To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AAN MEETING: Mirapex Effective In The Treatment Of Early Parkinson's URL: http://www.pslgroup.com/dg/F8972.htm Doctor's Guide April 21, 1999
TORONTO, ON -- April 21, 1999 -- Pharmacia & Upjohn's and Boehringer Ingelheim Pharmaceuticals Inc.'s Mirapex (pramipexole dihydrochloride tablets) is well-tolerated and proven effective as initial treatment of Parkinson's disease without levodopa, according to the three-year findings of two, ongoing open-label studies presented today at the American Academy of Neurology annual meeting. The data demonstrate that Mirapex is well tolerated and over that 50 percent of patients in the ongoing studies have been well maintained on Mirapex without the use of levodopa for up to three years. "I believe this is a significant advance in the way we treat Parkinson's disease," said Abraham Lieberman, M.D., medical director, National Parkinson Foundation. Levodopa is very effective initially, but over time most patients have to increase their dosage to maintain control of their symptoms. "These results are particularly compelling in light of the use of pramipexole in treating Parkinson's disease," said Susan Bressman, M.D., lead author and presenter of this data, Albert Einstein College of Medicine, New York, NY. 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. The open-label studies were initiated after the conclusion of two double-blind placebo-controlled studies. The open-label studies involved 282 patients in one study and 222 patients in a second study. Following a dose taper (lowering of dosage to zero) at the end of the double-blind studies, the dose of Mirapex was titrated to a maximum tolerable dose or up to a maximum of 4.5 mg per day. Study design did not allow increases in doses of Mirapex after titration. The mean dose in both studies was 4.0 mg per day. Patients return for regularly scheduled visits to be evaluated for safety and efficacy data based on the United Parkinson's Disease Rating Scale (UPDRS). Interim results show that 155 patients in the first study and 133 in the second were treated with Mirapex without levodopa. In the ongoing studies, 101 patients in the first study and 40 patients in second study have completed three years of treatment. The U.S. Food and Drug Administration approved Mirapex for the treatment of Parkinson's Disease in 1997. 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 Link: 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.