Abstract
Background & Aims: After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. Methods: This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology–Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality.
Results: Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin–bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin–bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization.
Conclusions: Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin–bismuth quadruple therapy, 14-day tetracycline–bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates. ClincialTrials.gov number: NCT02328131.
| Original language | English |
|---|---|
| Pages (from-to) | 2243-2257 |
| Number of pages | 12 |
| Journal | Clinical Gastroenterology and Hepatology |
| Volume | 20 |
| Issue number | 10 |
| Early online date | 23 Sept 2022 |
| DOIs | |
| Publication status | Published - Oct 2022 |
Bibliographical note
Funding Information:Funding This project was promoted and funded by the European Helicobacter and Microbiota Study Group , the Spanish Association of Gastroenterology , and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas .
Data Availability Statement
Data Transparency Statement Raw data were generated by the Spanish Association of Gastroenterology–Research Electronic Data Capture. Derived data supporting the findings of this study are available from the first author and senior corresponding author (O.P.N. and J.P.G.) upon request.Data Sharing Statement The data that support the findings of this study are not publicly available given that the information could compromise the privacy of research participants. However, previously published data on the Hp-EuReg study, or de-identified raw data referring to the current study, as well as further information on the methods used to explore the data, could be shared with no particular time constraint. Individual participant data will not be shared.
Keywords
- Bismuth
- Clarithromycin
- Helicobacter pylori
- Levofloxacin
- Rescue