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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced parkinson's disease patients
AAPS Journal, Volume 15, No. 2, Year 2013
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Description
Motor complications of Parkinson's disease (PD) are a consequence of pulsatile dopaminergic stimulation from standard oral levodopa therapy. Levodopa-carbidopa intestinal gel (LCIG) is infused continuously via an intrajejunal percutaneous gastrostomy tube. This was the first study designed to characterize the full pharmacokinetic profiles of levodopa, carbidopa, and levodopa metabolite, 3-O-methyldopa (3-OMD) with 16-h LCIG infusion. Nineteen advanced PD patients (mean age, 65 years) who were on LCIG therapy for ≥30 days were enrolled. Patients received their individualized LCIG infusion doses, and serial pharmacokinetic samples were collected. Eighteen patients completed the study; 19 were assessed for safety. Mean (SD) total levodopa and carbidopa doses were 1,580 (403) and 395 (101) mg, respectively. Mean (SD) C avg (μg/mL) were 2.9 (0.84) for levodopa, 17.1 (4.99) for 3-OMD, and 0.22 (0.08) for carbidopa. The degree of fluctuation [defined as (C max - C min)/C avg] in levodopa, 3-OMD, and carbidopa plasma concentrations was very low (0.52, 0.21, and 0.96, respectively) during hours 2-16 of infusion. Accordingly, the within-subject coefficients of variation in levodopa, 3-OMD, and carbidopa concentrations were low (13%, 6%, and 19%, respectively). Three patients (16%) reported ≥1 treatment-emergent adverse event; none were considered severe. Continuous intrajejunal LCIG infusion maintained stable plasma levodopa levels over 16 h. Consistent exposure has been shown to reduce motor and nonmotor complications associated with oral medications. LCIG was well tolerated, consistent with previous reports. © 2012 American Association of Pharmaceutical Scientists.
Authors & Co-Authors
Nyholm, Dag
Sweden, Uppsala
Uppsala Universitet
Odin, Per
Sweden, Lund
Skånes Universitetssjukhus
Germany, Bremerhaven
Klinikum Bremerhaven
Johansson, Anders
Sweden, Uppsala
Uppsala Universitet
Sweden, Stockholm
Karolinska Universitetssjukhuset
Chatamra, Krai
United States, Chicago
Abbott Laboratories
Locke, Charles
United States, Chicago
Abbott Laboratories
Dutta, Sandeep
United States, Chicago
Abbott Laboratories
Othman, Ahmed A.
United States, Chicago
Abbott Laboratories
Egypt, Cairo
Faculty of Pharmacy
Statistics
Citations: 7
Authors: 7
Affiliations: 6
Identifiers
Doi:
10.1208/s12248-012-9439-1
ISSN:
15507416
Research Areas
Health System And Policy