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Title:

Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

Document type:
Journal Article; Review
Author(s):
Zannad, Faiez; Stough, Wendy Gattis; Lipicky, Raymond J; Tamargo, Juan; Bakris, George L; Borer, Jeffrey S; Alonso García, Maria de Los Angeles; Hadjadj, Samy; Koenig, Wolfgang; Kupfer, Stuart; McCullough, Peter A; Mosenzon, Ofri; Pocock, Stuart; Scheen, André J; Sourij, Harald; Van der Schueren, Bart; Stahre, Christina; White, William B; Calvo, Gonzalo
Abstract:
The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i....     »
Journal title abbreviation:
Eur Heart J Cardiovasc Pharmacother
Year:
2016
Journal volume:
2
Journal issue:
3
Pages contribution:
200-5
Language:
eng
Fulltext / DOI:
doi:10.1093/ehjcvp/pvw007
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/27418973
Print-ISSN:
2055-6837
TUM Institution:
Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
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