US drug major's Merck & Co and Schering-Plough say that the independent panel for their ENHANCE cholesterol drug recommended focusing the primary endpoint to the common carotid artery to expedite the reporting of the findings, which are now expected to be presented at the American College of Cardiology meeting in March 2008.
ENHANCE is a multinational, randomized, double-blind, study examining the effects of the highest approved dose of their co-developed cholesterol drug Vytorin/Inegy (10mg ezetimibe plus 80mg simvastatin) versus the highest approved dose of simvastatin 80mg alone in patients with heterozygous familial hypercholesterolemia, an uncommon genetic condition where patients usually have very high cholesterol levels. While the clinical evaluation portion of the ENHANCE study is complete, the trial remains blinded and the data are now being analyzed. The study design and analytical process specified in the protocol require examination of more than 40,000 scans of the arterial intima-media thickness of the carotid and femoral arteries collected in 18 multinational sites, the companies noted.
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