SEAS Study Shows No Significant Difference Versus Placebo For Schering-Plough's (SGP), Merck's (MRK) Vytorin

July 21, 2008 1:30 PM EDT

Schering-Plough (NYSE: SGP), Merck (NYSE: MRK) study on Vytorin (Simvastatin and Ezetimibe) : no significant difference versus placebo in primary endpoint (major cardiovascular events), or secondary endpoint (aortic valve disease events and therosclerotic disease event). Vytorin reduced LDL-cholesterol by an average of 61%.

The SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study has investigated the effects of intensive cholesterol lowering with the combination of simvastatin (40 mg daily) and ezetimibe (10 mg daily) in patients with aortic stenosis.

"Compared with placebo, the combination of simvastatin and ezetimibe reduced LDL-cholesterol by an average of 61%, corresponding to a reduction of about 2 mmol/L (76 mg/dl), and this effect was sustained throughout the study. 688 patients had one or more primary endpoint events. No significant difference was observed between the treatment groups for the combined primary endpoint (333 patients with an event on LDL-lowering treatment versus 355 on placebo; hazard ratio [HR] 0.96; 95% confidence interval [CI] 0.83 to 1.12). Nor was there a significant difference for the secondary endpoint of aortic valve disease events alone (308 versus 326; HR 0.97; 95% CI 0.83 to 1.14). The combination of simvastatin and ezetimibe did, however, produce a statistically significant 22% (95% CI 3% to 37%; p=0.02) proportional reduction in the secondary endpoint of atherosclerotic events alone: 148 (15.7%) in the simvastatin plus ezetimibe group versus 187 (20.1%) in the placebo group.

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