Tegoprazan as First- and Second-Line Therapy for Eradication of Helicobacter pylori Infection: A Systematic Review and Meta-Analysis

Objective

To evaluate the efficacy and safety of tegoprazan (TPZ) compared to conventional proton pump inhibitors (PPIs) for Helicobacter pylori eradication as first- and second-line therapies.

Methods

Four databases were searched for randomized controlled trials (RCTs) and retrospective studies comparing TPZ- and PPI-based regimens for H. pylori eradication published until October 15, 2024. A random-effects model was used to calculate pooled odds ratio (OR) and 95% confidence interval (CI) based on intention-to-treat and per-protocol analyses. The PROSPERO registration number of the study is CRD42024622705.

Results

Nine studies (three RCTs and six retrospective studies) involving 5228 treatment-naïve patients were included. TPZ was non-inferior to PPIs as a first-line therapy (intention-to-treat: odds ratio [OR] 1.066, 95% confidence interval [CI] 0.929–1.224; per-protocol: OR 1.142, 95% CI: 0.967–1.349). Subgroup analyses showed no significant differences based on study design, therapeutic regimen, or treatment duration. In patients with clarithromycin-resistant strains confirmed by 23S rRNA sequencing, TPZ achieved a higher eradication rate (OR 4.961, 95% CI 1.024–24.030). TPZ was associated with significantly lower odds of abdominal discomfort compared to PPIs (OR 0.490, 95% CI 0.268–0.897). Regarding treatment duration, a 14-day regimen was linked to a lower risk of diarrhea, while a 7-day regimen was associated with a higher risk of abdominal pain. No significant differences were observed in second-line therapeutic outcomes.

Conclusions

TPZ represents a non-inferior alternative to PPIs for H. pylori eradication, with potential benefits in clarithromycin-resistant infections and favorable safety profiles. Future studies are warranted to assess higher dosages and address pharmacokinetic limitations.