Why the study?
Patients with chronic myeloid leukemia treated with nilotinib who develop dyslipidemia have an increased risk of atherosclerotic cardiovascular disease, and therapeutic discontinuation could be a strategy to prevent it.
Does nilotinib discontinuation reduce LDL concentrations in patients with chronic myeloid leukemia?
Observational (n=32)
No
Does nilotinib discontinuation reduce LDL concentrations in patients with chronic myeloid leukemia?
Mean Difference: -27.58
Absolute Event Rate: 98.33% vs 125.92%
p-value: p=0.030
Discontinuation of nilotinib in patients with chronic myeloid leukemia significantly reverses treatment-induced elevations in LDL cholesterol, potentially reducing long-term cardiovascular risk.
Dyslipidemia is a frequent side effect associated with nilotinib treatment. Patients with chronic myeloid leukemia (CML) under treatment with nilotinib who develop dyslipidemia have been shown to have a higher risk of presenting atherosclerotic cardiovascular disease (ACVD). Therapeutic discontinuation in selected individuals could be a strategy in order to prevent the development of ACVD. Observational study of patients with CML under nilotinib treatment. The lipid values were gathered before starting with nilotinib and after 3 months. Such values were also measured before discontinuation in patients who suspended nilotinib treatment, as well as 3 and 12 months later. 32 patients were included, 19 of them treated in monotherapy with nilotinib. The concentrations of total cholesterol and low-density lipoproteins (LDL) increased significantly after 3 months of treatment (27.29 mg/dL ± 22.88, p < 0.01). Of the total number of patients treated, 12 discontinued the treatment. LDL concentration was significantly reduced after 3 months of the nilotinib discontinuation (- 27.58 mg/dL ± 38.30, p = 0.030), remaining substantially lower after 12 months, compared to the time previous to discontinuation (- 24.58 mg/dL ± 37.31, p = 0.043). Nilotinib suspension reduces significantly LDL concentrations. These data support the strategy of therapeutic discontinuation in order to prevent future cardiovascular complications, especially in patients with prior cardiovascular risk factors.
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Roa-Chamorro et al. (2023) conducted an observational in Chronic myeloid leukemia (CML) (n=32). Nilotinib discontinuation vs. Pre-discontinuation baseline was evaluated on Change in LDL concentration 3 months after nilotinib discontinuation (MD -27.58 mg/dL, p=0.030).
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