{"title":"What Have We Learnt from Cardiovascular Outcome Studies of New Anti-diabetic Therapies in Last Decade?","authors":"Ashok Jaiswal","doi":"10.19080/CRDOJ.2020.13.555874","DOIUrl":null,"url":null,"abstract":"Diabetes has become a major health concern worldwide with a rapid increase in its prevalence rate. Cardiovascular complications are the leading cause of morbidity and mortality in diabetes. A 2007 meta-analysis of rosiglitazone showed significant increase in the risk of cardiovascular events with rosiglitazone therapy and that raised an alarm regarding cardiovascular safety of anti-diabetic drugs. Post this incidence in 2008, the UF FDA issued a guidance for the industry to conduct CVOT on new anti-diabetic therapies before they are approved for clinical use. Since then, all new anti-diabetic therapies underwent CVOTs for their cardiovascular safety evaluation. The objective of this paper is to review the key learnings from CVOTs of new anti-diabetic therapies published post 2008 FDA guidance.","PeriodicalId":92021,"journal":{"name":"Current research in diabetes & obesity journal","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2020-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current research in diabetes & obesity journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.19080/CRDOJ.2020.13.555874","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Diabetes has become a major health concern worldwide with a rapid increase in its prevalence rate. Cardiovascular complications are the leading cause of morbidity and mortality in diabetes. A 2007 meta-analysis of rosiglitazone showed significant increase in the risk of cardiovascular events with rosiglitazone therapy and that raised an alarm regarding cardiovascular safety of anti-diabetic drugs. Post this incidence in 2008, the UF FDA issued a guidance for the industry to conduct CVOT on new anti-diabetic therapies before they are approved for clinical use. Since then, all new anti-diabetic therapies underwent CVOTs for their cardiovascular safety evaluation. The objective of this paper is to review the key learnings from CVOTs of new anti-diabetic therapies published post 2008 FDA guidance.