Pharmaceutical giants Merck and Schering-Plough presented interim results of a clinical trial evaluating the effects of Vytorin (a controversial cholesterol-lowering drug that combines Zetia® [ezetimibe] and Zocor® [simvastatin]) on clinical outcomes in patients with aortic stenosis, a condition where the aortic valve in the heart is abnormally narrowed. Investigators found that, among the 1800 patients enrolled in the study, Vytorin was no better than a placebo pill in reducing valve-related and cardiovascular events.

Although Vytorin was significantly more effective than placebo in reducing the risk of non-fatal heart attacks, coronary artery bypass graft (CABG) surgery, angioplasty, and some types of stroke, it did not reduce the risk of valve-replacement surgery, hospitalization due to heart failure, or cardiovascular death. From these findings, the investigators concluded that intensive cholesterol-lowering does not influence the course of aortic stenosis, but does reduce the risk of coronary artery disease.

A safety concern also arose from the interim study findings - it seemed that there was a significantly higher incidence of cancer among patients who were taking Vytorin. However, independent analysis of two other large ongoing trials of Vytorin did not demonstrate the same cancer pattern.

In spite of this report, it is important to remember that this clinical trial included only patients with aortic stenosis. So, if you are taking Vytorin and are concerned about its safety or efficacy, your doctor can help you to figure out if the medication is right for you.