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From the Department of Neuroscience, Neurology (Drs. Nyholm, Aquilonius, and Askmark), Uppsala University Hospital, Department of Neurology (Dr. Nilsson Remahl), Karolinska University Hospital Huddinge, Stockholm, Department of Neurology (Dr. Dizdar), University Hospital, Linköping, Department of Clinical Neuroscience and Neurology (Drs. Constantinescu and Holmberg), Sahlgrenska University Hospital, Göteborg, and Department of Geriatric Medicine and Rehabilitation (Dr. Jansson), Sundsvall Hospital, Sweden.
Address correspondence and reprint requests to Dr. D.Nyholm, Department of Neuroscience, Neurology, Uppsala University Hospital, SE-75185 Uppsala, Sweden; e-mail: dag.nyholm{at}neurologi.uu.se
Objectives: 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.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the January 25 issue to find the title link for this article.
See also page 182
Supported by NeoPharma AB (Uppsala, Sweden).
Dr. S.-M. Aquilonius is one of the founders of NeoPharma (est. 1994). Dr. Nyholm serves as a consultant (medical advisor) to NeoPharma.
Received July 6, 2004. Accepted in final form September 17, 2004.
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