Hyperlipidemia-post-initiation-of-nilotinib-among-chronic-myeloid-leukemia-patients-in-a-tertiary-hospital-of-malaysia

Abstract

Introduction: Nilotinib is effective in patients with chronic myeloid leukemia (CML), but is also associated with hyperlipidemia, which can be a risk factor for atherosclerotic vascular events. Objective: To determine the completeness in monitoring the fasting lipid profile (FLP), changes in lipid levels before and after the initiation of nilotinib, and changes in lipid levels after statin therapy. Method: This was a retrospective cohort study that included all patients with CML in the chronic or accelerated phase, who were receiving follow up under the haematology clinic of a regional referral hospital in the state of Perak, Malaysia. Patients who had been prescribed nilotinib from the beginning of January 2010 to June 2020 were included in the study, including patients who were still on treatment as well as those who, despite having their treatment discontinued during the observation period, still followed up in the clinic. The monitoring of FLP was defined as either “complete” (with both pre-initiation and post-initiation FLP available); or “incomplete” (with either one of pre-initiation or post-initiation FLP available); or “not ordered”. An LDL level of ≥ 2.6 mmol / L was considered suboptimal. Since the changes in FLP parameters were found to not be normally distributed, the data were evaluated using the Wilcoxon test, whereby a two-tailed p-value of P < 0.05 was considered statistically significant. Result: 61 patients who met the inclusion criteria were included. The FLP test was not ordered in 16 patients, incomplete in 33 patients and complete in 11 patients (18%). Patients who had completed the test displayed a significant increase in median HDL, LDL, and total cholesterol level from 1.27 to 1.46 mmol / L (p = 0.009), 2.10 to 3.30 mmol / L (p = 0.003) and 3.90 to 5.33 mmol / L (p = 0.005) respectively after the initiation of nilotinib. Statin was prescribed to 6 patients with a baseline mean LDL of 4.77 mmol / L, whereby the mean LDL was significantly reduced by 1.82 mmol / L (p = 0.003) after treatment. Conclusion: Patients experienced a significant increase in total cholesterol and LDL levels with nilotinib. Treatment with statin has elicited a significant reduction in LDL. Only a small proportion of patients received complete FLP monitoring, which warrants attention from the health authority.