Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database.
Clinicians should be aware of the different cardiac adverse events associated with relugolix and degarelix and consider enhanced monitoring when prescribing these medications.
Where it sits
this study against the rest of the degarelix corpusSummary and findings
This study explored the association of relugolix and degarelix with cardiac adverse events (AEs) using the FAERS database. A total of 5,598 AEs were reported for relugolix and 372 for degarelix, with 235 and 56 being cardiac AEs, respectively. The findings indicate significant associations of both drugs with specific cardiac AEs.
Abstract
<h4>Background</h4>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).<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Conclusions</h4>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.
Background
The study addresses the cardiac safety of gonadotropin-releasing hormone antagonists, specifically relugolix and degarelix. Previous studies have raised concerns about the cardiac effects of these medications, but real-world data on their safety profile remains limited. Understanding the potential cardiac adverse events associated with these drugs is crucial for clinicians prescribing them.
Methods
This pharmacovigilance study utilized the FAERS database to analyze adverse event reports where relugolix or degarelix was the first suspected drug. The study focused on the reporting odds ratio (ROR) and empirical Bayes geometric mean (EBGM) to quantify associations with cardiac adverse events. The population primarily consisted of elderly patients aged over 65 years.
Results
A total of 5,598 adverse events were reported for relugolix, with 235 classified as cardiac adverse events. For degarelix, 372 adverse events were reported, with 56 being cardiac. The strongest signal for relugolix was for electrocardiogram abnormality (ROR = 77.54, EBGM = 68.64), while for degarelix, cardiac failure showed the strongest signal (ROR = 8.62, EBGM = 97.71).
Interpretation
The findings indicate significant associations between relugolix and cardiac abnormalities, as well as between degarelix and cardiac failure. While the statistical significance is notable, the clinical significance of these findings requires careful consideration, especially given the elderly population studied. The reliance on reported adverse events introduces potential confounding factors that may limit the conclusions drawn from this analysis.
Key findings
- 5,598 AEs reported for relugolix, 372 AEs for degarelix.
- 235 cardiac AEs for relugolix, 56 cardiac AEs for degarelix.
- ROR for electrocardiogram abnormality with relugolix was 77.54.
- ROR for cardiac failure with degarelix was 8.62.
- EBGM for electrocardiogram abnormality with relugolix was 68.64.
- EBGM for cardiac failure with degarelix was 97.71.
Limitations
- Relies on reported adverse events, which may not represent true incidence.
- Potential for underreporting and confounding factors in pharmacovigilance data.
- Analysis based on a single database, limiting generalizability.