PMID- 37067186
OWN - NLM
STAT- MEDLINE
DCOM- 20230803
LR  - 20230803
IS  - 2724-6442 (Electronic)
IS  - 2724-6051 (Linking)
VI  - 75
IP  - 4
DP  - 2023 Aug
TI  - Adverse events related to alpha-blockers: analysis of real-life data from 
      Eudra-Vigilance.
PG  - 479-485
LID - 10.23736/S2724-6051.23.05225-4 [doi]
AB  - BACKGROUND: Patients on alpha-blockers (ABs) treatment may have an increased risk 
      of adverse events (AEs). Aim of our study was to compare real-life data on 
      neuro-vascular and sexual AEs associated with ABs based on Eudra-Vigilance 
      reported AEs. METHODS: Eudra-Vigilance (EV) 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 sexual and neuro-vascular AEs for tamsulosin, 
      alfuzosin, silodosin, prazosin and doxazosin per category and severity until July 
      30(th), 2022. Pooled Relative Risk (PRR) was used to compare data between drugs. 
      RESULTS: Overall the number of AEs were 2842 for Alfuzosin, 11,086 for 
      tamsulosin, 792 for terazosin, 572 for prazosin and 4641 for doxazosin. Different 
      percentages of AEs were obtained for each drug and in different age groups 
      according to EV sub-groups (</=65, 65-85, >/=85). On PRR analysis, the risk of 
      ejaculatory disorders for Silodosin (11%) is 18.5 times higher (PRR 18.5 95%CI; 
      10.7-31.8; P<0.05) when compared to alfuzosin and the risk of orthostatic 
      hypotension is 2 times lower (PRR=1,84 95%CI 1.32-2.57; P<0.05). CONCLUSIONS: 
      Real life data is consistent with registry studies regarding side effects related 
      to alpha-blockers. Alfuzosin is safer in terms of ejaculatory disorders while 
      silodosin and tamsulosin in terms of orthostatic hypotension. Clinicians should 
      consider these data when prescribing ABs especially in younger and older 
      patients.
FAU - Cicione, Antonio
AU  - Cicione A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Nacchia, Antonio
AU  - Nacchia A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Baldassarri, Valeria
AU  - Baldassarri V
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Tema, Giorgia
AU  - Tema G
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Rovesti, Lorenzo M
AU  - Rovesti LM
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Mancini, Elisa
AU  - Mancini E
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Guarnotta, Giorgio
AU  - Guarnotta G
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Voglino, Olivia A
AU  - Voglino OA
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Franco, Antonio
AU  - Franco A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - D'Annunzio, Simone
AU  - D'Annunzio S
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Lombardo, Riccardo
AU  - Lombardo R
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Tubaro, Andrea
AU  - Tubaro A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - DE Nunzio, Cosimo
AU  - DE Nunzio C
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy - 
      cosimodenunzio@virgilio.it.
LA  - eng
PT  - Journal Article
DEP - 20230417
PL  - Italy
TA  - Minerva Urol Nephrol
JT  - Minerva urology and nephrology
JID - 101777299
RN  - NW1291F1W8 (Doxazosin)
RN  - G3P28OML5I (Tamsulosin)
RN  - 0 (Adrenergic alpha-Antagonists)
RN  - XM03YJ541D (Prazosin)
SB  - IM
MH  - Humans
MH  - Doxazosin/therapeutic use
MH  - Tamsulosin/therapeutic use
MH  - *Hypotension, Orthostatic/chemically induced/epidemiology/drug therapy
MH  - Adrenergic alpha-Antagonists/adverse effects
MH  - Prazosin/adverse effects
MH  - *Urogenital Diseases
EDAT- 2023/04/18 06:00
MHDA- 2023/08/03 06:42
CRDT- 2023/04/17 08:05
PHST- 2023/08/03 06:42 [medline]
PHST- 2023/04/18 06:00 [pubmed]
PHST- 2023/04/17 08:05 [entrez]
AID - S2724-6051.23.05225-4 [pii]
AID - 10.23736/S2724-6051.23.05225-4 [doi]
PST - ppublish
SO  - Minerva Urol Nephrol. 2023 Aug;75(4):479-485. doi: 
      10.23736/S2724-6051.23.05225-4. Epub 2023 Apr 17.