Prodest Study Shows Many Parkinson’s Disease Patients Continue to Experience PD-Related Depressive Symptoms Despite Receiving Anti-Depressant Treatment

BRUSSELS, Belgium, 28 August 2007
http://www.drugs.com/clinical_trials...sive-1804.html

Preliminary results of the pan-European PRODEST study in 1016 patients with Parkinson`s disease (PD) were presented at the 11th Congress of the European Federation of Neurological Societies (EFNS) in Brussels this week, revealing unique features of PD-related depression and its treatment.1 The study confirmed that depressive symptoms associated with PD are not only highly prevalent, but nearly half (44.1%) of patients receiving antidepressant treatment (n=211) continued to experience depressive symptoms.1

“These symptoms have a significant impact on PD patients’ quality of life, often equal in impact to that of the traditionally better known motor symptoms of Parkinson’s disease. The results suggest that many depressive symptoms are expression of Parkinson`s disease, rather than of a depressive syndrome. This consideration, if supported by further analysis of the PRODEST study results, might suggest different treatment approaches of depression in PD," commented Professor Paolo Barone, Department of Neurological Sciences, University of Napoli-Federico II, Naples, Italy, and lead investigator of PRODEST.

In those 282 patients with a reported medical history of depression, the study results also showed that over half (54.3 percent) of these patients had a marked score in DSM IV item 1 or 2*), with 66 percent (n=186) receiving anti-depressant treatment, confirming a persistence of depressive symptoms despite treatment.

Data from recent studies with pramipexole, a non-ergot dopamine agonist, have shown a beneficial effect on the depressive and motivational symptoms in Parkinson’s disease. Ongoing trials are aimed to confirm these previous findings and continue to investigate this aspect of pramipexole’s clinical profile in more detail.3,4

Commenting on the role of pramipexole, Professor Matthias Lemke, M.D., Professor of Psychiatry and Medical Director at the Rheinische Kliniken, Bonn, Germany, said: “PD-related depressive symptoms can overlap or even be mistaken for motor symptoms. It is therefore important that physicians learn to differentiate these in order to find the optimal treatment for their PD patients. While pramipexole has proven an effective treatment for the motor symptoms of PD, there is now evidence that pramipexole may also improve PD-related depressive symptoms.”

PD-related depressive symptoms have also been studied in an ongoing two year Italian study, known as PRIAMO. Initial findings of the 55 centre study support the evidence that non-motor symptoms (NMS) are highly prevalent with the majority of patients experiencing one or more NMS. Psychiatric symptoms (anxiety and depression) were rated most frequently and with a high impact on patients’ quality of life.5

“The conclusions from PRIAMO further support the PRODEST study in highlighting the need to address the often undiagnosed and under-treated aspects of Parkinson’s disease which impart a significant burden on PD patients, relative to their disease severity,” said Professor Barone, member of the Steering Committee of the PRIAMO Study Group.

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Notes to Editor:
*) The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) is the fourth edition of a comprehensive classification of diagnostic criteria of mental disorders published by the American Psychiatric Association. Items 1 and 2 refer to specific diagnostic criteria for depression as defined in Diagnostic and Statistical Manual of Mental Disorders (APA, 1995).

About Parkinson’s disease (PD)
PD 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.6,7 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 PRODEST-PD study1,8
The PROfile of DEpressive SympToms in Parkinson’s Disease study known as PRODEST is a multi-national, multicentre, prospective observational study in which 24 centres in eight European countries participated with 1016 patients with idiopathic PD and a score on the Mini Mental State Examination (MMSE) of > 24. The study population was evenly divided (51.7%:48.3%) early vs. advanced PD; no significant differences in results were observed between the two groups.

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 approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa. Since 2006, pramipexole is also widely registered for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS).

The most commonly reported adverse reactions in early and late Parkinson’s disease in clinical trials were dizziness, nausea, dyskinesia, hypotension, somnolence, insomnia, hallucinations, constipation, headache, and fatigue.

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 137 affiliates in 47 countries and 38,400 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 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.


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References:
1 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.
2 Ravina B et al. The impact of depressive symptoms in early Parkinson disease. Neurology. 2007;69(4):342-7.
3 Houben J et al. Pramipexole improves depressive and motivational symptoms in Parkinson’s disease. Abstract no. P575, presented at MDS 2006; Kyoto, Japan.
4 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.
5 Colosimo C, PRIAMO Study Group. Prevalence of non-motor symptoms in idiopathic Parkinson’s disease. Abstract 539 Presented at MDS 2007. Movement Disorders. Vol 22, Suppl. 16, 2007: S166-7.
6 Zhang ZX, et al. Worldwide occurrence of Parkinson`s disease: An updated review. Neuroepidemiology. 1993;12:195–208.
7 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. 1997;62:10–5.
8 Barone P et al. Depressive symptoms in Parkinson’s Disease: Design and methods of an observational study. Movement Disorders. Vol. 21, Suppl. 15, 2006: S476.