Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements

Fred Yang,1 Murray Stewart,2 June Ye,2 David DeMets3 1AstraZeneca, Gaithersburg, MD, USA; 2GlaxoSmithKline, Upper Merion, PA, USA; 3Department of Biostatistics and Medical Informatics, University of Wisconsin–Madison, Madison, WI, USA Abstract: For type 2 diabetes mellitus treatment and cl...

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Autores principales:	Yang F, Stewart M, Ye J, DeMets D
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/83d7c47aaf754534916efa4acf6f0be0
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spelling	oai:doaj.org-article:83d7c47aaf754534916efa4acf6f0be02021-12-02T06:30:17ZType 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements1178-7007https://doaj.org/article/83d7c47aaf754534916efa4acf6f0be02015-07-01T00:00:00Zhttp://www.dovepress.com/type-2-diabetes-mellitus-development-programs-in-the-new-regulatory-en-peer-reviewed-article-DMSOhttps://doaj.org/toc/1178-7007Fred Yang,1 Murray Stewart,2 June Ye,2 David DeMets3 1AstraZeneca, Gaithersburg, MD, USA; 2GlaxoSmithKline, Upper Merion, PA, USA; 3Department of Biostatistics and Medical Informatics, University of Wisconsin–Madison, Madison, WI, USA Abstract: For type 2 diabetes mellitus treatment and clinical development, proper evaluation of cardiovascular risk has been required by regulatory agencies (eg, the US Food and Drug Administration) since cardiovascular safety is very important in this patient population. The US Food and Drug Administration issued general guidelines for cardiovascular safety evaluation that outlined the requirements considered adequate for cardiovascular safety evaluation. However, there are multiple options to obtain the data and fulfill these requirements. In this paper, we outline the potential pathways and challenges in various aspects of cardiovascular safety evaluation in type 2 diabetes clinical development, including study design, populations, and endpoints. Specifically, we discuss some challenges in statistical analysis which have implications for the design, implementation, and interpretation of these outcome studies. Keywords: T2DM, cardiovascular outcome, CV risk, noninferiority, superiority, major adverse cardiac eventYang FStewart MYe JDeMets DDove Medical PressarticleSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol 2015, Iss default, Pp 315-325 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Specialties of internal medicine RC581-951
spellingShingle	Specialties of internal medicine RC581-951 Yang F Stewart M Ye J DeMets D Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
description	Fred Yang,1 Murray Stewart,2 June Ye,2 David DeMets3 1AstraZeneca, Gaithersburg, MD, USA; 2GlaxoSmithKline, Upper Merion, PA, USA; 3Department of Biostatistics and Medical Informatics, University of Wisconsin–Madison, Madison, WI, USA Abstract: For type 2 diabetes mellitus treatment and clinical development, proper evaluation of cardiovascular risk has been required by regulatory agencies (eg, the US Food and Drug Administration) since cardiovascular safety is very important in this patient population. The US Food and Drug Administration issued general guidelines for cardiovascular safety evaluation that outlined the requirements considered adequate for cardiovascular safety evaluation. However, there are multiple options to obtain the data and fulfill these requirements. In this paper, we outline the potential pathways and challenges in various aspects of cardiovascular safety evaluation in type 2 diabetes clinical development, including study design, populations, and endpoints. Specifically, we discuss some challenges in statistical analysis which have implications for the design, implementation, and interpretation of these outcome studies. Keywords: T2DM, cardiovascular outcome, CV risk, noninferiority, superiority, major adverse cardiac event
format	article
author	Yang F Stewart M Ye J DeMets D
author_facet	Yang F Stewart M Ye J DeMets D
author_sort	Yang F
title	Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
title_short	Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
title_full	Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
title_fullStr	Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
title_full_unstemmed	Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
title_sort	type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/83d7c47aaf754534916efa4acf6f0be0
work_keys_str_mv	AT yangf type2diabetesmellitusdevelopmentprogramsinthenewregulatoryenvironmentwithcardiovascularsafetyrequirements AT stewartm type2diabetesmellitusdevelopmentprogramsinthenewregulatoryenvironmentwithcardiovascularsafetyrequirements AT yej type2diabetesmellitusdevelopmentprogramsinthenewregulatoryenvironmentwithcardiovascularsafetyrequirements AT demetsd type2diabetesmellitusdevelopmentprogramsinthenewregulatoryenvironmentwithcardiovascularsafetyrequirements
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Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements

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