ArticleDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2023
Cardiac safety profile of type II kinase inhibitors: Analysis of post-marketing reports from databases of European Medicine Agency & World Health Organization.
Article in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 6 citations in OpenAlex.
- A real-world pharmacovigilance study of four anti-non-small cell lung cancer drugs using the WHO-VigiAccess database.Medicine · 2026Article
- Atrial fibrillation associated with tyrosine kinase inhibitors: A case-control study of real-world pharmacovigilance data.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Atrial Fibrillation and Cancer-Epidemiology, Mechanisms, and Management.Journal of clinical medicine · 2024Review
- Neuronal toxicity of monoclonal antibodies (mAbs): an analysis of post-marketing reports from FDA Adverse Event Reporting System (FAERS) safety database.European journal of clinical pharmacology · 2024Article
- Assessment of Neurologic Safety Profile of Immune Checkpoint Inhibitors: Evaluation of Adverse Drug Reaction Reports.Current drug safety · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTargeted therapy with type II kinase inhibitors (KIs) is one of the preferred choices in cancer treatment. However, type II KI therapy can be associated to serious cardiac risks.
objectivesThis study aimed to assess the occurrence of cardiac events reported with type II KIs in Eudravigilance (EV) and VigiAccess databases.
methodsTo evaluate reporting frequency of individual case safety reports (ICSRs) related to cardiac events, we referred EV and VigiAccess databases. The data was retrieved for the period from date of marketing authorization of respective type II KI till 30 July 2022. Computational analysis was conducted with data from EV and VigiAccess using reporting odds ratio (ROR) along with its 95% confidence interval (CI) under Microsoft excel.
resultsIn total, 14429 ICSRs in EV and 11522 ICSRs from VigiAccess were retrieved concerning cardiac events with at least one type II KI as the suspected drug. In both databases, most of the ICSRs were reported for Imatinib, Nilotinib, and Sunitinib, while most reported cardiac events were myocardial infarction/acute myocardial infarction, cardiac failure/congestive heart failure and atrial fibrillation. As per EV, 98.8% ICSRs with cardiac ADRs were assessed as serious and of which, 17.4% ICSRs were associated with fatal outcomes and approximately 47% included patient's recovery as a favorable outcome. Nilotinib (ROR 2.87, 95% CI 3.01-2.74) and Nintedanib (ROR 2.17, 95% CI 2.3-2.04) were associated with a significant increase in reporting frequency of ICSRs related to cardiac events.
conclusionsType II KI related cardiac events were serious and associated with unfavorable outcomes. A significant increase in ICSRs reporting frequency was observed with Nilotinib and Nintedanib. These results insist for a consideration of revision of cardiac safety profile of Nilotinib and Nintedanib, specifically for risks of myocardial infarction and atrial fibrillation. Additionally, the need for other ad-hoc studies is indicated.
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