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A Real-World Pharmacovigilance Analysis of HER2 Inhibitor-Induced Cardiovascular Toxicity
Jianhui Yao1,2, Chao Tao3,4, Weiyi Chen3
1West China Hospital Sichuan University, Meishan Hospital, Meishan, China.
Introduction:
With the widespread use of human epidermal growth factor receptor 2 (HER2) inhibitors in cancer treatment, cardiovascular diseases induced by these agents have become a significant adverse event.
Methods:
We retrieved reports of HER2 inhibitor-induced cardiovascular adverse events (CVAEs) from the FDA Adverse Event Reporting System(FAERS) database, covering the period from the first quarter of 2004 to the fourth quarter of 2024. Disproportionality analyses were conducted using reporting odds ratios and proportional reporting ratios. The signals of HER2 inhibitor-related CVAEs were evaluated at both the standardized MedDRA query and preferred term levels.
Results:
A total of 12,698 reports associated with CVAEs were identified, with HER2 inhibitors listed as the primary suspected drug, involving 12,398 patients. Most cases were observed in individuals aged 45 years and older, with a notably higher proportion in women. The time to onset of HER2 inhibitor-induced CVAEs showed certain variability. Trastuzumab exhibited higher cardiovascular toxicity compared with other HER2 inhibitors. In general, monoclonal antibodies demonstrated greater cardiovascular toxicity, whereas antibody-drug conjugates and HER2-tyrosine kinase inhibitors displayed comparable and lower effects.
Conclusion:
This pharmacovigilance analysis reveals a strong association between HER2 inhibitors and CVAEs, providing valuable insights for their prevention and clinical management.
Insights
Human epidermal growth factor receptor 2 (HER2) inhibitors are linked to cardiovascular adverse events (CVAEs). This study analyzed FAERS data, finding monoclonal antibodies showed higher toxicity, informing prevention and management strategies.
Area of Science:
- Pharmacovigilance
- Oncology
- Cardiology
Background:
- Widespread use of human epidermal growth factor receptor 2 (HER2) inhibitors in cancer therapy has led to an increase in associated cardiovascular diseases.
- Cardiovascular adverse events (CVAEs) are a significant concern with HER2 inhibitor treatments.
Purpose of the Study:
- To investigate the association between HER2 inhibitors and CVAEs.
- To analyze the safety profile of different classes of HER2 inhibitors regarding cardiovascular toxicity.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q4 2024.
- Conducted disproportionality analyses using reporting odds ratios and proportional reporting ratios.
- Evaluated HER2 inhibitor-related CVAEs at standardized MedDRA query and preferred term levels.
Main Results:
- Identified 12,698 reports of CVAEs linked to HER2 inhibitors, involving 12,398 patients.
- Observed higher cardiovascular toxicity with monoclonal antibodies compared to antibody-drug conjugates and HER2-tyrosine kinase inhibitors.
- Trastuzumab showed greater cardiovascular toxicity than other HER2 inhibitors; CVAEs were more prevalent in women aged 45 and older.
Conclusions:
- Confirmed a strong association between HER2 inhibitors and CVAEs.
- Findings provide crucial insights for the prevention and clinical management of HER2 inhibitor-induced cardiovascular toxicity.
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