Safety profile of Helicobacter pylori eradication treatments: literature review and updated data of the European Registry on Helicobacter pylori management (Hp-EuReg)

ABSTRACT

Introduction

Helicobacter pylori (H. pylori), the most prevalent chronic infection globally, is the major cause of relevant diseases such as gastric cancer, leading to high morbidity and mortality worldwide. Several studies have focused on optimize H. pylori eradication treatment through combination therapies and antibiotic resistance. However, the adverse events profile and its impact, as a primary outcome, remains underexplored.

The aim of this review was to summarize the available data on the safety of the most common regimens for H. pylori eradication and its impact on the compliance.

Areas covered

This review encompassed the published evidence from the years 2008 to 2023 regarding both the safety and compliance for most common H. pylori eradication regimens. The main sources for this review comprised MEDLINE, PubMed, and Cochrane electronic databases. Furthermore, it included a safety analysis of unpublished data from the European Registry on H. pylori management (Hp-EuReg).

Expert opinion

Poor compliance is correlated with significantly lower cure rates, and this is a unique modifiable source of H. pylori treatment failure. Eradication treatments have become complex, involving multiple drugs and dosing intervals. Thus, patient education is crucial; doctors must explain to the patient about potential temporary and most often harmless side effects.

KEYWORDS:

• Helicobacter pylori
• eradication treatment
• safety
• compliance
• European registry on Helicobacter pylori management (Hp-EuReg)

Article highlights

• H. pylori eradication regimens lead to at least one AE in 20–30% of patients, mainly digestive symptoms such as metallic taste, dyspepsia, and diarrhea.

• AEs are generally mild and temporary, leading to treatment discontinuation in less than 2% of the patients.

• The compliance influences in eradication, higher eradication rates are observed in compliant patients.

• Given the complexity of eradication treatments, patient education about potential adverse events is essential to improve compliance and manage expectations.

• Vonoprazan-containing regimens and the addition of probiotics to the regimens may improve tolerance and compliance. Further research is needed to confirm their benefits.

Declaration of interests

OP Nyssen has received research funding from Mayoly and Allergan. JP Gisbert has served as a speaker, consultant, and advisory member. Foror has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

I Luzko drafted the manuscript. OP Nyssen performed the data analysis update on the safety of treatments collected as part of the Hp-EuReg; performed the meta-analysis of included studies, and reviewed the manuscript drafts. JP Gisbert, and L Moreira critically reviewed the manuscript drafts. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.

Data for our meta-analysis

PROSPERO registration number for systematic review and meta-analysis: 498952.

No specific protocol was prepared.

Acknowledgments

The Hp-EuReg project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG) and received support from the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd).

The Hp-EuReg was co-funded by the European Union programme HORIZON (grant agreement number 101095359) and supported by the UK Research and Innovation (grant agreement number 10058099). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency (HaDEA). Neither the European Union nor the granting authority can be held responsible for them.

The Hp-EuReg was co-funded by the European Union programme EU4Health (grant agreement number 101101252).

The Hp-EuReg study was funded by Diasorin; however, clinical data were not accessible and the company was not involved in any stage of the Hp-EuReg study (design, data collection, statistical analysis, or manuscript writing). We want to thank Diasorin for their support.

Data availability statement

The data analyzed during the current study are openly available in public repositories.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2338245.

Additional information

Funding

This paper was not funded.