Role of pramipexole in key research areas of Parkinson’s disease management discussed at 12th EFNS Congress

PROUD is the first study to combine early versus delayed pramipexole treatment with a parallel imaging arm to investigate potential clinical benefits of early treatment of patients with Parkinson’s disease

For medical media, outside the US only

Madrid, Spain – Data presented during the 12th Congress of the European Federation of Neurological Sciences (EFNS), held in Madrid, Spain, from 23 to 26 August, highlight important new ongoing studies with pramipexole in a number of key research areas in Parkinson’s disease (PD): clinical benefits of early treatment initiation, management of PD-related depressive symptoms and a new formulation currently under investigation.

Professor Anthony Schapira, Chairman of the University Department of Clinical Neurosciences, Institute of Neurology, Queen Square, UCL, and Professor of Neurology at the National Hospital and Royal Free Hospital, London, UK and lead study investigator for PROUD*,1, presented a new approach to investigate the slowing of clinical progression in PD, a key focus of current research due to this important unmet need. Previous pramipexole studies have suggested a potential neuroprotective effect, such as the CALM-PD** study2,3 and in vitro studies. PROUD, however, is the first study to combine measurements of clinical outcomes in a PD patient with measurements of dopamine transporter density of certain brain areas (basal ganglia), through a SPECT imaging arm of the study.1

Commenting on the study so far, Professor Schapira said: “The debate on when and how to treat early Parkinson’s disease patients has been ongoing. Currently, treatment would typically be initiated when symptoms have caused disability. However, providing the medical evidence for a treatment to retard or prevent the progression of PD is a major therapeutic priority and the PROUD study aims to shed more light into this question. Pramipexole was considered an optimal candidate for this study due to evidence suggesting possible benefits to PD patients beyond treating the well-known core symptoms. Based on the unique technique used in this study, PROUD may provide a major breakthrough in our understanding of early PD treatment which would offer hope to the ever increasing number of patients diagnosed with Parkinson’s disease.”

Study results are expected to be available in 2009.

Pramipexole studies pursuing other new avenues of research to meet treatment needs
Further areas of current PD research with pramipexole are the management of PD-related depressive symptoms and ongoing studies to evaluate a new formulation so as to provide physicians and patients using pramipexole with an even broader treatment regimen to better meet differing patient needs and lifestyles.4,5,6

PD-related depressive symptoms
A new pramipexole study conducted in approximately 70 European centres aims to assess management of depressive symptoms in PD patients.7 Emerging data suggest that pramipexole may have a positive effect on depressive symptoms and motivation associated with PD, in addition to effectively controlling the motor symptoms of PD.8-16 The specific receptor profile of pramipexole may be responsible for the possible antidepressant properties of this compound and clinical research is ongoing to determine this aspect of pramipexole’s pharmacological profile in more detail.17,18,19

Professor Paolo Barone, Department of Neurological Sciences, University of Napoli-Federico II, Naples, Italy and lead investigator of both PRODEST4 and the new European study7 said: “Previously, the PRODEST study identified that PD-related depressive symptoms are common, with nearly half of those PD patients receiving anti-depressants continuing to experience depressive symptoms. These symptoms impact significantly on quality of life, both for PD patients and their carers. The new European study aims to provide answers on the role pramipexole may play in managing these commonly experienced PD-related depressive symptoms that are often under-recognised and consequently under-treated.”

Widening choice of pramipexole treatment options
Favourable results of pharmacokinetic phase I studies with a new once daily pramipexole extended release formulation were presented at EFNS and support the development of this new formulation.5,6 Pramipexole is the leading dopamine agonist treatment for PD and these ongoing studies aim to add to the existing treatment regimen with a once daily formulation to go one step further to meeting a broader range of patients’ needs.

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