ArticleCancer medicine2025
Cardiovascular and Metabolic Adverse Events of Endocrine Therapies in Women with Breast Cancer: A Disproportionality Analysis of Reports in the FDA Adverse Event Reporting System.
Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The trial behind it
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Who cites it
5 citing papers in PubMed.
- Regulatory challenges and current policy for cardiotoxicity detection in oncology drug development.Journal of thrombosis and thrombolysis · 2026Article
- Assessing the risk of adverse drug events from combining aromatase inhibitors with CDK4/6 inhibitors using the FAERS and JADER databases.Frontiers in medicine · 2026Article
- Nutritional Impact on Breast Cancer in Menopausal and Post-Menopausal Patients Treated with Aromatase Inhibitors.Cancers · 2025Review
- Cerebrovascular and Peripheral Vascular Complications in Cancer Patients.Current neurology and neuroscience reports · 2025Review
- Investigating cardiovascular diseases related to endocrine therapy in hormone receptor-positive early breast cancer: insights from a nationwide real-world study.Cardio-oncology (London, England) · 2025Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEmerging evidence suggests potential cardiovascular toxicities from oral endocrine therapies (ETs); however, results are conflicting. This study comprehensively examined adverse reactions of ETs and investigated cardiovascular and metabolic safety signals within the FDA Adverse Event Reporting System (FAERS).
methodsReports in the FAERS through December 2023 were analyzed for documented reactions to tamoxifen, letrozole, anastrozole, and exemestane in female breast cancer patients. Standardized queries were used to identify cases of cardiovascular (myocardial infarction, heart failure, arrhythmia, stroke) and metabolic (hypertension, dyslipidemia, hyperglycemia) disorders. Descriptive and disproportionality analyses were performed to assess reports and detect safety signals.
resultsAmong 14,327 unique ET-related reports, arthralgia (n = 1873 events) was the most prevalent reaction. We identified 2170 cardiovascular and 2252 metabolic events associated with ETs. Letrozole had the highest reporting rate of cardiac arrhythmia (7.7%) and showed positive signals for both arrhythmia (reporting odds ratio [ROR] = 2.2; 95% confidence interval [CI]: 1.8-2.5) and myocardial infarction (ROR = 1.9; 95% CI: 1.4-2.6). We also observed a significantly increased risk of heart failure with letrozole (ROR = 1.3; 95% CI: 1.1-1.6) and stroke with tamoxifen (ROR = 1.7; 95% CI: 1.5-2.1). Only anastrozole was significantly associated with metabolic dysfunctions with a notable hyperglycemia reporting rate of 12.2%.
conclusionOur findings provide valuable evidence on common reactions as well as controversial cardiovascular and metabolic abnormalities associated with the real-world use of ETs for breast cancer. Ongoing benefit-risk assessment and close monitoring of cardiac function during treatment, particularly in high-risk women, are warranted to optimize cancer outcomes while minimizing cardiovascular injury.
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