It is worth reading to the very end
Maryse



The drug, rasagiline (Azilect), was approved in 2006 by the U.S. Food and Drug 
Administration on the basis of studies showing that it reduced Parkinson's 
symptoms such as trembling and slowed motion. The new study, reported in the 
Sept. 24 issue of the New England Journal of Medicine, was designed to 
determine whether the drug also acts on the underlying nerve deterioration 
that causes the disease.

"In our heart, what we are hoping for is neuroprotection," said study author 
Dr. C. Warren Olanow, a professor of neurology and neuroscience at Mount Sinai 
School of Medicine, in New York City.

To distinguish the effect on symptoms from the hoped-for effect on the 
underlying disease, "we used a totally new study design, to see if it is 
disease-modifying," Olanow explained.

The study enlisted 1,176 people with previously untreated Parkinson's disease 
who were seen at medical centers around the world. At the start, half took 
daily doses of either 1 milligram or 2 milligrams of rasagiline for 36 weeks, 
while the other half took a placebo. After that, all the participants took 
either 1 milligram or 2 milligrams of rasagiline for another 36 weeks.

A complex system to measure the treatment effects showed an apparent 
improvement in the participants who took the 1-milligram doses but not in 
those taking the 2-milligram doses.

"It did something to affect the course of the disease," Olanow said. "We don't 
know why, but we are entitled to speculate."

His speculation is based on a detailed study of the 25 percent of participants 
who showed the greatest benefit. "What I think is right is that the higher dose 
had a greater effect on symptoms than the lower dose, so that masked our 
ability to detect its effect on disease progression," Olanow said. "We thought 
that this floor effect was why we couldn't see a difference."

Olanow was enthusiastic about the results. "This doesn't prove unequivocally 
that it [rasagiline] is neuroprotective, but there is no other rational 
explanation for the results," he said. "This is good news for Parkinson's 
patients."

Asked if he would prescribe the drug for that reason, Olanow said, "Yes, I 
would personally prescribe it."

A much more skeptical response came from Dr. William J. Weiner, chair of 
neurology at the University of Maryland, who took part in the study.

"The authors were very careful in the paper not to indicate that they had 
shown neuroprotection," Weiner said. "The tone of the article itself is 
moderate."

The methods used to determine trial results need scrutiny, he said. "They used 
a lot of very fancy mathematical models, some of which had not been used 
before," Weiner said. "Most neurologists wouldn't understand the mathematical 
models they used. Research neurologists don't deal with equations about the 
slope of curves."

And the end results were not impressive, he maintained. "The difference 
reported in the study is less than two points on a scale that has 150 points," 
Weiner said.

The reason why the lower dose worked, and the higher one didn't? "It simply 
could be luck," he said.

While rasagiline can provide benefits in reducing symptoms of early Parkinson's 
disease, Weiner said he was worried that "patients will be given what I 
believe to be false hopes" by the new study.

"It has mild symptomatic effects, but I do not prescribe this drug for 
neuroprotection and this study doesn't convince me to do that," Weiner said.

Several of the study authors have received consulting or lecturing fees from 
pharmaceutical companies, including Teva, the maker of Azilect.


http://health.usnews.com/articles/health/healthday/2009/09/23/new-parkinsons-
drug-draws-mixed-reviews.html

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