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Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study

Meina Lv1, Jianhui Chen2, Bin Zheng1

  • 1Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, China.

Expert Opinion on Drug Safety
|April 3, 2025
PubMed

Insights

Relugolix and degarelix, gonadotropin-releasing hormone antagonists, show distinct cardiac safety profiles. Relugolix is linked to ECG abnormalities and palpitations, while degarelix is associated with cardiac failure and myocardial infarction.

Area of Science:

  • Pharmacovigilance
  • Cardiovascular Safety
  • Endocrinology

Background:

  • Relugolix and degarelix are gonadotropin-releasing hormone (GnRH) antagonists.
  • Real-world cardiac safety data for these GnRH antagonists remain limited.
  • This study investigates the association between relugolix, degarelix, and cardiac adverse events.

Purpose of the Study:

  • To explore the potential association of relugolix and degarelix with cardiac adverse events (AEs).
  • To compare the cardiac safety profiles of relugolix and degarelix.

Main Methods:

  • Utilized the FAERS database for adverse event reports.
  • Selected reports where relugolix or degarelix was the first suspected drug.
  • Employed disproportionality analysis using Reporting Odds Ratio (ROR) and Empirical Bayes Geometric Mean (EBGM).

Main Results:

  • Relugolix was associated with electrocardiogram/heart rate abnormality and palpitations.
  • Degarelix showed associations with cardiac failure, myocardial infarction, and arrhythmia.
  • Cardiac AEs predominantly affected elderly patients (>65 years).

Conclusions:

  • Relugolix and degarelix exhibit different cardiac adverse event profiles.
  • Clinicians should be aware of these distinctions and consider enhanced ECG monitoring for patients on GnRH antagonists.
Abstract

Keywords:
Cardiac effectdegarelixpharmacovigilanceprostate cancerrelugolix

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