Comparison of vonoprazan-based with rabeprazole-based dual therapy for treatment-naive patients of Helicobacter pylori infection : a prospective, multi-center, randomized controlled study
© 2023. Japanese Society of Gastroenterology..
BACKGROUND: The application of vonoprazan significantly improved the eradication rate of Helicobacter pylori (H. pylori). This study aimed to compare efficacy and safety of the 10-day vonoprazan-amoxicillin (VA) and 14-day rabeprazole-amoxicillin (RA) dual therapy, and to provide a more efficient, safer, and convenient dual regimen for H. pylori infection.
METHODS: This was a prospective, open-label, multi-center, randomized controlled study of treatment-naive patients with H. pylori infection. The participants were randomly assigned to the 10-day VA group with vonoprazan 20 mg Bid plus amoxicillin 1 g Tid or the 14-day RA group with rabeprazole 10 mg Tid plus amoxicillin 1 g Tid. The effectiveness, the adverse events, and the patient compliance of the two groups were compared.
RESULTS: A total of 690 patients were enrolled. The eradication rates of 10-day VA and 14-day RA dual therapy were 89.3% and 84.9% in intention-to-treat (ITT) analysis (P = 0.088); 90.6% and 85.9% by modified intention-to-treat (mITT) analysis (P = 0.059); 91.4% and 86.6% by per-protocol (PP) analysis (P = 0.047). Non-inferiority was confirmed between the two groups (all P < 0.001). No discernible differences were observed in adverse effects and compliance between groups. Poor compliance reduced the eradication efficacy (P < 0.05).
CONCLUSIONS: The 10-day VA dual therapy was non-inferior to the 14-day RA dual therapy for H. pylori treatment-naive patients, which should be given priority in the first-line treatment. The application of vonoprazan reduced treatment course and antibiotic use. Patients' adherence was crucial for the success of eradication.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:58 |
|---|---|
| Enthalten in: |
Journal of gastroenterology - 58(2023), 12 vom: 01. Dez., Seite 1167-1177 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Han, Ying-Ying [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 27.11.2023 Date Revised 28.11.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s00535-023-02042-2 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM362738688 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM362738688 | ||
| 003 | DE-627 | ||
| 005 | 20231226091852.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s00535-023-02042-2 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1209.xml |
| 035 | |a (DE-627)NLM362738688 | ||
| 035 | |a (NLM)37777987 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Han, Ying-Ying |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Comparison of vonoprazan-based with rabeprazole-based dual therapy for treatment-naive patients of Helicobacter pylori infection |b a prospective, multi-center, randomized controlled study |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 27.11.2023 | ||
| 500 | |a Date Revised 28.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. Japanese Society of Gastroenterology. | ||
| 520 | |a BACKGROUND: The application of vonoprazan significantly improved the eradication rate of Helicobacter pylori (H. pylori). This study aimed to compare efficacy and safety of the 10-day vonoprazan-amoxicillin (VA) and 14-day rabeprazole-amoxicillin (RA) dual therapy, and to provide a more efficient, safer, and convenient dual regimen for H. pylori infection | ||
| 520 | |a METHODS: This was a prospective, open-label, multi-center, randomized controlled study of treatment-naive patients with H. pylori infection. The participants were randomly assigned to the 10-day VA group with vonoprazan 20 mg Bid plus amoxicillin 1 g Tid or the 14-day RA group with rabeprazole 10 mg Tid plus amoxicillin 1 g Tid. The effectiveness, the adverse events, and the patient compliance of the two groups were compared | ||
| 520 | |a RESULTS: A total of 690 patients were enrolled. The eradication rates of 10-day VA and 14-day RA dual therapy were 89.3% and 84.9% in intention-to-treat (ITT) analysis (P = 0.088); 90.6% and 85.9% by modified intention-to-treat (mITT) analysis (P = 0.059); 91.4% and 86.6% by per-protocol (PP) analysis (P = 0.047). Non-inferiority was confirmed between the two groups (all P < 0.001). No discernible differences were observed in adverse effects and compliance between groups. Poor compliance reduced the eradication efficacy (P < 0.05) | ||
| 520 | |a CONCLUSIONS: The 10-day VA dual therapy was non-inferior to the 14-day RA dual therapy for H. pylori treatment-naive patients, which should be given priority in the first-line treatment. The application of vonoprazan reduced treatment course and antibiotic use. Patients' adherence was crucial for the success of eradication | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Dual therapy | |
| 650 | 4 | |a Eradication rate | |
| 650 | 4 | |a Helicobacter pylori | |
| 650 | 4 | |a Rabeprazole | |
| 650 | 4 | |a Vonoprazan | |
| 650 | 7 | |a Rabeprazole |2 NLM | |
| 650 | 7 | |a 32828355LL |2 NLM | |
| 650 | 7 | |a 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |2 NLM | |
| 650 | 7 | |a Proton Pump Inhibitors |2 NLM | |
| 650 | 7 | |a Clarithromycin |2 NLM | |
| 650 | 7 | |a H1250JIK0A |2 NLM | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
| 650 | 7 | |a Amoxicillin |2 NLM | |
| 650 | 7 | |a 804826J2HU |2 NLM | |
| 700 | 1 | |a Zhou, Lin |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Yun-Lian |e verfasserin |4 aut | |
| 700 | 1 | |a Ding, Xiang-Wu |e verfasserin |4 aut | |
| 700 | 1 | |a Long, Hui |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Fei |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Ming |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Zhen-Yu |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Shuang-Ling |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Qiu-Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Su, Cheng-Xia |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Jie |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Ya |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Pei-Yuan |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of gastroenterology |d 1994 |g 58(2023), 12 vom: 01. Dez., Seite 1167-1177 |w (DE-627)NLM074913832 |x 1435-5922 |7 nnns |
| 773 | 1 | 8 | |g volume:58 |g year:2023 |g number:12 |g day:01 |g month:12 |g pages:1167-1177 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s00535-023-02042-2 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 58 |j 2023 |e 12 |b 01 |c 12 |h 1167-1177 | ||