Cardiovascular safety of gadoterate meglumine (Gd-DOTA)
Cardiovascular safety of gadoterate meglumine (Gd-DOTA)
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DOI：
10.1097/01.rli.0000251565.61487.1a
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发表时间：
2007-02-01
影响因子：
6.7
通讯作者：
Gaillard, Sophie
中科院分区：
文献类型：
--
作者：
Bourrinet, Philippe;Martel, Eric;Gaillard, Sophie
目的：钆络合物不被认为是延长心脏复极的高风险药物类别，这可能导致潜在危及生命的心律失常，如尖端扭转型室性心动过速。然而，尽管这些化合物在磁共振成像中广泛用作对比度增强剂，但只有有限的可靠数据可用。我们对最近获得的钆特酸葡胺（Gd-DOTA）的心血管安全性数据进行了概述。（狗浦肯野纤维）以及正常（狗）和致敏动物模型（兔）以及特定临床试验中患有各种疾病的患者的体内研究。结果：在所有这些研究中，Gd-DOTA没有表现出任何直接的有害影响，对心脏电生理，特别是对心室复极。结论：这些结果证实了良好的安全性，Gd-DOTA来自上市后的评价。用于磁共振对比增强的非特异性钆络合物不构成药物相关心律失常的风险类别。
Objectives: Gadolinium complexes are not considered to be a drug class at high risk for prolonging cardiac repolarization, which can lead to potentially life-threatening arrhythmias such as torsade de pointes. However, only limited robust data are available on these compounds despite their extensive use as contrast enhancers in magnetic resonance imaging. We present an overview of recent cardiovascular safety data obtained on gadoterate meglumine (Gd-DOTA).Materials and Methods: Cardiovascular safety was evaluated by "state-of-the-art" nonclinical ex vitro (dog Purkinje fibers) and in vivo studies in both normal (dogs) and sensitized animal models (rabbits) and in patients with various diseases in a specific clinical trial.Results: In all of these studies, Gd-DOTA did not show any direct deleterious effect on cardiac electrophysiology and especially on ventricular repolarization.Conclusion: These results confirmed the good safety profile of Gd-DOTA derived from postmarketing evaluations. Nonspecific gadolinium complexes used for magnetic resonance contrast enhancement do not constitute a class-at-risk for drug-related arrhythmias.