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Study Raises New Questions About Cholesterol Drug Zetia
Date:11/16/2009

ce on Zetia and a related drug, Vytorin, both made by Merck, have not been overwhelmingly positive. One study found that the combination of Vytorin and a statin was no better than the statin on its own.

Although statins -- drugs such as Crestor, Lipitor and Zocor -- reduce LDL cholesterol levels in a great many patients, some people need additional therapy. The ARBITER-6 HALTS study looked at either raising HDL levels (Niaspan) or further lowering LDL levels (Zetia).

The study enrolled 363 patients with or at high risk for heart disease, but was stopped after only 208 participants had finished the full 14 months.

Patients taking extended-release niacin, to boost HDL levels, in addition to a statin had less plaque build-up and fewer cardiovascular "events," such as heart attacks, compared to patients taking the combination drug Zetia, which delivers both a statin and ezetimibe, both of them dampening LDL levels.

Participants taking Zetia had more plaque build-up in their carotid artery.

In an accompanying editorial in the journal, researchers at Johns Hopkins University said the study findings were too preliminary to warrant any changes in how doctors treat high-risk patients.

Merck stood by its product. "The results of the small ARBITER 6 study do not, in any way, change our view of Zetia and Vytorin as effective medicines for fighting LDL cholesterol," said Peter S. Kim, president of Merck Research Laboratories. "Nothing from this study ... changes the well-established understanding that lowering LDL cholesterol is the primary target of therapy according to the guidelines. Zetia and Vytorin, when used as a supplement to a healthy diet, are effective in reducing LDL cholesterol."

And American Heart Association spokesman Dr. Robert Eckel recommended waiting for safety results from a larger ongoing trial involving Zetia, while emphasizing that there is no clear reason to stop using Zetia.


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