ArticlePharmaceuticals (Basel, Switzerland)2024
Pembrolizumab-Associated Cardiotoxicity: A Retrospective Analysis of the FDA Adverse Events Reporting System.
Article in Pharmaceuticals (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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Who cites it
9 citing papers in PubMed.
- Cardiac radiosensitivity in the era of thoracic chemoradiotherapy and immunotherapy: a scoping review.The Lancet. Oncology · 2026Article
- CDK4/6 inhibition with dual immunotherapy in chemorefractory SMARCA4-deficient undifferentiated tumor: a case report.Frontiers in immunology · 2026Article
- Reported drug spectrum and disproportionality signals for malignant neoplasm progression in FAERS: a real-world pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Immunotherapy-related cardiovascular toxicity: from mechanisms to management.Frontiers in pharmacology · 2026Review
- Immune checkpoint inhibitors and cardiovascular toxicity: immunology, pathophysiology, diagnosis, and management.Journal of thrombosis and thrombolysis · 2025Review
- A comparative review of myocarditis in pediatrics versus adults: pathogenesis, diagnosis, and management.Frontiers in immunology · 2025Review
- Association between immune check point inhibitors and digestive system inflammatory adverse reactions: evidence from pharmacovigilance analysis and systematic review.Frontiers in pharmacology · 2025Article
- Pharmacovigilance study on the reporting frequency of atrial fibrillation with immune checkpoint inhibitors: insights from FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- The role of immune checkpoints PD-1 and CTLA-4 in cardiovascular complications leading to heart failure.Frontiers in immunology · 2025Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImmune checkpoint inhibitors (ICIs) have been successfully used in the previous decade for the treatment of a variety of malignancies. Adverse events (AEs) can cause many symptoms, most notably cardiac. We analyzed the frequency of these adverse events, comparing pembrolizumab and other ICIs.
methodsUsing the Food and Drug Administration (FDA) adverse event reporting database (FAERS), we searched for all adverse events of interest reported for every ICI included in this study. After obtaining the data, we conducted a disproportionality analysis using the reporting odds ratio (ROR) and the information component (IC).
resultsA total of 6719 ICI-related cardiac adverse events of interest were reported in the database. Serious outcomes were reported in 100% of the cases, with 34.3% of the cases ending fatally. Compared with all other medications in the database, pembrolizumab use was more frequently associated with myocarditis, pericardial disease, heart failure, and atrial fibrillation. No difference was found in cardiotoxicity between different ICIs.
conclusionsAlthough infrequent, cardiac AEs in pembrolizumab use are associated with serious outcomes and high mortality. Prospective studies are needed to further research the connection between ICI use and cardiotoxicity.
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