Outcome of New Mirapexin(R)/Sifrol(R) (Pramipexole) Study set to Change Treatment of Depressive Symptoms in Parkinson's Disease

Ingelheim, Germany (ots/PRNewswire) -

- New Study Shows That Mirapexin(R)/Sifrol(R) (Pramipexole)
Relieves Depressive Symptoms of Parkinson's Disease (PD), a Common
Non-Motor Symptom Affecting PD Patients' Quality of Life

- For Non-US Healthcare Media

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Results from an international, placebo-controlled trial,(1)
presented for the first time at the American Academy of Neurology
(AAN) Annual Meeting in Seattle, U.S.A. demonstrate that
Mirapexin(R)/Sifrol(R) (pramipexole*) also improves depressive
symptoms, a common, disabling non-motor symptom of Parkinson's
disease (PD), in addition to its established efficacy in treating the
motor symptoms of PD.

The "PD-depression" study,(1) a large-scale, prospective,
double-blind trial, was designed to compare the non-ergot dopamine
agonist pramipexole versus placebo for the treatment of PD patients
with depressive symptoms and stable motor function. The results
confirm the findings from an earlier clinical study where pramipexole
had shown an antidepressive effect comparable to that of an SSRI when
treating PD-related depressive symptoms, (2) and support data from
other trials which suggested that pramipexole may have a positive
effect on depressive symptoms and motivation associated with
PD.(3-12)

"The wealth of data obtained from earlier trials with pramipexole
looking into the treatment of this often overlooked non-motor
symptom, along with its known efficacy in treating the motor symptoms
of PD, made this drug the optimal choice for this new trial,"
commented Professor Paolo Barone, Department of Neurological
Sciences, University of Napoli-Federico II, Naples, Italy and lead
investigator of both the PRODEST and the "PD-depression" studies.

Previously, the PRODEST study(13,14) had shown that up to 40
percent of the studied PD patients continued to experience
depressive symptoms in spite of receiving an antidepressant
treatment.

"The interpretation of these findings reinforces many experts'
view that depressive symptoms in PD patients may require a different
treatment approach. Establishing an effective treatment for this
non-motor symptom of PD is important for patients, caregivers and for
physicians, as it could also mean a reduction in the number of
medications needed to effectively manage the spectrum of PD symptoms.
This in turn would reduce patients' risk of drug-drug interactions
and possible antidepressant drug side effects," added Professor
Barone.

* See Notes to Editor for further trade names

Please be advised

This release is from Boehringer Ingelheim Corporate Headquarters
in Germany. Please be aware that there may be national differences
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licensed uses. Please take account of this when referring to the
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Notes to Editor:

About the "PD-depression" study(1)

The "PD-depression" study is a large scale, prospective,
randomised, double-blind, placebo controlled trial conducted at 76
centres in 13 countries in Europe and Africa with 296 patients
treated. The primary efficacy endpoint of the study was change in
depressive symptoms as measured by change in Beck Depression
Inventory version 1A (BDI). Results of the study showed a significant
improvement of depressive symptoms in the pramipexole group versus
the placebo group, as measured by a change from baseline in total
BDI.

Results of the study show:

- BDI scores improved by an adjusted mean -5.9 in pramipexole
treated patients vs. -4.0 in the placebo group (P=0.01)
- The mean Geriatric Depression Scale (GDS) score had improved
by 2.5 in the pramipexole group vs. 1.7 in the placebo group (P=0.03)
- UPDRS motor scores improved by -4.4 with pramipexole vs.
-2.2 in the placebo (P=0.003)
- UPDRS activities of daily living (ADL) scores improved by
-2.4 with pramipexole vs. -1.2 in the placebo (P=0.003)

About Parkinson's disease (PD)

Parkinson's disease is the second most common chronic
neurological disorder in older adults after Alzheimer's. Its
worldwide prevalence is estimated to be approximately one to two
percent of those over 65 years.(15,16,17,18) Although traditionally
PD is associated with motor symptoms (such as tremor, rigidity,
slowed motion, imbalance, shuffling gait, loss of facial
expression), the non-motor symptoms, including depressive symptoms,
pain, cognitive impairment and sleep disorders can be significant.
Symptoms can vary from patient to patient, but worsen over time.

About Mirapexin(R)/Sifrol(R) (pramipexole)

Pramipexole (known under the trade names Mirapexin(R), Sifrol(R),
Mirapex(R) and Pexola(R)) is a compound from Boehringer Ingelheim
research first approved in 1997 for the treatment of the signs and
symptoms of idiopathic Parkinson's disease, as monotherapy or in
combination with levodopa. Pramipexole was approved in 2006 for the
symptomatic treatment of moderate to severe idiopathic Restless Legs
Syndrome (RLS). Pramipexole is available in over 70 countries across
the globe.

