Comparative efficacy and safety of fexuprazan versus esomeprazole in gastroesophageal reflux disease: a systematic review and meta-analysis

Background Fexuprazan is a newly emerging potassium-competitive acid blocker (P-CAB) medication. P-CAB drugs have been introduced as alternative medications for gastroesophageal reflux disease (GERD) instead of traditionally used proton-pump inhibitors (PPIs). Aim This study aims to compare the efficacy and safety of fexuprazan in contrast to esomeprazole. Methods An electronic search was conducted on major databases, and retrieved results were subjected to two stages of filtration based upon a preset inclusion criterion. The first stage filtered articles based on their titles and abstracts, and the second stage filtered articles based on their full texts. Articles found fit to include in this study were extracted using a pre-set piloted extraction form. Extraction results were introduced into a spreadsheet. Data was divided into categorical and numerical data. Categorical data was reported as counts and frequencies, while continuous data was reported as proportions, means, and standard deviations. Common and random effect meta-analyses were conducted as found fit. Risk of bias assessment was performed using the Cochrane’s risk of bias assessment (RoB 2.0) tool. Results Five articles were included in the present review, describing 965 patients managed with fexuprazan 40 mg or esomeprazole 40 mg for a mean of 9.6 weeks. The mean age of patients was 50.2 ± 13.0 years. GERD symptom scores showed a numerically lower value in the fexuprazan group (SMD − 0.41 [95% CI: −1.10; 0.29], p = 0.25), though this difference was not statistically significant and the confidence interval crosses the null ( I 2 = 94.5%, p < 0.01). The proportion of patients reporting symptom improvement did not differ significantly between groups (RR 0.85 [95% CI: 0.6; 1.22], p = 0.39; I 2 = 91.3%, p < 0.01). No significant difference was observed in the incidence of treatment-emergent adverse events (TEAEs; RR 1.07 [95% CI: 0.9; 1.27], p = 0.45; I 2 = 0.0%) or adverse drug reactions (ADRs; RR 1.10 [95% CI: 0.79; 1.53], p = 0.59; I 2 = 0.0%). Conclusion No statistically significant difference in efficacy was identified between fexuprazan and esomeprazole; however, preliminary findings are consistent with non-inferiority. No statistically significant difference in the incidence of TEAEs or ADRs was observed between treatments, suggesting a comparable safety profile. Systematic review registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420261286108 .