Abstract
Objective This study aimed to examine the risk of diabetes mellitus induced by nilotinib, a second-generation tyrosine kinase inhibitor. Methods This retrospective study included 25 patients with chronic myeloid leukemia (CML) treated with nilotinib at our hospital. Four patients had diabetes mellitus at the start of nilotinib administration (prior DM group), and five patients were newly diagnosed with diabetes mellitus after the start of nilotinib administration (new DM group). Sixteen patients who were not diagnosed with diabetes mellitus were classified into the non-DM group. Changes in the blood glucose and HbA1c levels were evaluated in each group at the time of nilotinib administration and two years later. Results Molecular genetic remission of CML was achieved in 81.8% of patients with diabetes and 72.2% of patients without non-DM group. There were no cases in this study in which nilotinib was changed or discontinued owing to hyperglycemia. There was no difference in the blood glucose levels at the start of nilotinib treatment among the groups. Two years after starting nilotinib, the blood glucose levels in the new DM group [232 (186-296) mg/dL] and prior DM group [168 (123-269) mg/dL] were significantly higher than those in the non-DM group [100 (91-115) mg/dL]. ΔHbA1c levels in the new DM group [1.3 (0.9-2.2) %] and prior DM group [1.6 (0.7-1.7) %] were significantly higher than those in the non-DM group [-0.2 (-0.3-0.1) %]. Conclusion Nilotinib caused diabetes in 23.8% of the participants, but there were no hyperglycemia-related severe adverse events. Therefore, nilotinib may be safely continued with regular monitoring for the development of diabetes after nilotinib administration.