Randomized clinical trial: 7‐day vonoprazan‐based versus 14‐day omeprazole‐based triple therapy for Helicobacter pylori

• Published in: Journal of gastroenterology and hepatology Vol. 36; no. 12; pp. 3308 - 3313
• Main Authors: Bunchorntavakul, Chalermrat, Buranathawornsom, Arunluk
• Format: Journal Article
• Language: English
• Published: Australia Wiley Subscription Services, Inc 01.12.2021
• Subjects: Adult; Aged; Amoxicillin; Amoxicillin - adverse effects; Amoxicillin - therapeutic use; Anti-Bacterial Agents - therapeutic use; Bitter taste; Clarithromycin; Clarithromycin - adverse effects; Clarithromycin - therapeutic use; Clinical trials; Eradication; Female; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Male; Middle Aged; Nausea; Omeprazole; Omeprazole - adverse effects; Omeprazole - therapeutic use; potassium‐competitive acid blocker; Prospective Studies; Proton pump inhibitors; Proton Pump Inhibitors - therapeutic use; Pyrroles - adverse effects; Pyrroles - therapeutic use; Side effects; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; triple therapy; vonoprazan; omeprazole; potassium-competitive acid blocker; Helicobacter pylori; triple therapy; vonoprazan
• ISSN: 0815-9319; 1440-1746; 1440-1746
• DOI: 10.1111/jgh.15700

Background and Aim Vonoprazan has more potent and sustained acid inhibitory effects than proton pump inhibitors; therefore, Helicobacter pylori eradication rates are expected to improve with the use of vonoprazan‐based regimens. To date, no randomized trial has compared the efficacy of 7‐day vonoprazan‐based triple therapy (7‐VAC) with 14‐day omeprazole‐based triple therapy (14‐OAC). This study aimed to compare the H. pylori eradication rates of 7‐VAC and 14‐OAC. Methods This randomized clinical trial was performed at a tertiary hospital in Bangkok. Patients with active H. pylori infection who were naive to treatment were included and randomized (1:1) into either a 7‐VAC group (vonoprazan 20 mg bid. pc., amoxicillin 1000 mg bid. pc., and clarithromycin 500 mg bid. pc.) or a 14‐OAC group (omeprazole 20 mg bid. ac., amoxicillin 1000 mg bid. pc., and clarithromycin 500 mg bid. pc.). Eradication success was evaluated by urea breath test 4–6 weeks after completion of treatment. Results A total of 122 subjects were randomized to receive 7‐VAC (n = 61) or 14‐OAC (n = 61). The H. pylori eradication rates of the 7‐VAC and 14‐OAC groups were 96.7% and 88.5% (P = 0.083), respectively, by intention‐to‐treat analysis and 98.3% and 93.1% (P = 0.159), respectively, by per‐protocol analysis. All treatment‐related adverse events were mild and not significantly different between the two groups. Common side effects included bitter taste, nausea, and dizziness. Conclusions The 7‐VAC regimen was well tolerated and achieved similar eradication rates and side effects to those of 14‐OAC; therefore, 7‐VAC may be considered an alternative regimen for H. pylori treatment with the benefit of shorter duration.