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Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage.
Clin Neuropharmacol. 2007 Mar-Apr; 30(2):72-85.CN

Abstract

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.

Authors+Show Affiliations

The Parkinson's Institute, 1170 Morse Avenue, Sunnyvale, CA 94089-1605, USA. ctannermd@aol.com

Pub Type(s)

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

Language

eng

PubMed ID

17414939

Citation

Parkinson Study Group. "Pramipexole in Levodopa-treated Parkinson Disease Patients of African, Asian, and Hispanic Heritage." Clinical Neuropharmacology, vol. 30, no. 2, 2007, pp. 72-85.
Parkinson Study Group. Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage. Clin Neuropharmacol. 2007;30(2):72-85.
Parkinson Study Group. (2007). Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage. Clinical Neuropharmacology, 30(2), 72-85.
Parkinson Study Group. Pramipexole in Levodopa-treated Parkinson Disease Patients of African, Asian, and Hispanic Heritage. Clin Neuropharmacol. 2007 Mar-Apr;30(2):72-85. PubMed PMID: 17414939.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage. A1 - ,, PY - 2007/4/7/pubmed PY - 2007/6/15/medline PY - 2007/4/7/entrez SP - 72 EP - 85 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 30 IS - 2 N2 - 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. SN - 0362-5664 UR - https://www.unboundmedicine.com/medline/citation/17414939/Pramipexole_in_levodopa_treated_Parkinson_disease_patients_of_African_Asian_and_Hispanic_heritage_ L2 - https://doi.org/10.1097/01.wnf.0000240943.59617.4c DB - PRIME DP - Unbound Medicine ER -