Vytorin Continues to Break Hearts at Merck, Schering

The bad news just seems to keep coming. The results of the latest test of the prescription drug, Vytorin, show the drug produced no significant indication that it is effective in the treatment of aortic valve disease and heart disease. The test also showed that Vytorin actually increased the number of heart events deemed “serious” when cancer patients take the drug.

Vytorin is a cholesterol-lowering drug, jointly marketed by Merck & Co. and Schering-Plough Corp., that combines the popular drug, Zetia (ezetimibe), with Zocor (simvastatin), two drugs that employ differing mechanisms to reduce cholesterol levels. Merck originally marketed simvastatin under the brand name Zocor. The patent on Zocor expired in 2006 and the drug is now available in generic form. Combined sales of Vytorin and Zetia in 2007 exceeded $5 billion.

The two drug manufacturers released the results of a joint study, dubbed “Enhance,” in January that revealed the combination of drugs in Vytorin is no more effective than simvastatin alone for the treatment of cholesterol-clogged arteries although a reduction in low-density lipoproteins (LDL), otherwise known as “bad” cholesterol, was documented. The drug companies defend the outcome of this study as a positive event since Vytorin was found to reduce cholesterol, as designed. It is general perception that reducing cholesterol is an effective means of reducing the risk of heart attacks and similar conditions.

The Enhance study drew scrutiny from the US Congress as well as state and federal investigators once it became known that study results were not released for two years after completion of the study. The drug companies claim data-quality issues that led to lengthy analysis time.

The most recent test of Vytorin, called “SEAS,” the results of which were announced earlier today, involved 1,870 European patients under treatment for aortic stenosis, a condition that causes a narrowing of the aortic valve of the heart. Aortic stenosis is said to affect about 3% of the population age 75 and older. Unfortunately, Vytorin proved to be little more effective than a placebo in reducing the need for aortic-valve replacement and decreasing the risk of heart attacks and related medical events.

Yet another test of Vytorin is under way, this one called “Improve-It.” This test is designed to assess only heart attack risk in a larger patient population, with results expected in 2012.

Leading cardiologists in the US have called for curtailing the use of both Zetia and Vytorin due to an absence of definitive proof of efficacy after the Enhance study results were released. Sales have dropped since the companies released the results of the Enhance study in January, a situation that may account for a 37% year-to-date drop in stock prices for Merck and a 27% drop for Schering-Plough.

Both Merck and Schering-Plough were scheduled to report second-quarter earnings this morning but chose instead to wait until the closing of the stock market this afternoon. The delay was based on the announcement of the SEAS study, which was also scheduled for release today.

Source: CNN

Filed under: Cholesterol, Drugs, Heart Disease, Medical Research