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Selegiline slows the progression of the symptoms of Parkinson disease

From the Department of Neurology (S.P.), Karolinska University Hospital Huddinge, Stockholm, Sweden; Research & Development (E.H., O. M.-I.), Orion Pharma, Turku, Finland; Department of Medicine (J.H.), Mälar Hospital, Eskilstuna, Sweden; Department of Neurology (T.K.), University Hospital, Linköping, Sweden; and Department of Neurology and Rehabilitation (R.P.), Central Hospital, Karlstad, Sweden.

Address correspondence and reprint requests to Dr. S. Pålhagen, Department of Neurology, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden; e-mail: sven.palhagen{at}karolinska.se

Objective: To study the long-term effects of selegiline in monotherapy and in combination with levodopa in the early phase of Parkinson disease (PD).

Methods: One hundred fifty-seven de novo PD patients were randomized in a double-blind, placebo-controlled study of 7 years’ duration. In the monotherapy part, selegiline significantly delayed the initiation of levodopa therapy vs placebo. The authors now report the results from the combination part of the study, in which 140 patients received selegiline or placebo in addition to individually tailored levodopa therapy.

Results: Compared with placebo, selegiline slowed the progression of disease disability as measured by the Unified Parkinson Disease Rating Scale (UPDRS) total score (p = 0.003) or by motor (p = 0.002) and Activities of Daily Living (p = 0.0002) subscores. After 5 years in combination therapy, the mean difference in the UPDRS total score was nearly 10 points, with patients receiving placebo having 35% higher scores. Simultaneously, patients receiving placebo needed progressively higher doses of levodopa than patients receiving selegiline; after 5 years, the mean dosage of levodopa was 19% higher with placebo than with selegiline (p = 0.0002). Considering the entire (monotherapy and combination therapy) 7-year study time, there was a trend for selegiline to delay the start of wearing-off fluctuations (hazard ratio 0.55, p = 0.08). In both phases of the study, selegiline was safe and well tolerated.

Conclusions: The results of this long-term study confirm earlier findings indicating that selegiline delays the progression of the signs and symptoms of Parkinson disease.

*See the Appendix for the members of the Swedish Parkinson Study Group.

This article was previously published in electronic format as an Expedited E-Pub on March 15, 2006, at www.neurology.org.

Disclosure: This research is sponsored by Orion Corporation, Orion Pharma.

Received December 22, 2004. Accepted in final form December 7, 2005.

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