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首页> 美国卫生研究院文献>British Journal of Pharmacology and Chemotherapy >How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?
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How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?

机译：我们如何才能提高对心血管安全责任的认识以开发更安全的药物？

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摘要

Given that cardiovascular safety liabilities remain a major cause of drug attrition during preclinical and clinical development, adverse drug reactions, and post-approval withdrawal of medicines, the Medical Research Council Centre for Drug Safety Science hosted a workshop to discuss current challenges in determining, understanding and addressing ‘Cardiovascular Toxicity of Medicines’. This article summarizes the key discussions from the workshop that aimed to address three major questions: (i) what are the key cardiovascular safety liabilities in drug discovery, drug development and clinical practice? (ii) how good are preclinical and clinical strategies for detecting cardiovascular liabilities? and (iii) do we have a mechanistic understanding of these liabilities? It was concluded that in order to understand, address and ultimately reduce cardiovascular safety liabilities of new therapeutic agents there is an urgent need to: class="unordered" style="list-style-type:disc">Fully characterize the incidence, prevalence and impact of drug-induced cardiovascular issues at all stages of the drug development process.Ascertain the predictive value of existing non-clinical models and assays towards the clinical outcome.Understand the mechanistic basis of cardiovascular liabilities; by addressing areas where it is currently not possible to predict clinical outcome based on preclinical safety data.Provide scientists in all disciplines with additional skills to enable them to better integrate preclinical and clinical data and to better understand the biological and clinical significance of observed changes.Develop more appropriate, highly relevant and predictive tools and assays to identify and wherever feasible to eliminate cardiovascular safety liabilities from molecules and wherever appropriate to develop clinically relevant and reliable safety biomarkers.
机译：鉴于心血管安全责任仍然是临床前和临床开发，药物不良反应和批准后撤药期间药物消耗的主要原因，医学研究理事会药物安全科学中心举办了一个研讨会，讨论了当前在确定，理解，治疗和治疗方面面临的挑战。和解决“心血管药物毒性”问题。本文总结了研讨会上针对以下三个主要问题的关键讨论：（i）在药物发现，药物开发和临床实践中心血管安全的主要责任是什么？ （ii）检测心血管疾病的临床前和临床策略有多好？ （iii）我们对这些负债有机械的理解吗？结论是，为了理解，解决并最终减少新治疗药物的心血管安全责任，迫切需要： class =“ unordered” style =“ list-style-type：disc”> <！- list-behavior =无序的前缀词= mark-type = disc max-label-size = 0-> 完整地描述了在药物开发过程的所有阶段中药物引起的心血管疾病的发生率，患病率和影响。 确定现有的非临床模型和测定对临床结果的预测价值。 了解心血管疾病的机制基础；通过解决目前尚无法根据临床前安全性数据预测临床结果的领域。 为所有学科的科学家提供更多技能，使他们能够更好地整合临床前和临床数据并更好地了解生物学 开发更合适，高度相关和可预测的工具和测定方法，以鉴定并在可行的情况下从分子中消除心血管安全性责任，并在适当的情况下开发临床相关且可靠的安全性生物标记物。 / li>

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