PMID- 35726369
OWN - NLM
STAT- MEDLINE
DCOM- 20221006
LR  - 20221006
IS  - 1365-2710 (Electronic)
IS  - 0269-4727 (Linking)
VI  - 47
IP  - 10
DP  - 2022 Oct
TI  - Cardiovascular toxicities associated with immune checkpoint inhibitors: An 
      updated comprehensive disproportionality analysis of the FDA adverse event 
      reporting system.
PG  - 1576-1584
LID - 10.1111/jcpt.13707 [doi]
AB  - WHAT IS KNOWN AND OBJECTIVE: Immune checkpoint inhibitors (ICIs) have 
      significantly improved clinical outcomes for a wide range of cancers but can also 
      lead to cardiovascular toxicities. This study was to scientifically and 
      systematically explore the association between cardiovascular toxicities and 
      immune checkpoint inhibitors (ICIs) and also to characterize the main features of 
      ICI-related cardiovascular toxicities. METHODS: From January 2012 to December 
      2020, data in the Food and Drug Administration Adverse Event Reporting System 
      (FAERS) database were retrieved for disproportionality analysis. The definition 
      of adverse events (AEs) relied on the Medical Dictionary for Regulatory 
      Activities (MedDRA). We used the reporting odds ratio (ROR) with 95% confidence 
      intervals (CIs) to evaluate the association between ICIs and cardiovascular AEs. 
      Clinical characteristics of patients with ICI-associated cardiovascular 
      toxicities were collected, and the time to onset following different ICI regimens 
      was further investigated. RESULTS AND DISCUSSION: We identified a total of 13,713 
      ICI-associated cardiovascular toxicities which appeared to influence more men 
      (56.90%) than women (36.79%), with a median age of 67 (interquartile range [IQR] 
      58-74) years. ICI-associated cardiovascular AEs were most frequently reported in 
      lung, pleura, thymus and heart cancer patients (34.49%). Compared with the full 
      database, ICI therapies were detected with pharmacovigilance of myocardial 
      disorders (ROR: 2.64; 95% CI: 2.55-2.75) and pericardial disorders (ROR: 4.51; 
      95% CI: 4.30-4.74). Concerning myocardial and pericardial disorders, a 
      significant increased ROR was found for all anti-PD-1 and anti-PD-L1 
      monotherapies, with the exception of anti-CTLA-4 monotherapies. Regarding cardiac 
      arrhythmias, only tremelimumab among ICI monotherapies was associated with an 
      increased ROR (1.92, 1.09-4.72; 4 cases). Compared with ICI monotherapy, ICI 
      combination therapy detected an increase in cardiovascular toxicity spectrum, but 
      did not prolong the onset time. WHAT IS NEW AND CONCLUSION: We observed that the 
      spectrum and risk of ICI-associated cardiovascular AEs differed between 
      therapeutic regimens. The poor clinical outcome and early onset of these events 
      should attract clinical attention.
CI  - (c) 2022 John Wiley & Sons Ltd.
FAU - Wang, Feifei
AU  - Wang F
AUID- ORCID: 0000-0003-0693-3429
AD  - Department of Pharmacy, Hefei BOE Hospital, Hefei, People's Republic of China.
FAU - Wu, Xinan
AU  - Wu X
AD  - Department of Pharmacy, Hefei BOE Hospital, Hefei, People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20220620
PL  - England
TA  - J Clin Pharm Ther
JT  - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (Immune Checkpoint Inhibitors)
SB  - IM
MH  - Aged
MH  - *Antineoplastic Agents, Immunological/adverse effects
MH  - Female
MH  - Humans
MH  - Immune Checkpoint Inhibitors/adverse effects
MH  - Lung
MH  - Male
MH  - Middle Aged
MH  - *Neoplasms/drug therapy
MH  - Pharmacovigilance
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - adverse event reporting system
OT  - cardiovascular adverse event
OT  - immune checkpoint inhibitors
EDAT- 2022/06/22 06:00
MHDA- 2022/10/07 06:00
CRDT- 2022/06/21 02:22
PHST- 2022/05/11 00:00 [received]
PHST- 2022/05/18 00:00 [accepted]
PHST- 2022/06/22 06:00 [pubmed]
PHST- 2022/10/07 06:00 [medline]
PHST- 2022/06/21 02:22 [entrez]
AID - 10.1111/jcpt.13707 [doi]
PST - ppublish
SO  - J Clin Pharm Ther. 2022 Oct;47(10):1576-1584. doi: 10.1111/jcpt.13707. Epub 2022 
      Jun 20.