title: Immediate versus delayed switch from levodopa/carbidopa to levodopa/carbidopa/entacapone: effects on motor function and quality of life in patients with Parkinson's disease with end-of-dose wearing off.
abstract: OBJECTIVE
  Assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off (EODWO), comparing immediate and delayed switch (IS, DEL) to levodopa/carbidopa/entacapone (LCE).
  
  
  BACKGROUND
  LCE treatment improves motor function in PD patients with EODWO. Correlations with QoL have not been previously assessed.
  
  
  METHODS
  A 16-week, prospective, randomized, multicenter, open-label study in PD subjects on stable levodopa/carbidopa (LC) doses with EODWO. The IS subjects switched to LCE at baseline; DEL subjects at week 4. The primary efficacy variable was UPDRS III score (baseline to week 4). QoL measurements (PDQUALIF, PDQ-39) were assessed at baseline, weeks 4, 8, and study endpoint.
  
  
  RESULTS
  The intent-to-treat population comprised 350/359 patients (IS, n = 177; DEL, n = 173). A significant decrease in UPDRS III scores at week 4 was observed (IS, 3.7U, p < .0001; DEL, 1.8U, p = .0018). Group differences favored IS (1.9U, p = .0148). At week 8, IS subjects had significant total score decreases in PDQUALIF (2.5U, p = .0133) and PDQ-39 (5.8U, p = .0001). In the mobility and activities of daily living PDQ-39 subdomains, IS subjects had significantly larger week 4 decreases (versus DEL p = .0331 and p = .0125, respectively). Adverse events included diarrhea (14.5%), nausea (12.3%), and dizziness (8.4%).
  
  
  CONCLUSIONS
  The IS provided greater motor improvement at week 4 and improved QoL at week 8.
authors.affiliation: Department of Neurology, Division of Movement Disorders, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA. marklew@usc.edu
authors.forename: Mark F
authors.initials: MF
authors.lastname: Lew
authors.forename: Monique
authors.initials: M
authors.lastname: Somogyi
authors.forename: Kevin
authors.initials: K
authors.lastname: McCague
authors.forename: Mickie
authors.initials: M
authors.lastname: Welsh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D002230:Carbidopa / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D002396:Catechols / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D007980:Levodopa / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology* / Q000523:psychology; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D016037:Single-Blind Method
chemical_list: D000978:Antiparkinson Agents; D002396:Catechols; D009570:Nitriles; D007980:Levodopa; C071192:entacapone; D002230:Carbidopa