アブストラクト | 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. |
ジャーナル名 | Cancers |
Pubmed追加日 | 2020/4/3 |
投稿者 | Cirmi, Santa; El Abd, Asmae; Letinier, Louis; Navarra, Michele; Salvo, Francesco |
組織名 | Department of Chemical, Biological, Pharmaceutical and Environmental Sciences,;University of Messina, I-98168 Messina, Italy.;Inserm, UMR 1219, Team Pharmacoepidemiology, Bordeaux Population Health Research;Center, University of Bordeaux, F-33000 Bordeaux, France.;Service de Pharmacologie Medicale, Pole de Sante Publique, CHU de Bordeaux,;F-33000 Bordeaux, France. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/32235443/ |