Merck & Co/Schering-Plough's combo statin disappoints in ENHANCE trial

US drug majors Schering-Plough and Merck & Co have reported disappointing data from the ENHANCE trial of their co-developmental cholesterol-lowering drug candidate Vytorin (ezetimibe and high-dose simvastatin) versus simvastatin alone.

The news - which had been awaited by the investment community - showed that that the combination drug had failed to produce the desired effects and saw S-P's share price fall 3% to $27.02 while Merck's declined 2% to $59.40 in early trading on Janury 14, when the study results were revealed.

ENHANCE was a surrogate endpoint trial conducted in 720 patients with Heterozygous Familial Hypercholesterolemia (HeFH), a rare condition that affects approximately 0.2 % of the population. All analyses were conducted in accordance with the original statistical analysis plan. The primary endpoint was the mean change in the intima-media thickness measured at three sites in the carotid arteries (the right and left common carotid, internal carotid and carotid bulb) between patients treated with ezetimibe/simvastatin 10/80mg versus those given simvastatin 80mg alone over a two=year period.