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

IF 2.9 2区医学 Q2 ONCOLOGY Cancer Medicine Pub Date : 2024-12-30 DOI:10.1002/cam4.70548

Shaimaa Elshafie, Lorenzo Villa-Zapata, Randall L. Tackett, Iman Y. Zaghloul, Henry N. Young

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Abstract

Introduction

Emerging 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).

Methods

Reports 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.

Results

Among 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%.

Conclusion

Our 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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乳腺癌女性内分泌治疗的心血管和代谢不良事件：FDA不良事件报告系统报告的不相称性分析

新出现的证据表明口服内分泌疗法（ETs）有潜在的心血管毒性；然而，结果是相互矛盾的。本研究全面检查了ETs的不良反应，并在FDA不良事件报告系统（FAERS）中调查了心血管和代谢安全信号。方法：对FAERS截至2023年12月的报告进行分析，以记录女性乳腺癌患者对他莫昔芬、来曲唑、阿那曲唑和依西美坦的反应。使用标准化查询来确定心血管（心肌梗死、心力衰竭、心律失常、中风）和代谢（高血压、血脂异常、高血糖）疾病的病例。进行描述性和不相称性分析以评估报告和检测安全信号。结果：在14327例独特的et相关报告中，关节痛（n = 1873例）是最常见的反应。我们确定了2170例心血管事件和2252例代谢事件与ETs相关。来曲唑的心律失常报告率最高（7.7%），两种心律失常均显示阳性信号(报告优势比[ROR] = 2.2；95%可信区间[CI]: 1.8-2.5)和心肌梗死(ROR = 1.9；95% ci: 1.4-2.6)。我们还观察到来曲唑显著增加心力衰竭的风险(ROR = 1.3；95% CI: 1.1-1.6)和他莫昔芬治疗卒中(ROR = 1.7；95% ci: 1.5-2.1)。只有阿那曲唑与代谢功能障碍显著相关，高血糖报告率为12.2%。结论：我们的研究结果为与实际使用ETs治疗乳腺癌相关的常见反应以及有争议的心血管和代谢异常提供了有价值的证据。在治疗期间进行持续的获益-风险评估和密切监测心功能，特别是对高危妇女，有必要优化癌症结局，同时最大限度地减少心血管损伤。

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.