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Cardiovascular Events in Men with Prostate Cancer Receiving Hormone Therapy: An Analysis of the FDA Adverse Event Reporting System (FAERS)

  • Kathleen W Zhang 1,
  • Melissa A Reimers 2,
  • Adam Christopher Calaway 3,
  • Michael G Fradley 4,
  • Lee Ponsky 3,
  • Jorge A Garcia 5,
  • Jennifer Cullen 6,
  • Brian C Baumann 7,
  • Daniel Addison 8,
  • Courtney M Campbell 8,
  • Arjun K Ghosh 9,
  • Daniel J Lenihan 1,
  • Nihar R Desai 10,
  • Neal Weintraub 11,
  • Avirup Guha 12
1 Cardio-Oncology Center of Excellence, Cardiovascular Division, Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA 2 Division of Oncology, Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA 3 Department of Urology, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA 4 Cardio-Oncology Center of Excellence, Division of Cardiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA 5 Division of Oncology, Seidman Cancer Center, Cleveland, Ohio, USA 6 Department of Population and Quantitative Health Sciences, Case Comprehensive Cancer Center, Cleveland, Ohio, USA 7 Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri, USA 8 Cardio-Oncology Program, Division of Cardiology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA 9 Cardio-Oncology Service, Barts Heart Centre, St. Bartholomew's Hospital West Smithfield, London, United Kingdom 10 Cardiovascular Medicine Section, Yale School of Medicine, New Haven, Connecticut, USA 11 Division of Cardiovascular Medicine, Augusta University, Augusta, Georgia, USA 12 Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA

Publication: Journal of Urology, April 2021

https://www.auajournals.org/doi/10.1097/JU.0000000000001785

Purpose

The comparative cardiovascular risk profiles of available hormone therapies for the treatment of prostate cancer is not known.

Materials and Methods

We queried the FDA Adverse Event Reporting System (FAERS), a retrospective, pharmacovigilance database, for cardiovascular adverse event reports in men with prostate cancer receiving gonadotropin releasing hormone (GnRH) agonists, GnRH antagonists, androgen receptor antagonists, and/or androgen synthesis inhibitors from January 2000 to April 2020.

Results

Cardiovascular adverse events accounted for 6,231 reports (12.6%) on hormone monotherapy and 1,793 reports (26.1%) on combination therapy. Arterial vascular events were reported most commonly, followed by arrhythmias, heart failure, and venous thromboembolism. Compared to GnRH agonists, GnRH antagonists were associated with fewer cardiovascular adverse event reports as monotherapy (adjusted reporting odds ratio [ROR]= 0.70 [95% CI 0.59–0.84], p <0.001) and as combination therapy (ROR=0.47 [0.34–0.67], p <0.0001), driven by reductions in arterial vascular events. Second generation androgen receptor antagonists and abiraterone were associated with more reports of hypertension requiring hospitalization (ROR=1.21 [1.03–1.41], p=0.02 and ROR=1.19 [1.01–1.40], p=0.03, respectively), and more heart failure events when used in combination with GnRH antagonists (ROR=2.79 [1.30–6.01], p=0.009 and ROR=2.57 [1.12–5.86], p=0.03).

Conclusions

In this retrospective analysis of a pharmacovigilance database, arterial vascular events were the most commonly reported cardiovascular adverse events in men on hormone therapy for prostate cancer. GnRH antagonists were associated with fewer reports of overall cardiovascular events and arterial vascular events than GnRH agonists. Additional study is needed to identify optimal strategies to reduce cardiovascular morbidity among men with prostate cancer receiving hormone therapy.