Sunday, September 17, 2006

Hemophilia Drug May Work on Strokes

By THE ASSOCIATED PRESS
Published: February 24, 2005

A drug that keeps hemophiliacs from bleeding to death could also prove to be the first effective treatment for the most lethal and crippling type of stroke, the kind caused by a burst blood vessel in the brain, researchers are reporting today.

In an international study, the researchers said, stroke victims given the drug - recombinant activated factor VIIa, a clot-forming drug sold as NovoSeven - were one-third less likely to die and three times as likely to survive without severe disability.

But Dr. Stephan A. Mayer, a stroke specialist at Columbia University Medical Center who led the study, said that the drug needed more study and that it would be at least two years before the maker, Novo Nordisk, applied for Food and Drug Administration approval for this purpose.

Most of the 700,000 strokes in the United States each year are caused by a clot that cuts off the flow of blood to the brain. Over the past decade, the clot-busting drug T.P.A., or tissue plasminogen activator, has been effective in treating many of them.There has been no effective treatment for the 10 percent to 15 percent of strokes caused by bleeding in the brain.

More than half the victims die within a year, and only one in five recover well enough to regain mobility.

The researchers tested NovoSeven, which has been on the market since 1999 as a treatment for hemophilia, against bleeding strokes. The findings are reported today in The New England Journal of Medicine. The study was financed by Novo Nordisk; Dr. Mayer gets consulting fees from the company.

The study was conducted at 73 hospitals in 20 countries. Researchers assigned 399 patients to get the drug or a placebo. Patients who took the drug within four hours of the onset of a stroke had about half the amount of bleeding in their brain.

After three months, 18 percent of those who took the drug had died, compared with 29 percent of those in the other group.

The drug had side effects. Seven percent of patients who received it suffered heart attacks or strokes caused by blood clots, compared with 2 percent of those in the other group. But most recovered.

"The benefit definitely outweighs the risk," said Dr. Marc R. Mayberg, chairman of the Stroke Council of the American Heart Association. Dr. Mayberg had no role in the study.


Source: New York Times
http://www.nytimes.com/2005/02/24/health/24stroke.html

Related links:
Novo Nordisk
NovoSeven
European Medicines Agency
FDA
NovoSeven for Traumatic Coagulopathy
NovoSeven Drug information

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