Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease

Robert A. Hauser; Michel Panisset; Giovanni Abbruzzese; Linda Mancione; Nalina Dronamraju; Algirdas Kakarieka; Anwar Ahmed; Alberto Albanese; Ubaldo Bonuccelli; Raif Cakmur; Kelvin Chou; Martin Cloutier; Luis Cunha; Hiren Desai; Ruth Djaldetti; Vaclav Dostal; Bulent Elibol; Murat Emre; Urszula Fiszer; Joseph Friedman; Nir Giladi; Stephen Gollomp; Alan Goodridge; David Grimes; Tanya Gurevich; Mark Guttman; Sharon Hassin; Zhigao Huang; Robert Hutchman; Joohi Jimenez-Shahed; Petr Kanovsky; David King; Colin Klein; Scott Kraft; Anne Louise Lafontaine; Leonardo Lopiano; Peter Lewitt; Vojtech Mach; Paul Mazzeo; Giuseppe Meco; Tilak Mendis; Letterio Morgante; Grzegorz Opala; Gianni Pezzoli; Emmanuelle Pourcher; Jose Martin Rabey; Alexander Rajput; Jean Rivest; Mario Miguel Rosa; Michael Rossen; Monika Rudzinska; Stefano Ruggieri; Evzen Ruzicka; Michael Sauter; Dee Silver; Dwight Stewart; William Sunter; Ryan Uitti; Felix Veloso; Mario Zappia; Theresa Zesiewicz

doi:10.1002/mds.22343

Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease

Robert A. Hauser^*, Michel Panisset, Giovanni Abbruzzese, Linda Mancione, Nalina Dronamraju, Algirdas Kakarieka, Anwar Ahmed, Alberto Albanese, Ubaldo Bonuccelli, Raif Cakmur, Kelvin Chou, Martin Cloutier, Luis Cunha, Hiren Desai, Ruth Djaldetti, Vaclav Dostal, Bulent Elibol, Murat Emre, Urszula Fiszer, Joseph FriedmanNir Giladi, Stephen Gollomp, Alan Goodridge, David Grimes, Tanya Gurevich, Mark Guttman, Sharon Hassin, Zhigao Huang, Robert Hutchman, Joohi Jimenez-Shahed, Petr Kanovsky, David King, Colin Klein, Scott Kraft, Anne Louise Lafontaine, Leonardo Lopiano, Peter Lewitt, Vojtech Mach, Paul Mazzeo, Giuseppe Meco, Tilak Mendis, Letterio Morgante, Grzegorz Opala, Gianni Pezzoli, Emmanuelle Pourcher, Jose Martin Rabey, Alexander Rajput, Jean Rivest, Mario Miguel Rosa, Michael Rossen, Monika Rudzinska, Stefano Ruggieri, Evzen Ruzicka, Michael Sauter, Dee Silver, Dwight Stewart, William Sunter, Ryan Uitti, Felix Veloso, Mario Zappia, Theresa Zesiewicz

^*Corresponding author for this work

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

107 Scopus citations

Abstract

We performed a 39-week, randomized, double-blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/ entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty-three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three-times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject-reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator-rated CGI scores. Wearing-off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications.

Original language	English
Pages (from-to)	541-550
Number of pages	10
Journal	Movement Disorders
Volume	24
Issue number	4
DOIs	https://doi.org/10.1002/mds.22343
State	Published - 15 Mar 2009
Externally published	Yes

Keywords

Entacapone
Levodopa
Parkinson's disease
Stalevo
Treatment
UPDRS

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10.1002/mds.22343

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Hauser, R. A., Panisset, M., Abbruzzese, G., Mancione, L., Dronamraju, N., Kakarieka, A., Ahmed, A., Albanese, A., Bonuccelli, U., Cakmur, R., Chou, K., Cloutier, M., Cunha, L., Desai, H., Djaldetti, R., Dostal, V., Elibol, B., Emre, M., Fiszer, U., ... Zesiewicz, T. (2009). Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Movement Disorders, 24(4), 541-550. https://doi.org/10.1002/mds.22343

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title = "Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease",

abstract = "We performed a 39-week, randomized, double-blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/ entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty-three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three-times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject-reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator-rated CGI scores. Wearing-off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications.",

keywords = "Entacapone, Levodopa, Parkinson's disease, Stalevo, Treatment, UPDRS",

author = "Hauser, {Robert A.} and Michel Panisset and Giovanni Abbruzzese and Linda Mancione and Nalina Dronamraju and Algirdas Kakarieka and Anwar Ahmed and Alberto Albanese and Ubaldo Bonuccelli and Raif Cakmur and Kelvin Chou and Martin Cloutier and Luis Cunha and Hiren Desai and Ruth Djaldetti and Vaclav Dostal and Bulent Elibol and Murat Emre and Urszula Fiszer and Joseph Friedman and Nir Giladi and Stephen Gollomp and Alan Goodridge and David Grimes and Tanya Gurevich and Mark Guttman and Sharon Hassin and Zhigao Huang and Robert Hutchman and Joohi Jimenez-Shahed and Petr Kanovsky and David King and Colin Klein and Scott Kraft and Lafontaine, {Anne Louise} and Leonardo Lopiano and Peter Lewitt and Vojtech Mach and Paul Mazzeo and Giuseppe Meco and Tilak Mendis and Letterio Morgante and Grzegorz Opala and Gianni Pezzoli and Emmanuelle Pourcher and Rabey, {Jose Martin} and Alexander Rajput and Jean Rivest and Rosa, {Mario Miguel} and Michael Rossen and Monika Rudzinska and Stefano Ruggieri and Evzen Ruzicka and Michael Sauter and Dee Silver and Dwight Stewart and William Sunter and Ryan Uitti and Felix Veloso and Mario Zappia and Theresa Zesiewicz",

