ILLUSTRATE, RADIANCE, and ERASE: What Do the Imaging Trials With Torcetrapib Tell Us?

Linda Brookes, MSc

Disclosures

June 12, 2007

In This Article

Background Results of ILLUMINATE

The first analyses of the ILLUMINATE data are expected later this year and are expected to reveal a lot more information about whether the increase in cardiovascular events observed with torcetrapib-atorvastatin was due to the torcetrapib molecule itself or to some result of its mechanism of action. While the data are being analyzed, there has been wide speculation as to why torcetrapib might have produced this unfortunate and unexpected result, especially focusing on the rise in blood pressure associated with torcetrapib in clinical studies.

In anticipation of what these analyses of the clinical endpoints will reveal, attention naturally focused on the results of the now eagerly awaited imaging studies:

  1. Investigation of Lipid Level Management Using coronary UltraSound To assess reduction of Atherosclerosis by CETP Inhibition and HDL Elevation (ILLUSTRATE); and

  2. Rating Atherosclerotic Disease change by Imaging With A New CETP Inhibitor (RADIANCE), actually a 2-part trial, in patients with heterozygous familial hypercholesterolemia and in patients with mixed dyslipidemias, RADIANCE I and II, respectively.

It was hoped that the results of these studies might point to whether the adverse outcomes with torcetrapib were a class effect or an independent toxic effect, which would have important implications for other CETP inhibitors in development. They would also demonstrate whether assessing surrogate endpoints with either intravascular or carotid artery ultrasonography could be extrapolated to a clinical conclusion that is consistent with that of a morbidity and mortality trial.

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