Transdermal rotigotine : Double-blind, placebo-controlled trial in parkinson disease
Identifieur interne : 002626 ( Main/Exploration ); précédent : 002625; suivant : 002627Transdermal rotigotine : Double-blind, placebo-controlled trial in parkinson disease
Auteurs : Joseph Jankovic [États-Unis] ; Ray L. Watts [États-Unis] ; Wayne Martin [Canada] ; Babak Boroojerdi [États-Unis]Source :
- Archives of neurology : (Chicago) [ 0003-9942 ] ; 2007.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Activities of Daily Living, Administration, Cutaneous, Aged, Case-Control Studies, Dopamine Antagonists (administration & dosage), Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson Disease (epidemiology), Parkinson disease, Placebo, Rotigotine, Severity of Illness Index, Tetrahydronaphthalenes (administration & dosage), Thiophenes (administration & dosage).
- MESH :
- chemical , administration & dosage : Dopamine Antagonists, Tetrahydronaphthalenes, Thiophenes.
- drug therapy : Parkinson Disease.
- epidemiology : Parkinson Disease.
- Activities of Daily Living, Administration, Cutaneous, Aged, Case-Control Studies, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index.
Abstract
Objective: To assess the response to the rotigotine transdermal system (Neupro; Schwarz Pharma Ltd, Monheim, Germany), a nonergolinic dopamine agonist, in patients with early Parkinson disease. Design: Randomized, double-blind, multicenter, placebo-controlled study. Setting: Fifty sites in the United States and Canada. Patients: Two hundred seventy-seven patients with early Parkinson disease. Eligibility was assessed by means of routine clinical and neurological examinations. Patients were randomized 2:1 to receive either rotigotine therapy or placebo. Intervention: Treatment with the rotigotine transdermal system, 2,4, or 6 mg during 24 hours, for 24 weeks. Main Outcome Measure: Percentage of subjects achieving a 20% response or greater (reduction) as assessed with the Unified Parkinson Disease Rating Scale subtotal (parts II [activities of daily living] and III [motor function]) from baseline to the end of the maintenance phase. Results: Significant differences were observed between the rotigotine-treated and placebo groups for the 20% responder rate (48% for the rotigotine group and 19% for the placebo group; P<.001), least squares mean change in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (-941 for rotigotine vs -157 for placebo; P<.001), and percentage changes in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (-15.1% for rotigotine vs 7.3% for placebo; P<.001). Rotigotine treatment significantly increased the patients' Clinical Global Impression Scale scores (57% for rotigotine vs 30% for placebo; P<.001) and had a positive effect on their quality of life. The most common adverse events were application site reactions, nausea, and somnolence. Twenty-five (14%) of 181 patients in the rotigotine group withdrew from the study because of adverse effects. Conclusion: The rotigotine transdermal system consistently demonstrated statistically significant and clinically relevant efficacy over placebo in patients with early Parkinson disease and was well tolerated.
Affiliations:
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Le document en format XML
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<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
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<term>Middle Aged</term>
<term>Nervous system diseases</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson Disease (epidemiology)</term>
<term>Parkinson disease</term>
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<term>Thiophenes (administration & dosage)</term>
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<term>Tetrahydronaphthalenes</term>
<term>Thiophenes</term>
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<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
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<front><div type="abstract" xml:lang="en">Objective: To assess the response to the rotigotine transdermal system (Neupro; Schwarz Pharma Ltd, Monheim, Germany), a nonergolinic dopamine agonist, in patients with early Parkinson disease. Design: Randomized, double-blind, multicenter, placebo-controlled study. Setting: Fifty sites in the United States and Canada. Patients: Two hundred seventy-seven patients with early Parkinson disease. Eligibility was assessed by means of routine clinical and neurological examinations. Patients were randomized 2:1 to receive either rotigotine therapy or placebo. Intervention: Treatment with the rotigotine transdermal system, 2,4, or 6 mg during 24 hours, for 24 weeks. Main Outcome Measure: Percentage of subjects achieving a 20% response or greater (reduction) as assessed with the Unified Parkinson Disease Rating Scale subtotal (parts II [activities of daily living] and III [motor function]) from baseline to the end of the maintenance phase. Results: Significant differences were observed between the rotigotine-treated and placebo groups for the 20% responder rate (48% for the rotigotine group and 19% for the placebo group; P<.001), least squares mean change in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (-941 for rotigotine vs -157 for placebo; P<.001), and percentage changes in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (-15.1% for rotigotine vs 7.3% for placebo; P<.001). Rotigotine treatment significantly increased the patients' Clinical Global Impression Scale scores (57% for rotigotine vs 30% for placebo; P<.001) and had a positive effect on their quality of life. The most common adverse events were application site reactions, nausea, and somnolence. Twenty-five (14%) of 181 patients in the rotigotine group withdrew from the study because of adverse effects. Conclusion: The rotigotine transdermal system consistently demonstrated statistically significant and clinically relevant efficacy over placebo in patients with early Parkinson disease and was well tolerated.</div>
</front>
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