Risk of Clostridioides difficile infection with potassium-competitive acid blockers: A systematic review with restricted quantitative synthesis
Ah Young Lee, Kwanjoo Lee, Sun Jae Moon, Seung-Hun You, Jun-young Seo, Wonsuk ShinBackground
The risk of
Objective
This study aimed to systematically synthesize available evidence on CDI risk among P-CAB users.
Design
Systematic review with restricted quantitative synthesis.
Data sources and methods
Studies evaluating P-CAB use and CDI-related outcomes were identified through searches of PubMed/MEDLINE, Embase, and the Cochrane Library. Owing to heterogeneity in P-CAB agents, comparators, study designs, and effect measures, the primary quantitative synthesis was restricted to incidence-based odds ratio (OR)-scale estimates from studies directly comparing vonoprazan with proton pump inhibitors (PPIs). Studies involving other P-CABs, alternative comparators, hazard ratios, risk ratios, or pharmacovigilance-derived ORs were summarized narratively because they were not directly comparable with the primary clinical contrast.
Results
Five studies were included, of which two directly comparing vonoprazan with PPIs were eligible for quantitative synthesis. The pooled estimate indicated no significant difference in CDI risk between vonoprazan and PPIs (OR, 1.07; 95% confidence interval [CI], 0.91–1.25). Contextual cohort studies investigating tegoprazan or mixed P-CAB exposure did not show a significant increase in CDI risk compared with conventional acid suppressants; however, they differed in terms of the agents, comparators, and effect measures used. Pharmacovigilance analyses indicated disproportionate reporting signals for vonoprazan-associated CDI; however, these estimates were not pooled with incidence-based risk estimates.
Conclusion
Current incidence-based comparative evidence remains limited and does not support a significant increase in CDI risk with P-CABs compared with conventional acid suppressants. In the restricted vonoprazan-versus-PPI comparison, the pooled OR was 1.07 (95% CI, 0.91–1.25). Agent-specific conclusions remain limited.