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November 13, 2001

Ten-year follow-up of three different initial treatments in de-novo PD
A randomized trial

A. J. Lees, MD FRCP, R. Katzenschlager, MD, J. Head, MSc, Y. Ben–Shlomo, MD MRCP, and on behalf of the Parkinson’s Disease Research Group of the United Kingdom†Authors Info & Affiliations
November 13, 2001 issue
57 (9) 1687-1694


Background: The long-term effectiveness of three different initial drug regimes in patients with early, mild PD was evaluated by the PD Research Group of the United Kingdom (PDRGUK). In 1995, the selegiline arm of the trial was terminated following an interim analysis.
Method: This was an open, randomized trial. Between 1985 and 1990, 782 patients with de-novo PD were recruited and randomized to one of three treatment arms: levodopa plus dopa decarboxylase inhibitor; levodopa plus decarboxylase inhibitor and selegiline; or bromocriptine. The main endpoints were mortality, disability, and adverse events. Intention-to-treat analysis was used.
Results: There was no significant difference in mortality between the bromocriptine and the levodopa arms (hazard ratio 1.15 [95% CI 0.90, 1.47]). Patients initially randomized to bromocriptine had slightly worse disability scores throughout follow-up. This difference was significant during the first years. Patients in the bromocriptine arm returned to pretreatment disability levels one year earlier than those in the levodopa arm. Patients randomized to bromocriptine had a significantly lower incidence of dyskinesias than those randomized to levodopa (rate ratio 0.73 [95% CI 0.57, 0.93]). However, this difference was not significant when only moderate to severe dyskinesias were considered. Patients in the bromocriptine arm had slightly lower rates of dystonias and on-off fluctuations, but moderate and severe forms were equally frequent in both arms.
Conclusion: Starting treatment with the dopamine agonist bromocriptine does not reduce mortality in PD. A slightly lower incidence of motor complications is achieved at the expense of significantly worse disability scores throughout the first years of therapy.

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Information & Authors


Published In

Volume 57Number 9November 13, 2001
Pages: 1687-1694
PubMed: 11706112

Publication History

Received: April 11, 2001
Accepted: July 26, 2001
Published online: November 13, 2001
Published in print: November 13, 2001


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Affiliations & Disclosures

A. J. Lees, MD FRCP
*Both authors contributed equally to this study.
R. Katzenschlager, MD
*Both authors contributed equally to this study.
Y. Ben–Shlomo, MD MRCP
on behalf of the Parkinson’s Disease Research Group of the United Kingdom†
From the National Hospital for Neurology and Neurosurgery (Drs. Lees and Katzenschlager), London; Department of Epidemiology and Public Health (J. Head), University College London; Department of Social Medicine (Dr. Ben–Shlomo), University of Bristol, UK.


Address correspondence and reprint requests to Prof. Andrew J. Lees, Reta Lila Weston Institute of Neurological Studies, Windeyer Building, University College London and Royal Free Medical School, 46 Cleveland Street, London W1T 4JF, UK.

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