PMID- 32235443
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 12
IP  - 4
DP  - 2020 Mar 30
TI  - Cardiovascular Toxicity of Tyrosine Kinase Inhibitors Used in Chronic Myeloid 
      Leukemia: An Analysis of the FDA Adverse Event Reporting System Database (FAERS).
LID - 10.3390/cancers12040826 [doi]
LID - 826
AB  - Tyrosine kinase inhibitors (TKIs), the treatment of choice for chronic myeloid 
      leukemia (CML), can be associated to cardiovascular (CV) adverse events (AEs). A 
      case/non-case study was performed using AE reports registered in the Food and 
      Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to 
      compare the risk of CV event reports related to TKIs indicated in the management 
      of chronic myeloid leukemia (CML). Disproportionality of CV event-related TKIs 
      was computed using the Reporting Odds Ratio (ROR) as a measure of potential risk 
      increase. Nilotinib accounts for more than half of reported cases related to 
      TKIs. Signal of Disproportionate Reporting (SDR) was found for cardiac failure, 
      ischemic heart disease, cardiac arrhythmias, torsade de pointes/QT prolongation, 
      hypertension, and pulmonary hypertension. Dasatinib and bosutinib were related to 
      the highest disproportionality for cardiac failure. Nilotinib was associated with 
      the highest SDR for ischemic heart disease, torsade de pointes/QT prolongation 
      and cardiac arrhythmias. Only ponatinib was related to an SDR for hypertension, 
      while dasatinib and imatinib were related to pulmonary hypertension. In the 
      context of CML, TKIs have different safety profiles related to CV events, among 
      which nilotinib seems particularly related to. These results claim for a revision 
      of its CV safety profile mainly for the risk of torsade de pointes/QT 
      prolongation.
FAU - Cirmi, Santa
AU  - Cirmi S
AUID- ORCID: 0000-0002-6916-0307
AD  - Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, 
      University of Messina, I-98168 Messina, Italy.
AD  - Inserm, UMR 1219, Team Pharmacoepidemiology, Bordeaux Population Health Research 
      Center, University of Bordeaux, F-33000 Bordeaux, France.
FAU - El Abd, Asmae
AU  - El Abd A
AUID- ORCID: 0000-0001-9777-419X
AD  - Inserm, UMR 1219, Team Pharmacoepidemiology, Bordeaux Population Health Research 
      Center, University of Bordeaux, F-33000 Bordeaux, France.
FAU - Letinier, Louis
AU  - Letinier L
AD  - Inserm, UMR 1219, Team Pharmacoepidemiology, Bordeaux Population Health Research 
      Center, University of Bordeaux, F-33000 Bordeaux, France.
AD  - Service de Pharmacologie Medicale, Pole de Sante Publique, CHU de Bordeaux, 
      F-33000 Bordeaux, France.
FAU - Navarra, Michele
AU  - Navarra M
AUID- ORCID: 0000-0002-6492-7820
AD  - Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, 
      University of Messina, I-98168 Messina, Italy.
FAU - Salvo, Francesco
AU  - Salvo F
AD  - Inserm, UMR 1219, Team Pharmacoepidemiology, Bordeaux Population Health Research 
      Center, University of Bordeaux, F-33000 Bordeaux, France.
AD  - Service de Pharmacologie Medicale, Pole de Sante Publique, CHU de Bordeaux, 
      F-33000 Bordeaux, France.
LA  - eng
PT  - Journal Article
DEP - 20200330
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC7226142
OTO - NOTNLM
OT  - FAERS
OT  - adverse drug reaction
OT  - cardiovascular toxicity
OT  - chronic myeloid leukemia
OT  - tyrosine kinase inhibitors
COIS- The authors declare no conflict of interest.
EDAT- 2020/04/03 06:00
MHDA- 2020/04/03 06:01
PMCR- 2020/03/30
CRDT- 2020/04/03 06:00
PHST- 2020/01/30 00:00 [received]
PHST- 2020/03/24 00:00 [revised]
PHST- 2020/03/26 00:00 [accepted]
PHST- 2020/04/03 06:00 [entrez]
PHST- 2020/04/03 06:00 [pubmed]
PHST- 2020/04/03 06:01 [medline]
PHST- 2020/03/30 00:00 [pmc-release]
AID - cancers12040826 [pii]
AID - cancers-12-00826 [pii]
AID - 10.3390/cancers12040826 [doi]
PST - epublish
SO  - Cancers (Basel). 2020 Mar 30;12(4):826. doi: 10.3390/cancers12040826.