Everolimus Personalized Therapy: Second Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology.

IF 2.8 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Satohiro Masuda, Florian Lemaitre, Markus J Barten, Stein Bergan, Maria Shipkova, Teun van Gelder, Sander Vinks, Eberhard Wieland, Kirsten Bornemann-Kolatzki, Mercè Brunet, Brenda de Winter, Maja-Theresa Dieterlen, Laure Elens, Taihei Ito, Kamisha Johnson-Davis, Pawel K Kunicki, Roland Lawson, Nuria Lloberas, Pierre Marquet, Olga Millan, Tomoyuki Mizuno, Dirk Jan A R Moes, Ofelia Noceti, Michael Oellerich, Smita Pattanaik, Tomasz Pawinski, Christoph Seger, Ron van Schaik, Raman Venkataramanan, Phil Walson, Jean-Baptiste Woillard, Loralie J Langman
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引用次数: 0

Abstract

Abstract: The Immunosuppressive Drugs Scientific Committee of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology established the second consensus report to guide Therapeutic Drug Monitoring (TDM) of everolimus (EVR) and its optimal use in clinical practice 7 years after the first version was published in 2016. This version provides information focused on new developments that have arisen in the last 7 years. For the general aspects of the pharmacology and TDM of EVR that have retained their relevance, readers can refer to the 2016 document. This edition includes new evidence from the literature, focusing on the topics updated during the last 7 years, including indirect pharmacological effects of EVR on the mammalian target of rapamycin complex 2 with the major mechanism of direct inhibition of the mammalian target of rapamycin complex 1. In addition, various concepts and technical options to monitor EVR concentrations, improve analytical performance, and increase the number of options available for immunochemical analytical methods have been included. Only limited new pharmacogenetic information regarding EVR has emerged; however, pharmacometrics and model-informed precision dosing have been constructed using physiological parameters as covariates, including pharmacogenetic information. In clinical settings, EVR is combined with a decreased dose of calcineurin inhibitors, such as tacrolimus and cyclosporine, instead of mycophenolic acid. The literature and recommendations for specific organ transplantations, such as that of the kidneys, liver, heart, and lungs, as well as for oncology and pediatrics have been updated. EVR TDM for pancreatic and islet transplantation has been added to this edition. The pharmacodynamic monitoring of EVR in organ transplantation has also been updated. These updates and additions, along with the previous version of this consensus document, will be helpful to clinicians and researchers treating patients receiving EVR.

依维莫司个性化疗法:国际治疗药物监测和临床毒理学协会第二次共识报告》。
摘要:国际治疗药物监测和临床毒理学协会免疫抑制药物科学委员会在2016年发布第一版报告7年后,制定了第二版共识报告,以指导依维莫司(EVR)的治疗药物监测(TDM)及其在临床实践中的优化使用。这一版本重点介绍了过去 7 年中出现的新进展。关于 EVR 的药理学和 TDM 的一般内容,读者可参考 2016 年的文件。本版纳入了来自文献的新证据,重点关注过去 7 年中更新的主题,包括 EVR 对哺乳动物雷帕霉素靶点复合物 2 的间接药理作用,以及直接抑制哺乳动物雷帕霉素靶点复合物 1 的主要机制。此外,还包括监测 EVR 浓度、改善分析性能和增加免疫化学分析方法可选项的各种概念和技术方案。有关 EVR 的新药物遗传学信息还很有限;不过,已利用生理参数作为协变量(包括药物遗传学信息)构建了药物计量学和模型信息精确给药。在临床环境中,EVR 与降低剂量的钙神经蛋白抑制剂(如他克莫司和环孢素)结合使用,而不是与霉酚酸结合使用。针对特定器官移植(如肾脏、肝脏、心脏和肺)以及肿瘤和儿科的文献和建议也已更新。本版新增了胰腺和胰岛移植的 EVR TDM。器官移植中 EVR 的药效学监测也已更新。这些更新和补充内容以及本共识文件的上一版本将对治疗接受 EVR 患者的临床医生和研究人员有所帮助。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Therapeutic Drug Monitoring
Therapeutic Drug Monitoring 医学-毒理学
CiteScore
5.00
自引率
8.00%
发文量
213
审稿时长
4-8 weeks
期刊介绍: Therapeutic Drug Monitoring is a peer-reviewed, multidisciplinary journal directed to an audience of pharmacologists, clinical chemists, laboratorians, pharmacists, drug researchers and toxicologists. It fosters the exchange of knowledge among the various disciplines–clinical pharmacology, pathology, toxicology, analytical chemistry–that share a common interest in Therapeutic Drug Monitoring. The journal presents studies detailing the various factors that affect the rate and extent drugs are absorbed, metabolized, and excreted. Regular features include review articles on specific classes of drugs, original articles, case reports, technical notes, and continuing education articles.
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