Objective  To systematically review the efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease (GERD).

Methods  PubMed, Embase, Web of Science, Cochrane Library, SinoMed, CNKI, VIP, and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on tegoprazan for GERD treatment from inception to January 1, 2025. Two researchers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was performed using RevMan 5.4 software and Stata 16 software.

Results  A total of 7 RCTs were included, involving 1,329 patients. The results of Meta-analysis showed that there was no statistically significant difference in the overall effective rate between the tegoprazan group and the control group (placebo or proton pump inhibitors) [RR=1.08, 95%CI (0.99, 1.17), P=0.07]. There was also no statistically significant difference in the cure rate between the tegoprazan group and the control group (proton pump inhibitors) [RR=0.99, 95%CI (0.96, 1.02), P=0.53]. Comparing the incidence of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) during treatment between the tegoprazan group and the control group, no statistically significant differences were found [TEAE: RR=0.90, 95%CI (0.62, 1.32), P=0.60; SAE: RR=0.61, 95%CI (0.26, 1.48), P=0.28]. In terms of specific adverse event, the incidence of abnormal liver function was significantly higher in the tegoprazan group compared to the control group [RR=7.60, 95%CI (1.40, 42.27), P=0.02], while the incidence of other adverse reactions showed no significant differences (P>0.05).

Conclusion  Tegoprazan has relatively good overall efficacy and safety in the treatment of GERD, and its efficacy is similar to that of proton pump inhibitors, which can be used as an alternative treatment for proton pump inhibitors. Due to the limited quality and quantity of the included studies, more high-quality RCTs are needed to verify the above conclusion.

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