SELEGILINE AS THE PRIMARY-TREATMENT OF PARKINSONS-DISEASE - A LONG-TERM DOUBLE-BLIND-STUDY

Introduction - To assess the therapeutic efficacy of selegiline combin ed with levodopa in the long-term treatment of Parkinson's disease (PD ). Material and methods - A randomized, prospective, double-blind stud y on 44 patients with PD needing levodopa therapy after the initial do uble-blind treatment with placebo or selegiline was carried out. The p atients were followed-up for 5 years under combination therapy. Result s - Selegiline induced a significant (P<0.001) slowing in the need to increase the daily levodopa dose in order to compensate for the progre ssion of the disease. After 5 years of combination therapy the mean do se of levodopa was on average 320 mg lower in the selegiline group (40 5+/-59 mg vs 725+/-78 mg). The difference in the levodopa doses betwee n the two groups increased along with follow-up time, as also the rati o of the levodopa doses (placebo/selegiline group). The number of dail y levodopa doses needed to compensate for the occurrence of motor fluc tuations was significantly lower in the selegiline group. The parkinso nian disability did not differ between the two groups because the clin ical condition was kept as optimal as possible by adjusting the levodo pa dosage. Nine patients in the placebo group needed initiation of add itional dopaminergic therapy in comparison to one in the selegiline gr oup (P=0.004). During the 5-year follow-up period 11 patients were wit hdrawn from the selegiline group, 7 due to adverse events. There was n o difference in mortality between the two groups. Conclusion - Selegil ine therapy offers beneficial long-term effects in the treatment of PD .