May 21, 2021Scientific ReportsOpen Access

A pharmacovigilance study of association between proton pump inhibitor and dementia event based on FDA adverse event reporting system data

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Why the study?

Proton pump inhibitors are widely used globally, but prior studies have reported conflicting results regarding the association between proton pump inhibitor treatment and dementia events.

Does proton pump inhibitor use increase the risk of dementia events in patients reported in the FAERS database?

Structured PICO

Does proton pump inhibitor use increase the risk of dementia events in patients reported in the FAERS database?

Population

12,875,561 adverse event cases reported in the US FDA Adverse Event Reporting System (FAERS) database from 2004 to 2020, of which 6,074,285 were reported by health professionals. The analysis included 2,396 dementia cases with PPI treatment.

Intervention

Proton pump inhibitors (PPIs) including dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole

Comparator

Anticholinergic drugs (AC) and benzodiazepine drugs (BD) as positive controls, and background non-dementia cases in the FAERS database

Outcome

Dementia event (detected via proportional reporting ratio [PRR] and information component [IC])safety

Data mining of the FAERS database revealed no significant association between proton pump inhibitor use and dementia events, even with long-term therapy.

Limitations

FAERS is a spontaneous reporting system subject to under-reporting, over-reporting, or missing data
Time event comparison only included limited cases with time data reported
Risk of stimulated reporting could not be eliminated

Discussion

No takes yet. Share an insight, caveat, or question.

Implication

FAERS signals for PPI-dementia association warrant monitoring; leaves open causal confirmation in prospective studies.

Cite This Study

Wu et al. (2021) studied this question.

synapsesocial.com/papers/6a6fb6e435aa2c282ce10e23 https://doi.org/10.1038/s41598-021-90108-7

View Full Paper

Ask AI

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A pharmacovigilance study of association between proton pump inhibitor and dementia event based on FDA adverse event reporting system data

Structured PICO

Limitations

Discussion

Implication

Cite This Study

A pharmacovigilance study of association between proton pump inhibitor and dementia event based on FDA adverse event reporting system data

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Also Consider

Also Consider