Statin-related neurocognitive disorder: a real-world pharmacovigilance study based on the FDA adverse event reporting system.

Abstract

BACKGROUND:

Concerns regarding statin-related neurocognitive disorders have emerged in recent years. However, previous studies have reported inconsistent results. We evaluated the association between statins and neurocognitive disorders using the FDA Adverse Event Reporting System (FAERS).

RESEARCH DESIGN AND METHODS:

Data from 2004 to 2022 were obtained from the FAERS database. After deduplication and standardization of drug names, we extracted neurocognitive disorder event (NCDE) cases reported with statins as the suspected drugs. The significant association between statins and NCDE was evaluated using the reporting odds ratio (ROR) and information component.

RESULTS:

In total, 6,959 NCDE cases with statins as the primary suspected drugs were identified. Signals were detected in pravastatin (ROR, 1.49; 95% CI: 1.32-1.67), atorvastatin (ROR, 1.39; 95% CI: 1.34-1.44), and simvastatin (ROR, 1.31; 95% CI: 1.25-1.38). Age-stratified analysis showed that (1) in the population aged 65 years and older, signals were detected for atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, and pitavastatin; and (2) in populations under 65 years of age, signals were detected for atorvastatin, simvastatin, rosuvastatin, pravastatin, and lovastatin.

CONCLUSIONS:

This study suggests a significant association between the NCDE and statins, including atorvastatin, simvastatin, and pravastatin. The intensity of the association increased with age.

• Authors: Min Xiao, Li Li, Weiwei Zhu, Fengbo Wu, Bin Wu
• Journal: Expert review of clinical pharmacology (Expert Rev Clin Pharmacol) Vol. 17 Issue 3 Pg. 255-261 (Mar 2024) ISSN: 1751-2441 [Electronic] England
• PMID: 38275183 (Publication Type: Journal Article)

Chemical References

• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Rosuvastatin Calcium
• Atorvastatin
• Pravastatin
• Simvastatin
• Lovastatin

Topics

• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (adverse effects)
• Rosuvastatin Calcium (adverse effects)
• Atorvastatin (adverse effects)
• Pravastatin (adverse effects)
• Pharmacovigilance
• Adverse Drug Reaction Reporting Systems
• Simvastatin (adverse effects)
• Lovastatin
• Neurocognitive Disorders (chemically induced)