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Pramipexole Effective for Advanced Parkinson's Disease: Presented at MDS

By Bruce Sylvester
Special to DG News

MIAMI, FL -- November 14, 2002 -- Pramipexole treatment appears to be effective in advanced Parkinson's disease patients, researchers report.

It was well tolerated by subjects already receiving levodopa, and the researchers saw fewer adverse reactions than previously reported in phase III controlled clinical trials (Guttman, M. Neurology 1997,49(4):1060-5).

The research was presented this week at the Movement Disorder Society's (MDS) 7^th International Congress of Parkinson's Disease and Movement Disorders.

Investigators enrolled 243 subjects with advanced Parkinson's disease who were treated at 43 neurological outpatient sites. Investigators used the Modified Hoehn-Yahr (H-Y), Schwab-England (Sch-E), and global impression scale (GIS) to monitor changes in Parkinson's Disease symptoms.

Mean age of the subjects was 68 (ages 41-97). Mean disease duration prior to the study was 7.5 (2-27) years. Subject follow-up time was a mean of 11.2 weeks. Mean daily dose was 682 mg of levodopa at the beginning of the study and 495 mg daily by the end of follow- up.

Six patients were taken off levodopa completely during the study. On the H-Y scale patient improvement was 0.63 (p=0.0002). Improvement on the Sch-E scale was 13 (p=0.0004).

The researchers reported that, "The effect of pramipexole was very good or good for 69 percent of patients, in 23 percent of cases was satisfactory and in only 8 percent unsatisfactory."

Adverse reactions included gastrointestinal 14.3 percent, somnolence 5.8 percent, insomnia 5.8 percent, perimaleolar edema 4 percent, hallucinations 4 percent, dystonia 4 percent. Pramipexole treatment was withdrawn from only three subjects.

The investigators concluded, "Pramipexole is an effective and valuable medication as an add-on therapy to levodopa in advanced Parkinson's disease patients. Pramipexole was well tolerated. The overall frequency of adverse reactions reported by neurologists in outpatient departments was markedly lower than the ones reported in phase III controlled clinical trials. The low incidence of dyskinesias can be explained by the generally low dosing of levodopa at the beginning of the pramipexole add-on."

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