Dataset Information

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database.

ABSTRACT:

Introduction

Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs).

Objective

We aimed to investigate the occurrence of neuropsychiatric ADRs related to PCSK9Is.

Methods

We analyzed Individual Case Safety Reports (ICSRs) sent through the European pharmacovigilance database that reported alirocumab or evolocumab as the suspected drug and at least one neurological or psychiatric ADR. The reporting odds ratio (ROR) was computed to compare the probability of reporting ICSRs with neuropsychiatric ADRs between alirocumab, evolocumab and statins.

Results

Overall, 2041 ICSRs with alirocumab and/or evolocumab as the suspected drug described the occurrence of neuropsychiatric ADRs. The most reported preferred terms for both drugs were headache, insomnia and depression. No difference between alirocumab and evolocumab was observed for the RORs of ICSRs with ADRs belonging to the System Organ Classes (SOCs) 'Nervous system disorders' or 'Psychiatric disorders' (ROR 1.02, 95% confidence interval 0.91-1.14; and 1.12, 95% CI 0.94-1.34, respectively), while evolocumab and alirocumab had a higher reporting probability of ICSRs with ADRs belonging to the SOC 'Nervous system disorders' compared with atorvastatin and fluvastatin. A lower reporting probability was instead found for ICSRs with ADRs belonging to the SOC 'Psychiatric disorders' for evolocumab and alirocumab versus simvastatin, pravastatin and rosuvastatin.

Conclusion

Our results demonstrated that 22.7% of all ICSRs reporting alirocumab or evolocumab as suspect drugs described the occurrence of neuropsychiatric ADRs. The ROR showed that evolocumab and alirocumab had a higher reporting probability of neurological ADRs compared with statins. Further data from real-life contexts are needed.

SUBMITTER: di Mauro G

PROVIDER: S-EPMC7892743 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database.

di Mauro Gabriella G Zinzi Alessia A Scavone Cristina C Mascolo Annamaria A Gaio Mario M Sportiello Liberata L Ferrajolo Carmen C Rafaniello Concetta C Rossi Francesco F Capuano Annalisa A

Drug safety 20201222 3

<h4>Introduction</h4>Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs).<h4>Objective</h4>We aimed to investigate the occurrence of neuropsychiatric ADRs related to PCSK9Is.<h4>Methods</h4>We analyzed Individual Case Safety Reports (ICSRs) sent through the European pharmacovigilance database that reported alirocumab or evolocumab as the suspected drug and at least one neurological or psychiatric ADR. The ...[more]

PMID: 33351170

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Dataset Information

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database.

Introduction

Objective

Methods

Results

Conclusion

Publications

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database.

Similar Datasets

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