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
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...
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2025-01-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.70548 |
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| author | Shaimaa Elshafie Lorenzo Villa‐Zapata Randall L. Tackett Iman Y. Zaghloul Henry N. Young |
| author_facet | Shaimaa Elshafie Lorenzo Villa‐Zapata Randall L. Tackett Iman Y. Zaghloul Henry N. Young |
| author_sort | Shaimaa Elshafie |
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| description | 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. |
| format | Article |
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| institution | Kabale University |
| issn | 2045-7634 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
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| series | Cancer Medicine |
| spelling | doaj-art-cc25ccdbe97f403594b354c01ff156652025-01-13T13:22:38ZengWileyCancer Medicine2045-76342025-01-01141n/an/a10.1002/cam4.70548Cardiovascular and Metabolic Adverse Events of Endocrine Therapies in Women with Breast Cancer: A Disproportionality Analysis of Reports in the FDA Adverse Event Reporting SystemShaimaa Elshafie0Lorenzo Villa‐Zapata1Randall L. Tackett2Iman Y. Zaghloul3Henry N. Young4Department of Clinical and Administrative Pharmacy, College of Pharmacy University of Georgia Athens Georgia USADepartment of Clinical and Administrative Pharmacy, College of Pharmacy University of Georgia Athens Georgia USADepartment of Clinical and Administrative Pharmacy, College of Pharmacy University of Georgia Athens Georgia USASchool of Pharmacy MCPHS University Boston Massachusetts USADepartment of Clinical and Administrative Pharmacy, College of Pharmacy University of Georgia Athens Georgia USAABSTRACT 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.https://doi.org/10.1002/cam4.70548adverse drug reactionsbreast cancercardiovascular riskdisproportionality analysisendocrine therapyFAERS database |
| spellingShingle | Shaimaa Elshafie Lorenzo Villa‐Zapata Randall L. Tackett Iman Y. Zaghloul Henry N. Young 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 Cancer Medicine adverse drug reactions breast cancer cardiovascular risk disproportionality analysis endocrine therapy FAERS database |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | adverse drug reactions breast cancer cardiovascular risk disproportionality analysis endocrine therapy FAERS database |
| url | https://doi.org/10.1002/cam4.70548 |
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