Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease.
OBJECTIVE
To compare daytime intraduodenal levodopa/carbidopa infusion as monotherapy with individually optimized conventional combination therapies in patients with advanced Parkinson disease (PD) for motor fluctuations and quality of life (QoL).


METHODS
Twenty-four patients with motor fluctuations and dyskinesia were studied in a randomized crossover design to compare individualized conventional treatment and intraduodenal infusion of a levodopa/carbidopa gel for 3 + 3 weeks. Video scoring of motor function was assessed by blinded assessors on a global Treatment Response Scale from -3 to 0 to +3 (from severe "off" to "on" to "on" with severe dyskinesia). Patient self-assessment of motor performance and QoL was done using an electronic diary.


RESULTS
Median percentage of ratings in a functional "on" interval (-1 to +1) was increased from 81 to 100% by infusion therapy (p < 0.01). This improvement was accompanied by a decrease in "off" state (p < 0.01) and no increase in dyskinesia. Median Unified Parkinson's Disease Rating Scale score decreased from 53 to 35 in favor of infusion (p < 0.05). QoL was improved, using the two instruments: Parkinson's Disease Questionnaire-39 and 15D Quality of Life Instrument (p < 0.01). Adverse events were similar for both treatment strategies.


CONCLUSIONS
Continuous intraduodenal infusion of the levodopa/carbidopa enteral gel as monotherapy is safe and clinically superior to a number of individually optimized combinations of conventional oral and subcutaneous medications in patients with motor fluctuations. Intraduodenal infusion of levodopa offers an important alternative in treating patients with advanced Parkinson disease.
Nyholm
D
D
Department of Neuroscience, Neurology, Uppsala University Hospital, SE-75185 Uppsala, Sweden. dag.nyholm@neurologi.uu.se
Nilsson Remahl
A I M
AI
Dizdar
N
N
Constantinescu
R
R
Holmberg
B
B
Jansson
R
R
Aquilonius
S-M
SM
Askmark
H
H
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002230:Carbidopa / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D004386:Duodenum; D004409:Dyskinesia, Drug-Induced / Q000209:etiology; D005260:Female; D005782:Gels; D006801:Humans; D007440:Intubation; D007980:Levodopa / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D011597:Psychomotor Performance / Q000187:drug effects; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013535:Suspensions; D014743:Videotape Recording
D000978:Antiparkinson Agents; D005782:Gels; D013535:Suspensions; D007980:Levodopa; D002230:Carbidopa