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6563 Background: Asciminib, a newly developed drug, has shown promising results in the treatment of several diseases. It is a cellular tyrosine kinase inhibitor (TKI) that specifically targets ABL myristoyl pocket (STAMP) inhibitor, responsible for the malignant growth and proliferation of leukemia cells in chronic myeloid leukemia (CML) patients, assuring a positive treatment of CML. However, as with all medications, there are possible side effects that must be carefully monitored. In comparison to Ponatinib (tyrosine kinase inhibitor) which is extensively used to treat CML and exhibits a cardiovascular risk profile, cardiovascular side effects with the use of Asciminib are rarely reported in literature, prompting its use in patients at a higher risk of these events. Through this study, we aim to highlight the cardiovascular complications associated with the use of Asciminib by integrating patient experience and clinical research. Methods: A publicly available FDA Adverse Events Reporting System (FAERS) database was utilized to review cardiovascular events associated with the use of Asciminib in patients with Chronic Myeloid leukemia (CML) between 2018-2023. Cardiovascular events such as coronary artery disease (CAD), peripheral arterial disease (PAD), and cerebrovascular accidents (CVA) were reviewed. The study focused only on adverse events reported by healthcare providers and observed in adults (above 18 years old). Results: We identified a total of 563 adverse events pertaining to the use of Asciminib in patients with CML. Of which, 63 were cardiovascular events, contributing to 11.2% of the total adverse events. Out of the reported cardiovascular side effects, 29 (46%) were due to CAD, 6 (9.5%) were due to PAD, and 28 (44.45%) were due to CVA. The mortality rate amongst patients who experienced cardiovascular side effects was 11%. Moreover, cardiovascular events contributed to 7% of all mortality associated with the use of Asciminib, with CAD contributing to most of the deaths. Conclusions: It is imperative to consider the potential of cardiovascular events in patients initiated on Asciminib. This study emphasizes the importance of using patient records and medical research to obtain complete information. Patients with underlying risk factors for the development of cardiovascular diseases should be thoroughly evaluated before drug initiation. The minimum threshold for drug discontinuation should be considered in patients with suspected heart disease.
Savani et al. (Sat,) studied this question.