To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ICMD: Mirapex Shows Improvement In Tremor Among Patients With Parkinson's Disease URL: http://www.pslgroup.com/dg/B7512.htm Doctor's Guide October 19, 1998
NEW YORK, NY -- Oct. 19, 1998 -- A new study on rest tremor, a troubling symptom of Parkinson's disease (PD), indicates that patients taking Boehringer Ingelheim and Pharmacia & Upjohn's Mirapex(R) (pramipexole dyhydrochloride tablets) experience significant improvement in their symptoms compared to patients on placebo. "This is the first adequately powered, well-controlled study on tremor in PD," said professor Wolfgang Oertel, M.D., of the department of neurology at Philipps University, Marburg, Germany, who presented this study at the fifth International Congress on Movement Disorders meeting. The results revealed that pramipexole, a D[3]-preferring dopamine agonist, was significantly more effective than placebo in improving tremor in PD patients in whom tremor was a prominent feature of the disease. This effect was confirmed by patient, physician and electrophysiologic assessments. Parkinson's disease affects approximately one percent of people over age 60, or one million people in the United States, causing tremor, muscle rigidity, slowed motion, shuffling gait and a loss of facial expression. All of these effects worsen over time. "It is estimated that at least 70 percent of Parkinson's patients suffer from rest tremor and treatments often fail to provide effective control of tremor," Oertel said. "The results of this study with pramipexole are very impressive." Eight-four patients who suffered from tremor-dominant PD or mixed type PD with predominant rest tremor were enrolled in the placebo controlled, double-blind, multi-centre, randomised study. The use of other drugs with a potential influence on tremor were not allowed and pramipexole was titrated to an optimal dose (0.375-4.5 mg/day) during an ascending dose period of seven weeks. There was a significant difference in favour of pramipexole in the improvement of tremor score by three weeks of dose titration (pramipexole 1.5 mg/day) which was also observed through the end of the subsequent four-week maintenance period. Tremor score is a measurement of tremor severity derived from the three items on the Unified Parkinson's Disease Rating Scale (UPDRS) that assess tremor. Tremor score was the primary endpoint. Seventy-four percent of pramipexole-treated patients achieved a meaningful improvement in tremor (defined as a 30 percent improvement in tremor score) compared with only 25.6 percent of placebo patients. Efficacy of pramipexole was also shown in tremor self-rating scales and objective ambulatory 10-hour long-term EMG assessments. Other measures of efficacy such as activities of daily living and motor examination, confirmed pramipexole's overall efficacy as a treatment for PD. "Improvement was observed as early as week two and three," Oertel said. Mirapex is the number one prescribed dopamine agonist in the U.S. today and is indicated for idiopathic PD. The most frequently reported side effects of patients in early PD who were treated with pramipexole were nausea, dizziness, drowsiness and insomnia. The most frequent side effects reported by patients in advanced stages of PD who were treated with pramipexole and levodopa were postural hypotension, dyskinesias, extrapyramidal syndrome, insomnia, dizziness and hallucinations. All PD patients should be informed that postural hypotension may occur more frequently during initial treatment and hallucinations can occur at any time during the course of treatment. Related Links: Mirapex, Boehringer Ingelheim, Pharmacia & Upjohn --------------------------------------------------------------------------------------------- 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. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.