Pramipexole safe and effective in treatment of advanced
Parkinson's disease
WESTPORT, Apr 13 (Reuters Health) - The non-ergoline
dopamine agonist pramipexole is effective and well-tolerated as
add-on therapy for patients with advanced Parkinson's disease
who have treatment complications. These are the findings of a
multicenter phase II trial published in the April issue of the Journal
of Neurology, Neurosurgery and Psychiatry.
Dr. Michaela M. Pinter and colleagues from the Neurological
Hospital Maria Theresien Schloessel, in Vienna, Austria, studied
78 patients with advanced idiopathic Parkinson's disease who
experienced motor fluctuations and other complications during
stable treatment with antiparkinsonian medication.
The authors randomly assigned patients enrolled at nine study
centers to add-on treatment with pramipexole or placebo. The
pramipexole dose was titrated up to a maximum of 5 mg per day
over a period of 7 weeks, and was maintained for 4 weeks. The
primary endpoint was the change in the total score on the unified
Parkinson's disease rating scale (UPDRS) in a defined "on"
period, 2 hours after drug administration.
The investigators report that the "[m]ean UPDRS total score
decreased by 37.3% under pramipexole compared with 12.2%
under placebo." They also report that patients in the pramipexole
group showed significant improvements in the activities of daily
living and motor function, adding that the "...beneficial treatment
effect was prolonged, lasting through the whole maintenance
period."
According to the paper, "[p]atients under pramipexole reported an
overall reduction in 'off' periods of 12%--resulting in more than
1.7 more hours' 'on' time a day--compared with an increase in 'off'
periods of 2% under placebo."
Dr. Pinter's team notes that "[p]ramipexole showed a low
side-effect profile, was well tolerated and safe, with fatigue, vivid
dreams, and dyskinesia as the most prominent adverse events."
The researchers believe that the observed high incidence of
dyskinesia "...might be related to a dopaminergic overstimulation
under pramipexole when added to levodopa." They note that "...a
preliminary study of pramipexole in patients with advanced
Parkinson's disease showed that...dyskinesias could be controlled
by lowering the level of levodopa medication."
J Neurol Neurosurg Psychiatry 1999;66:436-441.
-Westport Newsroom 203 319 2700
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