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.

Plain Language Summary

With the extensive use of statins worldwide in recent years, some patients have reported that statins lead to cognitive impairment. Researchers have conducted studies on this issue; however, the results have been inconsistent. Some believe that statins have no impact on cognitive function, while others believe they are beneficial, and others believe they have negative effects.To further investigate this issue, we analyzed data from the FDA adverse event reporting system, which collects adverse drug reactions reported by people worldwide, to evaluate the association between statins and cognitive impairment. Our findings suggest that some statins are associated with cognitive impairment. Therefore, when cognitive changes occur in patients taking statins, they should be taken seriously.

KEYWORDS:

• FAERS
• neurocognitive disorder
• pharmacovigilance
• signal
• statin

Article highlights

• There is a significant association between certain statins (atorvastatin, simvastatin, and pravastatin) and neurocognitive disorders.

• The intensity of the association increases with age, indicating an increased risk in older populations.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

M Xiao: Conceptualization, Formal analysis, Writing-original draft. B Wu and F Wu: Methodology, Software, Validation, Writing-review & editing. L Li: Formal analysis and review. W Zhu: Formal analysis, Visualization analysis and review. All authors have read and approved the final version of the manuscript.

Acknowledgments

The authors thank the National Key Clinical Specialties Construction Program for its support.

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17512433.2024.2311875

Additional information

Funding

This manuscript was funded by the Sichuan Provincial Health Commission under Grant [No. ChuanGanYan 2022-119].