Rotigotine transdermal patch in combination therapy for Parkinson's disease--observations in routine clinical practice.

OBJECTIVE: The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson's disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice. METHODS: Data were collected by 688 German practice-based neurologists, initiating rotigotine treatment in patients with idiopathic Parkinson's disease. Assessments included rotigotine maintenance dose, changes in concomitant PD medication, changes in sleep quality, and rotigotine tolerability over an observation period of 12-16 weeks. RESULTS: The median rotigotine maintenance dose was 6 mg/24 h (n = 969, full analysis set). The proportion of all other prescribed PD medications declined over the observation period; combination therapy decreased by 18.7%. Daily levodopa intake was markedly reduced by 87 mg (18.9%) in 47.6% of the patients with levodopa documentation; 7% no longer required levodopa after 12-16 weeks. Mean overall sleep quality (PD Sleep Scale item 1) improved by 21.4 points, the occurrence of nocturias (PDSS item 8) by 13.4 points, and 'turning in bed' (Unified Parkinson's Disease Rating Scale part II) by 0.6 points. Drug-related adverse events were reported for 7.9% of all patients (n = 1152, safety population). Application site reactions were the most common adverse events (2.2%) resulting in early discontinuation in 1.4% of patients. CONCLUSIONS: In routine clinical practice, treatment initiation with rotigotine transdermal patch was associated with a reduction of other prescribed PD medications and with an improvement of self-reported sleep quality.

High compliance with rotigotine transdermal patch in the treatment of idiopathic Parkinson's disease.

PURPOSE: The non-ergot dopamine agonist rotigotine has been formulated in a once-daily transdermal patch for 24-h application which ensures continuous rotigotine release over 24 h. This open, prospective, non-interventional study investigated compliance with the patch under clinical practice conditions. METHODS: Data were collected by German practice-based neurologists, prescribing rotigotine to patients with idiopathic Parkinson's disease; the observation period was 4 months. Following titration, 943 patients (mean age 67.6 +/- 9.3 years; 59% male) were maintained on rotigotine for at least 4 weeks (per-protocol population). At the end of the observation period, this patient population was assessed for various aspects of compliance using a 4-item Morisky scale ranging from 1 = least compliance to 4 = maximal compliance. Safety was evaluated in all 1099 patients receiving rotigotine treatment. RESULTS: The mean satisfactory rotigotine dose of 5.4 +/- 1.6 mg/24 h was reached after 27 +/- 17 days; 84% of the patients did not require dose adjustments during maintenance. Complete compliance questionnaires were available for 863 patients (92%) who achieved a mean compliance sum score of 15.1 +/- 1.6 points out of the maximum 16 points. Mean scores of 3.6-3.9 points for the four scale items indicate that the patch was applied once-daily and at the appropriate time by the majority of the patients, independent of their clinical status. Skin reactions (3.7%) and known dopaminergic side-effects such as nausea (3.5%) were mostly mild or moderate in intensity. CONCLUSIONS: Rotigotine transdermal patch was associated with high compliance in patients with Parkinson's disease under clinical practice conditions.

Transdermal rotigotine for the perioperative management of Parkinson's disease.

Continuous delivery of antiparkinsonian medication during a perioperative period is desirable to avoid 'off'-symptom complications in surgical patients with concomitant Parkinson's disease (PD). Fourteen PD patients undergoing surgery under general anesthesia were switched from oral dopaminergic medication to transdermally delivered 24-h rotigotine (median dose 12 mg/24 h) for the perioperative period. Rotigotine treatment was considered feasible by patients, their anesthesiologists and neurologists with good control of PD symptoms and easy switching and re-switching of PD medication.

Rotigotine transdermal patch enables rapid titration to effective doses in advanced-stage idiopathic Parkinson disease: subanalysis of a parallel group, open-label, dose-escalation study.

OBJECTIVE: Rotigotine (Neupro) is formulated as a transdermal delivery system designed to provide a selective, non-ergot D3/D2/D1 agonist to the systemic blood flow over a 24-hour period. In clinical trials, patches were applied once daily and uptitrated to the individual effective dose in increments of 2 mg/24 h every week. The aim of this analysis was to determine the safety of a more rapid titration of rotigotine by assessing the tolerability of escalating transdermal doses of rotigotine given in 2 different titration schemes. METHODS: We analyzed the safety of rotigotine in 2 groups of patients with advanced stage Parkinson Disease. The starting dose of 4 mg/24 h was increased every week by 2 mg/24 h in the slow-titration group and 4 mg/24 h in the fast-titration group. The primary focus of this subanalysis was the separate tolerability of rotigotine in each randomized treatment arm, during the dose-escalation period. However, the 2 titration schemes were also compared with each other. RESULTS: The dose of first reported nausea and/or vomiting was 8 mg/24 h for the fast-titration group and 4 mg/ 24 h for the slow-titration group. There were no remarkable differences concerning the side-effect profile between the 2 different titration schemes. CONCLUSIONS: The fast-titration regimen had a similar adverse event profile to slower titration, and allowed rotigotine to be introduced quickly. This subanalysis suggests that rotigotine may be uptitrated more rapidly.