Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage

Clin Neuropharmacol. 2007 Mar-Apr;30(2):72-85. doi: 10.1097/01.wnf.0000240943.59617.4c.


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.

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

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

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

Intervention: 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.

Main outcome measure: 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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antiparkinson Agents / therapeutic use*
  • Asian
  • Benzothiazoles / pharmacology
  • Benzothiazoles / therapeutic use*
  • Black or African American
  • Cross-Cultural Comparison*
  • Double-Blind Method
  • Female
  • Hispanic or Latino
  • Humans
  • Levodopa / pharmacology
  • Levodopa / therapeutic use*
  • Male
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Pramipexole
  • Retrospective Studies
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome


  • Antiparkinson Agents
  • Benzothiazoles
  • Levodopa
  • Pramipexole