PMID- 37950531
OWN - NLM
STAT- MEDLINE
DCOM- 20240416
LR  - 20240425
IS  - 1755-5949 (Electronic)
IS  - 1755-5930 (Print)
IS  - 1755-5930 (Linking)
VI  - 30
IP  - 4
DP  - 2024 Apr
TI  - Psychiatric disorders associated with PCSK9 inhibitors: A real-world, 
      pharmacovigilance study.
PG  - e14522
LID - 10.1111/cns.14522 [doi]
LID - e14522
AB  - BACKGROUND: The relationship between Protein Convertase Subtilisin Kexin Type 9 
      inhibitor (PCSK9i) and psychiatric adverse events (AEs) remains unclear due to 
      the limitations of clinical trials. In this study, PCSK9i-related psychiatric AEs 
      were realistically observed and systematically summarized in the real world by 
      data mining the FDA AE Reporting System (FAERS). METHOD: Total AEs between the 
      third quarter of 2015 and the first quarter of 2023 were obtained from FAERS. 
      Psychiatric AEs were identified using disproportionality analysis and clinical 
      prioritization of signals using a rating scale, followed by univariate logistic 
      regression to explore factors influencing psychiatric AEs. RESULTS: Psychiatric 
      AEs accounted for 6.7% of the total number of PCSK9i reports. Eighteen 
      psychiatric AEs were defined as PCSK9i-related psychiatric adverse events (ppAEs) 
      (lower 95% CI of both ROR >1 and IC(025) > 0). The median age of ppAE reports was 
      68 years, and female patients accounted for 22.67% of reports, including 41.40% 
      of reports with a serious outcome. Eleven (61.11%) and seven (38.89%) ppAEs were 
      classified as weak and moderate clinical priority, respectively. The median time 
      to onset of ppAEs was 149 and 196 days after treatment with evolocumab and 
      alirocumab, respectively. Patients weighing >/=80 kg were 1.59 times more likely to 
      experience ppAEs. CONCLUSION: The results of this study facilitate the 
      prioritization of psychiatric AE signals by healthcare professionals with the 
      goal of mitigating the risk of PCSK9i-related psychiatric AEs. However, as an 
      exploratory study, our findings need to be confirmed in large-scale prospective 
      studies.
CI  - (c) 2023 The Authors. CNS Neuroscience & Therapeutics published by John Wiley & 
      Sons Ltd.
FAU - Deng, Zhifang
AU  - Deng Z
AD  - Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Liu, Jue
AU  - Liu J
AD  - Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Gong, Hongjian
AU  - Gong H
AD  - Institute of Maternal and Child Health, Wuhan Children's Hospital (Wuhan Maternal 
      and Child Healthcare Hospital), Tongji Medical College, Huazhong University and 
      Technology, Wuhan, China.
FAU - Cai, Xiaonan
AU  - Cai X
AD  - Institute of Maternal and Child Health, Wuhan Children's Hospital (Wuhan Maternal 
      and Child Healthcare Hospital), Tongji Medical College, Huazhong University and 
      Technology, Wuhan, China.
FAU - Xiao, Han
AU  - Xiao H
AD  - Institute of Maternal and Child Health, Wuhan Children's Hospital (Wuhan Maternal 
      and Child Healthcare Hospital), Tongji Medical College, Huazhong University and 
      Technology, Wuhan, China.
FAU - Gao, Wenqi
AU  - Gao W
AUID- ORCID: 0000-0003-1664-0830
AD  - Institute of Maternal and Child Health, Wuhan Children's Hospital (Wuhan Maternal 
      and Child Healthcare Hospital), Tongji Medical College, Huazhong University and 
      Technology, Wuhan, China.
LA  - eng
GR  - Top Medical Young Talents of Hubei Province/
GR  - Wuhan Yellow Crane Talent-Outstanding Young Talents Program/
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231110
PL  - England
TA  - CNS Neurosci Ther
JT  - CNS neuroscience & therapeutics
JID - 101473265
RN  - 0 (PCSK9 Inhibitors)
RN  - EC 3.4.21.- (PCSK9 protein, human)
RN  - EC 3.4.21.- (Proprotein Convertase 9)
SB  - IM
MH  - Humans
MH  - Female
MH  - Aged
MH  - *PCSK9 Inhibitors
MH  - Proprotein Convertase 9
MH  - Pharmacovigilance
MH  - Prospective Studies
MH  - Databases, Factual
MH  - *Mental Disorders/drug therapy/epidemiology
PMC - PMC11017405
OTO - NOTNLM
OT  - FDA adverse event reporting system
OT  - PCSK9i
OT  - pharmacovigilance
OT  - psychiatric disorders
COIS- None of the other authors reported a conflict of interest related to the study.
EDAT- 2023/11/11 11:45
MHDA- 2024/04/16 12:44
PMCR- 2023/11/10
CRDT- 2023/11/11 03:44
PHST- 2023/10/11 00:00 [revised]
PHST- 2023/09/06 00:00 [received]
PHST- 2023/10/27 00:00 [accepted]
PHST- 2024/04/16 12:44 [medline]
PHST- 2023/11/11 11:45 [pubmed]
PHST- 2023/11/11 03:44 [entrez]
PHST- 2023/11/10 00:00 [pmc-release]
AID - CNS14522 [pii]
AID - 10.1111/cns.14522 [doi]
PST - ppublish
SO  - CNS Neurosci Ther. 2024 Apr;30(4):e14522. doi: 10.1111/cns.14522. Epub 2023 Nov 
      10.