Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg).
Anti-Bacterial Agents
/ adverse effects
Bismuth
/ adverse effects
Drug Therapy, Combination
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Europe
/ epidemiology
Female
Helicobacter Infections
/ drug therapy
Helicobacter pylori
Humans
Incidence
Male
Middle Aged
Proton Pump Inhibitors
/ adverse effects
Registries
Journal
The American journal of gastroenterology
ISSN: 1572-0241
Titre abrégé: Am J Gastroenterol
Pays: United States
ID NLM: 0421030
Informations de publication
Date de publication:
01 06 2021
01 06 2021
Historique:
received:
07
07
2020
accepted:
23
02
2021
pubmed:
13
4
2021
medline:
1
7
2021
entrez:
12
4
2021
Statut:
ppublish
Résumé
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." 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. 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. 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.
Identifiants
pubmed: 33840725
doi: 10.14309/ajg.0000000000001246
pii: 00000434-202106000-00021
doi:
Substances chimiques
Anti-Bacterial Agents
0
Proton Pump Inhibitors
0
Bismuth
U015TT5I8H
Banques de données
ClinicalTrials.gov
['NCT02328131']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1220-1229Informations de copyright
Copyright © 2021 by The American College of Gastroenterology.
Déclaration de conflit d'intérêts
The remaining list of authors, their affiliations, contributions and conflicts of interests are listed in Supplementary file 1. Contribution Log, available online at http://links.lww.com/AJG/B961.
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