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 withlevodopa. 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.
RCT Entities:
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 PDpatients 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 PDpatients 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.
Authors: Myra G Schneider; Christopher J Swearingen; Lisa M Shulman; Jian Ye; Mona Baumgarten; Barbara C Tilley Journal: Parkinsonism Relat Disord Date: 2008-08-09 Impact factor: 4.891