Incomplete Data and Potential Risks of Drugs in People with Obesity.

IF 9.5 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Current Obesity Reports Pub Date : 2023-12-01 Epub Date: 2023-11-18 DOI:10.1007/s13679-023-00532-1
Caroline M Apovian, Christopher D Bruno, Theodore K Kyle, Christina R Chow, David J Greenblatt
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引用次数: 0

Abstract

Purpose of review: 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.

Recent findings: 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.

Abstract Image

肥胖患者用药的不完整数据和潜在风险。
综述的目的:提供当前肥胖人群药物治疗知识缺口的例子,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。最近的研究发现:肥胖及其合并症的治疗通常需要使用处方药,其中许多尚未对肥胖患者进行充分评估。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发起人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,以确保药物在这一人群中的安全性和有效性。此外,在已知的肥胖对药物处置的影响与根据药物处方信息和临床实践的当前药物使用之间存在严重差距。目前没有要求在药物审批过程中对肥胖人群进行药物测试,即使初步数据表明肥胖人群的动力学可能发生改变。缺乏对肥胖人群安全有效使用药物的信息可能会导致这一人群的健康状况较差。
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来源期刊
Current Obesity Reports
Current Obesity Reports Medicine-General Medicine
CiteScore
16.40
自引率
1.10%
发文量
25
期刊介绍: The main objective of Current Obesity Reports is to provide expert review articles on recent advancements in the interdisciplinary field of obesity research. Our aim is to offer clear, insightful, and balanced contributions that will benefit all individuals involved in the treatment and prevention of obesity, as well as related conditions such as cardiovascular diseases, endocrine disorders, gynecological issues, cancer, mental health, respiratory complications, and rheumatological diseases. We strive to redefine the way knowledge is expressed and provide organized content for the benefit of our readership.
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