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Previous Volume 328:176-183 January 21, 1993 Number 3 Next

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ABSTRACT

Background and Methods 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.

Results 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months of deprenyl treatment; the motor performance of deprenyl-treated patients worsened after the treatments were withdrawn.

Conclusions 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.

Source Information

The members of the Parkinson Study Group who conducted the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP) trial and wrote this report are listed in the Appendix. The preparation of the manuscript was overseen by the DATATOP Steering Committee: Ira Shoulson, M.D. (principal investigator), University of Rochester, Rochester, N.Y.; Stanley Fahn, M.D. (co-principal investigator), Columbia-Presbyterian Medical Center, New York; David Oakes, Ph.D. (chief biostatistician), and Karl Kieburtz, M.D. (medical director), University of Rochester; Anthony Lang, M.D., Toronto Hospital, Toronto; J. William Langston, M.D., California Parkinson's Foundation, San Jose; Peter LeWitt, M.D., Sinai Hospital, Detroit; C. Warren Olanow, M.D., University of South Florida, Tampa; John B. Penney, M.D., University of Michigan, Ann Arbor; Caroline Tanner, M.D., Rush-Presbyterian-St. Luke's Medical Center, Chicago; and Alice Rudolph, Ph.D. (senior study coordinator), and Rita M. Pelusio, M.S.Ed. (program manager), University of Rochester.

Address reprint requests to Dr. Ira Shoulson, Box 673, Department of Neurology, University of Rochester Medical Center, 601 Elmwood Ave., Rochester, NY 14642.

Full Text of this Article

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Protective Effect or Symptomatic Effect of Deprenyl?
Kofman O. S., Shoulson I., The DATATOP Steering Committee on behalf of the Parkinson Study Group
Extract | Full Text  
N Engl J Med 1993; 328:1715, Jun 10, 1993. Correspondence

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