Archives of neurology · 2007
Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Jankovic Joseph, Watts Ray L, Martin Wayne, Boroojerdi Babak
Аннотация
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.
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.