Cholesterol Drugs Zetia and Vytorin produce no benefits

Two cholesterol drugs, Zetia and its sister drug, Vytorin, which are used by millions of Americans are now the subject of concern once again. Doctors are now questioning whether these two blockbuster cholesterol drugs should be prescribed to patients.

In a clinical trial, patients on Zetia had significantly more heart attacks than those on Niaspan. There were nine so-called cardiovascular events in the Zetia group versus two in the Niaspan group. Ultrasound images of neck arteries showed that Niaspan shrank buildups by about 2 percent, while Zetia had no effect on this even though it lowered bad cholesterol as expected.

For the 14-month study, led by Dr. Alan Taylor, the research team followed 363 heart patients or high-risk people - most of them from Walter Reed Army Medical Center - who had been taking statins, like Lipitor and Crestor, for nearly six years on average.

“This is the third strike,” said Steven Nissen, chairperson of cardiovascular medicine at the Cleveland Clinic. “The studies are telling us that it doesn’t appear to produce benefits. This is a drug used by millions of Americans, a very big seller, in a health-care system where costs are a major issue. And the question has to be, is this the right approach?”

The FDA authorized Zetia in 2002 to lower bad cholesterol, a risk factor for heart disease. However, the drug has not yet proved to have a longer-term clinical benefit in cutting heart attacks and deaths. Merck, the maker of the drug, is conducting a clinical trial on that issue involving up to 18,000 patients. Statins like Lipitor have proved in studies to significantly lower the risk of heart attack.

Patients should not stop taking any heart medicine without checking with their doctors, heart experts say.