Comparative hepatic safety between tegoprazan and esomeprazole: a real-world cohort study
Abstract
Introduction: Tegoprazan is a newer P-CAB with favorable tolerability, yet data on hepatic safety remain limited. We compared the incidence of laboratory-defined hepatic events between tegoprazan and esomeprazole, a PPI with a well-established safety profile.
Methods: We conducted a retrospective new-user cohort study at a tertiary hospital in Korea. Adults prescribed tegoprazan or esomeprazole for ≥14 days between March 2019 and December 2024 were included. A laboratory-defined hepatic event was defined as ≥1.5-fold elevation from baseline in ALT, bilirubin, or GGT above the upper limit of normal within 120 days. Propensity score matching was applied, and risks were compared using Cox models.
Results: After matching, 2,970 tegoprazan and 4,634 esomeprazole users were analyzed. Tegoprazan was associated with fewer laboratory-defined hepatic events (adjusted HR 0.73, 95% CI 0.56-0.95). The association was consistent in sensitivity analyses and was also observed in patients with baseline ALT below the upper limit of normal (aHR 0.70, 95% CI 0.53-0.93). Follow-up ALT elevations >100 U/L were less frequent with tegoprazan than esomeprazole (0.8% vs. 2.0%, p = 0.007).
Conclusion: Tegoprazan was associated with fewer laboratory-defined hepatic events than esomeprazole in this dataset. These findings are hypothesis-generating and require confirmation using standardized monitoring and adjudicated outcomes.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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