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August 23, 2023Expert Opinion on Drug Safety

Cardiovascular toxicities following the use of tyrosine kinase inhibitors in hepatocellular cancer patients: a retrospective, pharmacovigilance study

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Why the study?

Cardiac adverse events are common with tyrosine kinase inhibitors, prompting exploration of their cardiac toxicities using the FAERS database.

What are the specific cardiac adverse events associated with different tyrosine kinase inhibitors in patients with hepatocellular cancer?

Population

4708 cardiac adverse event reports of sorafenib, regorafenib, lenvatinib, and cabozantinib in FAERS

Comparison

Sorafenib vs regorafenib vs lenvatinib vs cabozantinib

Design

Retrospective pharmacovigilance study using disproportionality and Bayesian analysis

Key result

Lenvatinib exposure was associated with a strong signal for cardiac failure (ROR 7.7; 95% CI 3.46-17.17) and acute coronary syndrome, while sorafenib was linked to aortic dissections.

Authors

XLXin LaiQWQing WanSJShoufeng Jiao

Discussion

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Member takes

Overview

Cardiac AE signals with these TKIs merit clinical awareness; hypothesis-generating and leaves open need for prospective validation.

Study Design

Type

Observational (n=4,708)

Structured PICO

What are the specific cardiac adverse events associated with different tyrosine kinase inhibitors in patients with hepatocellular cancer?

P
Population
4,708 cardiac adverse event reports in hepatocellular cancer patients receiving tyrosine kinase inhibitors from the FAERS database between 2004 and 2021.
E
Exposure
Tyrosine kinase inhibitors (sorafenib, regorafenib, lenvatinib, and cabozantinib)
O
Outcome
Cardiac adverse events (including hypertension, cardiac failure, acute myocardial infarction, acute coronary syndrome, atrial fibrillation, and aortic dissection)safety

Main Result

Odds Ratio: 7.7 (95% CI 3.46–17.17)

Different tyrosine kinase inhibitors used for hepatocellular cancer have distinct profiles of cardiac toxicities, with lenvatinib showing strong signals for heart failure and acute coronary syndrome, highlighting the need for tailored cardiovascular monitoring.

Cite This Study

Lai et al. (2023) conducted an observational in Hepatocellular cancer (n=4,708). Tyrosine kinase inhibitors (sorafenib, regorafenib, lenvatinib, cabozantinib) was evaluated on Cardiac adverse events (ROR 7.7, 95% CI 3.46-17.17). Lenvatinib exposure was associated with a strong signal for cardiac failure (ROR 7.7; 95% CI 3.46-17.17) and acute coronary syndrome, while sorafenib was linked to aortic dissections.

synapsesocial.com/papers/6a7c96c91c02bd024a6ee1achttps://doi.org/10.1080/14740338.2023.2251398
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Cardiovascular toxicities following the use of tyrosine kinase inhibitors in Hepatocellular Cancer Patients: A Retrospective, Pharmacovigilance Study2023 · 1 citations
  2. 2Cardiac Toxicity of Sunitinib and Sorafenib in Patients With Metastatic Renal Cell Carcinoma2008 · 616 citations
  3. 3Mechanisms, monitoring, and management of tyrosine kinase inhibitors-associated cardiovascular toxicities2018 · 132 citations
  4. 4Cardiovascular toxicities with pediatric tyrosine kinase inhibitor therapy: An analysis of adverse events reported to the Food and Drug Administration2022 · 7 citations
  5. 5Liver injury related to vascular endothelial growth factor tyrosine kinase inhibitors: a pharmacovigilance analysis of the USA FDA adverse event reporting system (FAERS) database2025 · 8 citations