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

Research output: Contribution to journalArticlepeer-review

89 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 languageEnglish (US)
Pages (from-to)541-550
Number of pages10
JournalMovement Disorders
Volume24
Issue number4
DOIs
StatePublished - Mar 15 2009

Keywords

  • Entacapone
  • Levodopa
  • Parkinson's disease
  • Stalevo
  • Treatment
  • UPDRS

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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