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【medical-news】罗替戈汀透皮贴片对早期帕金森病
Caroline Cassels
January 10, 2007 — Transdermal rotigotine, a dopamine agonist, is effective in controlling symptoms of early-stage Parkinson's disease (PD), a new study suggests.
The multicenter, randomized, double-blind study showed the safety and efficacy of once-daily rotigotine in a continuous dosing transdermal-patch formulation, which significantly improved Unified Parkinson Disease Rating Scale (UPDRS) scores — particularly in motor scores — compared with placebo.
"Parkinson's disease is a progressive disorder, and rotigotine seems to offset the variability we often see in the multiple-dose regimens of other drugs used to treat PD," said the study's principal investigator, Ray L. Watts, MD, from the University of Alabama at Birmingham, in a statement released by the university.
The study was published in Neurology online January 3.
Large, Multicenter Trial
The study recruited 302 patients with early-stage PD at 50 clinical sites in the United States and Canada between November 2001 through April 2003.
Study end points included a change from baseline to the end of the trial in Activities of Daily Living and the Motor Examination sections of the UPDRS scores. Efficacy was also measured using a responder score. A "responder" was defined as a person who experienced a 20% reduction in the sum of the UPDRS scores.
The study included patients aged 30 and older who had a diagnosis of idiopathic PD of less than or equal to 5 years in duration, a baseline UPDRS Motor Function examination score of at least 10, a Hoehn and Yahr stage score less than or equal to 3, and 2 or more cardinal signs of PD, including bradykinesia, resting tremor, rigidity, or postural instability.
Following completion of baseline requirements and training on how to use the patch, patients were randomized in a 2:1 ratio to receive either rotigotine or placebo.
Greater Improvement
Every week for 3 weeks after randomization, doses were titrated to an optimal or maximum dose of 2 mg/24 hours, 4 mg/24 hours, or 6 mg/24 hours. The optimal dose for each subject was defined as the dose that resulted in maximal reduction in parkinsonian symptoms, without intolerable side effects. In cases where side effects were too severe, patients were allowed to revert to the previous week's patch dose.
After achieving an optimal dose, patients began a 24-week maintenance phase and were evaluated every 4 weeks. At the end of the trial period, subjects gradually withdrew from the medication. They then returned for a follow-up visit 28 days after treatment ended.
Of the 277 patients who were randomized, 96 received placebo and 181 receive rotigotine. A total of 115 patients received the 6-mg/24-hour dose, 11 received 4-mg/24-hour dose, and 6 received 2-mg/24-hour dose during the maintenance period.
At the time of completion of the titration period, patients in the rotigotine group experienced greater UPDRS score improvements compared with those in the placebo group. These improvements were largely sustained throughout the maintenance period. In contrast, improvements in the placebo group diminished over time and ultimately dropped below baseline levels.
Sustained Effect
Six-month evaluations revealed that patients in the rotigotine group sustained their improved UPDRS scores, whereas those receiving placebo dropped below baseline levels. Patients in the placebo group had a mean increase in UPDRS subtotals of 1.31 vs a decrease in score of 3.98 in the rotigotine group. This equated to a mean difference of 5.28 points in favor of rotigotine.
Based on these results, rotigotine may offer a viable alternative to oral agents commonly used to treat PD, which, although they are effective, have the disadvantage of having to be taken orally 3 times per day. This, coupled with their half lives of 6 to 8 hours, can result in serum level fluctuations.
"The administration of rotigotine in a once-daily transdermal patch formulation provides continuous drug delivery, creates steady-state dose-linear plasma levels of the drug over 24 hours, and thus may overcome these perceived drawbacks of oral dopamine agonist formulations," the authors write.
Neurology. 2007;68:272-276.
http://www.medscape.com/viewarticle/550631 本人认领,若48小时未能提交,请其他战友认领. Rotigotine Patch Effective in Early-Onset Parkinson's Disease
罗替戈汀透皮贴片对早期帕金森病有效
Caroline Cassels
January 10, 2007 — Transdermal rotigotine, a dopamine agonist, is effective in controlling symptoms of early-stage Parkinson's disease (PD), a new study suggests.
2007.1.10—一项新研究显示，经皮给药的多巴胺激动剂罗替戈汀，在控制早期帕金森病症状时有效。
The multicenter, randomized, double-blind study showed the safety and efficacy of once-daily rotigotine in a continuous dosing transdermal-patch formulation, which significantly improved Unified Parkinson Disease Rating Scale (UPDRS) scores — particularly in motor scores — compared with placebo.
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作者:admin@医学,生命科学 2011-04-06 14:05
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