Primary studies included in this systematic review

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PARJUPAR Study: Bromocriptine, Selegeline or Both Delay the Need of Levodopa Therapy in \"De Novo\" Parkinson\'s Disease Patients

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Journal Personal communication.
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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Update on 10-year follow-up of the data of the Parkinson\'s Disease Research Group of United Kingdom randomised trial of levodopa, levodopa in combination with selegiline or bromocriptine in patients with early, mild Parkinson\'s disease

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Journal 11th Meeting of the European Neurological Society. http://congress.akm.ch/abstract/abstract/abt.ausgabe?xnkon_nr=48&xssprache=ENG. (accessed 19th September 2003).
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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Use of Selegiline as Monotherapy and in Combination with Levodopa in the Management of Parkinson's Disease: Perspectives from the MONOCOMB Study

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Journal Progress in Neurotherapeutics and Neuropsychopharmacology
Year 2008

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Fourteen-year final report of the randomized PDRG-UK trial comparing three initial treatments in PD

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Journal Neurology
Year 2008
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Background: Ten-year follow-up results from the Parkinson's Disease Research Group of the United Kingdom trial demonstrated that there were no long-term advantages to initiating treatment with bromocriptine compared with l-dopa in early Parkinson disease (PD). Increased mortality in patients on selegiline combined with l-dopa led to premature termination of this arm after 6 years. Methods: Between 1985 and 1990, 782 patients were recruited into an open pragmatic multicenter trial and were randomized to l-dopa/decarboxylase inhibitor (DDCI), l-dopa/DDCI plus selegiline, or bromocriptine. The main endpoints were mortality, disability, and motor complications. For final follow-up, health-related quality of life and mental function were also assessed. Results: Median duration of follow-up at final assessment was 14 years in the 166 (21%) surviving participants who could be contacted. After adjustment for baseline characteristics, disability scores were better in the l-dopa than in the bromocriptine arm (Webster: 16.6 vs 19.8; p = 0.03; Northwestern University Disability: 34.3 vs 30.0, p = 0.05). Physical functioning (difference 20.8; 95% CI 10.0, 31.6; p < 0.001) and physical summary scores (difference 5.2; 95% CI 0.7, 9.7; p = 0.03) on the 36-item short-form health survey were also superior on l-dopa. Differences in mortality rates and prevalence of dyskinesias, motor fluctuations, and dementia were not significantly different. Conclusion: Initial treatment with the dopamine agonist bromocriptine did not reduce mortality or motor disability and the initially reduced frequency in motor complications was not sustained. We found no evidence of a long-term benefit or clinically relevant disease-modifying effect with initial dopamine agonist treatment. © 2008 by AAN Enterprises, Inc. All rights reserved.

Primary study

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Selegiline slows the progression of the symptoms of Parkinson disease.

Journal Neurology
Year 2006
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This article is included in 3 Systematic reviews Systematic reviews (3 references)

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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.

Primary study

Unclassified

Impact of sustained deprenyl (selegiline) in levodopa-treated Parkinson's disease: a randomized placebo-controlled extension of the deprenyl and tocopherol antioxidative therapy of parkinsonism trial.

Journal Annals of neurology
Year 2002
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This article is included in 6 Systematic reviews Systematic reviews (6 references)

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Deprenyl (selegiline) delays the need for levodopa therapy in patients with early Parkinson's disease, but the long-term benefits of this treatment remain unclear. During 1987 to 1988, 800 patients with early Parkinson's disease were randomized in the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism trial to receive deprenyl, tocopherol, combined treatments, or a placebo and were then placed on active deprenyl (10mg/day). A second, independent randomization was carried out in early 1993 for 368 subjects who by that time had required levodopa and who had consented to continuing the deprenyl treatment (D subjects) or changing to a matching placebo (P subjects) under double-blind conditions. The first development of wearing off, dyskinesias, or on-off motor fluctuations was the prespecified primary outcome measure. During the average 2-year follow-up, there were no differences between the treatment groups with respect to the primary outcome measure (hazard ratio, 0.87; 95% confidence interval, 0.63, 1.19; p = 0.38), withdrawal from the study, death, or adverse events. Although 34% of D subjects developed dyskinesias and only 19% of P subjects did (p = 0.006), only 16% of D subjects developed freezing of gait but 29% of P subjects did (p = 0.0003). Decline in motor performance was less in D subjects than P subjects. Levodopa-treated Parkinson's disease patients who had been treated with deprenyl for up to 7 years, compared with patients who were changed to a placebo after about 5 years, experienced slower motor decline and were more likely to develop dyskinesias but less likely to develop freezing of gait.

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PDRGUK (Parkinson's Disease Research Group in the United Kingdom)

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Primary study

Unclassified

SELEDO: a 5-year long-term trial on the effect of selegiline in early Parkinsonian patients treated with levodopa.

Journal European journal of neurology : the official journal of the European Federation of Neurological Societies
Year 1999
Links Pubmed DOI

This article is included in 6 Systematic reviews Systematic reviews (6 references)

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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. 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.

Primary study

Unclassified

Mortality in DATATOP.

Authors Ben-Shlomo Y , Head J , Lees AJ
Journal Annals of neurology
Year 1999
Links Pubmed

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Primary study

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Does selegiline modify the progression of early Parkinson's disease? Results from a five-year study. The Norwegian-Danish Study Group.

Authors Larsen JP , Boas J , Erdal JE
Journal European journal of neurology : the official journal of the European Federation of Neurological Societies
Year 1999
Links Pubmed DOI

This article is included in 9 Systematic reviews Systematic reviews (9 references)

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The objective of this study was to examine the effect of long-term treatment with selegiline on the progression of Parkinson's disease (PD). One hundred and sixty-three patients with early PD were treated with levodopa and benserazide, combined with selegiline or placebo in a five-year randomized, placebo-controlled, double-blind, parallel group study followed by a one-month wash-out of selegiline or placebo. The main outcome measures were assessments of the severity of parkinsonism, levodopa requirements and the development of end-of-dose motor fluctuations over time and after wash-out at the end of the study period. Results indicated that patients treated with the combination of selegiline and levodopa developed markedly less severe parkinsonism and required lower doses of levodopa during the five-year study period than patients treated with levodopa and placebo. There was no trend towards worsening during wash-out among patients previously treated with selegiline. The results cannot easily be explained by a symptomatic effect of selegiline.