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Clinical cardiac safety profile of nilotinib

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Item Type:Article
Title:Clinical cardiac safety profile of nilotinib
Creators Name:Kim, T.D. and le Coutre, P. and Schwarz, M. and Grille, P. and Levitin, M. and Fateh-Moghadam, S. and Giles, F.J. and Doerken, B. and Haverkamp, W. and Koehncke, C.
Abstract:Background: Nilotinib is a second-generation tyrosine kinase inhibitor with significant efficacy as first- or second-line treatment in patients with chronic myeloid leukemia. Despite preclinical evidence indicating a risk for prolongation of the QT interval, which was confirmed in clinical trials, detailed information on nilotinib's cardiac safety profile is lacking. Design and Methods: Here, we retrospectively assessed cardiovascular risk factors in 81 patients with prior or ongoing nilotinib therapy and evaluated cardiovascular parameters by longitudinal monitoring of the QT interval and the left ventricular ejection fraction. Detailed information on the occurrence and management of defined cardiac adverse events were extracted. Results: Median duration of nilotinib therapy was 26 months (range, 1 - 72). Median QT interval at baseline was 413 msec (range, 368-499 msec). During follow-up, median QT was not significantly different from baseline at any timepoint. Sixteen of 81 patients (20 %) had new electrocardiographic changes. Cardiac function as assessed by measurement of left ventricular ejection fraction did not significantly change from baseline at any timepoint. During a median follow-up of 44 months (range, 2-73), seven patients (9 %), all of whom had received prior imatinib therapy, developed eleven clinical cardiac adverse events requiring treatment. Median time from start of nilotinib therapy to event was 14,5 months (range, 2 - 68). Five of 7 patients were able to continue nilotinib therapy with only one brief interruption. Conclusions: Whereas new electrocardiographic abnormalities were recorded in twenty percent of all patients and some of them developed severe or even life-threatening coronary artery disease, QT prolongation, changes in left ventricular ejection fraction, and clinical cardiac adverse events were uncommon in patients treated with nilotinib.
Keywords:Chronic Myelogenous Leukemia, Cardiotoxicity, Nilotinib, Tyrosine Kinase Inhibitor
Publisher:European Hematology Association
Page Range:883-889
Date:June 2012
Official Publication:https://doi.org/10.3324/haematol.2011.058776
PubMed:View item in PubMed

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