Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage.
BACKGROUND
Little is known regarding the effects of antiparkinsonian drugs in US racial or ethnic minorities.


OBJECTIVE
: To evaluate the safety, tolerability, and efficacy of adjunctive pramipexole in Parkinson disease (PD) patients of African, Asian, or Hispanic heritage stably treated with levodopa.


METHODS
Multicenter, parallel-group, double-blind, randomized, placebo-controlled trial.


METHODS
: Seventeen Parkinson Study Group sites in the United States and Puerto Rico.


METHODS
One hundred forty-four PD patients of African, Asian, or Hispanic heritage enrolled from January 1997 to August 1998 and observed until October 1998.


METHODS
Subjects received pramipexole or placebo (3:1 ratio), 0.375 mg/d to a maximum tolerated dose (<or=4.5 mg/d) over a 6-week period, achieving optimum levels (0.375, 1.5, 3.0, or 4.5 mg/d) in the 4-week maintenance period.


METHODS
Change in the sum of the Unified Parkinson's Disease Rating Scale parts 2 (activities of daily living) and 3 (motor) from baseline to week 10.


RESULTS
Parkinsonism improved (mean [SD] reduction in Unified Parkinson's Disease Rating Scale activities of daily living + motor score at 10 weeks, 10.27 [11.96] pramipexole vs 6.54 [13.58] placebo, P = 0.012) and was similar in each group. Adverse events occurred in 85.3% on pramipexole and 68.6% on placebo. Hallucinations and insomnia were more common on pramipexole than placebo (18 vs 0, P = 0.023, and 15 vs 0, P = 0.045, respectively).


CONCLUSIONS
Pramipexole is an effective adjunctive antiparkinsonian therapy in PD patients of African, Asian, and Hispanic heritage. Tolerability and safety overall were similar among the groups, but differences in profiles of adverse effects and tolerability were suggested.
The Parkinson's Institute, 1170 Morse Avenue, Sunnyvale, CA 94089-1605, USA. ctannermd@aol.com
D001741:Black or African American; D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D001213:Asian; D052160:Benzothiazoles / Q000494:pharmacology / Q000627:therapeutic use*; D003431:Cross-Cultural Comparison; D004311:Double-Blind Method; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D007980:Levodopa / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D000077487:Pramipexole; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D052160:Benzothiazoles; D007980:Levodopa; D000077487:Pramipexole