Cholesterol Drug Has No Benefit in Trial

[Guest guest]

Cholesterol Drug Has No Benefit in Trial

http://www.nytimes.com/2008/01/14/business/14cnd-drug.html?

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A clinical trial of Zetia, a cholesterol-lowering drug prescribed to

about 1 million people a week, failed to show that the drug has any

medical benefits, Merck and Schering-Plough said on Monday.

The results will add to the growing concern over Zetia and Vytorin,

a drug that combines Zetia with another cholesterol medicine in a

single pill. About 70 percent of patients who take Zetia do so in

the form of Vytorin, which combines Zetia with the cholesterol drug

Zocor.

While Zetia lowers cholesterol by 15 to 20 percent in most patients,

no trial has ever shown that it can reduce heart attacks and

strokes — or even that it reduces the growth of the fatty plaques in

arteries that can cause heart problems.

This trial was designed to show that Zetia could reduce the growth

of those plaques. Instead, the plaques actually grew somewhat faster

in patients taking Zetia along with Zocor than in those taking Zocor

alone. Patients in the trial who took the combination of Zetia and

Zocor were receiving it in the form of Vytorin pills.

Dr. Nissen, the chairman of cardiology at the Cleveland

Clinic, said the results were " shocking. " Patients should not be

prescribed Zetia unless all other cholesterol drugs have failed, he

said.

" This is as bad a result for the drug as anybody could have feared, "

Dr. Nissen said. Millions of patients may be taking a drug that has

no benefits for them, raising their risk of heart attacks and

exposing them to potential side effects, he said.

Both companies' stocks were down in mid-day trading in New York on

Monday, with Merck's share price off by 2.4 percent and Schering-

Plough's down nearly 6 percent.

The results will also add to the controversy surrounding a long

delay in releasing the results of the trial, which was known as

Enhance. Merck and Schering-Plough completed the trial in April 2006

and had initially planned to release the findings no later than

March 2007. But the companies then missed several self-imposed

deadlines, blaming the complexity of the data analysis from the

study and saying they did not know when or if the data would be

ready for publication.

Last month, after several news articles highlighted the delay, they

finally agreed to release the results soon.

For Merck and Schering-Plough, which jointly market Zetia and

Vytorin and share profits from the drugs, the trial's results are a

serious setback. Zetia and Vytorin are important contributors to

both companies' profits, especially to Schering, which is smaller

and less profitable than Merck.

Analysts estimate that about 70 percent of Schering's earnings

depend on the drugs. The controversy over the trial is also a

problem for Merck, which is trying to repair its reputation after

withdrawing the painkiller Vioxx from the market in September 2004.

[Guest guest]

This is very disappointing news.

I will need to let my family know, since some had switched to Zetia.

I hope that the pharmaceutical company will conduct a study on Zetia alone, but

it doesn't sound very promising. Darn!

Thanks for finding this information, Gretchen. More information is better and

allows us to make more informed healthcare decisions. I appreciate all of your

hard work!