Study data showed that Merck & Co.'s and Schering-Plough's cholesterol drug Vytorin (ezetimibe/simvastatin) failed to show an improvement in cardiovascular outcomes in patients with aortic stenosis, compared with placebo.
The SEAS study was designed to test the effects of intensive cholesterol-lowering in patients with aortic stenosis. In the trial, which involved 1873 patients with mild-to-moderate aortic stenosis without symptoms, patients were randomised to receive Vytorin or placebo. The findings showed that no significant difference was observed between the treatment groups in the primary endpoint of major cardiovascular events, which is the composite of events associated with aortic valve disease and atherosclerotic disease.
The results also demonstrated that there was no significant difference between treatment groups for the secondary endpoint of aortic valve disease events alone. Patients who received Vytorin did have a statistically significant 22-percent reduction in atherosclerotic events alone, compared with placebo. "The study has given a clear-cut answer whether lipid lowering will influence the cause of aortic stenosis and we can conclude it does not," commented lead researcher Terje Pedersen of Ulleval University Hospital in Oslo.
In addition, the data demonstrated that 39 patients who took the drug died of cancer, compared with 23 in the placebo group, which researchers indicated could be due to chance. No one type of cancer appeared to be more affected than another, and incidence rate didn't increase the longer patients took Vytorin, according to the findings. UK researchers who reviewed data from two other Vytorin trials commented that they did not find an increased cancer risk, even though more patients with cancer were enrolled in the two trials. Shares of Merck fell 6.2 percent, while Schering-Plough's shares decreased as much as 15 percent on the news.