To Parkinsn list:

The article referred to in that news release which Mario offered for
discussion does NOT debunk the connection between medications and sudden
sleep attacks (SSA).  The full article is available on-line, free of charge,
at:

http://jama.ama-assn.org/issues/v287n4/rfull/joc10367.html

If I may quote from the article itself:
Falling asleep at the wheel is typically preceded by a warning of sleepiness
rather than occurring suddenly and unpredictably. Patients should be warned
about the nature of excessive daytime sleepiness. They should be educated to
recognize the warning symptoms and the associated risks of these episodes
occurring while driving, and about the importance of never driving when
sleepy. Finally, patients should be asked regularly during follow-up visits
about symptoms that suggest daytime sleepiness39 or sudden onset of sleep.
EPISODES SUGGESTING SUDDEN "SLEEP ATTACKS" WERE VERY UNCOMMON IN OUR STUDY.
AT PRESENT IT SEEMS THAT THE BEST PREDICTOR OF FUTURE SLEEP ATTACKS AT THE
WHEEL IS AN INITIAL SLEEP ATTACK AT THE WHEEL

Conclusions  ***Excessive daytime sleepiness is common*** even in patients
with PD who are independent and do not have dementia. ***SUDDEN-ONSET SLEEP
WITHOUT WARNING IS INFREQUENT.*** The Epworth score has adequate sensitivity
for predicting prior episodes of falling asleep while driving and its
specificity can be increased by use of the Inappropriate Sleep Composite
Score. ***It is unknown if routinely performing these assessments could be
more effective in predicting future risk for these rare sleep attacks.***
PATIENTS SHOULD BE WARNED NOT TO DRIVE IF THEY DOZE IN UNUSUAL
CIRCUMSTANCES."

The article DOES NOT say that there is no connection between the sudden
sleep attacks and the drugs.

The article does say that PWP seem to have excessive daytime sleepiness to a
greater extent than non-PWP people, and suggests that excessive daytime
sleepiness could be a risk while driving, even more so than the sudden sleep
attacks.  This is not because the sudden sleep attacks do not happen, but
because they are infrequent, and are much less frequent than excessive
daytime sleepiness and drowsiness.  Even in non-PWP people, excessive
daytime sleepiness causes many accidents, and if excessive daytime
sleepiness occurs, extra caution is necessary.

Indeed, the following figures from the study are sobering:

1) 420 of the 638 patients studied were driving

2) Of those 420, 78 (19%) had experienced dozing while driving or being
stopped in traffic. 49 (12%) experienced dozing while actually in movement.

Another important issue emphasized in the article:

"""The fact that most individuals were taking multiple drugs reduced our
power to separate clearly the effects of individual medications."""

If you look carefully, however, one can see the following

1) There were 152 patients treated with levodopa ALONE amongst the drivers,
and only 5 of those (3.3%) dozed off while driving.

2) Of those 420, 268 were either on no drug or combination (which may have
included levodopa).  According to Table 3, 235 were on dopamine agonists
(alone, or in combination)  Of these, 42 (17.8%) dozed of while driving and
were on agonist alone or a combination of levodopa with agonist.

It seems that the data overwhelmingly support the notion that the risk of
falling asleep at the wheel is much greater if you are taking agonist, alone
or in combination, than with levodopa alone, whether you have sudden sleep
attack or just doze off.

It is sad to see that in this case, it is the media who distorted this
report.

Jorge A Romero, MD



----- Original Message -----
From: "supermario" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Saturday, February 02, 2002 9:32 AM
Subject: Please read - important


Parkinson's Drugs Don't Cause Sudden Sleep
      by: Ed Edelson, HealthScoutNews Reporter

      01/22/2002

(HealthScoutNews) -- Debunking previous research, a new study finds no
connection between medications people with Parkinson's disease take and
their sudden bouts of sleepiness while driving.

The finding is especially important in Canada, because that government has
required warning letters about pramipexole (Mirapex) and ropinirole
(Requip), based on studies suggesting they promote sleepiness, says Dr.
Douglas E. Hobson, lead author and an assistant professor of neurology at
the University of Manitoba.

"When the Canadian government requested the warning letters on these two
drugs, it said the warning was pending further information," Hobson says.
"This is further information."

The U.S. Food and Drug Administration has not issued a similar warning, but
many doctors here have been cautious about prescribing the drugs.

Excessive daytime sleepiness is known to be common among patients with
Parkinson's disease, in which a deficit of the brain chemical dopamine can
cause trembling, stiffness, difficulty walking, and reduced mental function.
The two drugs, which promote dopamine activity, have been reported to cause
sudden sleepiness while driving.

But a study of 638 patients at 18 Canadian clinics found no such connection,
says a report in tomorrow's issue of the Journal of the American Medical
Association.

The researchers used the Epworth Sleepiness Scale and an Inappropriate Sleep
Composite Score, specifically developed for the study, to determine not only
the risk of falling asleep, but also how often it occurs.

They found 51 percent of the patients reported daytime sleepiness, and the
number of times that happened was not affected by any medication the
patients were taking. They also found the risk of the much-feared sudden
onset of sleep while driving is rare. Only 16 patients reported a sudden
onset of sleep while driving, and only 3 said it occurred without warning.

The score on the two tests, taken together, "is a useful tool to identify
patients who are abnormally sleepy, and may play a role in increasing
patient and physician awareness of this significant clinical problem," the
journal report says.

"We were looking for predictors, because everyone was told they shouldn't
drive," Hobson says. "This will be helpful in selecting out the patients who
shouldn't be driving."

The study is also useful because it gives solid information about unwanted
sleepiness, he says.

"No one knew how often it happens," Hobson says. "Knowing the frequency will
help a lot in relation to regulations about driving."

The study will help doctors treating Parkinson patients because it gives
them a way of identifying patients at high risk of unwanted sleepiness, says
Dr. Cynthia L. Comella, of Rush-Presbyterian-St Luke's Medical Center in
Chicago.

"The most important point of the study is the ability to measure sleepiness
in Parkinson's disease," says Comella, who wrote an accompanying editorial.
"The method is quite simple and clinically applicable. Until now, nothing
has been shown to assess sleepiness in correlation with driving."

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