IMPACT OF DEPRENYL AND TOCOPHEROL TREATMENT ON PARKINSONS-DISEASE IN DATATOP SUBJECTS NOT REQUIRING LEVODOPA

In the controlled trial Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP), 310 of the 800 enrolled subjects did not re ach the primary end point of disability requiring levodopa therapy dur ing 21 +/- 4 (mean +/- SD) months of observation or need early initiat ion of deprenyl (selegiline) during a 2-month withdrawal of experiment al treatments. While maintaining the blindness of their original depre nyl and tocopherol treatment assignments, these 310 subjects were admi nistered deprenyl 10 mg/day (open label) and were monitored systematic ally at 1- to 3-month intervals for up to 18 months (12 +/- 5 mo). Dur ing this extended trial, the 189 subjects who had been assigned origin ally to active deprenyl tended to reach the end point of disability fa ster than the 121 subjects who had not been assigned originally to dep renyl (hazard ratio, 1.43; 95% CI, 0.98, 2.09; p = 0.065). However, th e differential rates of reaching the end point may have been due in pa rt to the more severe baseline impairment of deprenyl-assigned subject s, who benefited originally from deprenyl but who were more likely to require levodopa during this extended period of observation. Prior tre atment with deprenyl did not lead to superior survival with respect to the end point of disability requiring levodopa, suggesting that the i nitial advantages of deprenyl were not sustained.