Tags

Type your tag names separated by a space and hit enter

The effects of early selegiline therapy on long-term levodopa treatment and parkinsonian disability: an interim analysis of a Norwegian--Danish 5-year study. Norwegian-Danish Study Group.
Mov Disord. 1997 Mar; 12(2):175-82.MD

Abstract

In this study, we investigated the effects of selegiline on levodopa treatment and parkinsonian disability over several years of treatment in patients with early Parkinson's disease (PD). The 163 patients were randomized to receive either selegiline or placebo in addition to levodopa in a double-blind, parallel-group study design, and the patients were to be followed up until a defined termination point or for 5 years. All patients had previously either never (two thirds) or for < 6 months (one third) received levodopa. After 1 year of treatment or at withdrawal from study or both, the patients were divided according to specified diagnostic criteria into groups of definite, probable, possible, or unlikely PD. The efficacy parameters were levodopa therapy, Unified Parkinson's Disease Rating Scale (UPDRS) with subscales, and the time to develop wearing-off fluctuations or reaching the termination point. Evaluation of efficacy was performed for all patients with PD and for patients with a definite and probable disease. The results of this study are based on an interim analysis when 80% of the 163 randomized patients had been followed up for > or = 3 years. Nine patients were excluded from the study because of protocol violations or because the patients were diagnosed as unlikely PD. At the time of interim analysis, 39 patients had been withdrawn from the study because of adverse effects or their own wish. Eighteen patients had reached the termination point, and 97 patients (observation time, 30-54 months) were still in the study. Among the patients receiving selegiline, we found a rather stable daily levodopa dose during 54 months of therapy, compared with an anticipated increase among patients with levodopa monotherapy. Concurrently, patients in the selegiline group showed a trend to develop less severe parkinsonian disability and a lower frequency of motor fluctuations and need for additional antiparkinsonian medication. The results of this study indicate that early combination therapy of selegiline and levodopa compared with levodopa monotherapy has an increasingly favorable impact on the long-term daily levodopa dose and may possibly delay the development of disability in PD.

Authors+Show Affiliations

Department of Neurology, Central Hospital of Rogaland, Stavanger, Norway.No affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9087975

Citation

Larsen, J P., and J Boas. "The Effects of Early Selegiline Therapy On Long-term Levodopa Treatment and Parkinsonian Disability: an Interim Analysis of a Norwegian--Danish 5-year Study. Norwegian-Danish Study Group." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 12, no. 2, 1997, pp. 175-82.
Larsen JP, Boas J. The effects of early selegiline therapy on long-term levodopa treatment and parkinsonian disability: an interim analysis of a Norwegian--Danish 5-year study. Norwegian-Danish Study Group. Mov Disord. 1997;12(2):175-82.
Larsen, J. P., & Boas, J. (1997). The effects of early selegiline therapy on long-term levodopa treatment and parkinsonian disability: an interim analysis of a Norwegian--Danish 5-year study. Norwegian-Danish Study Group. Movement Disorders : Official Journal of the Movement Disorder Society, 12(2), 175-82.
Larsen JP, Boas J. The Effects of Early Selegiline Therapy On Long-term Levodopa Treatment and Parkinsonian Disability: an Interim Analysis of a Norwegian--Danish 5-year Study. Norwegian-Danish Study Group. Mov Disord. 1997;12(2):175-82. PubMed PMID: 9087975.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of early selegiline therapy on long-term levodopa treatment and parkinsonian disability: an interim analysis of a Norwegian--Danish 5-year study. Norwegian-Danish Study Group. AU - Larsen,J P, AU - Boas,J, PY - 1997/3/1/pubmed PY - 1997/3/1/medline PY - 1997/3/1/entrez SP - 175 EP - 82 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 12 IS - 2 N2 - In this study, we investigated the effects of selegiline on levodopa treatment and parkinsonian disability over several years of treatment in patients with early Parkinson's disease (PD). The 163 patients were randomized to receive either selegiline or placebo in addition to levodopa in a double-blind, parallel-group study design, and the patients were to be followed up until a defined termination point or for 5 years. All patients had previously either never (two thirds) or for < 6 months (one third) received levodopa. After 1 year of treatment or at withdrawal from study or both, the patients were divided according to specified diagnostic criteria into groups of definite, probable, possible, or unlikely PD. The efficacy parameters were levodopa therapy, Unified Parkinson's Disease Rating Scale (UPDRS) with subscales, and the time to develop wearing-off fluctuations or reaching the termination point. Evaluation of efficacy was performed for all patients with PD and for patients with a definite and probable disease. The results of this study are based on an interim analysis when 80% of the 163 randomized patients had been followed up for > or = 3 years. Nine patients were excluded from the study because of protocol violations or because the patients were diagnosed as unlikely PD. At the time of interim analysis, 39 patients had been withdrawn from the study because of adverse effects or their own wish. Eighteen patients had reached the termination point, and 97 patients (observation time, 30-54 months) were still in the study. Among the patients receiving selegiline, we found a rather stable daily levodopa dose during 54 months of therapy, compared with an anticipated increase among patients with levodopa monotherapy. Concurrently, patients in the selegiline group showed a trend to develop less severe parkinsonian disability and a lower frequency of motor fluctuations and need for additional antiparkinsonian medication. The results of this study indicate that early combination therapy of selegiline and levodopa compared with levodopa monotherapy has an increasingly favorable impact on the long-term daily levodopa dose and may possibly delay the development of disability in PD. SN - 0885-3185 UR - https://www.unboundmedicine.com/medline/citation/9087975/The_effects_of_early_selegiline_therapy_on_long_term_levodopa_treatment_and_parkinsonian_disability:_an_interim_analysis_of_a_Norwegian__Danish_5_year_study__Norwegian_Danish_Study_Group_ L2 - https://doi.org/10.1002/mds.870120207 DB - PRIME DP - Unbound Medicine ER -