Emerging cardiovascular toxicity associated with CDK4/6 inhibitors: real-world insights from the FDA adverse event reporting system.

ABSTRACT:

Background

Despite the unprecedented advancement of cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) in the treatment paradigm for hormone-dependent breast cancer, reports of cardiovascular adverse events (CVAEs) in both pivotal trials and real-world settings have garnered concerns.

Objectives

we aim to profile the incidence, clinical characteristics and risk factors of CVAEs associated CDK4/6i to provide a vigilant reference for cancer management.

Methods

The global disproportionality study was conducted by utilizing safety reports submitted to the FDA adverse event reporting system (FAERS) during the period from January 2015 to September 2024. Reporting odds ratio (ROR) was employed to identify and evaluate emerging CVAEs related to CDK4/6i. Multivariable logist

SUBMITTER: Liu W 

PROVIDER: S-EPMC12162638 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature