MP48-11: Cardiovascular adverse events-related to GnRH agonists and GnRH antagonists: Analysis of real-life data from Eudra-Vigilance database

Cosimo De Nunzio, Rome, Italy, Antonio Nacchia*, Rionero in Vulture, Italy, Antonio Cicione, Beatrice Turchi, Giacomo Gallo, Carmen Gravina, Alessandro Guercio, Jordi Stira, Lorenzo Maria Rivesti, Antonio Franco, Elisa Mancini, Olivia Alessandra Voglino, Valeria Baldassarri, Giorgio Guarnotta, Rome, Italy, Ferdinando Di Giacomo, Giuseppe Disabato, Rionero in Vulture, Italy, Andrea Tubaro, Rome, Italy

Introduction: GnRH agonists and GnRH antagonists are two of the mainstay of hormonal therapy (HT) for prostate cancer. These drugs are at increased risk of cardiovascular adverse events (AEs). Aim of our study was to compare real-life data on AEs associated with GnRH agonists and GnRH antagonists based on Eudra-Vigilance reported AEs.

Methods: Eudra-Vigilance database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded the number of cardiac and vascular disorders for degarelix, buserelin, goserelin, leuprorelin, triptorelin per category and severity until September 2021. Pooled Relative Risk (PRR) was used to compare data between drugs.

Results: Overall, the number of AEs reported were for Degarelix 1943, for Buserelin 539, for Goserelin 4684, for Leuprorelin 14687, for Triptorelin 3223. The risk of cardiovascular disorders was higher for GnRH agonists than GnRH antagonists with a frequency of 3-12% vs 7-8% respectively (p <0,05). Overall GnRH antagonists presented lower risk of hypertension (PRR 0,60 (95%CI 0,37-0,98), p 0,04) and of myocardial infarction (PRR 0,05 (95%CI 0,01-0,39), p<0,01) when compared to GnRH agonists. In particular,Degarelix presented lower risk of hypertension when compared to Goserelin (PRR 0,49 (95%CI 0,30-0,87), p 0,01) and to Triptorelin (PRR 0,45 (95%CI 0,23-0,64), p<0,01. Moreover, Degarelix presented lower risk of thrombosis (PRR 0,57 (95%CI 0,02- 0,80), p 0,03) when compared to leuprorelin. No significative differences were reported regarding atrial fibrillation, cerebrovascular accidents, T.I.A., stroke and embolism events (Table). Most of the reported cardiovascular disorders for drugs were present in the 65-85 range of age.

Conclusions: Real life data is consistent with registry studies regarding side effects related to HT. Real-life data suggest GnRH agonists are associated with higher cardiovascular AEs when compared to GnRH antagonists. Clinicians should consider these data when prescribing HT especially in young patients.

Source of Funding: None