Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor-Associated Cardiotoxicity: A Recent Five-Year Pharmacovigilance Study.
Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor-Associated Cardiotoxicity: A Recent Five-Year Pharmacovigilance Study.
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DOI：
10.3389/fphar.2022.858279
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发表时间：
2022
影响因子：
5.6
通讯作者：
Chen L
中科院分区：
文献类型：
--
作者：
Liu Y;Chen C;Rong C;He X;Chen L
背景资料：临床试验经常报告间变性淋巴瘤激酶酪氨酸激酶抑制剂（ALK-TKI）与心脏药物不良事件（AE）相关，但上市后数据很少。我们旨在根据美国食品药品监督管理局不良事件报告系统（FAERS）研究与ALK-TKI相关的真实心脏疾病。 方法：提取2016年1季度至2021年2季度FAERS报告。使用连续性分析对与ALK-TKI相关的心脏疾病进行数据挖掘，以确定AE的临床特征。 结果：共筛选出605例。发现这些事件在≥ 45岁患者（50.74%）和女性（50.74%）中更常见。心脏疾病的发作时间不一，集中在2个月内，中位时间为33天。预后较差，病死率为20.93%。心律失常是ALK TKI的常见不良事件，尤其是心动过缓。克唑替尼和劳拉替尼在心脏疾病中显示出阳性信号，尤其是心力衰竭，而brigatinib未显示出任何信号。研究还发现，塞瑞替尼引起的心肌炎和劳拉替尼引起的心肌病可能是潜在的新的药物不良反应。 结论：ALK-TKI的心脏毒性报告频率高于其他药物，并且通常可以更早出现。我们还在特定药物中发现了潜在的新AE信号，需要更多的临床研究来证实。我们的研究有助于填补ALK-TKI在心脏中的安全性信息，并为进一步研究提供方向。
Background: Clinical trials frequently reported anaplastic lymphoma kinase tyrosine kinase inhibitors (ALK-TKIs) associated with cardiac adverse drug events (AEs) but minimal postmarketing data. We aimed to research real-world cardiac disorders associated with ALK-TKIs based on the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Extract reports from the FAERS from the first quarter of 2016 to the second quarter of 2021 were obtained. Data mining of cardiac disorders associated with ALK-TKIs was carried out using disproportionality analysis to determine the clinical characteristics of AEs. Results: In total, 605 cases were screened out. These events were found to be more prevalent in patients ≥45 years (50.74%) and women (50.74%). The onset time of cardiac disorders was variable and concentrated within 2 months, with a median time of 33 days. The outcomes tended to be poor, with 20.93% fatality proportion. Cardiac arrhythmia was a common adverse event of ALK-TKIs, especially bradycardia. Crizotinib and lorlatinib showed positive signals in cardiac disorders, especially in heart failure, and brigatinib presented no signals. The study also found that myocarditis caused by ceritinib and cardiomyopathy caused by lorlatinib may be potential new adverse drug reactions. Conclusion: ALK-TKIs were reported more frequently in cardiotoxicity than other drugs and could often manifest earlier. We also found potential new AE signals in specific drugs and need more clinical studies to confirm. Our study helps fill the safety information of ALK-TKIs in the heart and provides directions for further research.
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克唑替尼治疗老年 ALK 重排非小细胞肺癌患者的有效方案：病例报告。
影响因子：
1.8
作者：
Fukuizumi A;Miyanaga A;Seike M;Kato Y;Nakamichi S;Chubachi K;Matsumoto M;Noro R;Minegishi Y;Kunugi S;Kubota K;Gemma A
通讯作者：
Gemma A
影响因子：
0.6
作者：
Gaillard, C. -M.;Churnbi-Flores, W.;Kiakouama-Maleka, L.
通讯作者：
Kiakouama-Maleka, L.
DOI：
10.1056/nejmoa1007056
发表时间：
2010-10-28
期刊：
The New England journal of medicine
影响因子：
--
作者：
Butrynski JE;D'Adamo DR;Hornick JL;Dal Cin P;Antonescu CR;Jhanwar SC;Ladanyi M;Capelletti M;Rodig SJ;Ramaiya N;Kwak EL;Clark JW;Wilner KD;Christensen JG;Jänne PA;Maki RG;Demetri GD;Shapiro GI
通讯作者：
Shapiro GI
影响因子：
2.9
作者：
Hao, Yue-Qin;Tang, Hua-Ping;Liu, Hong-Yun
通讯作者：
Liu, Hong-Yun
影响因子：
5.6
作者：
Chen, Chen;Wu, Bin;Xu, Ting
通讯作者：
Xu, Ting