Title: Cardiovascular Events Associated with Endothelin Receptor Antagonists: A Pharmacovigilance Analysis of Bosentan and Ambrisentan
Abstract Body (Do not enter title and authors here):
Introduction: Endothelin receptor antagonists (ERAs) are the mainstay therapy for pulmonary arterial hypertension (PAH). However, there is limited data on cardiac adverse drug events (ADEs) associated with ERA medications. We performed a pharmacovigilance study comparing bosentan and ambrisentan using the FDA Adverse Event Reporting System (FAERS) data.
Methods: Cardiac ADE data for bosentan and ambrisentan from January 1, 2004, to December 31, 2023, in the FAERS database were retrieved. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR) aligned with p-values. The following cardiac ADEs were included: atrial fibrillation (AF), right ventricular failure (RVF), and cardiac arrest (CA). Results: For adults ≥ 18 years, a total of 12,058 cardiac ADEs were reported for both bosentan (38%) and ambrisentan (62%). Among the selected cardiac ADEs, AF was more frequently reported with bosentan (ROR 3.99, 95% CI: 3.62-4.40) than ambrisentan (ROR 1.91, 95% CI: 1.77-2.07). RVF showed a significantly higher ROR for bosentan (73.60, 95% CI: 66.68-81.25) than ambrisentan (23.11, 95% CI: 20.99-25.46). CA was also more commonly associated with bosentan (ROR 2.25, 95% CI: 1.98-2.55) than with ambrisentan (ROR 0.69, 95% CI: 0.61-0.78), with all comparisons showing p-values < 0.001.
Conclusion: Our study identifies a significantly higher frequency of cardiac ADEs, particularly AF, RVF, and CA, in patients treated with bosentan compared to ambrisentan. This finding corroborates previous literature that has suggested differential safety profiles among ERAs, emphasizing the need for vigilant cardiac monitoring. Clinicians should integrate these insights into their practice, potentially favoring ambrisentan in patients with elevated cardiac risk, thus optimizing the management of PAH and improving patient outcomes.
Rathore, Azeem
( University of Florida
, Jacksonville
, Florida
, United States
)
Jonna, Sadhana
( Mayo Clinic
, Jacksonville
, Florida
, United States
)
Hanna, Daniel
( NCH Rooney Heart Institute
, Naples
, Florida
, United States
)
Verghese, Dhiran
( NCH Rooney Heart Institute
, Naples
, Florida
, United States
)
Muller, Laura
( NCH Rooney Heart Institute
, Naples
, Florida
, United States
)
Sierra, Juan
( NCH Rooney Heart Institute
, Naples
, Florida
, United States
)
Navas, Elsy
( NCH Rooney Heart Institute
, Naples
, Florida
, United States
)
Mirsaeidi, Mehdi
( Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida College of Medicine
, Jacksonville
, Florida
, United States
)
Author Disclosures:
Azeem Rathore:DO NOT have relevant financial relationships
| Sadhana Jonna:DO NOT have relevant financial relationships
| Daniel Hanna:DO NOT have relevant financial relationships
| Dhiran Verghese:No Answer
| Laura Muller:DO NOT have relevant financial relationships
| Juan Sierra:No Answer
| Elsy Navas:DO NOT have relevant financial relationships
| Mehdi Mirsaeidi:No Answer
