Fexuprazan and Esomeprazole in Patients with Disorders Associated with Acid Reflux: A Comprehensive Review and Meta-Analysis of Randomized Controlled Trials

TL;DR

This study compares fexuprazan and esomeprazole for acid reflux disorders but finds very uncertain evidence about their effectiveness and safety.

Contribution

A meta-analysis comparing fexuprazan and esomeprazole in acid reflux disorders using randomized controlled trials.

Findings

Fexuprazan showed little to no difference compared to esomeprazole in healing erosive esophagitis.

No significant differences were found in symptom resolution or adverse events between the two drugs.

The certainty of evidence for all outcomes was rated as very low.

Abstract

Background: This investigation compared the efficacy and safety of fexuprazan 40 mg and esomeprazole 40 mg in patients with acid reflux-related disorders, including erosive esophagitis (EE) and laryngopharyngeal reflux disease (LPRD). Methods: A systematic search was conducted across five databases until January 2025. Primary outcomes included esophageal lesion healing, complete resolution of symptoms (CRS), and 24 h symptom-free days. Meta-analyses used random-effects models with the inverse variance method. The Risk of Bias 2.0 tool and the certainty of evidence (CoE) using GRADE methodology were assessed. Results: Three randomized controlled trials (n = 695) conducted in Asian countries were included. Fexuprazan may have little to no effect compared to esomeprazole on EE healing rate at 4 weeks (RR 1.02, 95% CI 0.93 to 1.12, I2 = 0%, n = 2 studies, CoE very low) and 8 weeks. No significant differences were found between treatments regarding CRS at 1 week (RR 1.29; 95% CI: 0.84 to 1.99; I2 = 0%; n = 2 studies; CoE very low) and 8 weeks, or in the 24 h symptom-free days at 1 week (MD 2.67 days, 95% CI −2.76 to 8.10, I2 = 41%, n = 2 studies, CoE very low) and 8 weeks. Fexuprazan also showed little to no effect on treatment-emergent adverse events (RR 1.00, 95% CI 0.83 to 1.20, I2 = 0%, n = 3 studies, CoE very low). Nonetheless, the evidence for all outcomes was rated as very uncertain. Conclusions: Fexuprazan 40 mg may provide similar efficacy compared to esomeprazole 40 mg in EE, with a comparable safety profile to esomeprazole in EE and LPRD patients. However, the evidence is highly uncertain, requiring further studies.

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