PMID- 37873598
OWN - NLM
STAT- MEDLINE
DCOM- 20240308
LR  - 20240308
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 23
IP  - 3
DP  - 2024 Mar
TI  - Real-world safety of icosapent ethyl: analysis based on spontaneous reports in 
      FAERS database.
PG  - 373-383
LID - 10.1080/14740338.2023.2274946 [doi]
AB  - BACKGROUND: The triglyceride-lowering drug, icosapent ethyl (IPE), was granted a 
      new indication for the reduction of atherosclerotic cardiovascular disease risk 
      in 2019. This study aimed to investigate the safety profile of IPE by mining the 
      FDA Adverse Event Reporting System (FAERS) database. METHODS: The reporting odds 
      ratio was used to analyze IPE's adverse events (AEs) based on the FAERS data from 
      July 2012 to December 2022. We described the characteristics of AE reports and 
      evaluated the clinical prioritization of AEs. Then we defined and analyzed nine 
      interested adverse drug reactions (ADRs) in both overall and subgroups, and 
      investigated the times to onset. RESULTS: The findings of our study strengthen 
      the evidence for an increased risk of atrial fibrillation using IPE. IPE alone 
      may not increase the risk of bleeding unless combined with antithrombotic drugs. 
      Similar to statins, IPE alone can increase the risk of musculoskeletal pain, 
      drug-related hepatic disorders, and hyperglycemia, but the risk could not double 
      when IPE was combined with statins. Most ADRs occur in the early stage of 
      treatment. CONCLUSIONS: This study provides a comprehensive real-world safety 
      profile of IPE, which indicates that IPE is well-tolerated.
FAU - Cai, Haixia
AU  - Cai H
AUID- ORCID: 0000-0002-0075-879X
AD  - Department of Pharmacy, Henan Provincial People's Hospital, Zhengzhou, China.
FAU - Jia, Beixi
AU  - Jia B
AD  - Department of Pharmacognosy, School of Pharmaceutical Science, Zhengzhou 
      University, Zhengzhou, China.
FAU - Fu, Zhonghua
AU  - Fu Z
AD  - Department of Pharmacy, Henan Provincial People's Hospital, Zhengzhou, China.
FAU - Chen, Boya
AU  - Chen B
AD  - Department of Pharmacy, Henan Provincial People's Hospital, Zhengzhou, China.
FAU - Liu, Yinping
AU  - Liu Y
AD  - Department of Pharmacy, Henan Provincial People's Hospital, Zhengzhou, China.
FAU - Zhao, Shujuan
AU  - Zhao S
AUID- ORCID: 0000-0003-2835-3601
AD  - Department of Pharmacy, Henan Provincial People's Hospital, Zhengzhou, China.
LA  - eng
PT  - Journal Article
DEP - 20231027
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 6GC8A4PAYH (eicosapentaenoic acid ethyl ester)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - AAN7QOV9EA (Eicosapentaenoic Acid)
SB  - IM
MH  - Humans
MH  - United States/epidemiology
MH  - *Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
MH  - Adverse Drug Reaction Reporting Systems
MH  - Eicosapentaenoic Acid/adverse effects/*analogs & derivatives
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - FAERS
OT  - Icosapent ethyl
OT  - adverse event
OT  - data mining
OT  - pharmacovigilance
EDAT- 2023/10/24 06:41
MHDA- 2024/03/08 06:43
CRDT- 2023/10/24 04:23
PHST- 2024/03/08 06:43 [medline]
PHST- 2023/10/24 06:41 [pubmed]
PHST- 2023/10/24 04:23 [entrez]
AID - 10.1080/14740338.2023.2274946 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2024 Mar;23(3):373-383. doi: 10.1080/14740338.2023.2274946. 
      Epub 2023 Oct 27.