Abstract
INTRODUCTION: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the “European Registry on Helicobacter pylori management.” METHODS: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. RESULTS: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. DISCUSSION: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.
| Original language | English |
|---|---|
| Pages (from-to) | 1220-1229 |
| Number of pages | 10 |
| Journal | American journal of gastroenterology |
| Volume | 116 |
| Issue number | 6 |
| Early online date | 8 Apr 2021 |
| DOIs | |
| Publication status | Published - 1 Jun 2021 |
Bibliographical note
Funding Information:Guarantor of the article: Javier P. Gisbert, MD. Specific author contributions: O.P.N.: Scientific Director, member of the project’s Scientific Committee, coordinated the study, designed, and programmed the electronic case report form, reviewed, analyzed, and interpreted the data, drafted the manuscript, and approved the submitted manuscript. A.P.-A., B.T., M.C.-F., L.J., L.B., A.L., N.B.J., J.P.-L., G.F., J.M.H., Z.K., I.V., M.A., L.F.-S., L.R., S.A., J.B., J.O., M.P., L.V., P.M.R., O.Z., S.G., R.P., I.M., B.J.G.R., C.S., M.R.L., T.I., J.G.C., M.D.-C., V.N., N.N.D., and O.N.: collected and helped interpret data, critically reviewed the manuscript, and approved the submitted manuscript. J.K., O.S., D.B., M.L., J.C.M., T.R., G.M.B., I.S., P.P., F.L., M.V., and F.H.: acted as National Coordinators and as recruiters. They selected national recruiters, collected and helped interpret data, critically reviewed the manuscript, and approved the submitted manuscript. M.C.: supervised, coordinated, and monitored the data collection, interpreted the data, critically reviewed the manuscript, and approved the submitted manuscript. I.P.: Scientific Director and member of the project’s Scientific Committee, critically reviewed the manuscript draft, and approved the submitted manuscript. F.M.: member of the project’s Scientific Committee, designed the protocol, planned the study, critically reviewed the manuscript, and approved the submitted manuscript. C.O’M.: member of the project’s Scientific Committee, designed the protocol, planned the study, critically reviewed the manuscript, and approved the submitted manuscript. J.P.G.: director of the project and member of the project’s Scientific Committee, obtained funding, designed the protocol andplannedthe study, actedasthe National Spanish Coordinator, recruited patients, analyzed and interpreted the data, critically reviewed the manuscript, and approved the submitted manuscript. Funding support: This 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). Potential competing interests: J.P.G. served as a speaker, a consultant and advisory member for, or has received research funding from Mayoly, Allergan, and Diasorin. O.P.N. received research funding from Allergan and Mayoly. M.C.-F. received funding from Allergan for training activities. A.P.-A. received funding from Allergan and Mylan for training activities. D.B. served as a lecturer for Astellas, AstraZeneca, KRKA, and Abbott. The remaining authors have no conflicts of interest to declare.
