PMID- 37410030
OWN - NLM
STAT- MEDLINE
DCOM- 20230921
LR  - 20230921
IS  - 2724-6442 (Electronic)
IS  - 2724-6051 (Linking)
VI  - 75
IP  - 5
DP  - 2023 Oct
TI  - Adverse events related to darolutamide treatment: analysis of "real life" data 
      from EudraVigilance and the Food and Drug Administration database entries.
PG  - 600-606
LID - 10.23736/S2724-6051.23.05304-1 [doi]
AB  - BACKGROUND: Aim of our study was to analyze adverse events (AEs) associated with 
      darolutamide using real life data from Eudra-Vigilance (EV) and the Food and Drug 
      Administration (FDA) Adverse Event Reporting System (FAERS) databases. METHODS: 
      EV database in European Economic Area (EEA) and the FDA FAERS database were 
      queried to identify darolutamide AEs occurred from 30th July 2019 to May 2022. 
      AEs were recorded in according to category and severity. Real-life data was 
      compared to Aramis registry study. RESULTS: The total number of AEs including 
      data from both databases was 409 reported by FDA-FAERS and 253 reported by EV 
      databases. On registry study, 794 AEs were reported, with serious AEs occurring 
      in 24.8% of patients in the darolutamide group and with 1 death related to trial 
      regimen. The most frequently reported AEs from both database were general 
      disorders (33% and 26%), investigations (19% and 22%), gastrointestinal (15% and 
      11%), renal and urinary (9%), gastrointestinal (6%) and musculoskeletal disorder 
      (5%). CONCLUSIONS: According to our results darolutamide is safe in a real-life 
      scenario and the most frequent side effect is fatigue. Although up to now there 
      are few reports in both real-life databases, these data are encouraging for 
      clinicians using darolutamide in every day clinical practice.
FAU - Tema, Giorgia
AU  - Tema G
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Lombardo, Riccardo
AU  - Lombardo R
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Cicione, Antonio
AU  - Cicione A
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Nacchia, Antonio
AU  - Nacchia A
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Gravina, Carmen
AU  - Gravina C
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Franco, Antonio
AU  - Franco A
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Fiasconaro, Daniele
AU  - Fiasconaro D
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Sarcinelli, Luca
AU  - Sarcinelli L
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Ghezzo, Nicola
AU  - Ghezzo N
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Pastore, Antonio
AU  - Pastore A
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Al Salhi, Yazan
AU  - Al Salhi Y
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Fuschi, Andrea
AU  - Fuschi A
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Martoccia, Alessia
AU  - Martoccia A
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - Tubaro, Andrea
AU  - Tubaro A
AD  - Department of Urology, Sapienza University, Rome, Italy.
FAU - DE Nunzio, Cosimo
AU  - DE Nunzio C
AD  - Department of Urology, Sapienza University, Rome, Italy - 
      denunziocosimo@gmail.com.
LA  - eng
PT  - Journal Article
DEP - 20230706
PL  - Italy
TA  - Minerva Urol Nephrol
JT  - Minerva urology and nephrology
JID - 101777299
RN  - 0 (darolutamide)
RN  - 0 (Pyrazoles)
SB  - IM
MH  - United States/epidemiology
MH  - Humans
MH  - United States Food and Drug Administration
MH  - *Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Pyrazoles
EDAT- 2023/07/06 13:14
MHDA- 2023/09/21 06:42
CRDT- 2023/07/06 10:37
PHST- 2023/09/21 06:42 [medline]
PHST- 2023/07/06 13:14 [pubmed]
PHST- 2023/07/06 10:37 [entrez]
AID - S2724-6051.23.05304-1 [pii]
AID - 10.23736/S2724-6051.23.05304-1 [doi]
PST - ppublish
SO  - Minerva Urol Nephrol. 2023 Oct;75(5):600-606. doi: 
      10.23736/S2724-6051.23.05304-1. Epub 2023 Jul 6.