title: Results from a carotid intima-media thickness trial as a decision tool for launching a large-scale morbidity and mortality trial.
abstract: BACKGROUND
  Trials with carotid intima-media thickness (CIMT) as primary end point may improve the efficiency of the evaluation of new therapies targeting atherosclerosis considerably, and the results of CIMT trials 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.
  
  
  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-eight CIMT trials were included. CIMT trials (n=20) 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% (80-99%) and 83% (64-93%), respectively. The predictive values are higher for lipid-level modifying therapies than for other therapies.
  
  
  CONCLUSIONS
  A CIMT trial positioned before an 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.
authors.affiliation: Julius Center for Health Sciences and Primary Care and University Medical Center Utrecht, Utrecht, The Netherlands. s.a.e.peters@umcutrecht.nl
authors.forename: Sanne A E
authors.initials: SA
authors.lastname: Peters
authors.forename: Hester M
authors.initials: HM
authors.lastname: den Ruijter
authors.forename: Diederick E
authors.initials: DE
authors.lastname: Grobbee
authors.forename: Michiel L
authors.initials: ML
authors.lastname: Bots
mesh_terms: D050197:Atherosclerosis / Q000000981:diagnostic imaging / Q000453:epidemiology*; D002339:Carotid Arteries / Q000000981:diagnostic imaging*; D059168:Carotid Intima-Media Thickness; D003657:Decision Making; D018450:Disease Progression; D014943:Global Health; D006801:Humans; D009017:Morbidity / Q000639:trends; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D015996:Survival Rate / Q000639:trends