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 Tuesday > May 10 > 2005

Doctors snub stroke drug
Researchers challenge reluctance to use clot-busting medication

SHARON KIRKEY
CanWest News Service


Tuesday, May 10, 2005


More than one-third of stroke patients injected with clot-busting drugs
survive without significant brain damage, according to new Canadian
research that backs aggressive use of medication many emergency doctors
have been reluctant to use.

The nationwide study, which involved nearly 1,200 stroke patients at 60
hospitals, found the drug alteplase works better than expected and that
the most feared side-effect - bleeding in the brain - occurs in fewer
than five per cent of patients.

But fewer than two per cent of stroke victims received the drug over the
1999-2001 study, researchers estimate.

"My guess is that, across the country, we're probably not much better"
today, said co-

author Michael Hill, a stroke neurologist at the University of Calgary.

Part of the problem is that 70 per cent of stroke patients don't get to
the hospital in time to be eligible for a clot buster.

But another recent study found that nearly 10 years after its U.S.
approval, the drug still meets strong resistance from doctors.

A survey of 1,105 emergency physicians in the United States published
online last week in the Annals of Emergency Medicine found 40 per cent
said it was unlikely they would give the drug "to an ideal patient in an
ideal setting."

Of them, 65 per cent cited the concern over hemorrhage, according to
University of Michigan researchers.

Twenty-three per cent said they didn't think the drug would provide
benefit, while 12 per cent gave both reasons.

Every year, 50,000 Canadians suffer a stroke, making it the No. 1 cause
of long-term disability.

Almost 80 per cent of all strokes are ischemic strokes, where a blood
clot lodges in a vessel in the brain, squeezing off the flow of
oxygen-rich blood to that area.

Clot-busters can quickly dissolve the obstruction and, if given within
three hours of the onset of symptoms, stop neurons from dying. But the
drugs can also induce bleeding, including in the brain - with fatal
results.

The new study, published in today's issue of the Canadian Medical
Association Journal, found 37 per cent of ischemic stroke patients
treated with alteplase had an "excellent" outcome.

That means "they might have a little facial droop or a little numb hand
or that kind of thing, but they can get back to all their previous
activities, including driving," Hill said in an interview.

Alteplase is a genetically engineered version of tissue plasminogen
activator, or tPA, a naturally occurring enzyme that breaks down clots.

TPA for stroke was conditionally licensed in Canada in 1999. As a
condition of approval, Health Canada ordered a registry be created to
monitor "real world" use of the drug.

For the study, data were collected from 1,135 patients - nearly 85 per
cent of all patients treated with tPA between February 1999 through June
30, 2001. The patients were followed for up to 90 days; the median age
was 73.

Using census data, the researchers estimated that 1.4 per cent of 90,200
patients with ischemic stroke received tPA during the study period, a
low rate given "good access to basic technology such as CT scanning" in
hospitals.

An intracranial hemorrhage - brain bleeding - occurred in 52 of patients
treated, or 4.6 per cent. Thirty-nine died in hospital, and one
recovered to a level of "functional independence."

"There was a three per cent rate of fatal hemorrhage," Hill said. "That
means that 97 per cent of the time you don't kill someone - but you can
kill someone with the treatment.

"That's the worry. No doctor wants to do that. On the other hand, the
other side of it is that if you don't treat them, they often die from
their stroke."

About one-fifth of the patients died of their strokes, while 25 per cent
had a "moderate" outcome, meaning "they were not back to work, not
playing golf. It means they were disabled enough it impaired their
life," Hill said. The rest were left with more severe disabilities.

Neurologists most often administered the drug. "But we're hoping that
... we'll be able to continue to educate people and get this treatment
into the hands of more physicians," Hill said.

It costs about $15,000 to $18,000 in drugs and hospital care to treat
one patient with tPA, vs. "about $100,000 to take care of severely
disabled person for a year," Hill said.

The study was paid for by the Canadian Stroke Consortium, the Canadian
Stroke Network and Hoffmann-La Roche Canada Ltd.

C The Gazette (Montreal) 2005








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