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. T

SUBMITTER: di Mauro G 

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

REPOSITORIES: biostudies-literature