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Multidisciplinary Expert Panel highlights Boehringer Ingelheim’s continuing commitment to research in Parkinson’s disease

Pressmeddelande   •   Feb 08, 2007 17:13 CET

First findings from Pan-European study confirm need for improved management of non-motor symptoms in Parkinson`s disease

08 February 2007
For medical media, outside the US only
Ingelheim am Rhein/Germany, 8 February 2007 - Boehringer Ingelheim announced today first results of a pan-European study1 investigating the importance and relevance of depressive symptoms in Parkinson`s disease (PD). These first study findings clearly show that depressive symptoms of PD are highly prevalent. Depressive symptoms were observed in 27 percent of the 1023 PD patients studied, of which as many as 64 percent received therapy for their depressive symptoms. Nevertheless, the study further concludes that despite being treated with a variety of antidepressants, 39 percent of the patient group continue to experience sustained depressive symptoms.

‘Pramipexole in Parkinson’s disease: bringing a decade of patient experience to the focus of future research’ was the topic of focus at today’s event sponsored by Boehringer Ingelheim, where early results of the study were announced. To mark a decade of extensive research with pramipexole in Parkinson’s disease, the session was opened by Dr Alessandro Banchi, Chairman of the Board of Directors of Boehringer Ingelheim, who emphasised the company’s commitment to research and development in the field of neurology and its role in Parkinson’s disease research.

An international expert panel presented data on novel aspects of PD research, highlighting three important areas including neurodegenerative pathways, the clinical benefits of early initiation of dopaminergic therapy and new aspects of the management of highly prevalent mood symptoms in PD patients.

Commenting on the latest understanding of the neurodegenerative pathway and the role of dopamine in Parkinson’s disease, Professor Anthony Schapira, M.D., Royal Free & University College Medical School, London, United Kingdom said: “Since the discovery in the 1960s of the dopamine deficiency in the PD striatum, symptomatic treatment focused on addressing this problem with the use of the dopamine precursor levodopa. Meanwhile, dopamine agonists - which act directly on the dopamine receptors in the brain - are the most extensively studied class of drugs in PD and are widely used in the treatment of PD symptoms. Preliminary studies have suggested that these drugs may slow progression, but this needs to be confirmed by additional trials which are ongoing.2

A recently emerging area of PD research relates to the non-motor symptoms of the disease. Non-motor symptoms, such as the depressive symptoms of PD, are often a first indicator of Parkinson’s disease, occurring in many cases already in the early stages of the disease. PD is frequently complicated by psychiatric syndromes and cognitive impairment, affecting up to 90 percent of patients with idiopathic PD. These complications include depressive symptoms such as mood disorders, adjustment disorders, anxiety syndromes, psychosis or delirium and have been shown to precede development of motor symptoms, suggesting these symptoms are a neurological sign of PD.3

Recent research with pramipexole, a non-ergot dopamine agonist, has demonstrated advantages in clinical studies in managing the depressive symptoms of PD. "In addition to successfully managing the motor symptoms of PD, and significantly improving tremor in patients with treatment-resistant tremor, pramipexole has been shown to also improve motivation and reduce depressive symptoms associated with the disease,” said Professor Matthias Lemke, M.D., Professor of Psychiatry and Medical Director at the Rheinische Kliniken, Bonn, Germany who presented the latest data on PD related depressive symptoms.4,5,6,7,8

Professor Werner Poewe, M.D., Universitätsklinik für Neurologie, Innsbruck, Austria outlined how new approaches to early PD treatment can help improve these symptoms as well as delaying motor complications: “This research supports the opinion among experts that dopaminergic treatment in the early stages of the disease can bring additional benefit to patients who have developed Parkinson`s disease through control of motor and potentially non-motor symptoms.9 The long-term hope is that current research will bring us closer to a better understanding of Parkinson`s disease and the potential for a neuroprotective effect in this class of drugs.”

Notes to Editor

About Parkinson’s Disease
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.10,11 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. The symptoms can vary from patient to patient, but worsen over time.

About pramipexole
Pramipexole (known in Europe under the trade names Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first licensed in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa.

Pramipexole was licensed in April 2006 throughout the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) and is also approved in Australia, Brazil, Canada, Mexico, U.S.A. and others.

The most commonly reported adverse reactions in early and late Parkinson’s disease in clinical trials were dizziness, involuntary movement, postural hypotension, constipation, hallucinations, headache, difficulty falling asleep, sleepiness, nausea and fatigue.

The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, and tiredness.

Pramipexole may cause patients 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. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.


Contact:
Boehringer Ingelheim GmbH
Ursula Bardon
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 26 22
E-mail

References:
1 Barone P, Groot AA de, Goetz CG, Koester J, Leentjens AFG, Poewe W, Rascol O, Reichmann H, Schapira AH, Tolosa E . Depressive symptoms in Parkinson`s disease: design and methods of a prospective observational study. Movement Disorders, Vol. 21, Suppl. 15, 2006: S476. Poster 548
2 Schapira AHP, Disease modification in Parkinson`s disease, Lancet Neurol 3 (6), 362-368 (2004)
3 Chaudhuri KR, Healy DG, Schapira AHV. Non-motor symptoms of Parkinson`s disease: diagnosis and management. Lancet Neurology 2006; 5:235-245
4 Weiner et al. Relat Dis 2001; 7(2): 115-120
5 Pogarell et al. J Neurol Neurosurg Psychiatry 2002; 72(6): 713-720
6 Lemke et al. J Neuropsychiatry Clin Neurosci 2005 Spring;17(2):214-20
7 Lemke MR, Brecht HM, Koester J, Reichmann H. Effects of the dopamine agonist pramipexole on depression, anhedonia and motor functioning in Parkinson`s disease. J Neurol Sci 248 (1/2) , 266-270 (2006)
8 Barone et al. J Neurol, J Neurol 253 , 601-607 (2006)
9 Goetz CG, Poewe W, Rascol O, Sampaio C. Evidence-based medical review update: pharmacological and surgical treatments of Parkinson`s disease: 2001 to 2004. Mov Disord 20 (5), 523-539 (2005)
10 Schapira AHV et al. Design of a randomized, placebo-controlled trial of immediate vs deferred pramipexole for early-onset Parkinson’s disease. Abstract no. P511, presented at MDS 2006; Kyoto, Japan.
11 de Rijk MC, Tzourio C, Breteler MM 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 1997;62:10–5.