Why the study?
Cardiac adverse events are a serious concern with ponatinib, but their incidence in Japanese patients had not been described.
What are the risks and time to onset of cardiac adverse events associated with ponatinib in Japanese patients?
Population
1,772,494 adverse event reports including 1,152 ponatinib-related reports in Japan
Comparison
Ponatinib exposure vs other reported drugs
Design
Spontaneous reporting database pharmacovigilance study
Key result
Analysis of a Japanese adverse event database identified 163 cardiac adverse events among 1,152 ponatinib-related reports, with hypertension being the most frequent (27.6%).
Authors
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Supports extended cardiac monitoring with ponatinib; observational data leaves open incidence and causality confirmation.
Observational (n=1,772,494)
What are the risks and time to onset of cardiac adverse events associated with ponatinib in Japanese patients?
Ponatinib is associated with significant cardiac adverse events, most commonly hypertension, which can occur early or more than a year after starting treatment, necessitating long-term monitoring.
Kanbayashi et al. (2023) conducted an observational in Adverse drug events (n=1,772,494). Ponatinib was evaluated on Cardiac adverse events (CAEs). Analysis of a Japanese adverse event database identified 163 cardiac adverse events among 1,152 ponatinib-related reports, with hypertension being the most frequent (27.6%).