Statins and reporting signals for amnesia: a pharmacovigilance analysis based on adverse event reporting database.

BACKGROUND: This study aimed to explore the disproportionality reporting signals of amnesia associated with different statins based on a spontaneous adverse event database, so as to provide preliminary pharmacovigilance evidence for subsequent clinical safety evaluation and further pharmacoepidemiological verification. MATERIALS AND METHODS: This study employed pharmacovigilance analysis methods to monitor and analyze adverse event signals associated with seven commonly used statins. Additionally, subgroups were stratified by gender (male, female) and age (18, 45, and 65 years) to investigate the potential associations between statins and amnesia across different populations. Furthermore, a Weibull distribution analysis was used to assess the onset time of adverse events. RESULTS: A total of 56,401 statin-related adverse event reports were included, among which 1,108 valid cases were coded as amnesia. Significant positive pharmacovigilance signals were identified for atorvastatin (n = 326, ROR = 2.82, 95% CI: 2.53-3.15, P < 0.001), simvastatin (n = 600, ROR = 4.94, 95% CI: 4.55-5.35, P < 0.001), pravastatin (n = 68, ROR = 4.77, 95% CI: 3.76-6.06, P < 0.001), and lovastatin (n = 26, ROR = 6.96, 95% CI: 4.73-10.24, P < 0.001). Subgroup analyses stratified by gender and age further identified heterogeneous pharmacovigilance signals across distinct populations. Moreover, Weibull distribution analysis also revealed unique distribution patterns among different statin agents. CONCLUSION: This study identified significant positive pharmacovigilance signals between certain statins and amnesia. The findings of this study provide preliminary disproportionality signals regarding statin-related amnesia, offering exploratory pharmacovigilance references for subsequent safety evaluation and further pharmacoepidemiological validation.