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
Journal article
Preiss, David, Sattar, Naveed and McMurray, John J.. (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), pp. 210 - 219. https://doi.org/10.1016/j.ahj.2010.10.019
Authors | Preiss, David, Sattar, Naveed and 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. |
Year | 2011 |
Journal | American Heart Journal |
Journal citation | 161 (1), pp. 210 - 219 |
Publisher | Mosby Inc. |
ISSN | 0002-8703 |
Digital Object Identifier (DOI) | https://doi.org/10.1016/j.ahj.2010.10.019 |
Scopus EID | 2-s2.0-78650295935 |
Page range | 210 - 219 |
Research Group | Mary MacKillop Institute for Health Research |
Publisher's version | File Access Level Controlled |
Place of publication | United States |
Permalink -
https://acuresearchbank.acu.edu.au/item/86qzx/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
Restricted files
Publisher's version
(1 files)
79
total views0
total downloads2
views this month0
downloads this month