New Data Released On Switching Parkinson’s Disease Patients With Pre-Existing Gastrointestinal Symptoms From Oral PD Medications To Neupro®
This week UCB announced data from a non-interventional, observational study conducted in Germany that found that when Parkinson’s disease (PD) patients were switched from an oral PD medication to Neupro® (Rotigotine Transdermal System), they reported improvements in pre-existing gastrointestinal symptoms (GI) symptoms. The data were presented at the American Academy of Neurology’s (AAN) 2013 Annual Scientific Meeting in San Diego, March 16-23, 2013.
“GI symptoms are common non-motor symptoms in PD patients, and can significantly affect their daily life,” said Dirk Woitalla, MD, lead study author, St. Josef-Hospital Universitätsklinik. “The findings presented at AAN show the potential improvement rotigotine may have on these symptoms for people living with PD. Controlled clinical studies are needed to confirm this finding.”
In the study conducted in a clinical practice setting in Germany, PD patients experiencing GI symptoms (e.g., heartburn, bloating, nausea, vomiting, abdominal pain or diarrhea) while receiving oral drug treatment were switched by their physician to rotigotine transdermal system.1
Primary efficacy outcomes included changes in GI symptoms (measured by a visual analogue scale [intensity; 0-100 mm]) and the sum score of GI complaints (six items each rated 0-12 for sum of 0-72), in addition to patient satisfaction in relation to GI symptoms approximately six weeks after treatment switch.1
Of the 76 patients enrolled in the study, 58 had follow up data available for final analysis. The intensity of GI complaints improved numerically on the visual analogue scale (47.5±24.4 mm at baseline; 19.7±23.3 mm after approximately six weeks), as well as the sum score of GI complaints (11.2±9.0 at baseline; 2.1±4.4 after approximately six weeks). Fifty of the 58 patients reported being satisfied or very satisfied with the improvement in GI symptoms after approximately 6 weeks of treatment with rotigotine transdermal system. The study suggests that a switch from oral PD medication to rotigotine transdermal system may improve pre-existing GI symptoms among patients with PD.1 Neupro® can cause nausea, vomiting, and gastrointestinal distress, which may occur more frequently during initial therapy.
Neupro® is approved in the U.S. to treat the signs and symptoms of idiopathic PD.2 In the European Union, Neupro® is approved for the treatment of the signs and symptoms of early-stage idiopathic PD, as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur.3
About Parkinson’s disease
Parkinson’s disease is a chronic neurological condition that develops with the loss of nerve cells in the brain that produce a chemical called dopamine.4 The symptoms of PD include both motor and non-motor symptoms and can have a broad impact on patients.5 As dopamine levels fall, movement (motor) symptoms-tremors (uncontrollable shaking), rigidity (stiffness or muscle tensing) and bradykinesia (slowness and loss of spontaneous movement)-can progress, along with other non-motor symptoms of PD.4
The full prescribing information for Neupro® can be accessed here.
1. Abstract 1321: Woitalla, D., Lauterbach, T., Berkels, R., et al. Non-Interventional Study of the Switch from Oral Treatment to Rotigotine Transdermal System in Patients with Parkinson’s Disease and Gastrointestinal Symptoms. Presented at the Annual Scientific Meeting of the American Academy of Neurology (AAN) 2013.
2. Neupro PI
3. European Summary of Product Characteristics [Accessed February 2013]