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January 1, 2023Oncology4 citations

Evaluation of Time to Onset and Outcome of Cardiac Adverse Events Associated with Nilotinib using Post-Marketing Surveillance

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Why the study?

What are the risks, time to onset, and outcomes of cardiac adverse events associated with nilotinib in Japanese patients?

Population

Japanese patients with adverse drug event reports in the Japanese Adverse Drug Event Report database between…

Design

Cohort

Authors

YKYuko KanbayashiAKAsuka KojimaHWHaruka Wakabayashi

Discussion

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Overview

Nilotinib may be linked to CAEs in Japanese patients; hypothesis-generating and should not yet change practice.

Structured PICO

What are the risks, time to onset, and outcomes of cardiac adverse events associated with nilotinib in Japanese patients?

P
Population
Japanese patients with adverse drug event reports in the Japanese Adverse Drug Event Report database between April 2004 and March 2022 (n=2,021,907 total reports analyzed, 3,545 reports of AEs caused by nilotinib)
I
Intervention
Nilotinib
O
Outcome
Risk of nilotinib-induced cardiac adverse events (CAEs), time to onset, incidence rates, and post hoc outcomessafety

Nilotinib is associated with significant cardiac adverse events in Japanese patients, most commonly QT prolongation, but also potentially fatal events like myocardial infarction and cardiac tamponade, necessitating long-term monitoring.

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Cite This Study

Kanbayashi et al. (2023) studied this question.

synapsesocial.com/papers/6a74108a1d5278c71ceafe5bhttps://doi.org/10.1159/000533325
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