loading page

Adverse Event Profile Differences among Long-acting Gonadotropin-releasing hormone analogs: A Real-world, Pharmacovigilance Study
  • +4
  • Yuting Chen,
  • Weitao Lu,
  • Ruilian Liao,
  • Ximin Zhang,
  • Wang Chen,
  • Jing Wang,
  • Huancun Feng
Yuting Chen
Guangzhou Red Cross Hospital
Author Profile
Weitao Lu
Jiangmen Central Hospital
Author Profile
Ruilian Liao
Sun Yat-Sen University Zhongshan Ophthalmic Center
Author Profile
Ximin Zhang
Guangzhou Civil Aviation College
Author Profile
Wang Chen
Guangzhou Red Cross Hospital
Author Profile
Jing Wang
Guangzhou Red Cross Hospital
Author Profile
Huancun Feng
The Third Affiliated Hospital of Southern Medical University

Corresponding Author:[email protected]

Author Profile

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.
08 Oct 2024Submitted to Pharmacoepidemiology and Drug Safety
09 Oct 2024Submission Checks Completed
09 Oct 2024Assigned to Editor
09 Oct 2024Review(s) Completed, Editorial Evaluation Pending
16 Oct 2024Reviewer(s) Assigned