PMID- 31685981
OWN - NLM
STAT- MEDLINE
DCOM- 20210308
LR  - 20211204
IS  - 1476-5608 (Electronic)
IS  - 1365-7852 (Linking)
VI  - 23
IP  - 2
DP  - 2020 Jun
TI  - Adverse events related to abiraterone and enzalutamide treatment: analysis of the 
      EudraVigilance database and meta-analysis of registrational phase III studies.
PG  - 199-206
LID - 10.1038/s41391-019-0182-x [doi]
AB  - BACKGROUND: Data from clinical trials do not always provide adequate information 
      to judge the impact of new treatments when used in a real-world setting. The aim 
      of our study was to analyze adverse events (AEs) associated with enzalutamide 
      (ENZ) and abiraterone (ABI) using real-life data from the EudraVigilance (EV) 
      database. METHODS: The EV database is the system for managing and analyzing 
      information on suspected adverse reactions to medicines, which have been 
      authorized or are being studied in clinical trials in the European Economic Area. 
      We recorded the number of AEs for ABI and ENZ per category and severity from 
      January 2013 to January 2019. In addition, we recorded AEs per age group. A 
      meta-analysis of AEs reported in registrational phase III studies (AFFIRM, 
      PREVAIL, COU-AA) was performed. RESULTS: The number of individual cases 
      identified in EV database was 13,562 for ABI and 40,599 for ENZ. Over 90% of the 
      reported AEs were defined as serious for both drugs. Older patients (>85 years 
      and 65-85 years) treated with ABI or ENZ are at increased risk of cardiac, 
      infectious, metabolic, and respiratory disorders when compared with younger 
      patients (<65). According to registrational phase III studies, the most frequent 
      AEs in patients treated with ABI are hepatobiliary disorders, while the most 
      frequent AEs in patients treated with ENZ are psychiatric and vascular disorders. 
      Several AEs present in the EV database are not reported in the registrational 
      phase III studies. It is important to note that we have no information on the 
      number of patients under treatment in the EV database. CONCLUSIONS: The EV 
      database highlights several AEs that are not reported in registrational phase III 
      studies as well as different AEs profiles according to age. Clinicians should 
      consider these data when treating patients with castration-resistant prostate 
      cancer with ABI or ENZ.
FAU - De Nunzio, Cosimo
AU  - De Nunzio C
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy. 
      cosimodenunzio@virgilio.it.
FAU - Lombardo, Riccardo
AU  - Lombardo R
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy.
FAU - Tema, Giorgia
AU  - Tema G
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy.
FAU - Voglino, Olivia
AU  - Voglino O
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy.
FAU - Sica, Angela
AU  - Sica A
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy.
FAU - Baldassarri, Valeria
AU  - Baldassarri V
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy.
FAU - Nacchia, Antonio
AU  - Nacchia A
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy.
FAU - Iacovelli, Roberto
AU  - Iacovelli R
AD  - Oncologia Medica, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, 
      Italy.
FAU - Bracarda, Sergio
AU  - Bracarda S
AD  - Department of Urology, Azienda Ospedaliera di Terni, Terni, Italy.
FAU - Tubaro, Andrea
AU  - Tubaro A
AD  - Department of Urology, Ospedale Sant'Andrea, Rome, Italy.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20191104
PL  - England
TA  - Prostate Cancer Prostatic Dis
JT  - Prostate cancer and prostatic diseases
JID - 9815755
RN  - 0 (Androstenes)
RN  - 0 (Benzamides)
RN  - 0 (Nitriles)
RN  - 2010-15-3 (Phenylthiohydantoin)
RN  - 93T0T9GKNU (enzalutamide)
RN  - G819A456D0 (abiraterone)
SB  - IM
MH  - Androstenes/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects
MH  - Benzamides
MH  - *Clinical Trials, Phase III as Topic
MH  - Drug-Related Side Effects and Adverse Reactions/etiology/*pathology
MH  - Humans
MH  - Male
MH  - Nitriles
MH  - Phenylthiohydantoin/administration & dosage/analogs & derivatives
MH  - Prognosis
MH  - Prostatic Neoplasms/*drug therapy/pathology
MH  - Retrospective Studies
EDAT- 2019/11/07 06:00
MHDA- 2021/03/09 06:00
CRDT- 2019/11/06 06:00
PHST- 2019/06/25 00:00 [received]
PHST- 2019/10/23 00:00 [accepted]
PHST- 2019/09/27 00:00 [revised]
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2021/03/09 06:00 [medline]
PHST- 2019/11/06 06:00 [entrez]
AID - 10.1038/s41391-019-0182-x [pii]
AID - 10.1038/s41391-019-0182-x [doi]
PST - ppublish
SO  - Prostate Cancer Prostatic Dis. 2020 Jun;23(2):199-206. doi: 
      10.1038/s41391-019-0182-x. Epub 2019 Nov 4.