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

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.