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New Weapon in War Against Cholesterol

Drug called ZETIA can be added to current arsenal of medications

WEDNESDAY, Oct. 30, 2002 (HealthDayNews) -- ZETIA, the newest drug to help fight high cholesterol, isn't expected to eliminate the need for the statin drugs that are now the mainstay of treatment.

Rather, it will often complement the existing treatments and help when the statins -- such as Lipitor (atorvastatin) or Zocor (simvastatin) -- aren't enough to lower cholesterol and the risk of heart disease, experts say.

"It's not in any way meant to displace the statins," says Dr. Rick Veltri, vice president of clinical research for the Schering-Plough Research Institute in Kenilworth, N.J. Schering-Plough and Merck & Co. formed a joint venture to market the new drug.

Just approved last week by the U.S. Food and Drug Administration, ZETIA can be used as a stand-alone therapy or in combination with the statins. A 10-milligram tablet is meant to be taken once a day.

"ZETIA (ezetimibe) has a different mode of action [than the statins]," Veltri says.

To better understand how each drug works, it helps to know that cholesterol in the blood is controlled principally by the liver, which produces cholesterol and bile acids, and by the intestines, which absorb cholesterol from food and from the bile.

Statins work by blocking an enzyme involved in the production of LDL cholesterol, the bad cholesterol, especially in the liver. "ZETIA blocks cholesterol activity in the intestine," Veltri says. Its action is "distinct and complementary" from that of statins.

More than 100 million Americans have total blood cholesterol values above 200 milligrams per deciliter, considered the cutoff for a healthy level by the American Heart Association. LDL levels should be less than 100 milligrams per deciliter, ideally, experts say, although levels of 100 to 129 are considered "near optimal" by the heart association.

About 13 million Americans are treated with statins for their LDL levels, and 60 percent still have unhealthy LDL levels, even while on the medication, according to Schering-Plough.

ZETIA can reduce LDL cholesterol quickly and dramatically, Schering-Plough has found. In its so-called "add-on study," 769 subjects with high-cholesterol who were taking statins were assigned to take ZETIA as well, or to take placebo. The ZETIA group obtained a 25 percent reduction in LDL levels, while the placebo group only got a 4 percent reduction.

The ZETIA groups' LDL went from an average of 139 milligrams per deciliter to 102, but the placebo group's LDL dropped only from 139 to 133.

Although ZETIA is brand new, "It may get quickly into the mainstream," says Dr. Robert Bonow, chief of cardiology at Northwestern University School of Medicine and president of the American Heart Association.

Besides being used as an add-on therapy for patients already on statins who haven't lowered their LDL cholesterol enough, ZETIA might be used alone, eventually, Bonow speculates. However, he agrees with Veltri that the new drug won't replace statins.

"Statins are here to stay," he says.

A 30-day supply of ZETIA is about $58, and the drug is expected to be available in pharmacies by mid-November.

In addition to prescribing medication to those with high cholesterol, doctors advise their patients to reduce dietary cholesterol and fat, exercise regularly and lose weight if necessary.

What To Do

For more information on what to do about high cholesterol, see the National Institutes of Health. For information on cholesterol statistics, check the American Heart Association.

SOURCES: Rick Veltri, M.D., vice president, clinical research, Schering-Plough Research Institute, Kenilworth, N.J.; Robert Bonow, M.D., chief, cardiology, Northwestern University School of Medicine, Chicago, and president, American Heart Association, Dallas
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