Company Press Release
SOURCE: Pharmacia & Upjohn Inc.
New Study with Mirapex(R) (Pramipexole) Shows Improvement in Tremor
Among Patients with Parkinson's Disease
NEW YORK, Oct. 19, 1998 /PRNewswire/ -- A new study on rest tremor, a
troubling symptom of Parkinson's disease (PD), indicates that patients
taking Mirapex(R) (pramipexole dyhydrochloride tablets) experience
significant improvement in their symptoms compared to patients on
placebo.
``This is the first adequately powered, well-controlled study on tremor
in PD,'' said Professor Wolfgang Oertel, M.D., of the Department of
Neurology at Philipps University, Marburg, Germany, who presented this
study at the 5th International Congress on Movement Disorders meeting
here. The results revealed that pramipexole, a D[3]-preferring dopamine
agonist, was significantly more effective than placebo in improving
tremor in PD patients in whom tremor was a prominent feature of the
disease(a). This effect was confirmed by patient, physician and
electrophysiologic assessments.
``It is estimated that at least 70% of Parkinson's patients suffer from
rest tremor and treatments often fail to provide effective control of
tremor. The results of this study with pramipexole are very
mpressive,'' said Dr. Oertel.
Eight-four (84) patients who suffered from tremor-dominant PD or mixed
type PD with predominant rest tremor were enrolled in the placebo
controlled, double-blind, multi-center, randomized study(a). The use of
other drugs with a potential influence on tremor were not allowed and
pramipexole was titrated to an optimal dose (0.375-4.5 mg/day) during an
ascending dose period of seven weeks. There was a significant difference
in favor of pramipexole in the improvement of Tremor Score by three
weeks of dose titration (pramipexole 1.5 mg/day) which was also observed
through the end of the subsequent four-week maintenance period. Tremor
Score is a measurement of tremor severity derived from the three items
on the Unified Parkinson's Disease Rating Scale (UPDRS) that assess
tremor.
Tremor Score was the primary endpoint. Seventy-four (74%) percent of
pramipexole-treated patients achieved a meaningful improvement in tremor
(defined as a 30% improvement in Tremor Score) compared with only 25.6%
of placebo patients.
Efficacy of pramipexole was also shown in tremor self-rating scales, and
objective ambulatory 10-hour long-term EMG assessments. Other measures
of efficacy such as activities of daily living and motor examination,
confirmed pramipexole's overall efficacy as a treatment for PD.
``Improvement was observed as early as week two and three,'' said Dr.
Oertel.
Mirapex is the number one prescribed dopamine agonist in the U.S. today
and is indicated for idiopathic PD. The most frequently reported side
effects of patients in early PD who were treated with pramipexole were
nausea, dizziness, drowsiness and insomnia. The most frequent side
effects reported by patients in advanced stages of PD who were treated
with pramipexole and levodopa were postural hypotension, dyskinesias,
extrapyramidal syndrome, insomnia, dizziness and hallucinations. All PD
patients should be informed that postural hypotension may occur more
frequently during initial treatment and hallucinations can occur at any
time during the course of treatment.
References:
(a) Oertel W.H., Pogarell O., Gosser T. et al (1998). Pramipexole in the
treatment of tremo-dominant or mixed-type Parkinson's disease with
predominant rest tremor (Part 2). In programs and abstract of the 5th
International Movement Disorder Society Symposium, New York.
--
Judith Richards, London, Ontario, Canada
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