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; Jayaraman Rao; Clare Das; Kapil 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

doi:10.1097/01.wnf.0000240943.59617.4c

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 EverettJayaraman Rao, Clare Das, Kapil 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

Neurology

Research output: Contribution to journal › Article › peer-review

29 Scopus citations

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 language	English (US)
Pages (from-to)	72-85
Number of pages	14
Journal	Clinical neuropharmacology
Volume	30
Issue number	2
DOIs	https://doi.org/10.1097/01.wnf.0000240943.59617.4c
State	Published - Mar 2007

Keywords

African American
Asian
Hispanic
Parkinson disease
Pramipexole
Randomized clinical trials

ASJC Scopus subject areas

Pharmacology
Clinical Neurology
Pharmacology (medical)

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10.1097/01.wnf.0000240943.59617.4c

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Tanner, C., Comella, C., Kamp, C., Kieburtz, K., Oakes, D., Marshall, F., Day, D., Carter, J., Pahwa, R., Shoulson, I., Truong, D., Tran, A. H., Thompson, K., Shulman, L. M., Rodriguez, D., Fernandez, M., Ramos, C. S., Cruz, A. R., Petzinger, G., ... Goldman, S. (2007). Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage. Clinical neuropharmacology, 30(2), 72-85. https://doi.org/10.1097/01.wnf.0000240943.59617.4c

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, K, 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

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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.",

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

year = "2007",

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doi = "10.1097/01.wnf.0000240943.59617.4c",

language = "English (US)",

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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

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

Y1 - 2007/3

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.

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KW - Pramipexole

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

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