Real-world evidence on the efficacy and safety of vonoprazan-amoxicillin dual therapy for Helicobacter pylori treatment in elderly patients.

Background: A dual therapy regimen containing amoxicillin is a common treatment option for the eradication of Helicobacter pylori (H. pylori). While substantial research supports the efficacy and safety of vonoprazan and amoxicillin (VA) dual therapy in the general population, there is still a lack of studies specifically focusing on its safety in elderly patients.

Aim: To evaluate efficacy and safety of VA dual therapy as first-line or rescue treatment for H. pylori in elderly patients.

Methods: As a real-world retrospective study, data were collected from elderly patients aged 60 years and above who accepted VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg thrice daily for 14 days) for H. pylori eradication in the Department of Gastroenterology at Peking University First Hospital between June 2020 and January 2024. H. pylori status was evaluated by ¹³C-urease breath test 6 weeks after treatment. All adverse events (AEs) during treatment were recorded.

Results: In total, 401 cases were screened. Twenty-one cases were excluded due to loss to follow-up, lack of re-examination, or unwillingness to take medication. The total of 380 included cases comprised 250 who received VA dual therapy as first-line treatment and 130 who received VA dual therapy as rescue treatment. H. pylori was successfully eradicated in 239 cases (95.6%) in the first-line treatment group and 116 cases (89.2%) in the rescue treatment group. The overall incidence of AEs was 9.5% for both groups. Specifically, 9.2% of patients experienced an AE in the first-line treatment group and 10.0% in the rescue treatment group. Five patients discontinued treatment due to AE, with a discontinuation rate of 1.3%. No serious AE occurred.

Conclusion: The VA dual therapy regimen as a first-line treatment and a rescue therapy was effective and safe for elderly patients aged 60 and older.