Randomized trial of vonoprazan-based versus proton-pump inhibitor-based third-line triple therapy with sitafloxacin for Helicobacter pylori.
Aged
Amoxicillin
/ administration & dosage
Anti-Bacterial Agents
/ administration & dosage
Clarithromycin
/ administration & dosage
Drug Therapy, Combination
Esomeprazole
/ administration & dosage
Female
Fluoroquinolones
/ administration & dosage
Gastritis
/ drug therapy
Humans
Lansoprazole
/ administration & dosage
Male
Metronidazole
/ administration & dosage
Middle Aged
Prospective Studies
Proton Pump Inhibitors
/ administration & dosage
Pyrroles
/ administration & dosage
Rabeprazole
/ administration & dosage
Sulfonamides
/ administration & dosage
Treatment Failure
Treatment Outcome
7-day triple therapy
Helicobacter pylori
amoxicillin
sitafloxacin
vonoprazan
Journal
Journal of gastroenterology and hepatology
ISSN: 1440-1746
Titre abrégé: J Gastroenterol Hepatol
Pays: Australia
ID NLM: 8607909
Informations de publication
Date de publication:
Apr 2019
Apr 2019
Historique:
received:
12
05
2018
revised:
15
08
2018
accepted:
20
08
2018
pubmed:
29
8
2018
medline:
10
7
2019
entrez:
29
8
2018
Statut:
ppublish
Résumé
This was a prospective, randomized trial of the efficacy of vonoprazan-based and proton-pump inhibitor-based 7-day triple regimens with amoxicillin and sitafloxacin as a third-line therapy for eradicating Helicobacter pylori after failure of clarithromycin-based and metronidazole-based first-line and second-line therapy. We enrolled 63 patients positive for H. pylori in whom first-line and second-line regimens for eradicating failed. Patients were randomized to the V-AS group (vonoprazan 20-mg bid, amoxicillin 750-mg bid, and sitafloxacin 100-mg bid for 7 days) or PPI-AS group (esomeprazole 20-mg bid, rabeprazole 10-mg bid, or lansoprazole 30-mg bid; amoxicillin 750-mg bid; and sitafloxacin 100-mg bid for 7 days). We assessed the outcome of eradication therapy using the The intention-to-treat and per-protocol eradication rates of V-AS were 75.8% (95% confidence interval [CI]: 57.7-88.9%) and 83.3% (95% CI: 65.3-94.4%), respectively. The respective eradication rates of PPI-AS were 53.3% (95% CI: 34.3-71.7%) and 57.1% (95% CI: 37.2-75.5%). In per-protocol analyses, the eradication rate of the V-AS group was significantly higher than that of the PPI-AS group (P = 0.043); however, no significant differences were observed in intention-to-treat analyses (P = 0.071). Questionnaire scores did not differ significantly between the groups. The findings suggest that 7-day triple therapy with vonoprazan, amoxicillin, and sitafloxacin is more effective than proton-pump inhibitor, amoxicillin, and sitafloxacin as a third-line regimen for eradicating H. pylori.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
This was a prospective, randomized trial of the efficacy of vonoprazan-based and proton-pump inhibitor-based 7-day triple regimens with amoxicillin and sitafloxacin as a third-line therapy for eradicating Helicobacter pylori after failure of clarithromycin-based and metronidazole-based first-line and second-line therapy.
METHODS
METHODS
We enrolled 63 patients positive for H. pylori in whom first-line and second-line regimens for eradicating failed. Patients were randomized to the V-AS group (vonoprazan 20-mg bid, amoxicillin 750-mg bid, and sitafloxacin 100-mg bid for 7 days) or PPI-AS group (esomeprazole 20-mg bid, rabeprazole 10-mg bid, or lansoprazole 30-mg bid; amoxicillin 750-mg bid; and sitafloxacin 100-mg bid for 7 days). We assessed the outcome of eradication therapy using the
RESULTS
RESULTS
The intention-to-treat and per-protocol eradication rates of V-AS were 75.8% (95% confidence interval [CI]: 57.7-88.9%) and 83.3% (95% CI: 65.3-94.4%), respectively. The respective eradication rates of PPI-AS were 53.3% (95% CI: 34.3-71.7%) and 57.1% (95% CI: 37.2-75.5%). In per-protocol analyses, the eradication rate of the V-AS group was significantly higher than that of the PPI-AS group (P = 0.043); however, no significant differences were observed in intention-to-treat analyses (P = 0.071). Questionnaire scores did not differ significantly between the groups.
CONCLUSIONS
CONCLUSIONS
The findings suggest that 7-day triple therapy with vonoprazan, amoxicillin, and sitafloxacin is more effective than proton-pump inhibitor, amoxicillin, and sitafloxacin as a third-line regimen for eradicating H. pylori.
Substances chimiques
1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
0
Anti-Bacterial Agents
0
Fluoroquinolones
0
Proton Pump Inhibitors
0
Pyrroles
0
Sulfonamides
0
Lansoprazole
0K5C5T2QPG
Metronidazole
140QMO216E
Rabeprazole
32828355LL
Amoxicillin
804826J2HU
sitafloxacin
9TD681796G
Clarithromycin
H1250JIK0A
Esomeprazole
N3PA6559FT
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
686-692Subventions
Organisme : Yokohama City University
ID : Basic research expenditure
Informations de copyright
© 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.