Cardiovascular toxicity profile of doxorubicin: data mining of the FDA adverse event reporting system (FAERS)

Abstract Funding Acknowledgements None. Background Doxorubicin (DOX), an effective anticancer agent, is associated with dose-dependent cardiovascular toxicity. Understanding its mechanisms and risk factors will facilitate novel interventions to minimize DOX-induced cardiovascular toxicity. Purpose W...

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Veröffentlicht in:Cardiovascular research 2024-05, Vol.120 (Supplement_1)
Hauptverfasser: Kattan, L, Cerbito, E, Dhulkifle, H, Korashy, H, Maayah, Z
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container_issue Supplement_1
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container_title Cardiovascular research
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creator Kattan, L
Cerbito, E
Dhulkifle, H
Korashy, H
Maayah, Z
description Abstract Funding Acknowledgements None. Background Doxorubicin (DOX), an effective anticancer agent, is associated with dose-dependent cardiovascular toxicity. Understanding its mechanisms and risk factors will facilitate novel interventions to minimize DOX-induced cardiovascular toxicity. Purpose We aimed to perform a comprehensive analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database to identify, describe, and quantify the latest cardiovascular DOX-associated adverse-events (AEs). Methods Data from 2004 Q1 – 2022 Q3, where DOX was the primary-suspect, were extracted from FAERS via OpenVigil 2.1. For data collection, preferred-terms (PTs) from Medical Dictionary for Regulatory Activities (MedDRA) were used, while ROR with 95% CIs for disproportionality analysis was performed. Results 1987 reports were collected for significant PTs. The most prevalent DOX-associated AE was heart failure (77.6%, n=1542), followed by cardiac fibrosis and inflammation (7.75%, n=154) and vascular disorders (7.45%, n=148). Others include arrhythmias, systemic inflammation, and endothelial dysfunction. Most patients were females (51.1%, n=1016), 18-64 years-old (41%, n = 815), primarily from Europe (41.87%, n=832) and the United States (34.12%, n = 678). Six outcomes were associated with DOX-induced cardiotoxicities, mainly "Death", "Initial/prolonged hospitalization", and "Others". Conclusion This study provides valuable insights on DOX-induced cardiovascular toxicity using real-world data from FAERS.Total Case Count of all Adverse EventPatients' Demographics and outcomes
doi_str_mv 10.1093/cvr/cvae088.069
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Background Doxorubicin (DOX), an effective anticancer agent, is associated with dose-dependent cardiovascular toxicity. Understanding its mechanisms and risk factors will facilitate novel interventions to minimize DOX-induced cardiovascular toxicity. Purpose We aimed to perform a comprehensive analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database to identify, describe, and quantify the latest cardiovascular DOX-associated adverse-events (AEs). Methods Data from 2004 Q1 – 2022 Q3, where DOX was the primary-suspect, were extracted from FAERS via OpenVigil 2.1. For data collection, preferred-terms (PTs) from Medical Dictionary for Regulatory Activities (MedDRA) were used, while ROR with 95% CIs for disproportionality analysis was performed. Results 1987 reports were collected for significant PTs. The most prevalent DOX-associated AE was heart failure (77.6%, n=1542), followed by cardiac fibrosis and inflammation (7.75%, n=154) and vascular disorders (7.45%, n=148). Others include arrhythmias, systemic inflammation, and endothelial dysfunction. Most patients were females (51.1%, n=1016), 18-64 years-old (41%, n = 815), primarily from Europe (41.87%, n=832) and the United States (34.12%, n = 678). Six outcomes were associated with DOX-induced cardiotoxicities, mainly "Death", "Initial/prolonged hospitalization", and "Others". Conclusion This study provides valuable insights on DOX-induced cardiovascular toxicity using real-world data from FAERS.Total Case Count of all Adverse EventPatients' Demographics and outcomes</description><identifier>ISSN: 0008-6363</identifier><identifier>EISSN: 1755-3245</identifier><identifier>DOI: 10.1093/cvr/cvae088.069</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><ispartof>Cardiovascular research, 2024-05, Vol.120 (Supplement_1)</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,27931,27932</link.rule.ids></links><search><creatorcontrib>Kattan, L</creatorcontrib><creatorcontrib>Cerbito, E</creatorcontrib><creatorcontrib>Dhulkifle, H</creatorcontrib><creatorcontrib>Korashy, H</creatorcontrib><creatorcontrib>Maayah, Z</creatorcontrib><title>Cardiovascular toxicity profile of doxorubicin: data mining of the FDA adverse event reporting system (FAERS)</title><title>Cardiovascular research</title><description>Abstract Funding Acknowledgements None. Background Doxorubicin (DOX), an effective anticancer agent, is associated with dose-dependent cardiovascular toxicity. Understanding its mechanisms and risk factors will facilitate novel interventions to minimize DOX-induced cardiovascular toxicity. Purpose We aimed to perform a comprehensive analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database to identify, describe, and quantify the latest cardiovascular DOX-associated adverse-events (AEs). Methods Data from 2004 Q1 – 2022 Q3, where DOX was the primary-suspect, were extracted from FAERS via OpenVigil 2.1. For data collection, preferred-terms (PTs) from Medical Dictionary for Regulatory Activities (MedDRA) were used, while ROR with 95% CIs for disproportionality analysis was performed. Results 1987 reports were collected for significant PTs. The most prevalent DOX-associated AE was heart failure (77.6%, n=1542), followed by cardiac fibrosis and inflammation (7.75%, n=154) and vascular disorders (7.45%, n=148). Others include arrhythmias, systemic inflammation, and endothelial dysfunction. Most patients were females (51.1%, n=1016), 18-64 years-old (41%, n = 815), primarily from Europe (41.87%, n=832) and the United States (34.12%, n = 678). Six outcomes were associated with DOX-induced cardiotoxicities, mainly "Death", "Initial/prolonged hospitalization", and "Others". 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Background Doxorubicin (DOX), an effective anticancer agent, is associated with dose-dependent cardiovascular toxicity. Understanding its mechanisms and risk factors will facilitate novel interventions to minimize DOX-induced cardiovascular toxicity. Purpose We aimed to perform a comprehensive analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database to identify, describe, and quantify the latest cardiovascular DOX-associated adverse-events (AEs). Methods Data from 2004 Q1 – 2022 Q3, where DOX was the primary-suspect, were extracted from FAERS via OpenVigil 2.1. For data collection, preferred-terms (PTs) from Medical Dictionary for Regulatory Activities (MedDRA) were used, while ROR with 95% CIs for disproportionality analysis was performed. Results 1987 reports were collected for significant PTs. 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title Cardiovascular toxicity profile of doxorubicin: data mining of the FDA adverse event reporting system (FAERS)
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