Alfons Schnitzler1, Karl-Werner Leffers, Hermann-Josef Häck. 1. Institute of Clinical Neuroscience and Medical Psychology, Heinrich Heine University, Universitätsstr. 1, Düsseldorf, Germany. schnitza@uni-duesseldorf.de
Abstract
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. Crown
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. Crown
Authors: Florent F Richy; Guilhem Pietri; Kimberly A Moran; Emmanuelle Senior; Lydia E Makaroff Journal: Appl Health Econ Health Policy Date: 2013-08 Impact factor: 2.561
Authors: Michelle H S Tosin; Glenn T Stebbins; Christopher G Goetz; Rosimere F Santana; Marco A A Leite; Beatriz Guitton R B Oliveira Journal: Mov Disord Clin Pract Date: 2020-07-08