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Selegiline as initial treatment in de novo parkinsonian patients

Department of Neurology, Oulu University Central Hospital, Oulu; and Orion Corporation Farmos, Turku, Finland.

To investigate the efficacy and safety of selegiline in the early phase of Parkinson's disease (PD), we carried out a placebo-controlled, double-blind, parallel trial. De novo PD patients were randomized to receive either selegiline (10 mg/d) or matching placebo. We continued selegiline or placebo until levodopa therapy became necessary and assessed the disability using three different rating scales at baseline, after 3 weeks, at 2, 4, 8, and 12 months, and at every 4 months thereafter. Fifty-two patients were eligible for the analysis, 27 in the selegiline group and 25 in the placebo group. The median duration of time before levodopa had to be initiated was 545 ± 90 days with selegiline and 372 ± 28 days with placebo (p = 0.03). Disability was significantly less in the selegiline group than in the placebo group up to 12 months. The period of time during which the mean total Columbia University Rating Scale score stayed below the baseline was used to express the initial symptomatic effect of the treatments. The difference in this initial improvement time between the two groups was about 3 months and did not alone explain the difference in the delay of the need to start levodopa therapy. Selegiline was well tolerated and there were no severe side effects. We conclude that selegiline delays the need to start levodopa in de novo PD patients, has symptomatic efficacy, and possibly retards the progression of the disease.

Address correspondence and reprint requests to Dr. Vilho Myllylä, Department of Neurology, Oulu University Central Hospital, SF-90220 Oulu, Finland.

Published in part at the European Conference on Parkinson's Disease and Extrapyramidal Disorders, Rome, July 10–14, 1990.

Received December 13, 1990. Accepted for publication in final form July 11, 1991.

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