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Therapeutics |

Initial bromocriptine did not change mortality in early, mild Parkinson disease

Alberto Albanese, MD
[+] Article, Author, and Disclosure Information

*See Glossary.

†Information provided by author.

Source of funding: Parkinson’s Disease Society of the United Kingdom.

For correspondence: Professor A.J. Lees, University College London and Royal Free Medical School, London, England, UK. E-mail a.lees@ion.ucl.ac.uk.

Ann Intern Med. 2002;136(3):109. doi:10.7326/ACPJC-2002-136-3-109
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Question: In patients with early, mild Parkinson disease (PD), does the long-term effectiveness of levodopa alone differ from that of levodopa plus selegiline or initial bromocriptine monotherapy?

Design: Randomized {allocation concealed*}†, blinded {data safety and monitoring committee}†,* controlled trial with a mean 9.2-year follow-up.

Setting: United Kingdom.

Patients: 782 patients with a clinical diagnosis of PD. Exclusion criteria were failure to respond to an adequate trial of dopaminergic drugs or incapacitating cognitive impairment.

Intervention: 249 patients were allocated to levodopa alone, 271 to levodopa plus selegiline, and 262 to initial bromocriptine. 104 patients in the bromocriptine group were rerandomized to 1 of the other 2 treatment groups after bromocriptine was withdrawn, but all patients were analyzed in the groups to which they were initially randomized.

Main outcome measures: Mortality, disability, and adverse effects.

Main results: Analysis was by intention to treat. The groups did not differ for mortality (Table). At 3 years, those assigned to initial bromocriptine had worse disability scores than those assigned to levodopa alone (difference in adjusted mean Webster score 1.3, 95% CI 0.4 to 2.1). This difference was no longer statistically significant at 9 years (0.2, CI −1.5 to 1.5). At a mean of 9.2 years of follow-up, a lower incidence of dyskinesia occurred in patients initially assigned to bromocriptine than in those in the levodopa-alone group (relative risk 0.73, CI 0.57 to 0.93). However, when only moderate-to-severe dyskinesias were analyzed, this difference was no longer statistically significant. The groups did not differ for incidence of dystonia or on-off fluctuations.

Conclusions: In patients with mild, early Parkinson disease, initial treatment with bromocriptine did not reduce mortality more than levodopa. Disability scores were worse during the first 3 years of treatment with initial bromocriptine.

Initial bromocriptine (IB) vs levodopa alone (L) and levodopa plus selegiline (LS) in early, mild Parkinson disease at a mean 9.2 years

OutcomeComparisonsEvent rates (person-yr at risk)Unadjusted hazard ratios (95% CI)
MortalityIB vs L58% (140) vs 51% (118)1.15 (0.90 to 1.47)‡
LS vs IB61% (148) vs 58% (140)1.06 (0.84 to 1.34)‡
LS vs L61% (148) vs 51% (118)1.22 (0.95 to 1.55)‡

‡Not significant.





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