Publication Date
2011
Publication Details
Preiss, D., Sattar, N. & McMurray, JJ. (2011). 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. American Heart Journal,161(1), 210-219. United States: Mosby Inc.. Retrieved from https://doi.org/10.1016/j.ahj.2010.10.019
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