JGH open : an open access journal of gastroenterology and hepatology · 2025
Tegoprazan Versus Proton Pump Inhibitors for Erosive Esophagitis: A Meta-Analysis of Noninferiority Randomized Controlled Trials.
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Bhatti Muhammad Imaz, Safiullah Muhammad, Ijaz Azka, Mehmood Qasim, Shahid Ishmal Fatima, Shahriar Zahin
Аннотация
PURPOSE: Proton pump inhibitors (PPIs) remain the standard treatment option for erosive esophagitis (EE) but have notable limitations due to side effects associated with long-term use. Tegoprazan, a novel potassium-competitive acid suppressant (P-CAB), may provide an alternative treatment option. In this study, we aim to evaluate the healing rates of EE using tegoprazan versus PPIs, along with their respective safety profiles.
METHODS: A comprehensive literature search was conducted in PubMed, Embase, and ClinicalTrials.gov from inception to March 2025. Risk of bias was evaluated using the Cochrane RoB 2.0 tool. Pooled estimates were calculated using random-effects models in Review Manager 5.4.
RESULTS: Three RCTs encompassing a total of 766 patients were included in the analysis. Tegoprazan demonstrated comparable healing rates to PPIs at both 4 weeks (risk ratio [RR] 1.05; 95% confidence interval [CI]: 0.99-1.11; p = 0.12) and 8 weeks (RR 1.02; 95% CI: 0.98-1.06; p = 0.35). Subgroup analyses by dose (50 and 100 mg) showed no significant differences. While overall adverse event rates were similar between groups, the incidence of headache was numerically lower in the tegoprazan group (1.3% vs. 4.2%; RR = 0.40; 95% CI: 0.08-2.00; p = 0.26), though this difference was not statistically significant.
CONCLUSION: Tegoprazan shows comparable efficacy and safety to standard PPIs for treating EE. While healing rates were slightly higher, particularly with the 100 mg dose, the differences were not statistically significant. Tegoprazan may be a suitable alternative for patients intolerant to PPIs, though larger, long-term, multiethnic studies are warranted to confirm these findings and assess patient-centered outcomes.
METHODS: A comprehensive literature search was conducted in PubMed, Embase, and ClinicalTrials.gov from inception to March 2025. Risk of bias was evaluated using the Cochrane RoB 2.0 tool. Pooled estimates were calculated using random-effects models in Review Manager 5.4.
RESULTS: Three RCTs encompassing a total of 766 patients were included in the analysis. Tegoprazan demonstrated comparable healing rates to PPIs at both 4 weeks (risk ratio [RR] 1.05; 95% confidence interval [CI]: 0.99-1.11; p = 0.12) and 8 weeks (RR 1.02; 95% CI: 0.98-1.06; p = 0.35). Subgroup analyses by dose (50 and 100 mg) showed no significant differences. While overall adverse event rates were similar between groups, the incidence of headache was numerically lower in the tegoprazan group (1.3% vs. 4.2%; RR = 0.40; 95% CI: 0.08-2.00; p = 0.26), though this difference was not statistically significant.
CONCLUSION: Tegoprazan shows comparable efficacy and safety to standard PPIs for treating EE. While healing rates were slightly higher, particularly with the 100 mg dose, the differences were not statistically significant. Tegoprazan may be a suitable alternative for patients intolerant to PPIs, though larger, long-term, multiethnic studies are warranted to confirm these findings and assess patient-centered outcomes.