Incomplete Data and Potential Risks of Drugs in People with Obesity.
Incomplete Data and Potential Risks of Drugs in People with Obesity.
复制标题
DOI：
10.1007/s13679-023-00532-1
复制
发表时间：
2023-12
影响因子：
8.8
通讯作者：
Greenblatt, David J.
中科院分区：
文献类型：
--
作者：
Apovian, Caroline M.;Bruno, Christopher D.;Kyle, Theodore K.;Chow, Christina R.;Greenblatt, David J.
提供肥胖症患者当前药物治疗知识差距的例子，并呼吁在药物发现和开发过程中改变监管和药物临床研究要求。治疗肥胖及其合并症通常需要使用处方药，其中许多药物尚未在肥胖患者中进行充分评估。尽管关于这一主题的研究越来越多，但肥胖对药物的药代动力学和药效学的影响往往没有得到药物申办者和监管机构的充分研究，随后也没有得到临床医生和护理人员的充分重视。目前，药物有多种机会包括专门针对肥胖患者的剂量信息，以确保药物在该人群中的安全性和有效性。此外，根据药物处方信息和临床实践，已知肥胖对药物处置的影响与当前药物使用之间存在严重差距。目前，在药物批准过程中，没有要求在肥胖人群中测试药物，即使初步数据表明该人群中可能存在动力学改变。缺乏关于肥胖症患者安全有效使用药物的信息可能导致这一人群的健康状况较差。
To provide examples of knowledge gaps in current pharmaceutical treatments for people with obesity and call for changes to regulatory and pharmaceutical clinical research requirements during the drug discovery and development process. Treatment of obesity and its comorbidities often require the use of prescription drugs, many of which have not been fully evaluated in people with obesity. Despite a growing body of research on this topic, the impact of obesity on the pharmacokinetics and pharmacodynamics of drugs is often under-studied by drug sponsors and regulators, and subsequently underappreciated by clinicians and caretakers. There are currently multiple opportunities for pharmaceuticals to include dosing information specifically for patients with obesity in order to ensure safety and efficacy of drugs in this population. Additionally, there are serious gaps between what is known about the effects of obesity on drug disposition and the current use of drugs according to drug prescribing information and clinical practice. There is currently no requirement to test drugs in people with obesity during the drug approval process, even when preliminary data suggests there may be altered kinetics in this population. The lack of information on the safe and effective use of drugs in people with obesity may be contributing to poorer health outcomes in this population.
登录
查看更多内容
影响因子：
7.2
作者：
Edelman, Alison B.;Hennebold, Jon D.;Bond, Kise;Lim, Jeong Y.;Cherala, Ganesh;Archer, David F.;Jensen, Jeffrey T.
通讯作者：
Jensen, Jeffrey T.
影响因子：
2.9
作者：
Edelman, Alison B.;Cherala, Ganesh;Jensen, Jeffrey T.
通讯作者：
Jensen, Jeffrey T.
影响因子：
4.2
作者：
Pinner NA;Tapley NG;Barber KE;Stover KR;Wagner JL
通讯作者：
Wagner JL
影响因子：
6.9
作者：
Drincic, Andjela T.;Armas, Laura A. G.;Heaney, Robert P.
通讯作者：
Heaney, Robert P.
影响因子：
2.9
作者：
Glasier, Anna;Cameron, Sharon T.;Ulmann, Andre
通讯作者：
Ulmann, Andre