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Published on: February 28, 2012
Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance
Joachim Alexandre1, Joe-Elie Salem2,3, Javid Moslehi3
1PICARO Cardio-oncology Program, Department of Pharmacology, Normandie University, UNICAEN, CHU de Caen Normandie, EA 4650, Signalisation, électrophysiologie et imagerie des lésions d'ischémie-reperfusion myocardique, F-14000 Caen, France.
Aims:
The explosion of novel anticancer therapies has meant emergence of cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability of anticancer drugs in inducing AF are scarce. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and AF.
Methods And Results:
A disproportionality analysis evaluating the multivariable-adjusted reporting odds ratios for AF with their 99.97% confidence intervals was performed for 176 U.S. Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-labelled anticancer drugs in VigiBase®, followed by a descriptive analysis of AF cases for the anticancer drugs identified in VigiBase®. ClinicalTrial registration number: NCT03530215. A total of 11 757 AF cases associated with at least one anticancer drug were identified in VigiBase® of which 95.8% were deemed serious. Nineteen anticancer drugs were significantly associated with AF of which 14 (74%) are used in haematologic malignancies and 9 (45%) represented new AF associations not previously confirmed in literature including immunomodulating agents (lenalidomide, pomalidomide), several kinase inhibitors (nilotinib, ponatinib, midostaurin), antimetabolites (azacytidine, clofarabine), docetaxel (taxane), and obinutuzumab, an anti-CD20 monoclonal antibody.
Conclusion:
Although cancer malignancy itself may generate AF, we identified 19 anticancer drugs significantly associated with a significant increase in AF over-reporting. This pharmacovigilance study provides evidence that anticancer drugs themselves could represent independent risk factors for AF development. Dedicated prospective clinical trials are now required to confirm these 19 associations. This list of suspected anticancer drugs should be known by physicians when confronted to AF in cancer patients, particularly in case of haematologic malignancies.
Insights
Novel anticancer drugs are linked to atrial fibrillation (AF). A study found 19 cancer drugs significantly associated with AF, highlighting potential cardiotoxicity risks for patients undergoing cancer treatment.
Area of Science:
- Cardiology
- Pharmacovigilance
- Oncology
Background:
- Novel anticancer therapies are emerging, alongside cardiotoxicity concerns like atrial fibrillation (AF).
- Data linking specific anticancer drugs to AF development is limited.
- Understanding these associations is crucial for patient safety.
Purpose of the Study:
- To investigate the association between anticancer drugs and the risk of developing atrial fibrillation (AF).
- To identify specific anticancer agents that may increase the likelihood of AF in patients.
- To provide data for clinicians managing cancer patients with cardiac risks.
Main Methods:
- Utilized the World Health Organization's VigiBase® database for individual case safety reports.
- Conducted a disproportionality analysis on 176 FDA- or EMA-labelled anticancer drugs.
- Analyzed 11,757 AF cases reported in association with anticancer drugs, with 95.8% deemed serious.
Main Results:
- Nineteen anticancer drugs showed a significant association with increased AF reporting.
- Fourteen of these drugs (74%) are used for hematologic malignancies.
- Nine drugs, including immunomodulators and kinase inhibitors, represent new potential AF associations.
Conclusions:
- Anticancer drugs can be independent risk factors for AF development, beyond the cancer itself.
- A list of 19 anticancer drugs significantly associated with AF has been identified.
- Prospective studies are needed to confirm these findings, informing clinical practice for cancer patients at risk of AF.
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