Reference : Initiation and dose optimization for levodopa-carbidopa intestinal gel: Insights from...

	Document type :	Scientific journals : Article
	Discipline(s) :	Human health sciences : Neurology
	To cite this reference:	http://hdl.handle.net/10993/22630

Title :	Initiation and dose optimization for levodopa-carbidopa intestinal gel: Insights from phase 3 clinical trials
Language :	English
Author, co-author :	Lew, M. F. [> >]
	Slevin, J. T. [> >]
	Krüger, Rejko [University of Luxembourg > Faculty of Science, Technology and Communication (FSTC) > Life Science Research Unit]
	Martinez, Castrillo [> >]
	Chatamra, K. [> >]
	Dubow, J. S. [> >]
	Robieson, W. Z. [> >]
	Benesh, J. A. [> >]
	Fung, V. S. [> >]
Publication date :	2015
Journal title :	Parkinsonism and Related Disorders
Volume :	21
Issue/season :	7
Pages :	742-748
Peer reviewed :	Yes (verified by ORBilu)
ISSN :	1353-8020
e-ISSN :	1873-5126
Country :	England
Keywords :	[en] Dosing ; Levodopa-carbidopa intestinal gel ; Motor fluctuations ; PEG-J procedure ; Parkinson's disease
Abstract :	[en] BACKGROUND: Levodopa-carbidopa intestinal gel (LCIG) provides continuous infusion and reduces "off" time in advanced Parkinson's disease (PD) patients with motor fluctuations despite optimized pharmacotherapy. METHODS: Clinical experience with 2 LCIG dosing paradigms from phase 3 studies was examined. In an open-label, 54-week study, LCIG was initiated as daytime monotherapy via nasojejunal (NJ) tube then switched to percutaneous endoscopic gastrojejunostomy (PEG-J) tube; adjunctive therapy was permitted 28 days postPEG-J. In a 12-week, double-blind, placebo-controlled, double-dummy trial, patients continued stable doses of existing anti-PD medications, but LCIG replaced daytime oral levodopa-carbidopa and was initiated directly via PEG-J. RESULTS: In the open-label study, 92% of 354 patients received monotherapy at post-PEG-J week 4; mean titration duration was 7.6 days; dosing remained stable post-titration (mean total daily dose [TDD] was 1572 mg at last visit). In the double-blind trial, 84% received polypharmacy; mean titration took 7.1 days for the LCIG arm (TDD post-titration: 1181 mg; n = 37). At post-PEG-J week 4, mean "off" time with LCIG was reduced by 3.9 h (open-label/monotherapy study) and 3.7 h (double-blind/polypharmacy trial). NJ treatment (open-label study only) required an additional procedure with related adverse events (AEs) and withdrawals. The most common AEs during PEG-J weeks 1-4 in the open-label/monotherapy and double-blind/polypharmacy trials, respectively, were complication of device insertion (35%, 57%) and abdominal pain (26%, 51%). Discontinuations due to nonprocedure/nondevice AEs were low (2.2%, 2.7%). CONCLUSION: These results support the option of initiating LCIG with or without NJ and as either monotherapy or polypharmacy.
Research centres :	Luxembourg Centre for Systems Biomedicine (LCSB): Clinical & Experimental Neuroscience (Krüger Group)
Permalink :	http://hdl.handle.net/10993/22630
DOI :	10.1016/j.parkreldis.2015.04.022

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