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

Caroline Tanner, Cynthia Comella, Cornelia Kamp, Karl Kieburtz, David Oakes, Frederick Marshall, Denni Day, Julie Carter, Rajesh Pahwa, Ira Shoulson, Daniel Truong, An Hao Tran, Karen Thompson, Lisa M. Shulman, Dinorah Rodriguez, Mariella Fernandez, Carmen Serrano Ramos, Adelma Rivera Cruz, Giselle Petzinger, Sheila Everett & 33 others Jayaraman Rao, Clare Das, Kapil Dev Sethi, Kathy Ligon, Cheryl Waters, Mickie Welsh, Andrew Feigin, Joel Perlmutter, Lori McGee-Minnich, Kenneth Marek, Susan Broshjeit, Janet Cellar, Howard Hurtig, Mary Matthews, Kathleen Shannon, Kimberly Janko, George Paulson, Carolyn Weeks, Carson Reider, Richard Trosch, Kathie Mistura, William Koller, Marian Evatt, Colleen Wood, Ronald Pfeiffer, Sara Rast, Brenda Pfeiffer, Alicia Brocht, Cindy Casaceli, Andrea Freimuth, Karen Hodgeman, Arthur Watts, Sam Goldman

Research output: Contribution to journalArticle

21 Citations (Scopus)

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 (≤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.

Original languageEnglish (US)
Pages (from-to)72-85
Number of pages14
JournalClinical Neuropharmacology
Volume30
Issue number2
DOIs
StatePublished - Mar 1 2007

Fingerprint

Levodopa
Hispanic Americans
Parkinson Disease
Placebos
Antiparkinson Agents
Activities of Daily Living
Safety
Puerto Rico
Maximum Tolerated Dose
Hallucinations
Sleep Initiation and Maintenance Disorders
Parkinsonian Disorders
pramipexole
Randomized Controlled Trials
Maintenance
Pharmaceutical Preparations

Keywords

  • African American
  • Asian
  • Hispanic
  • Parkinson disease
  • Pramipexole
  • Randomized clinical trials

ASJC Scopus subject areas

  • Pharmacology
  • Clinical Neurology
  • Pharmacology (medical)

Cite this

Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage. / Tanner, Caroline; Comella, Cynthia; Kamp, Cornelia; Kieburtz, Karl; Oakes, David; Marshall, Frederick; Day, Denni; Carter, Julie; Pahwa, Rajesh; Shoulson, Ira; Truong, Daniel; Tran, An Hao; Thompson, Karen; Shulman, Lisa M.; Rodriguez, Dinorah; Fernandez, Mariella; Ramos, Carmen Serrano; Cruz, Adelma Rivera; Petzinger, Giselle; Everett, Sheila; Rao, Jayaraman; Das, Clare; Sethi, Kapil Dev; Ligon, Kathy; Waters, Cheryl; Welsh, Mickie; Feigin, Andrew; Perlmutter, Joel; McGee-Minnich, Lori; Marek, Kenneth; Broshjeit, Susan; Cellar, Janet; Hurtig, Howard; Matthews, Mary; Shannon, Kathleen; Janko, Kimberly; Paulson, George; Weeks, Carolyn; Reider, Carson; Trosch, Richard; Mistura, Kathie; Koller, William; Evatt, Marian; Wood, Colleen; Pfeiffer, Ronald; Rast, Sara; Pfeiffer, Brenda; Brocht, Alicia; Casaceli, Cindy; Freimuth, Andrea; Hodgeman, Karen; Watts, Arthur; Goldman, Sam.

In: Clinical Neuropharmacology, Vol. 30, No. 2, 01.03.2007, p. 72-85.

