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.

• Authors: Robert A Hauser, Michel Panisset, Giovanni Abbruzzese, Linda Mancione, Nalina Dronamraju, Algirdas Kakarieka, FIRST-STEP Study Group
• Journal: Movement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 24 Issue 4 Pg. 541-50 (Mar 15 2009) ISSN: 1531-8257 [Electronic] United States
• PMID: 19058133 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiparkinson Agents
• Catechols
• Nitriles
• Levodopa
• entacapone
• Carbidopa

Topics

• Adult
• Aged
• Aged, 80 and over
• Antiparkinson Agents (therapeutic use)
• Carbidopa (therapeutic use)
• Catechols (therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Levodopa (therapeutic use)
• Male
• Middle Aged
• Nitriles (therapeutic use)
• Outcome Assessment, Health Care (methods)
• Parkinson Disease (drug therapy)
• Severity of Illness Index