Zovant-- Long-sought drug said to fight sepsis

February 11, 2001

CNN.com - Health - Long-sought drug said to fight sepsis - February 9, 2001

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Long-sought drug said to fight sepsis

BOSTON, Massachusetts (AP) -- An international research team says it has

discovered the first drug that successfully combats sepsis, a blood infection

that kills about 225,000 Americans each year.

Researchers have spent about 15 years looking for a drug to fight the

disease.

" From what we saw, this is a tremendous breakthrough, " said Dr.

Matthay of the University of California in San Francisco. " This is truly a

landmark trial. "

Matthay reviewed the test results with other scientists for The New

England Journal of Medicine.

The findings were initially set to be published March 8, but the journal

is releasing them earlier because of their medical importance.

The research was carried out on 1,690 patients with severe sepsis at 164

locations in 11 countries. It was coordinated at Vanderbilt University in

Nashville, Tennessee, and funded by Eli Lilly and Co.

Much of the public has never heard of sepsis, even though about 750,000

cases are diagnosed in the U.S. each year, researchers say. Many medical

problems give rise to sepsis, including pneumonia, trauma, surgical

complications and cancer.

Sepsis, a bacterial infection of the bloodstream, sets off a chain of

chemical reactions that lead to excessive inflammation and clotting. It often

causes death by destroying a patient's internal organs.

The new drug is derived from a natural blood product known as activated

protein C. In the blood, activated protein C curbs inflammation and clotting.

Sepsis patients are currently treated with antibiotics, fluids and

ventilators for lung failure. But no existing treatment directly attacks the

blood infection.

Dr. Goodman, a University of Washington researcher who has studied

sepsis, said the new drug " gives us a new bullet to shoot at this disease. "

In the study, half of the patients took the drug intravenously for four

days, and the rest took a placebo. The patients were monitored for 28 days.

While only 25 percent of the patients given the drug died, 31 percent died

in the comparison group. Patients who took the drug had a 19 percent lesser

chance of dying than the others.

" It's been a terrible frustration as an intensive-care doctor to watch

huge numbers of patients who develop sepsis, " said lead researcher Gordon

Bernard of Vanderbilt. " This drug will be used widely for these patients. "

Eli Lilly has applied for approval from the U.S. Food and Drug

Administration, and plans to market the drug under the name Zovant. Bernard, who

has acted as a consultant for Lilly, said approval could come within six months.

Researchers in the study acknowledged that the drug may yield some

negative side effects. Of the patients who took the drug, 3.5 percent developed

serious bleeding, compared with 2 percent of placebo-takers. But doctors said

even a 3.5 percent risk is fairly small.

Still, they said the drug should not be given to patients who are

susceptible to bleeding. They also said the drug has not yet been tested on

children.

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