Get access

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

Authors


  • Disclosures: No compensation was provided to Drs Hauser, Panisset, or Abbruzzese for their work on this manuscript. Drs Hauser, Panisset, and Abbruzzese's institutions received compensation from Novartis for their sites' conduct of the study. Drs Hauser, Panisset, and Abbruzzese have received honoraria and consulting fees from Novartis and Orion Pharma. Linda Mancione, Nalina Dronamraju, and Algirdas Kakarieka are employees of Novartis. Non-Sponsor Disclosures: Dr Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KGA, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant and Vernalis. Dr Panisset has received honoraria or consulting fees from Teva, Allergan, UCB-Perdue, Prestwick, Smith-Kline Beecham and Solvay. Dr Abbruzzese has received honoraria or consulting fees from Boehringer Ingelheim and Wyeth Lederle. The authors have confirmed that their work complies with the Journal's Editorial policy on ghost-writing. (Movement Disorders Vol. 20., No. 12, 2005, p. 1536)

  • Members of FIRST-STEP Study Group are listed in the Appendix.

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. © 2008 Movement Disorder Society

Get access to the full text of this article

Ancillary