year = "2009",

month = mar,

day = "15",

doi = "10.1002/mds.22343",

language = "אנגלית",

volume = "24",

pages = "541--550",

journal = "Movement Disorders",

issn = "0885-3185",

publisher = "John Wiley and Sons Inc.",

number = "4",

}

Hauser, RA, Panisset, M, Abbruzzese, G, Mancione, L, Dronamraju, N, Kakarieka, A, Ahmed, A, Albanese, A, Bonuccelli, U, Cakmur, R, Chou, K, Cloutier, M, Cunha, L, Desai, H, Djaldetti, R, Dostal, V, Elibol, B, Emre, M, Fiszer, U, Friedman, J, Giladi, N, Gollomp, S, Goodridge, A, Grimes, D, Gurevich, T, Guttman, M, Hassin, S, Huang, Z, Hutchman, R, Jimenez-Shahed, J, Kanovsky, P, King, D, Klein, C, Kraft, S, Lafontaine, AL, Lopiano, L, Lewitt, P, Mach, V, Mazzeo, P, Meco, G, Mendis, T, Morgante, L, Opala, G, Pezzoli, G, Pourcher, E, Rabey, JM, Rajput, A, Rivest, J, Rosa, MM, Rossen, M, Rudzinska, M, Ruggieri, S, Ruzicka, E, Sauter, M, Silver, D, Stewart, D, Sunter, W, Uitti, R, Veloso, F, Zappia, M & Zesiewicz, T 2009, 'Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease', Movement Disorders, vol. 24, no. 4, pp. 541-550. https://doi.org/10.1002/mds.22343

TY - JOUR

T1 - Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease

AU - Hauser, Robert A.

AU - Panisset, Michel

AU - Abbruzzese, Giovanni

AU - Mancione, Linda

AU - Dronamraju, Nalina

AU - Kakarieka, Algirdas

AU - Ahmed, Anwar

AU - Albanese, Alberto

AU - Bonuccelli, Ubaldo

AU - Cakmur, Raif

AU - Chou, Kelvin

AU - Cloutier, Martin

AU - Cunha, Luis

AU - Desai, Hiren

AU - Djaldetti, Ruth

AU - Dostal, Vaclav

AU - Elibol, Bulent

AU - Emre, Murat

AU - Fiszer, Urszula

AU - Friedman, Joseph

AU - Giladi, Nir

AU - Gollomp, Stephen

AU - Goodridge, Alan

AU - Grimes, David

AU - Gurevich, Tanya

AU - Guttman, Mark

AU - Hassin, Sharon

AU - Huang, Zhigao

AU - Hutchman, Robert

AU - Jimenez-Shahed, Joohi

AU - Kanovsky, Petr

AU - King, David

AU - Klein, Colin

AU - Kraft, Scott

AU - Lafontaine, Anne Louise

AU - Lopiano, Leonardo

AU - Lewitt, Peter

AU - Mach, Vojtech

AU - Mazzeo, Paul

AU - Meco, Giuseppe

AU - Mendis, Tilak

AU - Morgante, Letterio

AU - Opala, Grzegorz

AU - Pezzoli, Gianni

AU - Pourcher, Emmanuelle

AU - Rabey, Jose Martin

AU - Rajput, Alexander

AU - Rivest, Jean

AU - Rosa, Mario Miguel

AU - Rossen, Michael

AU - Rudzinska, Monika

AU - Ruggieri, Stefano

AU - Ruzicka, Evzen

AU - Sauter, Michael

AU - Silver, Dee

AU - Stewart, Dwight

AU - Sunter, William

AU - Uitti, Ryan

AU - Veloso, Felix

AU - Zappia, Mario

AU - Zesiewicz, Theresa

PY - 2009/3/15

Y1 - 2009/3/15

N2 - We performed a 39-week, randomized, double-blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/ entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty-three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three-times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject-reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator-rated CGI scores. Wearing-off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications.

AB - We performed a 39-week, randomized, double-blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/ entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty-three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three-times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject-reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator-rated CGI scores. Wearing-off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications.

KW - Entacapone

KW - Levodopa

KW - Parkinson's disease

KW - Stalevo

KW - Treatment

KW - UPDRS

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DO - 10.1002/mds.22343

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SN - 0885-3185

VL - 24

SP - 541

EP - 550

JO - Movement Disorders

JF - Movement Disorders

IS - 4

ER -

Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease

Abstract

Keywords

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