期刊
DIABETES METABOLIC SYNDROME AND OBESITY-TARGETS AND THERAPY
卷 8, 期 -, 页码 315-324出版社
DOVE MEDICAL PRESS LTD
DOI: 10.2147/DMSO.S84005
关键词
T2DM; cardiovascular outcome; CV risk; noninferiority; superiority; major adverse cardiac event
资金
- GlaxoSmithKline
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.
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