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A systematic review of event rates in clinical trials in diabetes mellitus: The importance of quantifying baseline cardiovascular disease history and proteinuria and implications for clinical trial design
Preiss, David Sattar, Naveed McMurray, John J.
Preiss, David
Sattar, Naveed
McMurray, John J.
Abstract
Food and Drug Administration guidance now proposes that cardiovascular safety of new diabetes medicines be demonstrated. Consequently, trials should include a sufficient number of individuals with diabetes who are at high cardiovascular risk. We aimed to examine the impact of the presence of baseline cardiovascular disease and proteinuria, as binary criteria, on cardiovascular event rates in diabetes trials and to examine whether predicted primary end-point event rates are achieved.
Keywords
Date
2011
Type
Journal article
Journal
American Heart Journal
Book
Volume
161
Issue
1
Page Range
210-219
Article Number
ACU Department
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Event URL
Open Access Status
License
File Access
Controlled