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Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease.
Mov Disord. 2009 Mar 15; 24(4):541-50.MD

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.

Authors+Show Affiliations

Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606, USA. rhauser@health.usf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19058133

Citation

Hauser, Robert A., et al. "Double-blind Trial of Levodopa/carbidopa/entacapone Versus Levodopa/carbidopa in Early Parkinson's Disease." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 24, no. 4, 2009, pp. 541-50.
Hauser RA, Panisset M, Abbruzzese G, et al. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009;24(4):541-50.
Hauser, R. A., Panisset, M., Abbruzzese, G., Mancione, L., Dronamraju, N., & Kakarieka, A. (2009). Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Movement Disorders : Official Journal of the Movement Disorder Society, 24(4), 541-50. https://doi.org/10.1002/mds.22343
Hauser RA, et al. Double-blind Trial of Levodopa/carbidopa/entacapone Versus Levodopa/carbidopa in Early Parkinson's Disease. Mov Disord. 2009 Mar 15;24(4):541-50. PubMed PMID: 19058133.
* Article titles in AMA citation format should be in sentence-case
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 - ,, PY - 2008/12/6/pubmed PY - 2009/7/29/medline PY - 2008/12/6/entrez SP - 541 EP - 50 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 24 IS - 4 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. SN - 1531-8257 UR - https://www.unboundmedicine.com/medline/citation/19058133/Double_blind_trial_of_levodopa/carbidopa/entacapone_versus_levodopa/carbidopa_in_early_Parkinson's_disease_ DB - PRIME DP - Unbound Medicine ER -