2009-04-30

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 CommonNon-Motor Symptom Affecting PD Patients' Quality of Life

- For Non-US Healthcare Media

To view the Multimedia News Release, go to:http://www.prnewswire.com/mnr/boehringeringelheim/37836/

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 thatMirapexin(R)/Sifrol(R) (pramipexole*) also improves depressivesymptoms, a common, disabling non-motor symptom of Parkinson'sdisease (PD), in addition to its established efficacy in treating themotor symptoms of PD.

The "PD-depression" study,(1) a large-scale, prospective,double-blind trial, was designed to compare the non-ergot dopamineagonist pramipexole versus placebo for the treatment of PD patientswith depressive symptoms and stable motor function. The resultsconfirm the findings from an earlier clinical study where pramipexolehad shown an antidepressive effect comparable to that of an SSRI whentreating PD-related depressive symptoms, (2) and support data fromother trials which suggested that pramipexole may have a positiveeffect on depressive symptoms and motivation associated withPD.(3-12)

"The wealth of data obtained from earlier trials with pramipexolelooking into the treatment of this often overlooked non-motorsymptom, along with its known efficacy in treating the motor symptomsof PD, made this drug the optimal choice for this new trial,"commented Professor Paolo Barone, Department of NeurologicalSciences, University of Napoli-Federico II, Naples, Italy and leadinvestigator of both the PRODEST and the "PD-depression" studies.

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

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

* See Notes to Editor for further trade names

Please be advised

This release is from Boehringer Ingelheim Corporate Headquartersin Germany. Please be aware that there may be national differencesbetween countries regarding specific medical information, includinglicensed uses. Please take account of this when referring to theinformation provided in this document. This press release is notintended for distribution within the U.S.A.

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 76centres in 13 countries in Europe and Africa with 296 patientstreated. The primary efficacy endpoint of the study was change indepressive symptoms as measured by change in Beck DepressionInventory version 1A (BDI). Results of the study showed a significantimprovement of depressive symptoms in the pramipexole group versusthe placebo group, as measured by a change from baseline in totalBDI.

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 chronicneurological disorder in older adults after Alzheimer's. Itsworldwide prevalence is estimated to be approximately one to twopercent of those over 65 years.(15,16,17,18) Although traditionallyPD is associated with motor symptoms (such as tremor, rigidity,slowed motion, imbalance, shuffling gait, loss of facialexpression), 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 Ingelheimresearch first approved in 1997 for the treatment of the signs andsymptoms of idiopathic Parkinson's disease, as monotherapy or incombination with levodopa. Pramipexole was approved in 2006 for thesymptomatic treatment of moderate to severe idiopathic Restless LegsSyndrome (RLS). Pramipexole is available in over 70 countries acrossthe globe.

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

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

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

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 138 affiliates in 47 countries and 41,300employees. Since it was founded in 1885, the family-owned company hasbeen committed to researching, developing, manufacturing andmarketing novel products of high therapeutic value for human andveterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billioneuro while spending one fifth of net sales in its largest businesssegment Prescription Medicines on research and development.

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

Related links:

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

References

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

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

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

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

5. Rektorova I et al. Pramipexole and pergolide in the treatmentof depression in Parkinson's disease: a national multicentreprospective 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 Neurol2004 Sep;251 Suppl 6:VI/24-7.

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

9. Rektorova I et al. Cognitive performance in people withParkinson's disease and mild or moderate depression: effects ofdopamine 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 fortreatment-resistant bipolar depression. Am J Psychiatry 2004 Mar;161(3): 564-6.

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

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

13. Barone P et al. Depression and antidepressant use inParkinson's disease: Results from the PRODEST-PD study. AbstractP1122 poster presented at 11th Congress of EFNS, Brussels, 26 Aug2007.

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'sdisease. N Engl J Med 2003;348:1356-64.

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

17. Parkinson Study Group, Holloway RG et al. Pramipexole vslevodopa as initial treatment for Parkinson disease. Arch Neurol2004; 61(7): 1044-1053.

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

ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de

Contact:Contact: Ursula Bardon, Corporate Division Communications, BoehringerIngelheim GmbH, 55216 Ingelheim/Germany, Phone: + 49-6132-77-2622, Fax: + 49-6132-72-2622, Email: press@boehringer-ingelheim.com

Boehringer Ingelheim

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

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