Abstract
Objective: To evaluate the use, effectiveness and safety of Helicobacter pylori empirical rescue therapy in third and subsequent treatment lines in Europe.
Design: International, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis.
Results: Overall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatments other than 10-day single-capsule therapy used high proton-pump inhibitor doses and lasted ≥14 days. Quadruple therapy containing metronidazole, tetracycline and bismuth achieved optimal eradication rates only when prescribed as third-line treatment, either as 10-day single-capsule therapy (87%) or as 14-day traditional therapy with tetracycline hydrochloride (95%). Triple amoxicillin-levofloxacin therapy achieved 90% effectiveness in Eastern Europe only or when optimised. The overall incidence of adverse events was 31%.
Conclusion: Empirical rescue treatment in third and subsequent lines achieved suboptimal effectiveness in most European regions. Only quadruple bismuth-metronidazole-tetracycline (10-day single-capsule or 14-day traditional scheme) and triple amoxicillin-levofloxacin therapies reached acceptable outcomes in some settings. Compliance with empirical therapy optimisation principles is still poor 5 years after clinical practice guidelines update. Trial registration number: NCT02328131.
| Original language | English |
|---|---|
| Article number | 328232 |
| Pages (from-to) | 1054-1072 |
| Number of pages | 19 |
| Journal | Gut |
| Volume | 72 |
| Early online date | 5 Dec 2022 |
| DOIs | |
| Publication status | Published - 5 Dec 2023 |
Bibliographical note
Funding Information:This project was supported and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd).
OPN has received research funding from Mayoly and Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma and Richen. MC-F has received retribution from Allergan for formative actions. AP-A has received retribution from Allergan and Mylan for formative actions. Laimas Jonaitis has served as speaker for KRKA. AL has served as a consultant to Bayer.
Data Availability Statement
Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article or uploaded as supplementary information. The data supporting the conclusions of this study are not publicly available, as their content may compromise the privacy of research participants. However, previously published data from 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, may be shared, with no particular time constraint. Individual participant data will not be shared.Keywords
- antibiotic therapy
- antibiotics
- drug resistance
- Helicobacter pylori
- proton pump inhibition