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Dear Friends, Dr. Lieberman has just posted some articles that may of interest to Parkinsn members. I will send them in successive posts. Best, Kathrynne ***********A message from Ask the Doctor************** The NPF website is updated several times each week. Go to http://www.parkinson.org/whatsnew.htm to read recent articles regarding Parkinson disease. ****************************************************** This study will be presented at the American Academy of Neurology, April 2002, in Denver Colorado The abstract was modified by Dr. Abe Lieberman to make it more readable for lay people Pramipexole (Mirapex) Versus Levodopa as Initial Treatment for PD: A 4-year Randomized Controlled Trial Parkinson Study Group, Robert G. Holloway OBJECTIVE: To compare the 4-year outcomes of dopamine motor complications after initial treatment of early PD with pramipexole (Mirapex) vs levodopa. BACKGROUND: Our original trial report showed that after 2 years from randomization (the original article appeared in JAMA 2000;284:1931-1938) ) 28% of patients assigned to pramipexole developed dopamine complications 51% of patients assigned to levodopa developed dopamine complications This is statistically significant (p statistical value of less than .001) The original report also showed that the mean improvement in total Unified Parkinson's Disease Rating Scale (UPDRS) score was greater in those assigned to levodopa compared with pramipexole 9.2 unit improvement for levodopa 4.5 unit improvement for pramipexole This is statistically significant (p statistical value of less than .001). The current report extends the period of blinded, controlled observation to 4 years. DESIGN/METHODS: 301 early PD patients who had developed disability requiring dopamine therapy consented to be randomized in a double-blind fashion to (1) pramipexole (2) levodopa. Subjects were followed for 48 months at 22 movement disorder sites in the United States and Canada. During the initial 10 weeks after randomization, subjects were permitted in a blinded fashion to adjust therapy to treat residual disability to one of 3 dosage levels (1) 1.5-mg, (2) 3.0-mg, (3) 4.5-mg of pramipexole (1) 75/300-mg (2) 112.5/450-mg, (3) 50/600-mg carbidopa/levodopa. >From week 11 to month 48, investigators were permitted to add open-label levodopa to treat continuing or emerging disability. After month 24, subjects were also allowed to alter the dosage level of the originial study medication. The primary outcome variable was the time to the first occurrence of any of three dopaminergic motor complications: (1) dyskinesias (2) wearing off (3) on-off fluctuations. The UPDRS was assessed at baseline and follow-up evaluations. RESULTS: After 4 years, 52% of subjects assigned to initial pramipexole treatment reached the primary endpoint compared with 74% in the levodopa group. The percentage of subjects experiencing specific dopamine the following complications dyskinesias: 25% of pramipexole patients versus 54% of levodopa patients wearing off: 47% of pramipexole patients versus 63% of levodopa patients on-off fluctuations: 7% of pramipexole patients versus 8% of levodopa patients The mean improvement in total UPDRS scores from baseline to 48 months was greater in the levodopa group than in the pramipexole group 3.6 units for levodopa versus 0.98 units for pramipexole. This is statistically significant CONCLUSIONS: In patients with early PD, initial treatment with pramipexole compared with levodopa, reduced the 4-year risk of developing a dopamine motor complication by about 30% including a greater than 50% reduction in dyskinesias. Despite the opportunity for supplementation with open-label levodopa in both treatment groups, subjects assigned initially to levodopa showed greater improvement in total UPDRS than subjects assigned initially to pramipexole. Supported By: Pharmacia Corporation and Boehringer Ingelheim -- Kathrynne Holden, MS, RD "Ask the Parkinson Dietitian" http://www.parkinson.org/ Author: "Eat well, stay well with Parkinson's disease" "Guidelines for Medical Nutrition Therapy for Parkinson's disease" http://www.nutritionucanlivewith.com/ ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn