title: Pooled analysis of phase III with entacapone in Parkinson's disease.
abstract: OBJECTIVE
  To investigate efficacy and safety of entacapone across phase III studies in Parkinson's disease (PD) with wearing-off symptoms.
  
  
  METHODS
  Retrospective, pooled analysis of four phase 3 randomized, double-blind, placebo-controlled studies with entacapone.
  
  
  RESULTS
  475 of 808 patients with PD received entacapone and 333 received placebo. Entacapone improved daily OFF- and ON-times (change from baseline) by 0.8 h compared with placebo (P < 0.0001 for both variables). Entacapone was also better in UPDRS II (P < 0.01) and III (P < 0.01) scores and global evaluation (P < 0.05). Similar benefits were seen in subgroups of patients with and without dopamine agonist (DA) or selegiline, but the subgroup results should be regarded as exploratory. Entacapone was generally well tolerated. Dyskinesia and nausea were more frequently reported by patients on entacapone (25.7% and 14.5% of patients, respectively) than those receiving placebo (15.6% and 6.0%, respectively). However, there was no difference in reports of hallucinations between entacapone (4.8%) and placebo (4.8%).
  
  
  CONCLUSIONS
  Entacapone improved daily OFF- and ON-times by a mean of 0.8 h compared with placebo across the four pooled efficacy studies and was generally well tolerated. The results of this pooled analysis potentially serve as a useful benchmarking data for new therapies (especially levodopa products) in advanced patients with PD.
authors.affiliation: Orion Pharma, Turku, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Kuoppamäki
authors.forename: M
authors.initials: M
authors.lastname: Vahteristo
authors.forename: J
authors.initials: J
authors.lastname: Ellmén
authors.forename: K
authors.initials: K
authors.lastname: Kieburtz
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D002396:Catechols / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D018491:Dopamine Agonists / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009570:Nitriles / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012642:Selegiline / Q000627:therapeutic use
chemical_list: D000978:Antiparkinson Agents; D002396:Catechols; D018491:Dopamine Agonists; D009570:Nitriles; D012642:Selegiline; D007980:Levodopa; C071192:entacapone
keywords: dopamine agonist; entacapone; levodopa; selegiline; wearing-off