Cardiovascular Medications and Dementia Risk in Older Adults: A Literature Review and Disproportionality Analysis Using OpenVigil FAERS Data

Abstract

Background

Cardiovascular medications are commonly prescribed to older adults; however, their potential association with cognitive decline remains poorly understood.

Objective

This study aimed to systematically evaluate the relationship between cardiovascular drugs and the risk of dementia.

Methods

(1) A retrospective disproportionality analysis of the FDA Adverse Event Reporting System data, accessed via OpenVigil 2.1, which examined 97 cardiovascular drugs across 14 therapeutic categories in patients aged ≥60 years, and (2) a literature review of case-reports of drug-induced cognitive impairment.

Results

Of the 97 drugs analyzed, disproportionate reporting signals (indicating more frequent reporting than expected by chance) were identified for 38 (39.2%) across four types of dementia: dementia (13.4%), Alzheimer’s disease (16.5%), vascular dementia (18.6%), and dementia with Lewy-bodies (6.2%). ACE inhibitors exhibited the highest signal rate (75.0%). Thirteen case-reports were identified, primarily involving statins (53.8%). Discontinuation of the drug resulted in cognitive improvement in 12/13 cases.

Conclusions

This study identifies disproportionate dementia-related adverse event reporting for nearly 40% of cardiovascular drugs examined, with ACE inhibitors and ARBs showing the highest signal rates. However, these findings are preliminary and require validation through future pharmacoepidemiological studies.