A Japanese population-based meta-analysis of vonoprazan versus PPI for Helicobacter pylori eradication therapy: Is superiority an illusion?

Abstract

Background

Vonoprazan (VPZ) is a novel acid suppressant that has been used in Helicobacter pylori (H. pylori) eradication therapies in recent years. However, the efficacy and safety of VPZ vs proton-pump inhibitor (PPI) in H. pylori eradication therapies remain controversial.

Objective

To perform a meta-analysis in order to assess the efficacy and safety of VPZ vs PPI for H. pylori eradication.

Materials and Methods

The PubMed, EMBASE, and Cochrane Library databases were searched up to July 10, 2017, for relevant randomized controlled trials (RCTs) and nonrandomized clinical studies (NRCTs). The pooled eradication rate (ER) and pooled occurrence rates of adverse events were used to compare the efficacy and safety of VPZ - and PPI-containing regimens.

Result

A total of 14 studies with 14 636 patients were included in this meta-analysis. The results showed that the pooled ER of VPZ -containing regimens was much higher than that of PPI-containing regimens when used as first-line therapies. This difference was significant for both intention-to-treat (85.1% vs 68.0%, P < .00001) and per-protocol analyses (89.0% vs 74.2%, P < .00001). Moreover, subgroup analysis indicated significant superiority of VPZ in both patients with clarithromycin-resistant strains (81.5% vs 40.9%, P < .00001) and those with clarithromycin-susceptible strains (94.9% vs 89.6%, P = .006). However, VPZ did not show superiority to PPI as part of a second-line triple therapy based on both intention-to-treat (83.4% vs 82.0%, P = .79) and per-protocol analyses (89.3% vs 90.1%, P = .06). Finally, RCT subgroup analysis showed the safety of VPZ -containing regimens to be better than PPI-containing regimens (26.4% vs 33.3%, P = .008), whereas there was no significant difference in this regard for the NRCT subgroup analysis (5.7% vs 4.7%, P = .08).

Conclusions

The efficacy of VPZ is superior to PPI in first-line H. pylori triple eradication therapies but not in second-line therapies. The safety of VPZ -containing regimens appears to be equal or even superior to that of PPI. However, most reports included in this study had low levels of evidence. Hence, adequate and high-quality RCTs will be needed to support our results.

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