Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database.

Abstract

Background: Relugolix and degarelix are gonadotropin-releasing hormone antagonist. However, the cardiac safety of relugolix and degarelix in the real world remains uncertain. The purpose of this study was to explore the potential association of relugolix and degarelix with cardiac adverse events (AEs).

Methods: We queried the FAERS database and selected AE reports with relugolix or degarelix as the first suspected drug for analysis. Reporting odds ratio (ROR) and empirical Bayes geometric mean (EBGM) were used to quantify the association between relugolix and degarelix and cardiac AEs.

Results: A total of 5,598 and 372 AEs were reported for relugolix and degarelix, respectively, with 235 and 56 being cardiac AEs. The cardiac AEs associated with relugolix and degarelix predominantly occurred in elderly patients (>65 years). Disproportionality analysis showed that relugolix was significantly associated with electrocardiogram/heart rate abnormality and palpitations, with the strongest signal for electrocardiogram abnormality (ROR = 77.54, EBGM = 68.64). While degarelix was significantly associated with cardiac failure, myocardial Infarction, and arrhythmia, with cardiac failure showing the strongest signal (ROR = 8.62, EBGM = 97.71).

Conclusions: There are differences in the types of cardiac adverse events induced by relugolix and degarelix. Clinicians should consider their differences and enhanced electrocardiogram monitoring when prescribing GnRH antagonists to their patients.