Parkinson's Disease Neuropsychiatric Features And Fatigue Respond To Transdermal Rotigotine

Editor's Choice Main Category: Parkinson's Disease Article Date: 28 Apr 2012 - 6:00 PDT

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In the EU, Neupro (rotigotine) is approved for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as a monotherapy, i.e. without levodopa, or in combination with levodopa over the course of the disease until the late stages, when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or on-off fluctuations). It is also approved in the EU for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.

Parkinson's disease (PD) is a progressive, chronic neurodegenerative disease that affects about 1 in every 500 people. In the UK, 127,000 people suffer from PD, which is mainly characterized by problems with 'motor symptoms', of which the most predominant one is body tremor.

Over 90% of people with Parkinson's disease suffer from NMS or non-motor symptoms like sleep disturbance, mood disorders, pain and gastro-intestinal problems, which are a major cause of disability, but because they are either embarrassed or unaware that the symptoms are associated with Parkinsons, they often fail to report them to healthcare professionals. Neurologists also overlook NMS in about 50% of consultations, which is particularly concerning as some, yet not all NMS symptoms of PD can be treated.

Researchers performed a post-hoc analysis of five placebo-controlled studies of rotigotine transdermal system in patients with early-PD (SP512, SP513), advanced-PD (PREFER, CLEOPATRA-PD), and PD with unsatisfactory control of early-morning motor symptoms (RECOVER), and discovered that in comparison with placebo, rotigotine transdermal system achieved improvements in apathy (p<0.04), anhedonia (p=0.026), anxiety (p=0.002), anxiety/depression (p<0.03), depression (p<0.02) and fatigue (p<0.003).

A post hoc analysis of the RECOVER study data also examined the impact rotigotine transdermal system had on pain in Parkinson's sufferers. Patients were asked to rate their pain level on a 0 to 10 Likert pain scale, with 0 meaning no pain and 10 classed as the worst pain ever experienced. The nocturnal akinesia, dystonia and cramps score (NADCS) was on a 0 to 4 scale with 0 meaning normal and 4 as maximum severity.

The change of pain as measured on the Likert pain scale improved amongst patients with a score of 1 at baseline in the rotigotine group as compared with the placebo group with a treatment difference of -0.88 (p=0.0128), whilst those with a baseline score of 4 had a treatment difference of -1.38 (p=0.0117), and those in the 1-3 sub-group had a treatment difference of -0.37 (p=0.3756).

Rotigotine transdermal system patients who scored 1 in the pain score had improved with a treatment difference of -0.54 in the NADCS scale compared with those in the placebo group, whilst the treatment differences for 1-3 and 4 subgroups were -0.47 (p=0.1416), and -0.62 (p=0.0825) respectively.

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Parkinson's Disease Neuropsychiatric Features And Fatigue Respond To Transdermal Rotigotine