PMID- 38034088
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231202
IS  - 2050-1161 (Print)
IS  - 2050-1161 (Electronic)
IS  - 2050-1161 (Linking)
VI  - 11
IP  - 5
DP  - 2023 Oct
TI  - Safety profile and signal detection of phosphodiesterase type 5 inhibitors for 
      erectile dysfunction: a Food and Drug Administration Adverse Event Reporting 
      System analysis.
PG  - qfad059
LID - 10.1093/sexmed/qfad059 [doi]
LID - qfad059
AB  - BACKGROUND: Phosphodiesterase type 5 inhibitors (PDE5Is) are generally well 
      tolerated but have been associated with uncommon and significant adverse events 
      (AEs). AIM: This study aims to investigate and compare the characteristics of AEs 
      associated with PDE5Is used for erectile dysfunction and identify any safety 
      signals in a postmarketing surveillance database between 2010 and 2021. METHODS: 
      A descriptive analysis was conducted for all AEs reported to the Food and Drug 
      Administration Adverse Event Reporting System for 4 PDE5Is-avanafil, sildenafil, 
      tadalafil, and vardenafil-indicated for erectile dysfunction between January 2010 
      and December 2021. The frequency of the most reported AEs and outcomes were 
      identified. A disproportionality analysis based on proportional reporting ratio 
      (PRR) and reporting odds ratio (ROR) was conducted for the most common and 
      clinically important AEs to identify signals to gain insights into potential 
      differences in safety profiles. OUTCOMES: The outcome measures of the study are 
      frequency of reported AEs and outcomes following AE. RESULTS: A total of 29 236 
      AEs were reported for PDE5Is during the study period. The most reported AE was 
      "drug ineffective" with 7115 reports (24.3%). Eight safety signals were detected 
      across the 4 drugs. Key signals were sexual disorders (PRR, 3.13 [95% CI, 
      2.69-3.65]; ROR, 3.24 [95% CI, 2.77-3.79]) and death (PRR, 3.17 [2.5-4.01]; ROR, 
      3.211 [2.52-4.06]) for sildenafil, priapism (PRR, 3.63 [2.11-6.24]; ROR, 3.64 
      [2.12-6.26]) for tadalafil, and drug administration error (PRR, 2.54 [1.84-3.52]; 
      ROR, 2.6 [1.86-3.63]) for vardenafil. The most reported outcomes were other 
      serious events with 6685 events (67.2%) and hospitalization with 1939 events 
      (19.5%). CLINICAL IMPLICATIONS: The commonly reported AEs and detected signals 
      may guide clinicians in treatment decision making for men with erectile 
      dysfunction. STRENGTHS AND LIMITATIONS: This is the first comprehensive report 
      and disproportionality analysis on all types of AEs associated with PDE5Is used 
      for erectile dysfunction in the United States. The findings should be interpreted 
      cautiously due to limitations in the Adverse Event Reporting System, which 
      includes self-reports, duplicate and incomplete reports, and biases in reporting 
      and selection. Therefore, establishing a causal relationship between the reported 
      AEs and the use of PDE5Is is uncertain, and the data may be confounded by other 
      medications and indications. CONCLUSION: PDE5Is demonstrate significantly 
      increased risks of reporting certain clinically important AEs. While these events 
      are not common, it is imperative to continually monitor PDE5I use at the levels 
      of primary care to national surveillance to ensure safe utilization.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of The 
      International Society of Sexual Medicine.
FAU - Shin, Young Eun
AU  - Shin YE
AUID- ORCID: 0000-0003-3050-0252
AD  - Division of Pharmacy Practice and Administrative Sciences, James L. Winkle 
      College of Pharmacy, University of Cincinnati, Cincinnati, OH 45229, United 
      States.
AD  - Health Economics and Market Access, Boston Scientific, Marlborough, MA 01752, 
      United States.
FAU - Rojanasarot, Sirikan
AU  - Rojanasarot S
AD  - Health Economics and Market Access, Boston Scientific, Marlborough, MA 01752, 
      United States.
FAU - Hincapie, Ana L
AU  - Hincapie AL
AD  - Division of Pharmacy Practice and Administrative Sciences, James L. Winkle 
      College of Pharmacy, University of Cincinnati, Cincinnati, OH 45229, United 
      States.
FAU - Guo, Jeff Jianfei
AU  - Guo JJ
AD  - Division of Pharmacy Practice and Administrative Sciences, James L. Winkle 
      College of Pharmacy, University of Cincinnati, Cincinnati, OH 45229, United 
      States.
LA  - eng
PT  - Journal Article
DEP - 20231129
PL  - England
TA  - Sex Med
JT  - Sexual medicine
JID - 101631053
PMC - PMC10687329
OTO - NOTNLM
OT  - FAERS
OT  - PDE5 inhibitors
OT  - adverse events
OT  - avanafil
OT  - erectile dysfunction
OT  - signal detection
OT  - sildenafil
OT  - tadalafil
OT  - vardenafil
COIS- S.R. is a full-time employee of Boston Scientific. Y.E.S. is a graduate student 
      at the University of Cincinnati and not a Boston Scientific employee; however, 
      she is working on a global health economics and market access project with Boston 
      Scientific.
EDAT- 2023/11/30 18:45
MHDA- 2023/11/30 18:46
PMCR- 2023/11/29
CRDT- 2023/11/30 17:29
PHST- 2023/06/21 00:00 [received]
PHST- 2023/10/15 00:00 [revised]
PHST- 2023/10/20 00:00 [accepted]
PHST- 2023/11/30 18:46 [medline]
PHST- 2023/11/30 18:45 [pubmed]
PHST- 2023/11/30 17:29 [entrez]
PHST- 2023/11/29 00:00 [pmc-release]
AID - qfad059 [pii]
AID - 10.1093/sexmed/qfad059 [doi]
PST - epublish
SO  - Sex Med. 2023 Nov 29;11(5):qfad059. doi: 10.1093/sexmed/qfad059. eCollection 2023 
      Oct.