Evaluation of time to onset and outcome of cardiac adverse events
associated with nilotinib using post-marketing surveillance
Abstract
Purpose: The present study aimed to evaluate the risk of
nilotinib-induced cardiac adverse events (CAEs), time to onset,
incidence rates, and post hoc outcomes using the Japanese Adverse Drug
Event Report database. Methods: We analysed data for the period
between April 2004 and March 2022. Data on CAEs were extracted and
relative risk of adverse events (AEs) was estimated using the reporting
odds ratio (ROR). Results: We analysed 2,021,907 reports and
identified 3,545 reports of AEs caused by nilotinib. Of these, 511
reports involved CAEs. Signals were detected for 19 CAEs. Of these,
electrocardiogram QT prolonged was the most frequently reported
(30.9%). Fatal outcomes were observed in eight AEs: cardiac failure,
atrial fibrillation, acute myocardial infarction, pericardial effusion,
myocardial infarction, cardiac arrest, pericarditis, and cardiac
tamponade. Of these, acute myocardial infarction, myocardial infarction,
pericarditis, and cardiac tamponade exhibited mortality rates
>10%. A histogram of median times to onset showed
nilotinib-associated AEs occurring 3–485 days after nilotinib
administration. Conclusions: We focused on CAEs caused by
nilotinib as post-marketing AEs. Some cases resulted in serious
outcomes. Patients should be monitored for signs of onset of these AEs
not only at the start of administration, but for a long period of time.