PMID- 36641533
OWN - NLM
STAT- MEDLINE
DCOM- 20231113
LR  - 20231122
IS  - 1476-5608 (Electronic)
IS  - 1365-7852 (Linking)
VI  - 26
IP  - 4
DP  - 2023 Dec
TI  - Cardiovascular adverse events-related to GnRH agonists and GnRH antagonists: 
      analysis of real-life data from Eudra-Vigilance and Food and Drug Administration 
      databases entries.
PG  - 765-771
LID - 10.1038/s41391-022-00640-4 [doi]
AB  - INTRODUCTION AND OBJECTIVES: GnRH agonists and GnRH antagonists are two of the 
      mainstays of hormonal therapy (HT) for prostate cancer (PCa). These drugs are at 
      increased risk of cardiovascular (CV) 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 (EV) and Food and Drug Administration (FDA) 
      reported AEs. MATERIALS AND METHODS: EV and FDA databases were queried and the 
      number of CV adverse events (AEs) for degarelix, buserelin, goserelin, 
      leuprorelin, triptorelin until September 2021 were recorded. Specific CV AEs were 
      recorded and data were analyzed per age and severity. pooled relative risk (PRR) 
      was used to compare data between drugs. RESULTS: CV events were reported in 
      315/5128 (6%) for Degarelix, in 55/628 for Buserelin (9%), in 843/12,145 (7%) for 
      Goserelin, in 3395/71,160 (5%) for Leuprorelin and in 214/4969 (5%) for 
      Triptorelin. In terms of specific CV disorders, Degarelix presented lower risk of 
      hypertension (PRR 0.60 (95% CI 0.37-0.98), p = 0.04), of myocardial infarction 
      (PRR 0.05 (95% CI 0.01-0.39), p < 0.01) and thrombosis (PRR 0.14 (0.02-1.07), 
      p = 0.06) when compared to GnRH agonists. Overall, younger patients (<65 years) 
      presented a very low risk of CV AEs. Side effects were classified as serious in 
      90-96% of the cases. Fatal AEs were 5-20% over the CV AEs and 0.2-1% over the 
      total AEs. CONCLUSIONS: Real-life data are consistent with registry studies 
      regarding side effects related to HT. Real-life data suggest GnRH agonists are 
      associated with higher CV AEs when compared to GnRH antagonists. Clinicians 
      should consider these data when prescribing HT especially in patients with CV 
      comorbidities.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Limited.
FAU - Cicione, Antonio
AU  - Cicione A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - Nacchia, Antonio
AU  - Nacchia A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - Guercio, Alessandro
AU  - Guercio A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - Gravina, Carmen
AU  - Gravina C
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - Franco, Antonio
AU  - Franco A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - Grimaldi, Maria Chiara
AU  - Grimaldi MC
AD  - Catholic University of Sacred Heart, Cardiology, Rome, Italy.
FAU - Tema, Giorgia
AU  - Tema G
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - Lombardo, Riccardo
AU  - Lombardo R
AUID- ORCID: 0000-0003-2890-3159
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - Tubaro, Andrea
AU  - Tubaro A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy.
FAU - De Nunzio, Cosimo
AU  - De Nunzio C
AUID- ORCID: 0000-0002-2190-512X
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, 
      Italy. cosimodenunzio@virgilio.it.
LA  - eng
PT  - Journal Article
DEP - 20230114
PL  - England
TA  - Prostate Cancer Prostatic Dis
JT  - Prostate cancer and prostatic diseases
JID - 9815755
RN  - EFY6W0M8TG (Leuprolide)
RN  - 33515-09-2 (Gonadotropin-Releasing Hormone)
RN  - 0F65R8P09N (Goserelin)
RN  - 08AN7WA2G0 (Triptorelin Pamoate)
RN  - PXW8U3YXDV (Buserelin)
RN  - 0 (Androgen Antagonists)
SB  - IM
MH  - United States/epidemiology
MH  - Male
MH  - Humans
MH  - *Leuprolide/adverse effects
MH  - Gonadotropin-Releasing Hormone
MH  - *Prostatic Neoplasms/drug therapy/chemically induced
MH  - Goserelin/therapeutic use
MH  - Triptorelin Pamoate/adverse effects
MH  - Buserelin/therapeutic use
MH  - United States Food and Drug Administration
MH  - Androgen Antagonists/therapeutic use
EDAT- 2023/01/15 06:00
MHDA- 2023/11/13 06:42
CRDT- 2023/01/14 23:19
PHST- 2022/11/04 00:00 [received]
PHST- 2022/12/30 00:00 [accepted]
PHST- 2022/12/27 00:00 [revised]
PHST- 2023/11/13 06:42 [medline]
PHST- 2023/01/15 06:00 [pubmed]
PHST- 2023/01/14 23:19 [entrez]
AID - 10.1038/s41391-022-00640-4 [pii]
AID - 10.1038/s41391-022-00640-4 [doi]
PST - ppublish
SO  - Prostate Cancer Prostatic Dis. 2023 Dec;26(4):765-771. doi: 
      10.1038/s41391-022-00640-4. Epub 2023 Jan 14.