused on the H. pylori eradication rate assessed through a 13 C urea breath test ( 13 C‐UBT), 27 conducted 4 weeks after the treatment. Subjects refrained from taking PPIs or P‐cab 2 weeks before the test, and any antibiotics 4 weeks prior.…”

“…Comprehensive data, encompassing age, sex, body mass index (BMI), and history of smoking and drinking were harvested from all patients. Endpoint 1 focused on the H. pylori eradication rate assessed through a 13 C urea breath test ( 13 C-UBT), 27 conducted 4 weeks after the treatment. Subjects refrained from taking PPIs or P-cab 2 weeks before the test, and any antibiotics 4 weeks prior.…”