Abstract P376: Results From a Carotid Intima-Media Thickness Trial as a Decision Tool for Launching a Large Scale Morbidity and Mortality Trial
Background Trials with carotid intima-media thickness (CIMT) as primary endpoint may improve the efficiency of the evaluation of new therapies targeting atherosclerosis considerably and may be used as a decision tool to help in the choice to launch or not to launch a large scale morbidity and mortality (M&M) trial. We evaluated the literature to provide evidence to support or refute this proposition.
Methods and results PubMed Medline was systematically searched on May 1, 2012 for randomized double-blind controlled CIMT trials. The agreement between the results from CIMT and M&M trials was assessed and positive and negative predictive values were calculated. Forty-nine CIMT trials were included. CIMT trials (n= 21) on lipid-level modifying therapies are all, except one, in agreement with the M&M trial findings. For blood pressure lowering trials (n=13), 3 were not congruent with the M&M trial. The positive and negative predictive value (95% confidence interval) of a CIMT trial to predict the outcome of a M&M trial are 96% (81 to 99%) and 83% (64 to 93%), respectively. The predictive values are higher for lipid-level modifying therapies than for other therapies.
Conclusion A CIMT trial positioned before a M&M trial may considerably improve the efficiency of the evaluation of new drug therapies on atherosclerosis and cardiovascular disease risk. Hence, the results of a CIMT trial should be seen as a decision tool to support or refute the start of a large scale M&M trial on drugs targeting atherosclerosis.
- © 2013 by American Heart Association, Inc.