Effectiveness and safety of vonoprazan-based regimens compared with those of proton pump inhibitor (PPI)-based regimens as first-line agents for Helicobacter pylori: a meta-analysis of randomized clinical trials

Yingchao Sun; Lei Yue; Weiling Hu

doi:10.1007/s00228-022-03430-y

Effectiveness and safety of vonoprazan-based regimens compared with those of proton pump inhibitor (PPI)-based regimens as first-line agents for Helicobacter pylori: a meta-analysis of randomized clinical trials

Eur J Clin Pharmacol. 2023 Feb;79(2):279-288. doi: 10.1007/s00228-022-03430-y. Epub 2022 Dec 17.

Authors

Yingchao Sun¹, Lei Yue¹, Weiling Hu^{2

3

4}

Affiliations

¹ Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China.
² Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, No. 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, China. huweiling@zju.edu.cn.
³ Institute of Gastroenterology, Zhejiang University (IGZJU), Hangzhou, China. huweiling@zju.edu.cn.
⁴ Zhejiang University Cancer Center, Hangzhou, China. huweiling@zju.edu.cn.

PMID: 36527456
DOI: 10.1007/s00228-022-03430-y

Abstract

Purpose: Vonoprazan (VPZ), a reversible H⁺-K⁺ ATPase inhibitor, has a relatively fast and sustained acid-suppression action that is unaffected by diet or gene polymorphisms. Several randomized controlled trials have evaluated the difference in the eradication rate of Helicobacter pylori (HP) between VPZ-based and proton pump inhibitor (PPI)-based regimens. The present review aimed to (1) evaluate the efficacy, safety, and compliance of VPZ-based regimens compared with those of PPI-based regimens as first-line treatments for HP infection and (2) perform a subgroup analysis to examine the influence of differences in clarithromycin-resistance status, treatment duration, treatment regimens, and research region on treatment outcomes.

Methods: We conducted a systematic literature search on PubMed, Embase, Cochrane Library, Web of Science, and ChiCTR Register. Systematic searches, study selection, data extraction, risk of bias assessment, and statistical analysis were performed according to pre-registered protocol on the PROSPERO (CRD42022336608).

Results: Eight studies and 2956 HP-infected patients were enrolled. Only first-line therapy and RCT study were considered. VPZ-based group had a superior eradication efficacy compared to PPI-based group by intention-to-treat (ITT) (pooled risk ratio (RR): 1.14, 95% CI: 1.08-1.21, p < 0.00001) and per-protocol analysis (pooled RR: 1.13, 95% CI: 1.07-1.20, p < 0.00001). This finding was further validated by subgroup analysis depending on treatment regimens, duration, region, and clarithromycin resistance. In addition, there was no significant difference in adverse events (p = 0.33) and compliances (p = 0.30) between the regimens.

Conclusion: The VPZ-based regimens showed a superior eradication efficacy compared to the already frequently used PPI-based regimens. Furthermore, VPZ-based therapy showed comparable tolerability and incidence of adverse events.

Keywords: First-line therapy; Helicobacter pylori eradication; Meta-analysis; Proton-pump inhibitor; Vonoprazan.

Publication types

Meta-Analysis
Review

MeSH terms

Amoxicillin
Anti-Bacterial Agents / adverse effects
Anti-Bacterial Agents / therapeutic use
Clarithromycin / adverse effects
Clarithromycin / therapeutic use
Drug Therapy, Combination
Helicobacter Infections* / drug therapy
Helicobacter pylori
Humans
Proton Pump Inhibitors* / adverse effects
Proton Pump Inhibitors* / therapeutic use
Pyrroles* / adverse effects
Pyrroles* / therapeutic use
Randomized Controlled Trials as Topic
Treatment Outcome

Substances

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
Amoxicillin
Anti-Bacterial Agents
Clarithromycin
Proton Pump Inhibitors
Pyrroles