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A 5-year long-term trial on the effect of selegiline in early
parkinsonian patients treated with levodopa.

The SELEDO (from selegiline plus levodopa) study was carried out as a
randomized, prospective, placebo-controlled, double- blind, multicenter
long-term, 5-year trial to evaluate the possible advantages of combining
selegiline and levodopa in the early treatment of Parkinson's disease.

116 patients were randomized either to selegiline or placebo.

Before starting the study medication, the levodopa dose was titrated to the
individual requirements of each patient.

The primary study end point (time when levodopa had to be increased by >50%
of the titrated dose) was reached in 23 of 59 patients in the selegiline
group and 26 of 48 patients in the placebo group.

At the end of the 5 years' treatment period the rates derived from a
life-table analysis were 50.4% in the selegiline group and 74.1% in the
placebo group (P = 0.027, log-rank test).

The median time to reach the primary end point was 4.9 years in the
selegiline group and 2.6 years in the placebo group.

In patients treated with selegiline, the mean levodopa dose changed only
slightly over the 5 years of treatment compared to the initially titrated
dose, but rose markedly in the placebo group, where the dose of levodopa
had to be adjusted earlier than in the selegiline group.

At the same time, the lower levodopa dosage in the selegiline group was
accompanied by at least equal therapeutic efficacy (which is necessary for
an unambiguous interpretation).

Subgroup analyses showed greater benefit for selegiline treated) patients
in the earlier stages.

Long-term side effects appeared later in the selegiline group, although the
difference was not significant.

The early combination of selegiline and levodopa proved to be clearly
superior to levodopa monotherapy.


Eur J Neurol 6:141-150 Copyright
1999 Lippincott Williams & Wilkins

Eur J Neurol 1999 Mar;6(2):141-150
Przuntek H, Conrad B, Dichgans J, Kraus PH, Krauseneck P, Pergande G,
Rinne U, Schimrigk K, Schnitker J, Vogel HP
Neurologische Klinik, Ruhr-Universitat, St. Josef-Hospital, Bochum, Germany.
PMID: 10053226

http://www.ncbi.nlm.nih.gov/PubMed

janet paterson
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