Sad story for patients who suffer from ALS. Gabapentin does not work.
Maybe BDNF, even if delivered intrathetaly, will do better for this terrible and untreatable disease.
Miljenko
msnbc.com
“OUR GROUP has concluded that if there is an effect with gabapentin, it's very small indeed,” said Dr. Robert Miller, a professor of neurology at the University of California, San Francisco, and director of the ALS center at California Pacific Medical Center.
“I was definitely disappointed about the results of this study,” he said. “We all were.”
“We had our fingers crossed,” said Mike Havlicek, president of the ALS Association. “We had hoped this would be good news for people dealing with this horrific disease.”
Miller was one of the researchers involved in a 1996 study that found that gabapentin, a drug approved for the treatment of epilepsy and sold under the brand name Neurontin, could also help slow the progression of Lou Gehrig's disease.
“At the time, we said the findings were encouraging, but by no means conclusive,” said Miller, who spoke here at the annual meeting of the American Neurological Association.
JUST ONE APPROVED THERAPY
Nevertheless, because there is only one approved treatment for the fatal disease — riluzole (Rilutek), which has only a modest effect on disease progression — the gabapentin results raised a lot of hopes among patients and doctors alike who were eager to try something new.
Currently, gabapentin is taken by 30 percent of patients with Lou Gehrig's disease, Miller said.
Though it is not clear what causes Lou Gehrig's disease, doctors know that a neurotransmitter called glutamate builds up in critical motor control areas of the brain and spinal cord. Because gabapentin reduces the body's production of glutamate, the drug was expected to help.
An estimated 25,000 to 30,000 Americans are afflicted with Lou Gehrig's disease, medically known as amyotrophic lateral sclerosis (ALS). Average age of diagnosis is 56.
The neurological disorder, which has no cure and is always fatal, is characterized by progressive degeneration of nerve cells that control muscle movement. The disease causes muscle weakness, especially in the arms and legs. Speech, swallowing and breathing become impaired as the disease progresses. Other symptoms include twitching and cramping of muscles, and disturbed sleep.
The disease causes death within three or four years for most patients, though about a quarter of patients live beyond five years, according to Miller.
STUDY DETAILS
In the new trial, 204 patients at 14 centers around the United States were given either 3,600 milligrams of gabapentin or placebo daily. After nine months, results showed that those who took the drug were no more likely than those who took dummy pills to see a slowing in the progression of the disease, fewer muscle cramps and twitches, improved sleep or improvements in other quality-of-life parameters.
The 1996 study involved 152 patients who were given the same drug or placebo, and followed for six months. Results showed a slight benefit with gabapentin, Miller said, but the effect was just slightly more than would have been expected by chance.
“When we analyzed the data in the larger study, we found there was no significant difference between the group that took the drug and the group that took placebo,” Miller said.
Carol Goodrich, a spokesperson for Parke-Davis, which makes gabapentin and supported the new study, said the findings are discouraging. “The company is certainly disappointed with the results of the study, especially with the desperate need ALS patients have for a treatment,” she said.
Miller advised that patients currently taking gabapentin speak with their doctors. “If you're taking it because you believe it will slow down the disease process, that is not a valid reason,” he said.
Patients on the drug who feel they're experiencing fewer symptoms — such as less cramping and twitching — should talk about the new findings with their physicians, he said, adding that there may be another explanation for the perceived benefit. |
