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Addition of Rasagiline to Levodopa/Carbidopa Reduces Parkinson's Symptoms : Presented at ANA

By Marvin Ross

TORONTO, ON -- October 8, 2004 -- The drug rasagiline at a dose of 1 mg daily is associated with significant reduction of symptoms when used as initial monotherapy in patients with early Parkinson's disease.

In patients with more advanced disease who experience motor fluctuations while on optimized doses of levodopa/carbidopa or other anti-Parkinson's disease agents, the addition of rasagiline also improves symptom control, according to the findings from two clinical trials presented here October 4^th at the American Neurological Association 129^th Annual Meeting.

Phyllis M. Salzman, PhD, Medical Affairs Department, Teva Neuroscience Inc., North Wales, Philadelphia, presented the two trials -- TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients (TEMPO) and Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "OFF" (PRESTO).

The TEMPO trial involved 404 patients with early Parkinson's disease who did not require dopaminergic therapy. They were randomized to receive rasagiline 1 mg or 2 mg or placebo per day. The PRESTO trial studied 472 patients who were on 3 or more levodopa/carbidopa doses per day, who were randomized to rasagiline 0.5 mg or 1 mg or placebo once daily.

The treatment benefits of rasagiline 1 mg were statistically significant in both trials. Total scores on the Unified Parkinson's Disease Rating Scale (UPDRS) remained essentially unchanged in patients treated with 1 mg of rasagiline but they worsened in the placebo group. In both studies, UPDRS motor scores were significantly better in the 1 mg rasagiline group than in the placebo group (P < .0001 and P = .0011 for TEMPO and PRESTO respectively). Rasagiline 1 mg also proved to be significantly better than placebo for reducing tremor. Rigidity was statistically improved in the PRESTO study (P = .0239) but remained unchanged in the TEMPO study.

Treatment discontinuation due to adverse events occurred in fewer than 4% of patients in TEMPO and in 9% or fewer in PRESTO, and was not significantly different between the rasagiline and placebo groups.


[Presentation title: "Rasagiline provides significant symptom benefit as initial monotherapy and as adjunct therapy in early and moderate to advanced Parkinson's disease." Abstract 8]

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