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Neupro Effective In Controlling Early Morning Motor Impairment And Generally Well-Tolerated For Long-Term Use In Patients With Parkinson's Disease

UCB, Inc. presented data from two clinical trials that showed Neupro® (Rotigotine Transdermal System), a once-daily non-ergolinic dopamine agonist patch, is effective in controlling early morning motor impairment, provides improvement in sleep quality, and is generally well-tolerated for long-term use in patients with Parkinson's disease. Studies examining patients who have either early or advanced-stage Parkinson's disease were also presented.

"Neupro offers continuous delivery of a dopamine agonist for 24 hours, leading to stable plasma levels," said Rajesh Pahwa, M.D., Professor of Neurology and Director of the Parkinson Disease and Movement Disorder Center at the University of Kansas Medical Center. "These data showed that Neupro has a positive effect on patients' early morning symptoms, improves quality of sleep, and is generally well-tolerated for long-term use in patients with Parkinson's disease." Dr. Pahwa is an investigator for the long-term, open-label study.

An open-label, single-arm, exploratory 18-week study investigated the efficacy of Neupro® on early morning motor impairment and sleep disorders. Fifty-four patients with mostly advanced-stage Parkinson's disease and unsatisfactory control of these symptoms received Neupro® in doses from 4 to 16 mg/24 hours during a 4-week maintenance period. Motor improvement upon waking and changes in sleep disturbances were assessed.

Forty-nine percent of patients treated per protocol with Neupro® showed considerable improvement in early morning motor function sufficient to meet response criteria (≥30% improvement of UPDRS III score). Nocturnal akinesia - inability to move at night - was reduced by 56%, and improvement was also noted in nocturnal dystonia - painful muscle contraction - and cramps. Neupro® improved sleep quality, reduced excessive daytime sleepiness, decreased night-time urinary symptoms (nocturias), and appeared generally well-tolerated. The most frequently reported adverse events in patients treated with Neupro® were application site reactions (20%), nausea (19%), and somnolence (11%).

Additionally, new, interim safety data from a four-year, open-label extension of a separate pivotal Phase III, double-blind clinical trial were presented. These data, in 216 patients with early-stage Parkinson's disease, showed Neupro® was generally well-tolerated at 33 months of treatment. Patients were tapered to their Neupro® starting dose and re-titrated over a 3-week period. Neupro® doses were limited to





Neupro eficientã în controlul Early Morning Motor Deprecierea ºi, în general, bine tolerat pe termen lung Utilizarea la pacienþii cu boala Parkinson - Neupro Effective In Controlling Early Morning Motor Impairment And Generally Well-Tolerated For Long-Term Use In Patients With Parkinson's Disease - articole medicale engleza - startsanatate