Incidence of cardiovascular events in patients with chronic myeloid leukaemia treated with tyrosine kinase inhibitors

Casavecchia, Grazia; Spinosa, Giuseppina; Zicchino, Stefano; Gravina, Matteo; Magnesa, Michele; Brunetti, Natale Daniele

doi:10.1080/00015385.2021.1888017

Cited by 7 publications

(3 citation statements)

References 31 publications

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“…Observational studies based on systematic reviews and realworld data have revealed that among patients with CML treated with TKIs, therapy with ponatinib was associated with a higher risk of cardiovascular adverse events than with other TKIs [5][6][7][8]. A previous meta-analysis demonstrated that three of the new-generation BCR-ABL TKIs (dasatinib, nilotinib, and ponatinib) are associated with an increased risk of vascular occlusive events in patients with Ph+ chronic myeloid leukemia compared with imatinib [9,10]. However, no reports have described the incidence of CAEs associated with ponatinib in Japanese patients.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Cardiac Adverse Events with Ponatinib Using a Spontaneous Reporting Database

Kanbayashi¹,

Uchida²,

Nakano³

et al. 2023

Oncology

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Introduction: The efficacy of ponatinib was demonstrated in patients resistant or intolerant to prior BCR-ABL tyrosine kinase inhibitors. However, cardiac adverse events (CAEs) have become a concern as a serious side effect of ponatinib administration. No reports have described the incidence of CAEs associated with ponatinib in Japanese patients. Thus, this study aimed to determine the risk of ponatinib-induced CAEs, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. Methods: We analyzed data for the period between April 2004 and March 2021. Data on CAEs were extracted, and relative risk of AEs was estimated using the reporting odds ratio. Results: We analyzed 1,772,494 reports and identified 1,152 reports of AEs caused by ponatinib. Of these, 163 CAEs were reportedly associated with ponatinib. Signals were detected for thirteen CAEs: hypertension, cardiac failure, acute cardiac failure, atrial fibrillation, increased blood pressure, coronary artery stenosis, myocardial infarction, angina pectoris, pulmonary hypertension, prolonged QT on electrocardiography, cardiomyopathy, cardiac dysfunction, and acute myocardial infarction. Among these, hypertension was the most frequently reported AE (27.6%). A histogram of times to onset showed occurrence from 4.5 to 150.5 days. Discussion/Conclusion: Hypertension, cardiac failure, coronary artery stenosis, and myocardial infarction could potentially result in serious outcomes and some cases occurred earlier or even more than 1 year after starting administration. Patients should be monitored for signs of the onset of these AEs not only at the start of ponatinib administration but also over the longer term.

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Section: Introductionmentioning

confidence: 99%

Evaluation of Cardiac Adverse Events with Ponatinib Using a Spontaneous Reporting Database

Kanbayashi¹,

Uchida²,

Nakano³

et al. 2023

Oncology

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“…However, cardiac adverse events (CAEs) have become a concern as serious adverse events (AEs) of nilotinib administration. Observational studies based on systematic reviews and real-world data have revealed that among patients with CML treated using TKIs, therapy with nilotinib was associated with a higher risk of CAEs than with other TKIs [6][7][8]. A previous meta-analysis demonstrated that three of the new-generation BCR::ABL1 TKIs (dasatinib, nilotinib, and ponatinib) are associated with increased risks of vascular occlusive events among patients with Ph+ CML compared with imatinib [9,10].…”

Section: Introductionmentioning

confidence: 99%

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

Kanbayashi,

Kojima,

Wakabayashi

et al. 2023

Oncology

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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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“…Observational studies based on systematic reviews and real-world data have revealed that among patients with CML treated with TKIs, therapy with ponatinib was associated with a higher risk of cardiovascular adverse events (CVE) than with other TKIs [5][6][7][8]. A previous meta-analysis demonstrated that three of the new-generation BCR-ABL TKIs (dasatinib, nilotinib, and ponatinib) are associated with an increased risk of vascular occlusive events in patients with Ph + chronic myeloid leukemia compared with imatinib [9,10]. However, no reports have described the incidence of CAEs associated with ponatinib in Japanese patients.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of cardiac toxicity with ponatinib using a spontaneous reporting database

Kanbayashi

Uchida

Nakano

et al. 2022

Preprint

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This study aimed to determine the risk of ponatinib-induced cardiac toxicity, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. We analyzed data for the period between April 2004 and March 2021. Data on cardiac toxicities were extracted, and relative risk of adverse events (AEs) was estimated using the reporting odds ratio. We analyzed 1,772,494 reports and identified 1,152 reports of AEs caused by ponatinib. Of these, 163 cardiac toxicities were reportedly associated with ponatinib. Signals were detected for thirteen cardiac toxicities: hypertension, cardiac failure, acute cardiac failure, atrial fibrillation, increased blood pressure, coronary artery stenosis, myocardial infarction, angina pectoris, pulmonary hypertension, prolonged QT on electrocardiography, cardiomyopathy, cardiac dysfunction, and acute myocardial infarction. Among these, hypertension was the most frequently reported AE (27.6%). A histogram of times to onset showed occurrence from 4.5 to 150.5 days. Hypertension, cardiac failure, coronary artery stenosis, and myocardial infarction could potentially result in serious outcomes and some cases occurred earlier or even more than 1 year after starting administration. In conclusion, patients should be monitored for signs of the onset of these AEs not only at the start of ponatinib administration but also over the longer term.

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Incidence of cardiovascular events in patients with chronic myeloid leukaemia treated with tyrosine kinase inhibitors

Cited by 7 publications

References 31 publications

Evaluation of Cardiac Adverse Events with Ponatinib Using a Spontaneous Reporting Database

Evaluation of Cardiac Adverse Events with Ponatinib Using a Spontaneous Reporting Database

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

Evaluation of cardiac toxicity with ponatinib using a spontaneous reporting database

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