NEW
YORK (AP)—Researchers are reporting the first treatment to speed
recovery from severe brain injuries caused by falls and car crashes: a
cheap flu medicine whose side benefits were discovered by accident
decades ago.
Severely
injured patients who were given amantadine got better faster than those
who received a dummy medicine. After four weeks, more people in the flu
drug group could give reliable yes-and-no answers, follow commands or
use a spoon or hairbrush—things that few of them could do at the start.
Far fewer patients who got amantadine remained in a vegetative state, 17
percent versus 32%.
“This
drug moved the needle in terms of speeding patient recovery, and that’s
not been shown before,” said neuropsychologist Joseph Giacino of
Boston’s Spaulding Rehabilitation Hospital, co-leader of the study. He
added: “It really does provide hope for a population that is viewed in
many places as hopeless.”
Many
doctors began using amantadine for brain injuries years ago, but until
now there’s never been a big study to show that it works. The results of
the federally funded study appear in Thursday’s New England Journal of
Medicine.
A
neurologist who wasn’t involved in the research called it an important
step. But many questions remain, including whether people less severely
injured would benefit, and whether amantadine actually improves
patients’ long-term outcome or just speeds up their recovery.
Each
year, an estimated 1.7 million Americans suffer a traumatic brain
injury. Falls, car crashes, colliding with or getting hit by an object,
and assaults are the leading causes. About three-quarters are
concussions or other mild forms that heal over time. But about 52,000
people with brain injuries die each year and 275,000 are hospitalized,
many with persistent, debilitating injuries, according to government
figures.
With
no proven remedies to rely on, doctors have used a variety of medicines
approved for other ailments in the hopes that they would help brain
injury patients. Those decisions are based on “hunches and logic rather
than data,” said Dr. John Whyte, of the Moss Rehabilitation Research
Institute in suburban Philadelphia. He led the study along with Giacino.
Amantadine
(uh-MAN’-tah-deen), an inexpensive generic, was approved for the flu in
the mid-1960s. The first inkling that it might have other uses came a
few years later when it appeared to improve Parkinson’s symptoms in
nursing home patients who got it. It was found to have an effect on the
brain’s dopamine system, whose many functions include movement and
alertness, and it was later approved for Parkinson’s.
It’s
now commonly used for brain injuries, and the researchers felt it was
important to find out “whether we’re treating patients with a useful
drug, a harmful drug or a useless drug,” Whyte said.
The
study was done in the U.S., Denmark and Germany and involved 184
severely disabled patients, about 36 years old on average. About a third
were in a vegetative state, meaning unconscious but with periods of
wakefulness. The rest were minimally conscious, showing some signs of
awareness. They were treated one to four months after getting injured, a
period when a lot of patients get better on their own, Giacino noted.
They
were randomly assigned to receive amantadine or a dummy drug daily for
four weeks. Both groups made small but significant improvement, but the
rate of recovery was faster in the group getting amantadine. When
treatment stopped, recovery in the drug group slowed. Two weeks later,
the level of recovery in the two groups was about the same.
There was no group difference in side effects, which included seizure, insomnia and rigid muscles.
The
study was short, and the effect on long-term outcome is unknown. But
Giacino said the drug still has value even if it only hastens recovery.
“What condition would we not jump for joy if we could have it over with faster?” he said.
The
study didn’t include those with penetrating head injuries, like the
gunshot wound former Rep. Gabrielle Giffords suffered, but Giacino said
the drug should have similar effects in those patients. Whether it would
work in patients with brain injuries not caused by trauma, such as a
stroke, isn’t known.
Whyte said the researchers want to test the drug for longer periods.
Dr.
Ramon Diaz-Arrastia said the results were welcome news in a field that
has seen many failed efforts. He is director of clinical research at the
government’s Center for Neuroscience and Regenerative Medicine, which
works with the military and government scientists on brain injury
research.
“It’s an important step toward developing better therapies,” he said.
Since
amantadine is so commonly used, he said U.S. troops with severe brain
injuries in Iraq or Afghanistan probably get it, or should get it now.
Since 2000, some 233,000 troops have suffered traumatic brain injuries,
including about 6,100 serious cases, many of them from bomb blasts or
shrapnel.
Laura
Bacon said amantadine seems to be helping her brother recover from a
car accident in Vermont last October. Nicholas Gnazzo, 47, of Rochester,
N.H., was in a coma for weeks before he was taken for rehabilitation to
Spaulding, where doctors put him on amantadine in January.
Since
then he has been more alert, able to communicate with nods or
gestures—like pointing to his eyes when he wants his glasses, his sister
said. Giacino agreed her brother has gotten better, but whether it is
because of the drug can’t be determined. Gnazzo wasn’t part of the
study.
“It’s
been four months now, and we know we still have a long way to go,”
Bacon said. “Anything that could be faster—or feel faster to us—is a
positive.”
Placebo-Controlled Trial of Amantadine for Severe Traumatic Brain Injury
SOURCE: The Associated Press
Filed Under: Drug Discovery
