Publication Date

2011

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.

School/Institute

Mary MacKillop Institute for Health Research

Document Type

Journal Article

Access Rights

ERA Access

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