Pembrolizumab-Associated Cardiotoxicity: A Retrospective Analysis of the FDA Adverse Events Reporting System

Area of Science:

• Oncology
• Cardiology
• Pharmacovigilance

Background:

• Immune checkpoint inhibitors (ICIs) are widely used cancer therapies.
• Cardiac adverse events (AEs) are significant complications of ICI treatment.
• Pembrolizumab is a commonly used ICI, and its cardiac safety profile requires investigation.

Purpose of the Study:

• To analyze the frequency and characteristics of cardiac AEs associated with pembrolizumab and other ICIs.
• To compare the cardiotoxicity profiles of different ICIs.
• To assess the severity and outcomes of ICI-related cardiac events.

Main Methods:

• Utilized the FDA adverse event reporting database (FAERS) for data extraction.
• Included all reported adverse events for all ICIs in the study.
• Conducted disproportionality analysis using reporting odds ratio (ROR) and information component (IC).

Main Results:

• Identified 6719 ICI-related cardiac AEs, with 100% serious outcomes and 34.3% mortality.
• Pembrolizumab use showed a higher association with myocarditis, pericardial disease, heart failure, and atrial fibrillation compared to other medications.
• No significant difference in cardiotoxicity was observed between different ICIs.

Conclusions:

• Cardiac AEs associated with pembrolizumab, though infrequent, lead to severe outcomes and high mortality.
• Further prospective studies are essential to understand the link between ICI use and cardiotoxicity.
• Findings highlight the need for vigilant cardiac monitoring in patients receiving ICIs.