Effects of Tocopherol and Deprenyl on the Progression of Disability in Early Parkinson's Disease
- 21 January 1993
- journal article
- clinical trial
- Published by Massachusetts Medical Society in The New England Journal of Medicine
- Vol. 328 (3), 176-183
- https://doi.org/10.1056/nejm199301213280305
Abstract
In 1987 we began a multicenter controlled clinical trial of deprenyl (a monoamine oxidase inhibitor) and tocopherol (a component of vitamin E that traps free radicals) in the treatment of early Parkinson's disease. We randomly assigned 800 patients to one of four treatments: placebo, active tocopherol and deprenyl placebo, active deprenyl and tocopherol placebo, or both active drugs. The primary end point was the onset of disability prompting the clinical decision to begin administering levodopa. An interim analysis showed that deprenyl was beneficial . We report the results of tocopherol treatment after a mean (±SD) follow-up of 14 ±6 months, as well as the follow-up results for deprenyl. There was no beneficial effect of tocopherol or any interaction between tocopherol and deprenyl. The beneficial effects of deprenyl, which occurred largely during the first 12 months of treatment, remained strong and significantly delayed the onset of disability requiring levodopa therapy (hazard ratio, 0.50; 95 percent confidence interval, 0.41 to 0.62; P<0.001). The difference in the estimated median time to the end point was about nine months. The ratings for Parkinson's disease improved during the first three months of deprenyl treatment; the motor performance of deprenyl-treated patients worsened after the treatments were withdrawn. Deprenyl (10 mg per day) but not tocopherol (2000 IU per day) delays the onset of disability associated with early, otherwise untreated Parkin-son's disease. The action of deprenyl that accounts for its beneficial effects remains unclear.Keywords
This publication has 27 references indexed in Scilit:
- SelegilineDrugs & Aging, 1991
- Effect of Deprenyl on the Progression of Disability in Early Parkinson's DiseaseThe New England Journal of Medicine, 1989
- DATATOP: A Multicenter Controlled Clinical Trial in Early Parkinson's DiseaseArchives of Neurology, 1989
- Monoamine Oxidase Activity and Monoamine Metabolism in Brains of Parkinsonian Patients Treated with l‐DeprenylJournal of Neurochemistry, 1986
- Oxygen radicals and the nervous systemTrends in Neurosciences, 1985
- The 2 × 2 factorial design: Its application to a randomized trial of aspirin and U.S. physiciansStatistics in Medicine, 1985
- Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examplesBritish Journal of Cancer, 1977
- Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and designBritish Journal of Cancer, 1976
- A RATING SCALE FOR DEPRESSIONJournal of Neurology, Neurosurgery & Psychiatry, 1960
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958