PMID- 38270617
OWN - NLM
STAT- Publisher
LR  - 20240125
IS  - 1432-1912 (Electronic)
IS  - 0028-1298 (Linking)
DP  - 2024 Jan 25
TI  - Cardiac toxicity of brentuximab vedotin: a real-word disproportionality analysis 
      of the FDA Adverse Event Reporting System (FAERS) database.
LID - 10.1007/s00210-024-02955-6 [doi]
AB  - Brentuximab vedotin (BV) has obtained approval for the therapeutic management of 
      classical Hodgkin lymphoma as well as systemic anaplastic large cell lymphoma. 
      Given the inherent constraints of conventional clinical trials, the correlation 
      between BV and cardiac adverse events (AEs) remains enigmatic. The objective of 
      this investigation is to comprehensively assess cardiac AEs attributed to BV by 
      employing advanced data mining techniques, utilizing the FDA Adverse Event 
      Reporting System (FAERS). The indices for the assessment of disproportionality 
      encompass the reporting odds ratio (ROR), the proportional reporting ratio, the 
      information component, and the empirical Bayesian geometric mean. Employing these 
      sophisticated metrics, we gauged the extent of disproportionate occurrences. The 
      dataset was sourced from the FAERS from the first quarter of 2012 to first 
      quarter of 2023, facilitating a comprehensive analysis of the potential 
      correlation between BV and cardiac AEs. This scrutiny encompassed a comparative 
      analysis of both cardiac and non-cardiac AEs. A total of 495 cases of BV's 
      cardiac AEs were discerned, with the identification of 31 preferred terms (PTs). 
      Among these, 8 PTs emerged as conspicuous signals of cardiac AEs, notably 
      encompassing ventricular hypokinesia (ROR 7.59), tachyarrhythmia (ROR 7.06), 
      sinus tachycardia (ROR 6.18), cardiopulmonary failure (ROR 4.44), pericardial 
      effusion (ROR 4.32), acute coronary syndrome (ROR 4.02), cardiomyopathy (ROR 
      3.30), and tachycardia (ROR 2.76). The manifestation of severe outcomes 
      demonstrates a discernible correlation with the cardiac AEs (P < 0.001). Our 
      investigation furnishes invaluable insights for healthcare practitioners to 
      proactively mitigate the incidence of BV-associated cardiac AEs.
CI  - (c) 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Ke, Chengjie
AU  - Ke C
AD  - Department of Pharmacy, The First Affiliated Hospital of Fujian Medical 
      University, Fuzhou, 350005, China.
AD  - Department of Pharmacy, National Regional Medical Center, Binhai Campus of the 
      First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, China.
FAU - Chen, Maohua
AU  - Chen M
AD  - Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan 
      Comprehensive Experimental Area, Fuzhou, 350400, China.
FAU - Huang, Yaping
AU  - Huang Y
AD  - Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical 
      University, Fujian Provincial Hospital, Fuzhou, 350005, China.
FAU - Chen, Yan
AU  - Chen Y
AD  - Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan 
      Comprehensive Experimental Area, Fuzhou, 350400, China.
FAU - Lin, Cuihong
AU  - Lin C
AD  - Department of Pharmacy, The First Affiliated Hospital of Fujian Medical 
      University, Fuzhou, 350005, China. lincuihong1974@sina.com.
AD  - Department of Pharmacy, National Regional Medical Center, Binhai Campus of the 
      First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, China. 
      lincuihong1974@sina.com.
FAU - Huang, Pinfang
AU  - Huang P
AD  - Department of Pharmacy, The First Affiliated Hospital of Fujian Medical 
      University, Fuzhou, 350005, China. abstract2016@163.com.
AD  - Department of Pharmacy, National Regional Medical Center, Binhai Campus of the 
      First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, China. 
      abstract2016@163.com.
LA  - eng
PT  - Journal Article
DEP - 20240125
PL  - Germany
TA  - Naunyn Schmiedebergs Arch Pharmacol
JT  - Naunyn-Schmiedeberg's archives of pharmacology
JID - 0326264
SB  - IM
OTO - NOTNLM
OT  - Brentuximab vedotin
OT  - Cardiac toxicity
OT  - FAERS
OT  - Pharmacovigilance study
EDAT- 2024/01/25 12:42
MHDA- 2024/01/25 12:42
CRDT- 2024/01/25 11:04
PHST- 2023/10/14 00:00 [received]
PHST- 2024/01/15 00:00 [accepted]
PHST- 2024/01/25 12:42 [medline]
PHST- 2024/01/25 12:42 [pubmed]
PHST- 2024/01/25 11:04 [entrez]
AID - 10.1007/s00210-024-02955-6 [pii]
AID - 10.1007/s00210-024-02955-6 [doi]
PST - aheadofprint
SO  - Naunyn Schmiedebergs Arch Pharmacol. 2024 Jan 25. doi: 
      10.1007/s00210-024-02955-6.