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

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          Abstract

          Introduction: Cardiac adverse events (CAEs) have become a concern as serious adverse events (AEs) of nilotinib administration. No reports have described the incidence of CAEs associated with nilotinib in Japanese patients. Thus, we conducted this study to evaluate the risk of nilotinib-induced 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 AEs was estimated using the reporting odds ratio. 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. Conclusion: 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.

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          Author and article information

          Journal
          OCL
          Oncology
          10.1159/issn.0030-2414
          Oncology
          Oncology
          S. Karger AG
          0030-2414
          1423-0232
          2023
          18 August 2023
          : 101
          : 12
          : 799-807
          Affiliations
          [_a] aDepartment of Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
          [_b] bDepartment of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women’s College of Liberal Arts, Kyotanabe, Japan
          [_c] cSchool of Pharmacy, Hyogo University of Health Sciences, Kobe, Japan
          Article
          533325 Oncology 2023;101:799–807
          10.1159/000533325
          37598671
          50e5fbb2-2f9d-4967-9cbf-72fbcf3c13de
          © 2023 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.

          History
          : 11 May 2023
          : 21 July 2023
          Page count
          Figures: 3, Tables: 3, Pages: 9
          Funding
          The authors have not disclosed any funding.
          Categories
          Clinical Translational Research

          Medicine
          Cardiac adverse event,Outcome,Time to onset,Japanese Adverse Drug Event Report database,Nilotinib

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