To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Mirapex May Help Reduce Tremor In Parkinson's Patients URL: http://www.pslgroup.com/dg/872EA.htm Doctor's Guide June 18, 1998
BRIDGEWATER, NJ -- June 18, 1998 -- Preliminary data from two clinical studies by Pharmacia & Upjohn and Boehringer Ingelheim Pharmaceuticals, Inc. suggest that Mirapex Tablets (pramipexole dihydrochloride tablets) may reduce tremor in Parkinson's disease patients. The studies were presented at the eighth meeting of the European Neurological Society in Nice, France last week. Parkinson's disease involves progressive loss of brain nerve cells producing dopamine, a neurochemical that transmits nerve signals necessary for normal muscle movements. Symptoms include tremors, rigid muscles, difficulty in initiating movement, a stooped posture, a shuffling gait and slow movement. Tremor is considered one of the most noticeable signs of this disease. Tremor in Parkinson's patients is often called rest tremor as it occurs at rest and usually abates when the affected limb is in motion. The presence of tremor significantly affects Parkinson's patients' quality of life as it can inhibit basic activities of daily living, such as eating, sleeping and getting dressed. In a double-blind, placebo-controlled trial involving 354 patients with advanced Parkinson's disease, 174 patients treated for 24 months with Mirapex following a seven-week dose escalation period showed 46.8 percent improvement from baseline in tremor at rest as measured by individual items on Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) compared with a reduction of 32.5 percent for 180 patients treated with placebo. The study was presented by Wolfgang Oertel, M.D., professor of neurology at Philipps University, Marburg, Germany at the ENS meeting. All 354 patients were receiving concomitant levodopa. In another double-blind, placebo-controlled study by Oertel in 47 patients with advanced Parkinson's disease, a subset of 16 tremor-dominant patients was analysed. Based on UPDRS Part II/III, there was a reduction of tremor by 60 percent from baseline in 11 patients treated for 12 weeks with Mirapex, while five patients in the placebo group showed no improvement from baseline. All 16 patients were receiving concomitant levodopa. "Preliminary results from these studies warrant further investigation of the long-term impact of Mirapex on the symptomatic reduction of tremor at rest in Parkinson's patients and a comparison with levodopa or other dopamine agonists, as no controlled study has compared their effects on rest tremor," Oertel said. Levodopa, a medication the body converts into dopamine, is commonly used to treat Parkinson's patients. However, levodopa's effectiveness usually diminishes over time and many patients experience recurring symptoms and drug side effects, including spontaneous uncontrolled body movements and sudden temporary loss of mobility. Mirapex was approved by the U.S. Food and Drug Administration in July 1997 for the treatment of the signs and symptoms of idiopathic Parkinson's disease in early-stage patients without levodopa and in advanced-stage patients with levodopa. The most common side effects of Mirapex reported in clinical trials for early-stage Parkinson's disease were nausea, dizziness, drowsiness and insomnia. The most common side effects of Mirapex taken with levodopa observed in clinical trials for advanced-stage Parkinson's disease were postural hypotension (low blood pressure caused by a change in posture), dyskinesias (impaired movement), extrapyramidal syndrome (involuntary movements), insomnia, dizziness and hallucinations. All 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. More information on: Mirapex --------------------------------------------------------------------------------------------- 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.