EFNS: Cabergoline May Be Effective In Reducing
Symptoms Of Restless Legs Syndrome
http://www.pslgroup.com/dg/1e800e.htm
COPENHAGEN, DENMARK -- October 25, 2000 -- Results of a pilot study
suggest that cabergoline may be effective in reducing the symptoms of
restless legs syndrome (RLS). In particular, patients with severe RLS
proving
resistant to traditional therapy may find cabergoline effective.
This study has just been published in a recent issue of Sleep, the
official
journal of the American Academy of Sleep Medicine and the Sleep Research
Society. Dr Karin Stiasny, MD, of the Department of Neurology at
Philipps
University, Marburg, Germany, presented the research at the
International
Congress of European Federation of Neurological Societies (14th -18th
October, 2000; Copenhagen, Denmark).
Doctors continue to seek potential new treatments for RLS, one of the
most
common neurological disorders, and an uncomfortable and distressing
condition that frequently causes serious night-time sleep disruption in
up to 15
percent1 of the population.
"Imagine trying to fall asleep at night or simply trying to relax in a
chair, yet
being unable to do so because you have an irresistible urge to move,
combined with abnormal and uncomfortable sensations or even pain in your
legs. This is what people suffering from restless legs syndrome have to
face
everyday when they try to rest," said study investigator Dr Karin
Stiasny.
Although the traditional treatment, levodopa therapy, has long been
known to
be effective for people with RLS, its usage may also be associated with
causing an "augmentation" of the condition’s uncomfortable sensations
and
symptoms in many patients. People experiencing augmentation find that
their
RLS symptoms begin to go beyond bed-time to a problem that can occur at
any time during the day. The symptoms, which include tingling and
'crawling'
sensations in their skin, pain, repetitive jerking of the legs (periodic
leg
movements, PLM) and the desire to move, may also occur with greater
intensity in such cases.
Based on the study findings, Dr Stiasny said, "Cabergoline may be an
effective alternative treatment for RLS." The pilot study conducted at
her
research unit examined nine RLS patients treated with 1-4 mg of
cabergoline
administered as a single evening dose in a 12 week, open label trial.
All the
patients had moderate or severe RLS and had experienced insufficient
benefit
with levodopa, or had also developed some daytime augmentation.
Five of the nine patients who entered the study were taking doses of
levodopa
ranging from 400 - 800mg (they were allowed to stop, taper off or
continue
levodopa during the study). The remaining four were off any specific RLS
medication during the study; two patients had been previously treated
with
other dopamine agonists.
At the conclusion of the study all patients, including those with
augmentation,
reported a relevant relief or had become free of RLS symptoms. At the
end
of 12 weeks, physician’s rated the severity of RLS to be very much
better in
five patients, much better in three patients and minimally better in one
patient
receiving cabergoline. Supplemental domperidone (available to prevent
nausea, vomiting, vertigo and arterial hypotension) was stopped in all
patients
due to good tolerability. Five patients reported mild to moderate,
temporary
side effects, including vertigo, dizziness, headache and diarrhea.
Study measurements demonstrated a significant decrease in the total
number
of periodic leg movements during time in bed, from 195.8 ± 109.1 to 26.4
±
40.2 (p=0.002). Total sleep time was prolonged by more than an hour
(302.7
± 50.7 minutes to 379.4 ± 59.8 minutes) and sleep efficiency improved
from
63.1 percent (± 10.5) to 79.1 percent (±12.5).
Based on subjective ratings recorded in patient diaries, the overall
quality of
the previous nights’ sleep was rated much higher at the end of the study
(6.8)
than at the beginning (3.2), on a scale from zero (very bad) to 10 (very
good).
Also, at the endpoint, using the Hamburger Visual Analogue Scale,
patients
rated their quality of life much better than at baseline.
Explained Dr Stiasny, "There have been a small number of trials with
other
dopamine agonists, which have also shown benefit in patients with
augmentation, i.e., pergolide. But augmentation was also reported with
pergolide but to a lower degree. In our trial, patients saw an
improvement in
their condition after just four weeks of treatment and there were no
withdrawals due to adverse effects."
Cabergoline is currently licenced for the treatment of Parkinson's
disease
(PD) and is the only dopamine agonist that is recommended for once-a-day
dosing. It has a longer duration of action than any other dopamine
agonist,
giving symptom control in the treatment of PD for a full 24 hours.
All contents Copyright © 2000 P\S\L Consulting Group Inc. All rights
reserved.
--
Judith Richards, London, Ontario, Canada
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