title: Sustained efficacy of apomorphine in Japanese patients with advanced Parkinson's disease.
abstract: BACKGROUND
  This report presents data from one of the first trials of apomorphine rescue treatment for advanced Parkinson's disease (PD) conducted in Japan. This 3 month trial aimed to evaluate the sustainability of efficacy of intermittent apomorphine rescue treatment.
  
  
  METHODS
  A phase III, double-blind, placebo-controlled trial was conducted in PD patients (n = 31) with motor fluctuations in spite of individually titrated treatment with levodopa and other anti PD. Intermittent treatment was titrated to the maintenance dose with a subsequent unblind 12-week outpatient phase. At the week-12 visit, response to apomorphine or placebo was assessed as primary efficacy endpoint using the Unified Parkinson's Disease Rating Scale (UPDRS) part III (Motor Examination) under double-blind crossover conditions.
  
  
  RESULTS
  In the crossover phase (n = 28), least squares mean changes in the UPDRS part III score from pre-dose were -24.5 points with apomorphine and -2.3 points with placebo, showing that apomorphine, compared with placebo, provided a significantly greater improvement in the UPDRS part III score change (difference between treatments: -22.1 [95% confidence interval, -27.8, -16.4]; P < 0.001). The most frequently reported adverse events during the study were increased eosinophil count (8 patients), nausea (7), somnolence (6), dyskinesia (5), yawning (5), and decreased blood pressure (3).
  
  
  CONCLUSIONS
  Our results indicate that a 3-month use of intermittent apomorphine is an effective rescue therapy for "off" episodes in advanced PD patients.
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, 3-1-3 Hongo, Bunkyo, Tokyo 113-8421, Japan. Electronic address: nhattori@juntendo.ac.jp.
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Hattori
authors.affiliation: Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Ehime, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nomoto
mesh_terms: D000368:Aged; D001058:Apomorphine / Q000627:therapeutic use*; D044466:Asian People; D018592:Cross-Over Studies; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*
chemical_list: D018491:Dopamine Agonists; D001058:Apomorphine
keywords: Apomorphine; Dopamine agonist; Parkinson's disease; Randomized controlled study