SELEDO: a 5‐y‐ear long‐term trial on the effect of selegiline in early parkinsonian patients treated with levodopa
Identifieur interne : 001D39 ( Main/Exploration ); précédent : 001D38; suivant : 001D40SELEDO: a 5‐y‐ear long‐term trial on the effect of selegiline in early parkinsonian patients treated with levodopa
Auteurs : H. Przuntek ; B. Conrad [Allemagne] ; J. Dichgans ; P. H. Kraus ; P. Krauseneck ; G. Pergande ; U. Rinne [Finlande] ; K. Schimrigk ; J. Schnitker ; H. P. Vogel [Allemagne]Source :
- European Journal of Neurology [ 1351-5101 ] ; 1999-03.
English descriptors
- KwdEn :
Abstract
The SELEDO (from selegiline plus levodopa) study was carried out as a randomized, prospective, placebo‐controlled, double‐blind, multicenter long‐term, 5‐y‐ear trial to evaluate the possible advantages of combining selegiline and levodopa in the early treatment of Parkinson's disease. One‐hundred‐and‐sixteen 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.
Url:
DOI: 10.1111/j.1468-1331.1999.tb00007.x
Affiliations:
- Allemagne, Finlande
- Bavière, Berlin, District de Haute-Bavière, Finlande occidentale
- Berlin, Munich, Turku
- Université de Turku
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Vogel</name></country><country name="Finlande"><region name="Finlande occidentale"><name sortKey="Rinne, U" sort="Rinne, U" uniqKey="Rinne U" first="U." last="Rinne">U. Rinne</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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