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Sex and age disparities in goserelin safety: a global pharmacovigilance study
Zizhen Liu1,2, Han Qu3, Zuan Li2
1School of Pharmacy, Shanghai Jiao Tong University, Shanghai, China.
Abstract:
Goserelin, a synthetic analogue of gonadotropin-releasing hormone, is widely used in breast cancer and prostate cancer. However, significant sex-based disparities exist in its therapeutic effects and safety profiles. What's more, current evidence remains insufficient to characterize age-related adverse drug event (ADEs) risks. Given these gaps, comprehensive real-world studies are required to systematically analyze ADEs in male and female patients separately. The analytical dataset was derived from the FAERS (2004 Q1-2025 Q1) and VigiBase (1987.01.01-2025.07.01) databases. Disproportionality analysis was performed using the reporting odds ratio and information component. All statistical analyses and visualizations were conducted using Microsoft Excel 2019, R4.4.2, and GraphPad Prism. The FAERS database recorded 8,245 ADEs (2,325 female; 3,190 male), while VigiBase contained 10,524 (3,274 female; 4,941 male). Baseline clinical outcomes revealed higher mortality rates and more serious reports in males. System organ class analysis demonstrated that males showed greater susceptibility to general disorders and administration site conditions. Several strong signals in the preferred term level not currently listed in the drug label were identified, including neutropenia, jaundice, and pleural effusion. Age-stratified analysis indicated ADEs predominantly occurred in males aged 65-74 years and females aged 40-54 years. The most frequently reported events, hot flush and interstitial lung disease, displayed stronger associations in male patients. Using real-world pharmacovigilance data, we identify sex- and age-related safety disparities for goserelin, supporting individualized monitoring and risk management to enhance treatment safety.
Insights
Goserelin treatment shows significant sex and age disparities in adverse drug events (ADEs). Real-world data reveal males experience higher mortality and specific ADEs, while age groups show distinct risk profiles, necessitating personalized goserelin safety monitoring.
Area of Science:
- Pharmacovigilance
- Oncology
- Drug Safety
Background:
- Goserelin, a gonadotropin-releasing hormone analogue, is used for breast and prostate cancer.
- Existing research shows sex-based differences in goserelin's efficacy and safety.
- Limited data exist on age-related adverse drug event (ADE) risks associated with goserelin.
Purpose of the Study:
- To systematically analyze ADEs in male and female patients using real-world data.
- To identify and characterize sex- and age-related safety disparities for goserelin.
- To provide evidence for individualized monitoring and risk management strategies for goserelin therapy.
Main Methods:
- Utilized disproportionality analysis on data from the FAERS and VigiBase pharmacovigilance databases.
- Analyzed reporting odds ratio and information component to detect safety signals.
- Conducted age-stratified analyses to assess ADE risks across different age groups.
Main Results:
- Males exhibited higher mortality rates and more serious ADE reports compared to females.
- Males were more susceptible to general disorders and administration site conditions.
- Identified potential new safety signals including neutropenia, jaundice, and pleural effusion, with distinct ADE patterns observed in males aged 65-74 and females aged 40-54.
Conclusions:
- Real-world pharmacovigilance data reveal significant sex- and age-related safety disparities for goserelin.
- Findings support the need for sex- and age-specific monitoring and risk management to improve goserelin treatment safety.
- Further research into the mechanisms underlying these disparities is warranted.
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