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From National Hospital for Neurology and Neurosurgery (R.K., A.E., A.J.L.), London; Reta Lila Weston Institute of Neurological Studies (R.K., A.E., A.J.L.) and Department of Epidemiology and Public Health (J.H.), University College London; Department of Neurology (R.K.), Donauspital/SMZ-Ost, Vienna, Austria; University Department of Clinical Neurosciences (A.S.), Royal Free and University College Medical School, London; and Department of Social Medicine (Y.B.-S.), University of Bristol, UK.
Address correspondence and reprint requests to Professor Andrew J. Lees, National Hospital for Neurology and Neurosurgery, Queen Square, London WC1 3BG, UK alees{at}ion.ucl.ac.uk.
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.
Abbreviations: DDCI = l-dopa/decarboxylase inhibitor; Hr-QoL = health-related quality-of-life; MMSE = Mini-Mental State Examination; NHS = National Health Service; NWUD = Northwestern University Disability; PD = Parkinson disease; PDRG-UK = Parkinson's Disease Research Group of the United Kingdom; SF-36 = Short-Form health survey; SMR = standardized mortality ratio.
e-Pub ahead of print on June 25, 2008, at www.neurology.org.
*Members of the Parkinson's Disease Research Group of the United Kingdom are listed in the appendix.
Disclosure: A.J.L. has received fees for speaking, consulting, and organizing educational events from Britannia and Novartis. R.K. and A.E. have received fees for speaking and organizing educational events from Britannia and Novartis. A.S. has received fees for consulting from Novartis. No other potential conflicts of interest exist for any of the authors.
Received May 17, 2007. Accepted in final form January 8, 2008.
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