Abstract | BACKGROUND: One-week triple therapy with vonoprazan is endorsed by Japanese guidelines as an alternative to proton pump inhibitor (PPI)-based triple therapy for first-line Helicobacter pylori eradication. This contrasts with Western guidelines recommending 2-week PPI-based triple therapy. AIM: To verify the non-inferiority of 1-week vonoprazan-based triple therapy versus 2-week PPI-based triple therapy as first-line H. pylori eradication in a multiracial Asian cohort. METHODS: Randomised controlled trial of treatment-naïve patients with H. pylori infection assigned 1:1 to either 7 days amoxicillin 1 g + clarithromycin 500 mg + vonoprazan 20 mg twice per day or 14 days amoxicillin 1 g + clarithromycin 500 mg + omeprazole OR esomeprazole OR rabeprazole 20 mg twice/day. Subjects were randomly assigned to each PPI 1:1:1 Demographics, H. pylori resistance, CYP 2C19 genotype, eradication success and safety profiles were compared between groups. RESULTS: Between June 2019 and June 2021, 252 of 1097 subjects screened were randomised. 244 (age [SD] 51.7 [14.6]) received vonoprazan- (n = 119) or PPI-based (n = 125) triple therapy. Eradication rates by intention-to-treat analysis were 87.4% ( vonoprazan-based triple therapy) versus 88.0% (PPI-based triple therapy. By per protocol analysis: 96.3% ( vonoprazan-based triple therapy) versus 94.0% (PPI-based triple therapy). Clarithromycin resistance predicted treatment failure on multivariate analysis: RR 11.4; 95% CI [1.4-96.3], p = 0.025. No significant differences in CYP 2C19 genotypes or adverse events occurred between groups. CONCLUSION: One-week vonoprazan-based triple therapy achieved comparable efficacy to 2-week PPI-based triple therapy and was well tolerated.
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Authors | Daphne Ang, Seok Hwee Koo, Yiong Huak Chan, Thean Yen Tan, Gaik Hong Soon, Chin Kimg Tan, Kenneth Weicong Lin, Jaydeesh-Khanna Krishnasamy-Balasubramanian, Yu Jun Wong, Rahul Kumar, Rajesh R, Yiyuan Tan, Peng-Lan Jeannie Ong, Yi-Lyn Jessica Tan, James Weiquan Li, Andrew Boon-Eu Kwek, Tiing Leong Ang |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 56
Issue 3
Pg. 436-449
(08 2022)
ISSN: 1365-2036 [Electronic] England |
PMID | 35665947
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2022 John Wiley & Sons Ltd. |
Chemical References |
- 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
- Anti-Bacterial Agents
- Proton Pump Inhibitors
- Pyrroles
- Sulfonamides
- Amoxicillin
- Clarithromycin
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Topics |
- Amoxicillin
(adverse effects)
- Anti-Bacterial Agents
(adverse effects)
- Clarithromycin
(adverse effects)
- Drug Therapy, Combination
- Helicobacter Infections
(drug therapy)
- Helicobacter pylori
- Humans
- Proton Pump Inhibitors
(adverse effects)
- Pyrroles
- Sulfonamides
- Treatment Outcome
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