Shift from surrogate end point to outcome trials: implications for cardiovascular safety assessment in development programs for antidiabetic drugs.

@article{Marcinak2012ShiftFS,
  title={Shift from surrogate end point to outcome trials: implications for cardiovascular safety assessment in development programs for antidiabetic drugs.},
  author={John F Marcinak and Prabhakar Viswanathan and Vini Arora and L E Roebel and Thomas R Strack and Eckhard Leifke},
  journal={Clinical pharmacology and therapeutics},
  year={2012},
  volume={91 3},
  pages={514-20}
}
We assessed the effect of extending the range of cardiovascular (CV) end points to include hospitalization for unstable angina and hospitalization for coronary revascularization (Extended Major Adverse Cardiac Event criteria (MACE)) in addition to the standard ones, namely, CV-related death, nonfatal stroke, and nonfatal myocardial infarction (Core MACE… CONTINUE READING