Safety and Tolerability of Transdermal Rotigotine in a Clinical Practice Cohort for 2 Years

Abstract

Background: Parkinson's disease (PD) is a progressive neurodegenerative disease that occurs as a result of loss of dopaminergic neurons from the substantia nigra. Rotigotine is a non-ergolinic dopamine agonist available as a silicone-based transdermal patch for the treatment of PD. In the European Union, rotigotine transdermal patch is indicated for use as monotherapy in early idiopathic PD, or in combination with levodopa through the disease course to the late stages where motor complications with levodopa become an issue. Objective: To investigate the safety and tolerability of transdermal rotigotine, in patients with PD being treated during routine clinical practice for 2 years. Results: 114 patients were enrolled, and evaluated for adverse events over a 24-month period. Adverse events occurred in 39 patients (34.21%). 23 patients (20.17%) reported application site reactions (dermatitis, erythema, itching), and 16 (14.03%) had systemic adverse events. Sleep disorders were the most common problem; the others were hallucinations, depression, dizziness, and syncope. No patient experienced dyskinesia. Adverse events necessitated the discontinuation of rotigotine for application site reactions in fourteen patients (12.28%) and 11 patients (9.64%); reasons for discontinuation were systemic adverse events. Conclusion: Rotigotine is safe and well tolerated when used to treat PD in routine clinical practice.