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

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 mono-therapy? Randomized {allocation concealed*} †, blinded {data safety and monitoring commit-tee} †,* controlled trial with a mean 9.2-year follow-up. P a t i e n t s 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. 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104 patients in the bromocriptine group were rerandomized to 1 of the other 2 treatment groups after bromocriptine was withdrawn, but all patients were analyzed in the groups to which they were initially randomized. M a i n o u t c o m e m e a s u r e s Mortality, disability, and adverse effects. Analysis was by intention to treat. The groups did not differ for mortality (Table). At 3 years, those assigned to initial bromo-criptine 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 dyski-nesias were analyzed, this difference was no longer statistically significant. The groups did not differ for incidence of dystonia or on-off fluctuations. In patients with mild, early Parkinson disease , initial treatment with bromocriptine did not reduce mortality more than lev-odopa. Disability scores were worse during the first 3 years of treatment with initial bromocriptine. C o m m e n t a r y The study by Lees and colleagues shows that initiating treatment with bromocriptine or levodopa does not affect mortality rates and that patients who began treatment with levodopa had slightly better motor scores during follow-up but a higher incidence of dyskinesias. The study has methodologic limitations, the main one being that outcome assessment was not blinded to treatment allocation. Potential bias is suggested by the much higher number of deaths from cerebrovascular disease in the bromocriptine group than in the levodopa group. Dyskinesia scores are rather …