Research output: Contribution to journalArticle

Tanner, C, Comella, C, Kamp, C, Kieburtz, K, Oakes, D, Marshall, F, Day, D, Carter, J, Pahwa, R, Shoulson, I, Truong, D, Tran, AH, Thompson, K, Shulman, LM, Rodriguez, D, Fernandez, M, Ramos, CS, Cruz, AR, Petzinger, G, Everett, S, Rao, J, Das, C, Sethi, KD, Ligon, K, Waters, C, Welsh, M, Feigin, A, Perlmutter, J, McGee-Minnich, L, Marek, K, Broshjeit, S, Cellar, J, Hurtig, H, Matthews, M, Shannon, K, Janko, K, Paulson, G, Weeks, C, Reider, C, Trosch, R, Mistura, K, Koller, W, Evatt, M, Wood, C, Pfeiffer, R, Rast, S, Pfeiffer, B, Brocht, A, Casaceli, C, Freimuth, A, Hodgeman, K, Watts, A & Goldman, S 2007, 'Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage', Clinical Neuropharmacology, vol. 30, no. 2, pp. 72-85. https://doi.org/10.1097/01.wnf.0000240943.59617.4c
Tanner, Caroline ; Comella, Cynthia ; Kamp, Cornelia ; Kieburtz, Karl ; Oakes, David ; Marshall, Frederick ; Day, Denni ; Carter, Julie ; Pahwa, Rajesh ; Shoulson, Ira ; Truong, Daniel ; Tran, An Hao ; Thompson, Karen ; Shulman, Lisa M. ; Rodriguez, Dinorah ; Fernandez, Mariella ; Ramos, Carmen Serrano ; Cruz, Adelma Rivera ; Petzinger, Giselle ; Everett, Sheila ; Rao, Jayaraman ; Das, Clare ; Sethi, Kapil Dev ; Ligon, Kathy ; Waters, Cheryl ; Welsh, Mickie ; Feigin, Andrew ; Perlmutter, Joel ; McGee-Minnich, Lori ; Marek, Kenneth ; Broshjeit, Susan ; Cellar, Janet ; Hurtig, Howard ; Matthews, Mary ; Shannon, Kathleen ; Janko, Kimberly ; Paulson, George ; Weeks, Carolyn ; Reider, Carson ; Trosch, Richard ; Mistura, Kathie ; Koller, William ; Evatt, Marian ; Wood, Colleen ; Pfeiffer, Ronald ; Rast, Sara ; Pfeiffer, Brenda ; Brocht, Alicia ; Casaceli, Cindy ; Freimuth, Andrea ; Hodgeman, Karen ; Watts, Arthur ; Goldman, Sam. / Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage. In: Clinical Neuropharmacology. 2007 ; Vol. 30, No. 2. pp. 72-85.
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T1 - Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage

AU - Tanner, Caroline

AU - Comella, Cynthia

AU - Kamp, Cornelia

AU - Kieburtz, Karl

AU - Oakes, David

AU - Marshall, Frederick

AU - Day, Denni

AU - Carter, Julie

AU - Pahwa, Rajesh

AU - Shoulson, Ira

AU - Truong, Daniel

AU - Tran, An Hao

AU - Thompson, Karen

AU - Shulman, Lisa M.

AU - Rodriguez, Dinorah

AU - Fernandez, Mariella

AU - Ramos, Carmen Serrano

AU - Cruz, Adelma Rivera

AU - Petzinger, Giselle

AU - Everett, Sheila

AU - Rao, Jayaraman

AU - Das, Clare

AU - Sethi, Kapil Dev

AU - Ligon, Kathy

AU - Waters, Cheryl

AU - Welsh, Mickie

AU - Feigin, Andrew

AU - Perlmutter, Joel

AU - McGee-Minnich, Lori

AU - Marek, Kenneth

AU - Broshjeit, Susan

AU - Cellar, Janet

AU - Hurtig, Howard

AU - Matthews, Mary

AU - Shannon, Kathleen

AU - Janko, Kimberly

AU - Paulson, George

AU - Weeks, Carolyn

AU - Reider, Carson

AU - Trosch, Richard

AU - Mistura, Kathie

AU - Koller, William

AU - Evatt, Marian

AU - Wood, Colleen

AU - Pfeiffer, Ronald

AU - Rast, Sara

AU - Pfeiffer, Brenda

AU - Brocht, Alicia

AU - Casaceli, Cindy

AU - Freimuth, Andrea

AU - Hodgeman, Karen

AU - Watts, Arthur

AU - Goldman, Sam

PY - 2007/3/1

Y1 - 2007/3/1

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 (≤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.

AB - 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 (≤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.

KW - African American

KW - Asian

KW - Hispanic

KW - Parkinson disease

KW - Pramipexole

KW - Randomized clinical trials

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