To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AAN MEETING: Requip May Provide Long-Term Efficacy In Early-Stage Parkinson's URL: http://www.pslgroup.com/dg/6FFDE.htm Doctor's Guide April 30, 1998
MINNEAPOLIS, MN -- April 30, 1998 -- According to two new studies presented today at the 50th annual meeting of the American Academy of Neurology in Minneapolis, SmithKline Beecham's Requip (ropinirole hydrochloride) alone may preserve dopaminergic function (dopamine activity) in the specific regions of the brain that regulate movement and provide long-term symptomatic control in patients with early Parkinson's disease. The results of a first-of-its-kind pilot study using 18Fluoro-dopa Positron Emission Tomography (PET) scans suggest that Requip may preserve dopaminergic function in patients who have had Parkinson's disease for less than two years. A large-scale, multicentre clinical trial is currently underway to further test these findings. If similar results are shown in this study, it may significantly impact future Parkinson's disease progression studies and could potentially have positive clinical implications for patients. In another study, Requip was shown to be more effective than bromocriptine, an older dopamine agonist, in the treatment of early Parkinson's disease for at least three years. "Although these findings are preliminary and the numbers are small, these promising new results suggest that by using Requip alone in the early stages of Parkinson's disease we may preserve dopaminergic function," said David Brooks, M.D., professor of neurology, MRC Cyclotron unit, Hammersmith Hospital in England. "This is particularly important since other commonly used therapies, such as levodopa, may be associated with unwanted side effects after long-term use. "If the results of this 18Fluoro-dopa PET scan study are replicated in the large clinical trial, we may be able to prolong patients ability to perform daily activities and maintain a normal, active life." In an ongoing five-year, double-blind, multicentre study, patients with early Parkinson's disease were randomised to receive either Requip or levodopa. Of those enrolled, 37 patients were scanned using 18Fluoro-dopa PET within the first year and then approximately two years later to measure the gradual decline in basal ganglia (a region of the brain that is critical in regulating movement) dopaminergic function. This decline results in the decrease in motor function which is characteristic of Parkinson's disease. PET scanning, a form of brain imaging, involves scanning both sides of the brain simultaneously. Images from both the better (less deteriorated) and worse (more deteriorated) sides of the brain were analysed -- however, these results focus on an average of both sides of the brain. The following endpoints were assessed: mean percent change in putamen (the larger component part of the corpus striatum, a section of the basal ganglia that receives messages from other parts of the brain) dopaminergic function in all patients; mean percent change in putamen dopaminergic function in Parkinson's disease patients with symptoms present for under two years; and mean percent change in putamen dopaminergic function in Parkinson's disease patients with symptoms present for more than two years. When considering all patients who entered the study, there appeared to be a slower loss of putamen dopaminergic function for patients treated with Requip compared with those patients treated with levodopa (13 percent versus 18 percent, respectively). In the subgroup of patients with Parkinson's disease for less than two years, this difference became more obvious, the decrease in putamen dopaminergic function was also less for patients treated with Requip (14 percent) versus levodopa-treated patients (28 percent). There was no statistically significant difference between treatment groups for patients with Parkinson's disease for more than two years. Overall, patients treated with Requip who have had Parkinson's disease for less than two years demonstrated the greatest preservation of putamen dopaminergic function. Although the patient sample size was small, this pilot study suggests that Requip may preserve dopaminergic function in early stage Parkinson's patients. In another three-year, international, multicentre, double-blind comparative clinical trial, Parkinson's patients were randomised to receive either Requip or bromocriptine. Thirty-three percent of patients received selegiline concomitantly with either Requip or bromocriptine. Of those enrolled, 214 patients completed the study (approximately 39 percent of patients treated with Requip and 33 percent of bromocriptine patients withdrew from the study). Efficacy was based on the following: mean Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) score at completion; improvement in the UPDRS total motor examination score; percentage of patients who were considered responders, defined as those with at least a 30 percent reduction from baseline in total motor examination score on the UPDRS; average combined ADL and motor score at endpoint; and the percentage of patients who required supplemental levodopa therapy. Among patients who completed the study, patients treated with Requip demonstrated a statistically-significant mean improvement in the UPDRS ADL score versus patients treated with bromocriptine. In this same patient population, patients treated with Requip also showed a greater mean improvement in UPDRS motor score than patients in the bromocriptine group (31 percent versus 22 percent, respectively). At the study's completion, 53 percent of patients treated with Requip were considered responders compared with 42 percent for the bromocriptine group. In addition, the average improvement in the combined ADL and motor scores was statistically significantly greater for patients treated with Requip versus bromocriptine-treated patients. Fewer patients treated with Requip than expected required supplemental levodopa (34 percent versus 42 percent for bromocriptine). There was a very low incidence of dyskinesias for both treatment groups (eight percent for Requip versus seven percent for bromocriptine). "We are pleased to see that Requip remains effective on a long-term basis in early stage Parkinson's disease," said Jan Petter Larsen, M.D., professor of neurology, Central Hospital of Rogaland in Norway. "This study clearly shows that using Requip in early disease can sustain motor function and limit levodopa use for at least three years." More information on: SmithKline Beecham. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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