title: Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients.
abstract: OBJECTIVE
  The purpose of this study was to assess the effect of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) in advanced Parkinson's disease patients with troublesome dyskinesia.
  
  
  METHODS
  Post hoc analyses of patient data from a 12-week, randomized, double-blind study and a 54-week open-label study were performed. Efficacy was assessed in the subgroup of patients defined by ≥1 hour of "on" time with troublesome dyskinesia at baseline as recorded in Parkinson's disease symptom diaries (double blind: n = 11 levodopa-carbidopa intestinal gel, n = 12 oral levodopa-carbidopa; open label: n = 144 levodopa-carbidopa intestinal gel). The changes in "off" time, "on" time with and without troublesome dyskinesia, and the overall safety and tolerability of levodopa-carbidopa intestinal gel were analyzed.
  
  
  RESULTS
  Although not significantly different from oral levodopa treatment (P > .05) in the double-blind study, levodopa-carbidopa intestinal gel treatment resulted in a reduction from baseline in "on" time with troublesome dyskinesia (mean [standard deviation] hours: baseline = 3.1 [1.7], change from baseline to final = -1.8 [1.8], P = .014), increase in "on" time without troublesome dyskinesia (baseline = 7.4 [2.2], change = 4.4 [3.6], P = .004), and decrease in "off" time (baseline = 5.5 [1.3], change = -2.7 [2.8], P = .015). Similar trends were found in the open-label study. An increase in levodopa-carbidopa intestinal gel dose was not significantly correlated with increased "on" time with troublesome dyskinesia in either study (double blind: r = -.073, P = .842; open label: r = -0.001, P = .992). Adverse events were usually mild to moderate in severity and related to the gastrointestinal procedure.
  
  
  CONCLUSIONS
  Our exploratory analyses suggest that optimizing levodopa delivery with levodopa-carbidopa intestinal gel may reduce troublesome dyskinesia in advanced Parkinson's disease.
authors.affiliation: Parkinson and Movement Disorders Unit, IRCCS Hospital San Camillo, Venice, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Antonini
authors.affiliation: Movement Disorders Unit, Westmead Hospital and Sydney Medical School, Sydney, Australia.
authors.forename: Victor S C
authors.initials: VS
authors.lastname: Fung
authors.affiliation: Department of Neurology, University of Vermont College of Medicine, Burlington, Vermont, USA.
authors.forename: James T
authors.initials: JT
authors.lastname: Boyd
authors.affiliation: University of Kentucky College of Medicine, Lexington, Kentucky, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Slevin
authors.affiliation: AbbVie, Inc., North Chicago, Illinois, USA.
authors.forename: Coleen
authors.initials: C
authors.lastname: Hall
authors.affiliation: AbbVie, Inc., North Chicago, Illinois, USA.
authors.forename: Krai
authors.initials: K
authors.lastname: Chatamra
authors.affiliation: AbbVie, Inc., North Chicago, Illinois, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Eaton
authors.affiliation: AbbVie, Inc., North Chicago, Illinois, USA.
authors.forename: Janet A
authors.initials: JA
authors.lastname: Benesh
mesh_terms: D058956:Administration, Mucosal; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D002230:Carbidopa / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004311:Double-Blind Method; D004338:Drug Combinations; D004409:Dyskinesia, Drug-Induced / Q000517:prevention & control*; D005260:Female; D005782:Gels; D006801:Humans; D007980:Levodopa / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D004338:Drug Combinations; D005782:Gels; C009265:carbidopa, levodopa drug combination; D007980:Levodopa; D002230:Carbidopa
keywords: Parkinson's disease; carbidopa-levodopa enteral suspension; dyskinesia; infusion; levodopa-carbidopa intestinal gel; percutaneous endoscopic gastrojejunostomy
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