Two popular cholesterol drugs may not work

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Two popular cholesterol drugs may not work

Vytorin, Zetia failed to improve heart disease in a key study

http://www.msnbc.msn.com/id/23868978/

Full results of a failed trial on Vytorin, a medicine taken by

millions of people to lower cholesterol, left doctors stunned that

the drug did not improve heart disease even though it worked as

intended to lower three key risk factors.

Use of Vytorin and a related drug, Zetia, seemed sure to continue to

fall after the findings reported Sunday and fresh questions about why

drugmakers took nearly two years after the study ended to give

results.

" A lot of us thought that there would be some glimmer of benefit, "

said Dr. Blumenthal, a s Hopkins University cardiologist

and spokesman for the American Heart Association.

Many doctors were prescribing Vytorin without trying older, proven

medications first, as guidelines advise. The key message from the

study is " don't do that, " Blumenthal said.

Doctors have long focused on lowering LDL or bad cholesterol as a way

to prevent heart disease. Statins like Merck & Co.'s Zocor, which

recently became available in generic form, do this, as do niacin,

fibrates and other medicines.

Vytorin, which came out in 2004, combines Zocor with Schering-Plough

Corp.'s Zetia, which came on the market in 2002 and attacks

cholesterol in a different way.

The study tested whether Vytorin was better than Zocor alone at

limiting plaque buildup in the arteries of 720 people with super high

cholesterol because of a gene disorder.

The results show the drug had " no result — zilch. In no subgroup, in

no segment, was there any added benefit " in terms of reducing plaque,

said Dr. Kastelein, the Dutch scientist who led the study.

That happened even though Vytorin dramatically lowered LDL, other

fats in the blood called triglycerides and a measure of artery

inflammation called CRP.

Results were presented at an American College of Cardiology

conference in Chicago and published on the Internet by the New

England Journal of Medicine.

The journal also published a report showing that Vytorin and Zetia's

use soared in the United States amid a $200 million-marketing blitz.

In Canada, where advertising drugs to consumers is not allowed, sales

were four times lower.

Congress and state officials in New York have been investigating why

results were not released for nearly two years after the study ended.

The drug appeared safe in the study, and patients should not

discontinue using it or any heart drug without talking with their

doctors, heart specialists stressed.

However, doctors prescribing Vytorin in the mistaken belief it always

works " should be thinking twice, " said Duke University cardiologist

Dr. Califf.

He is co-leader of an even more pivotal study of the drug that was

expanded to include more patients because early signs suggest it will

be harder than anticipated to see if Vytorin is any better than Zocor

alone.

Califf himself takes the drug because he cannot tolerate the high

dose of statins he otherwise would need.

" It will be 2012 — ten years after the drug was introduced — before

we know the answer, " said Dr. Nissen, a Cleveland Clinic

cardiologist who has no role in the Vytorin studies and has

criticized the drugmakers' handling of the one reported Sunday.