Efficacy of vonoprazan versus omeprazole in high-dose amoxicillin dual regimen for eradication of Helicobacter pylori infection: A randomized controlled trial

Background and aim Helicobacter pylori (H. pylori) is a spiral-shaped gram-negative bacterium that colonizes the intestines, This work aimed to evaluate Vonoprazan’s and Omeprazole’s clinical effectiveness and safety in a high-dose amoxicillin dual regimen for the treatment of H. pylori infection. Patients and methods In this prospective superiority parallel open-label randomized controlled trial, 100 patients with dyspeptic symptoms who tested positive for an H. pylori infection by stool antigen test (SAT) were included in the study at Al-Azhar-Assiut University Hospital. Patients were divided into two groups at random using a 1:1 allocation ratio in parallel. Group 1 (Omeprazole-based high-dose amoxicillin dual therapy (DT)) ( n =50): Patients were treated with amoxicillin1000 mg t.i.d and omeprazole 40 mg t.i.d for 14 days and group 2 (Vonoprazan based high dose amoxicillin DT) ( n =50): Patients were treated, amoxicillin 1000 mg t.i.d and Vonoprazan 20 mg b.i.d for 14 days. Results Intention to treat (ITT) and per protocol (PP) analyses of the eradication rates by SAT were (90% and 93.75%, respectively) in vonoprazan group compared to (74% by ITT analysis and 78.72% by PP analysis) in omeprazole group and ITT analysis and PP analysis were significantly higher in group 2 than group 1 ( P value <0.05). Conclusions DT based on vonoprazan is a safe and effective alternative for the eradication of H. pylori infection in regions with high antibiotic resistance, as it is characterized by high symptom relief rates, excellent compliance, and a reduction in antibiotic consumption. Place of the study: Hepatology, Gastroenterology, and Infectious diseases, Al-Azhar University, Assiut, Egypt