MP48-06 ADVERSE EVENTS RELATED TO DAROLUTAMIDE TREATMENT: ANALYSIS OF “REAL LIFE” DATA FROM EUDRAVIGILANCE (EV) AND THE FOOD AND DRUG ADMINISTRATION (FDA) DATABASE ENTRIES

Abstract

You have accessJournal of UrologyCME1 May 2022MP48-06 ADVERSE EVENTS RELATED TO DAROLUTAMIDE TREATMENT: ANALYSIS OF “REAL LIFE” DATA FROM EUDRAVIGILANCE (EV) AND THE FOOD AND DRUG ADMINISTRATION (FDA) DATABASE ENTRIES Antonio Cicione, Antonio Nacchia, Beatrice Turchi, Carmen Gravina, Giacomo Gallo, Alessandro Guercio, Lorenzo Maria Rovesti, Giorgio Guarnotta, Elisa Mancini, Jordi Stira, Sara Riolo, Antonio Franco, Olivia Alessandra Voglino, Valeria Baldassarri, Simone D'Annunzio, Ferdinando Di Giacomo, Giuseppe Disabato, Alfredo Tartarone, Cosimo De Nunzio, and Andrea Tubaro Antonio CicioneAntonio Cicione More articles by this author , Antonio NacchiaAntonio Nacchia More articles by this author , Beatrice TurchiBeatrice Turchi More articles by this author , Carmen GravinaCarmen Gravina More articles by this author , Giacomo GalloGiacomo Gallo More articles by this author , Alessandro GuercioAlessandro Guercio More articles by this author , Lorenzo Maria RovestiLorenzo Maria Rovesti More articles by this author , Giorgio GuarnottaGiorgio Guarnotta More articles by this author , Elisa ManciniElisa Mancini More articles by this author , Jordi StiraJordi Stira More articles by this author , Sara RioloSara Riolo More articles by this author , Antonio FrancoAntonio Franco More articles by this author , Olivia Alessandra VoglinoOlivia Alessandra Voglino More articles by this author , Valeria BaldassarriValeria Baldassarri More articles by this author , Simone D'AnnunzioSimone D'Annunzio More articles by this author , Ferdinando Di GiacomoFerdinando Di Giacomo More articles by this author , Giuseppe DisabatoGiuseppe Disabato More articles by this author , Alfredo TartaroneAlfredo Tartarone More articles by this author , Cosimo De NunzioCosimo De Nunzio More articles by this author , and Andrea TubaroAndrea Tubaro More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002619.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Darolutamide, an oral androgen receptor inhibitor, has been approved for treating nonmetastatic castration-resistant prostate cancer (nmCRPC), based on significant improvements in metastasis-free survival (MFS) in the ARAMIS clinical trial. Aim of our study was to analyse adverse events (AEs) associated with darolutamide using real life data from EV and the FAERS databases. METHODS: EV database in European Economic Area and the FAERS database were queried to identify darolutamide AEs occurred from 30th July 2019 to 1st October 2021. AEs were recorded in according to category and severity. Real-life data was compared to Aramis registry study. Furthermore, AEs reported in EV database were categorized by patient’s age into more or less than 85 years. Pooled relative risk (PRR) was used to compare groups. RESULTS: On EV database 139 AEs related to Darolutamide were identified, of which 54 (39%) were serious and 2 (0,01%) were deaths. On FDA FAERS database 257 adverse events related to Darolutamide were reported with 137 (53%) serious events and 8 (3%) death cases. 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. Fatigue was the most common AE reported in all three datasets, respectively 115 events (12,1%) in the registry study, 33 events (12,8%) in FDA-FAERS and 13 events (9,3%) in EV. However, no significative differences were found in all three datasets for fatigue, diarrhea and nausea (PRR 0,80 – 1,50), p >0,05. Higher rates of back pain, arthalgia, hypertension, constipation, pain in an extremity, anemia, hot flush, UTIs and urinary retention were found in the registry study when compared to EV and FDA-FAERS databases (PRR 1,50-7,00, p <0,05). Unfortunately, no information on the number of patients under treatment was reported in the EV database. 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. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e822 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Antonio Cicione More articles by this author Antonio Nacchia More articles by this author Beatrice Turchi More articles by this author Carmen Gravina More articles by this author Giacomo Gallo More articles by this author Alessandro Guercio More articles by this author Lorenzo Maria Rovesti More articles by this author Giorgio Guarnotta More articles by this author Elisa Mancini More articles by this author Jordi Stira More articles by this author Sara Riolo More articles by this author Antonio Franco More articles by this author Olivia Alessandra Voglino More articles by this author Valeria Baldassarri More articles by this author Simone D'Annunzio More articles by this author Ferdinando Di Giacomo More articles by this author Giuseppe Disabato More articles by this author Alfredo Tartarone More articles by this author Cosimo De Nunzio More articles by this author Andrea Tubaro More articles by this author Expand All Advertisement PDF DownloadLoading ...