Safety Monitoring of Hepatic and Renal Events with Potassium-Competitive Acid Blockers Using WHO VigiBase

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Key Points

The study aimed to identify hepatic and renal adverse events linked to potassium-competitive acid blockers (P-CABs) and assess their safety profiles.
Analyzed VigiBase data from 2014 to 2024 to find adverse events related to P-CABs.
Compared adverse events with those of all other drugs and proton pump inhibitors (PPIs).
Coded adverse events using Preferred Terms for both hepatic and renal issues.
Conducted disproportionality analyses to find significant safety signals.
Significant RORs for hepatic events were noted: 5.94 compared to all other drugs and 15.82 compared to PPIs.
Limited renal events showed RORs of 1.62 and 0.03 for comparators, indicating no significant safety signals.
The majority of adverse events were reported in women and individuals over 65 years.
Vonoprazan was identified as a significant contributor to hepatic adverse events.

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Analysis identified safety profiles of potassium-competitive acid blockers, highlighting adverse hepatic events, especially with Vonoprazan.

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Hong et al. (2026) studied this question.

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