Adverse Event Profile Differences among Long-acting
Gonadotropin-releasing hormone analogs: A Real-world, Pharmacovigilance
Study
Abstract
Background Long-acting Gonadotropin-releasing hormone
analogs(GnRHa), including leuprolide, goserelin, histrelin, buserelin,
triptorelin, have been widely used for a variety of diseases including
prostate cancer, breast cancer, endometriosis, uterine leiomyomas, and
central precocious puberty. However, their real-world safety profile
differences have not been adequately compared. Objective: We
aimed to investigate the adverse event (AE) profile differences of
long-acting GnRHa reported by the US Food and Drug Administration
Adverse Event Reporting System (FAERS). Methods: All
indications were searched long-acting GnRHa, as primary suspect drugs,
from FAERS data (January 2004 to September 2023). We performed
disproportionality analyses by reporting odds ratios (ROR) and conducted
univariate and multivariate logistical regression analyses to determine
the odds ratio (OR) of serious AEs associated with long-acting GnRHa
under different exposure factors. Results: Reproductive system
and breast disorders possessed the greatest proportion in AEs of the
five long-acting GnRHa. Buserelin and histrelin demonstrated a higher
percentage of AEs in the gastrointestinal and psychiatric disorders
separately, which also exhibited a higher risk of important medical
events in logistic regression analysis and the risk was lower in
patients under 18 years old than those over 18 .
Conclusions:Significant disparities exist between the adverse
event profiles of long-acting GnRHa.The identification of high-risk
factors and the enhancement of AEs monitoring are crucial during
clinical application.