アブストラクト | Brentuximab vedotin (BV) has obtained approval for the therapeutic management of classical Hodgkin lymphoma as well as systemic anaplastic large cell lymphoma. Given the inherent constraints of conventional clinical trials, the correlation between BV and cardiac adverse events (AEs) remains enigmatic. The objective of this investigation is to comprehensively assess cardiac AEs attributed to BV by employing advanced data mining techniques, utilizing the FDA Adverse Event Reporting System (FAERS). The indices for the assessment of disproportionality encompass the reporting odds ratio (ROR), the proportional reporting ratio, the information component, and the empirical Bayesian geometric mean. Employing these sophisticated metrics, we gauged the extent of disproportionate occurrences. The dataset was sourced from the FAERS from the first quarter of 2012 to first quarter of 2023, facilitating a comprehensive analysis of the potential correlation between BV and cardiac AEs. This scrutiny encompassed a comparative analysis of both cardiac and non-cardiac AEs. A total of 495 cases of BV's cardiac AEs were discerned, with the identification of 31 preferred terms (PTs). Among these, 8 PTs emerged as conspicuous signals of cardiac AEs, notably encompassing ventricular hypokinesia (ROR 7.59), tachyarrhythmia (ROR 7.06), sinus tachycardia (ROR 6.18), cardiopulmonary failure (ROR 4.44), pericardial effusion (ROR 4.32), acute coronary syndrome (ROR 4.02), cardiomyopathy (ROR 3.30), and tachycardia (ROR 2.76). The manifestation of severe outcomes demonstrates a discernible correlation with the cardiac AEs (P < 0.001). Our investigation furnishes invaluable insights for healthcare practitioners to proactively mitigate the incidence of BV-associated cardiac AEs. |
ジャーナル名 | Naunyn-Schmiedeberg's archives of pharmacology |
Pubmed追加日 | 2024/1/25 |
投稿者 | Ke, Chengjie; Chen, Maohua; Huang, Yaping; Chen, Yan; Lin, Cuihong; Huang, Pinfang |
組織名 | Department of Pharmacy, The First Affiliated Hospital of Fujian Medical;University, Fuzhou, 350005, China.;Department of Pharmacy, National Regional Medical Center, Binhai Campus of the;First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, China.;Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan;Comprehensive Experimental Area, Fuzhou, 350400, China.;Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical;University, Fujian Provincial Hospital, Fuzhou, 350005, China.;University, Fuzhou, 350005, China. lincuihong1974@sina.com.;lincuihong1974@sina.com.;University, Fuzhou, 350005, China. abstract2016@163.com.;abstract2016@163.com. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38270617/ |