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Early Treatment with Rasagiline Better than 6-Month Delay in Parkinson's Disease, Results in Less Functional Decline
Archives of Neurology
04/20/2004
By Elda Hauschildt
Patients with early Parkinson's disease who are treated with rasagiline show less functional decline at 12 months than do those patients whose treatment is delayed for 6 months, say researchers.
Andrew Siderowf, MD, of the Parkinson's Disease and Movement Disorders Center, University of Philadelphia, Pennsylvania, United States, and colleagues undertook a double-blind, parallel-group, delayed start clinical trial in order to compare the effects of immediate versus delayed treatment with rasagiline in patients with early Parkinson's disease.
A total of 404 patients were enrolled at 32 sites in the United States and Canada between November 1997 and June 1999. Participants were older than 35 years and had been confirmed with idiopathic Parkinson's disease.
The patients were randomised to receive rasagiline, 1 mg/day for 1 year, 2 mg/day for 1 year, or matching placebo for 6 months, followed by rasagiline, 2 mg daily, for 6 more months.
The researchers found that the patients who were treated with 2 mg/day of rasagiline had a 2.29-unit smaller increase in mean, adjusted total UPDRS score compared with those who received placebo for 6 months before rasagiline (P = .05).
Examinations took place at baseline and at 4, 8, 14, 20, 26, 32, 42 and 52 weeks after randomisation. The assessments included mental, activities of daily living and motor subscales of the Unified Parkinson's Disease Rating Scale (UPDRS) as well as other scales for activities of daily living.
The 1-year efficacy analysis included the 371 patients who took part in the active treatment phase. There were no significant differences in baseline characteristics of these participants.
Of the patients receiving 2 mg of rasagiline for the full 12 months, 63.8% were considered responders as were 52.5% of those who received 1 mg. Of the delayed treatment group, 52.3% were responders. The difference between the delayed group and the 1 mg group was not considered significant (P = .93).
Rasagiline mesylate, an irreversible monoamine oxidase type B inhibitor, has been shown to improve symptoms of early Parkinson's, Dr. Siderowf notes. An earlier 6-month placebo-controlled phase of the study had demonstrated better symptom control among patients taking rasagiline over those taking placebo. In this study, a randomised, delayed-start design was used to separate an immediate, symptomatic effect from an effect on disease progression.
"Because all subjects were receiving rasagiline in the second phase, the symptomatic effects of the drug were presumably balanced at the last examination," the researchers explain. Differences observed in performance, therefore, could not be explained by the symptomatic effects of the drug.
Archives of Neurology 2004;61:561-566.
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