Vytorin Problems Mount as Drug Found to Not Improve Outcomes in Heart Study

A new study has found that cholesterol drug Vytorin provides no benefit in reducing the risk of major heart-valve problems, raising questions about why the drug is still on the market. Earlier this year, sales of Vytorin plummeted after another study raised questions whether the drug carried any medical benefits. This study, which was designed to demonstrate the effects of the cholesterol drug on heart attacks, will likely put further pressure on sales of the drug and could lead to the filing of additional lawsuits.

Vytorin, which is marketed jointly by Merck & Co. and Schering-Plough Corporation, is prescribed to treat high levels of cholesterol in the blood. It is a combination of Zetia (ezetmibe) and an older drug commonly known as Zocor (simvastatin), which is also available as a generic.

The new study, known as Simvastatin and Ezetimibe in Aortic Stenosis (SEAS), shows that the controversial cholesterol-lowering medication was no better than a placebo in treating cardiovascular events associated with heart disease, which was the primary endpoint of the analysis. A similar result was observed in the prevalence of aortic valve disease events, which was the secondary endpoint of the study. However, the combination of simvastatin and ezetimibe in Vytorin did bring about a statistically significant 22% reduction in atherosclerotic events.

The study also found that the drug combination reduced the risk of coronary heart disease in patients with mild to moderate aortic stenosis but could not alter the rate of progression of aortic valve disease.

Earlier this year, the manufacturers released another study, known as ENHANCE, which found Vytorin to be no better than generic Zocor in reducing plaque buildup. Following the release of further details from the ENHANCE study in March, cardiologists recommended that doctors revert to older, cheaper and well-proven treatments for high cholesterol.

A number of Vytorin class action lawsuits have already been filed alleging that the drug provides no benefits over cheaper generics. Potential injury lawsuits are also being reviewed by several lawyers who indicate that if Vytorin provides no medical benefits, than even the slightest degree of health risk is unacceptable.

The SEAS study did suggest a potential cancer risk among patients using Vytorin. There were 39 reports of cancer deaths among patients using the drug, compared with 23 reports of cancer among patients taking the placebo. However, this does not rise to the level of statistical significance and could be attributed to chance. According to researchers, larger studies and other ongoing trials of Vytorin or Zetia do not suggest an increased risk of cancer.