Caroline M Apovian, Christopher D Bruno, Theodore K Kyle, Christina R Chow, David J Greenblatt
{"title":"Incomplete Data and Potential Risks of Drugs in People with Obesity.","authors":"Caroline M Apovian, Christopher D Bruno, Theodore K Kyle, Christina R Chow, David J Greenblatt","doi":"10.1007/s13679-023-00532-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose of review: </strong>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.</p><p><strong>Recent findings: </strong>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.</p>","PeriodicalId":10846,"journal":{"name":"Current Obesity Reports","volume":null,"pages":null},"PeriodicalIF":9.5000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Obesity Reports","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13679-023-00532-1","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/11/18 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
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.
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.