Efficacy and safety of high-dose cabergoline in Parkinson's disease
2006
Objectives – To assess the efficacy and safety of high-dose (up to 20 mg/day) cabergoline in Parkinson's disease (PD) patients with motor fluctuations and/or dyskinesias.
Materials and methods – Thirty-four PD patients had cabergoline up-titrated and their levodopa (l-dopa) reduced over a maximum of 20 weeks, followed by at least 6 weeks steady cabergoline dosing. Primary endpoint was change in mean hyperkinesia intensity at the final visit (week 26).
Results – Mean (± SD) cabergoline was increased from 6.43 ± 2.66 to 12.78 ± 5.67 mg/day and mean l-dopa reduced from 606.6 ± 263.9 to 370.6 ± 192.5 mg/day. A significant reduction (P < 0.001) in mean hyperkinesia intensity occurred from baseline (day 0) to week 26. Improvements in ‘on with dyskinesias’, mean dystonia intensity (P < 0.05), time spent in ‘severe off’ condition, severity of ‘off’ periods as well as clinical/patient global impression, and health-related quality of life were observed. Twenty-four drug-related adverse events were recorded of which four were regarded as serious.
Conclusion – High-dose cabergoline was well tolerated and provided significant improvements in the Parkinson symptomatology and a reduced requirement for l-dopa.
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