The most commonly (greater than or equal to 5 %) reported adverse
drug reactions in patients with Parkinson's disease treated with
pramipexole were nausea, dyskinesia, hypotension, dizziness,
somnolence, insomnia, constipation, hallucination, headache and
fatigue.

Pramipexole may cause patients, particularly with Parkinson's
disease, to fall asleep without any warning even while doing normal
daily activities such as driving. When taking pramipexole
hallucinations may occur and sometimes patients may feel dizzy,
sweaty or nauseated upon standing up.

Patients and caregivers should be aware of the fact that abnormal
behaviour (reflecting symptoms of impulse control disorders and
compulsive behaviours) such as binge eating, compulsive shopping,
hypersexuality and pathological gambling have been reported in
patients treated with dopaminergic drugs, including pramipexole. Dose
reduction/tapered discontinuation should be considered.

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pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 138 affiliates in 47 countries and 41,300
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euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.

For more information please visit
http://www.boehringer-ingelheim.com.

Related links:

Further information on Parkinson's disease and pramipexole can be
found at http://www.PDKnowledgeGuide.com.

References

1. Barone P et al. Pramipexole ameliorates depression in
Parkinson's disease: A randomized double-blind vs placebo trial.
Abstract S43.004, presented during scientific session 'Evaluation and
Treatment of Parkinson's Disease' on 30 April 2009 at AAN 61st Annual
Meeting, Seattle, USA.

2. Barone P et al. Pramipexole versus sertraline in the treatment
of depression in Parkinson's disease: a national multicenter
parallel-group randomized study. J Neurol. 2006;253(5):601-7.

3. Lemke MR. Depressive symptoms in Parkinson's disease. Eur J
Neurol 2008 Apr; 15 Suppl 1:21-5.

4. Möller JC et al. Long-term efficacy and safety of pramipexole
in advanced Parkinson's disease: results from a European multicenter
trial. Mov Disord 2005 May; 20(5): 602-10.

5. Rektorova I et al. Pramipexole and pergolide in the treatment
of depression in Parkinson's disease: a national multicentre
prospective randomized study. Eur J Neurol 2003; 10(4): 399-406.

6. Reichmann H et al. Pramipexole in routine clinical practice.
CNS Drugs 2003; 17(13): 965-973.

7. Lemke MR et al. Depression and Parkinson's disease. J Neurol
2004 Sep;251 Suppl 6:VI/24-7.

8. Lemke MR et al. Anhedonia, depression, and motor functioning
in Parkinson's disease during treatment with pramipexole. J
Neuropsychiatry Clin Neurosci 2005 Spring; 17(2): 214-20.

9. Rektorova I et al. Cognitive performance in people with
Parkinson's disease and mild or moderate depression: effects of
dopamine agonists in an add-on to L-dopa therapy. Eur J Neurol 2005;
12: 9-15.

10. Goldberg JF et al. Preliminary randomized, double-blind,
placebo-controlled trial of pramipexole added to mood stabilizers for
treatment-resistant bipolar depression. Am J Psychiatry 2004 Mar;
161(3): 564-6.

11. Künig G et al. Pramipexole, a nonergot dopamine agonist, is
effective against rest tremor in intermediate to advanced Parkinson's
disease. Clin Neuropharm 1999; 22: 301-305.

12. eentjens A et al. The effect of pramipexole on mood and
motivational symptoms in Parkinson's disease: a meta-analysis of
placebo-controlled studies. Clin Ther. 2009 Jan;31(1):89-98.

13. Barone P et al. Depression and antidepressant use in
Parkinson's disease: Results from the PRODEST-PD study. Abstract
P1122 poster presented at 11th Congress of EFNS, Brussels, 26 Aug
2007.

14. Barone P et al. Depressive symptoms in Parkinson's disease:
Design and methods of an observational study. Mov Disord. Vol. 21,
Suppl. 15, 2006: S476.

15. Nussbaum R et al. Alzheimer's disease and Parkinson's
disease. N Engl J Med 2003;348:1356-64.

16. de Rijk MC et al. Prevalence of Parkinsonism and Parkinson's
disease in Europe: the EUROPARKINSON Collaborative Study. European
Community Concerted Action on the Epidemiology of Parkinson's
disease. J Neurol Neurosurg Psychiatry.

17. Parkinson Study Group, Holloway RG et al. Pramipexole vs
levodopa as initial treatment for Parkinson disease. Arch Neurol
2004; 61(7): 1044-1053.

18. de Lau LM, Breteler MM. Epidemiology of Parkinson's disease.
Lancet Neurol 2006;5:525-35.

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