title: Global long-term study on motor and non-motor symptoms and safety of levodopa-carbidopa intestinal gel in routine care of advanced Parkinson's disease patients; 12-month interim outcomes.
abstract: BACKGROUND
  Intermittent oral delivery of levodopa is a major contributing factor for motor complications in Parkinson's disease (PD). Continuous infusion of levodopa-carbidopa intestinal gel (LCIG) into the jejunum using a portable pump via percutaneous endoscopic gastrostomy (PEG) improves motor complications and quality of life (QoL).
  
  
  OBJECTIVE
  To record long-term effectiveness of advanced PD patients undergoing LCIG infusion in routine care, by Unified Parkinson's Disease Rating Scale (UPDRS), Non-Motor Symptoms Scale (NMSS), PDQ-8 and EQ-5D questionnaires.
  
  
  METHODS
  Overall, 375 patients from 75 movement disorder centers in 18 countries were enrolled in this prospective non-interventional study. The 12-month interim outcomes of the first 172 included patients are presented here.
  
  
  RESULTS
  There were reductions of mean daily "Off" time from baseline (BL) (7.1 ± 3.5 h) and "On" time with dyskinesias (5.2 ± 4.5 h) at month 12 (M12) of -4.7 ± 3.4 and -1.7 ± 5.0 h respectively (p < 0.0001; p = 0.0228). UPDRS II and III "On" scores decreased from BL to M12 (p = 0.0107 and p = 0.0128). Total NMSS and PDQ-8 scores improved at M12 (p = 0.0014 and p = 0.0100). Mean LCIG dose administered through PEG at first visit (day after implantation) was 1304 ± 618 mg/day and remained stable through M12. Continuous LCIG infusion tolerability and adverse drug reactions were consistent with the known safety profile of previous studies.
  
  
  CONCLUSIONS
  This observational, routine-care study supports long-term safety and efficacy of LCIG infusion in advanced PD including motor, non-motor and QoL improvements.
authors.affiliation: Parkinson and Movement Disorders Unit, IRCCS Hospital San Camillo, Venice, Italy. Electronic address: angelo3000@yahoo.com.
authors.forename: Angelo
authors.initials: A
authors.lastname: Antonini
authors.affiliation: AbbVie, Inc., USA.
authors.forename: Ashley
authors.initials: A
authors.lastname: Yegin
authors.affiliation: AbbVie, Inc., USA.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Preda
authors.affiliation: AbbVie, Inc., USA.
authors.forename: Lars
authors.initials: L
authors.lastname: Bergmann
authors.affiliation: Dept of Neurology, Innsbruck Medical University, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage*; D002230:Carbidopa / Q000008:administration & dosage*; D005060:Europe; D005260:Female; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D007391:International Cooperation; D007422:Intestines / Q000502:physiology*; D007980:Levodopa / Q000008:administration & dosage*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D005782:Gels; D007980:Levodopa; D002230:Carbidopa
keywords: Advanced Parkinson's disease; Duodenal levodopa-carbidopa infusion; Motor symptoms; Non-motor symptoms; Quality of life; Routine patient care