Initiation and dose optimization for levodopa-carbidopa intestinal gel: Insights from phase 3 clinical trials
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. Clinical experience with 2 LCIG dosing paradigms from phase 3 studies was examined. In an open-la...
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| Vydáno v: | Parkinsonism & related disorders Ročník 21; číslo 7; s. 742 - 748 |
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| Médium: | Journal Article |
| Jazyk: | angličtina |
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Elsevier Ltd
01.07.2015
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| ISSN: | 1353-8020, 1873-5126, 1873-5126 |
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| Abstract | 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.
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.
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%).
These results support the option of initiating LCIG with or without NJ and as either monotherapy or polypharmacy.
•LCIG can be initiated directly via PEG-J; consider temporary NJ in select patients.•In advanced PD, LCIG is effective as monotherapy or as part of existing polytherapy.•Dose optimization with LCIG can be achieved within days.•Once titrated, LCIG dosage remained stable during a study of more than a year.•Discontinuations due to nonprocedure/nondevice AEs were low (<3%). |
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| AbstractList | 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.
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.
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%).
These results support the option of initiating LCIG with or without NJ and as either monotherapy or polypharmacy.
•LCIG can be initiated directly via PEG-J; consider temporary NJ in select patients.•In advanced PD, LCIG is effective as monotherapy or as part of existing polytherapy.•Dose optimization with LCIG can be achieved within days.•Once titrated, LCIG dosage remained stable during a study of more than a year.•Discontinuations due to nonprocedure/nondevice AEs were low (<3%). 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.BACKGROUNDLevodopa-carbidopa intestinal gel (LCIG) provides continuous infusion and reduces "off" time in advanced Parkinson's disease (PD) patients with motor fluctuations despite optimized pharmacotherapy.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.METHODSClinical 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.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%).RESULTSIn 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%).These results support the option of initiating LCIG with or without NJ and as either monotherapy or polypharmacy.CONCLUSIONThese results support the option of initiating LCIG with or without NJ and as either monotherapy or polypharmacy. Abstract 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. 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. 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. 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%). These results support the option of initiating LCIG with or without NJ and as either monotherapy or polypharmacy. |
| Author | Benesh, Janet A. Fung, Victor S.C. Martínez Castrillo, Juan Carlos Dubow, Jordan S. Lew, Mark F. Krüger, Rejko Chatamra, Krai Slevin, John T. Robieson, Weining Z. |
| Author_xml | – sequence: 1 givenname: Mark F. surname: Lew fullname: Lew, Mark F. email: Mark.Lew@med.usc.edu organization: Department of Neurology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA – sequence: 2 givenname: John T. surname: Slevin fullname: Slevin, John T. organization: Department of Neurology, University of Kentucky, Lexington, KY, USA – sequence: 3 givenname: Rejko surname: Krüger fullname: Krüger, Rejko organization: Department for Neurodegenerative Diseases and Hertie-Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany – sequence: 4 givenname: Juan Carlos surname: Martínez Castrillo fullname: Martínez Castrillo, Juan Carlos organization: Servicio de Neurología, IRYCIS, Hospital Ramón y Cajal de Madrid, Madrid, Spain – sequence: 5 givenname: Krai surname: Chatamra fullname: Chatamra, Krai organization: AbbVie Inc., North Chicago, IL, USA – sequence: 6 givenname: Jordan S. surname: Dubow fullname: Dubow, Jordan S. organization: Formerly with AbbVie Inc., North Chicago, IL, USA – sequence: 7 givenname: Weining Z. surname: Robieson fullname: Robieson, Weining Z. organization: AbbVie Inc., North Chicago, IL, USA – sequence: 8 givenname: Janet A. surname: Benesh fullname: Benesh, Janet A. organization: AbbVie Inc., North Chicago, IL, USA – sequence: 9 givenname: Victor S.C. surname: Fung fullname: Fung, Victor S.C. organization: Department of Neurology, Westmead Hospital and Sydney Medical School, Sydney, Australia |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25962554$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1016_j_parkreldis_2015_11_017 crossref_primary_10_2169_internalmedicine_4394_24 crossref_primary_10_1016_j_parkreldis_2017_03_006 crossref_primary_10_1007_s12325_021_01747_1 crossref_primary_10_1111_imj_13754 crossref_primary_10_1002_mds_28595 crossref_primary_10_1007_s12325_019_01014_4 crossref_primary_10_1177_1756285616681280 crossref_primary_10_1007_s40265_019_01201_1 crossref_primary_10_1111_imj_13757 crossref_primary_10_1002_mdc3_12526 crossref_primary_10_2217_nmt_2016_0011 |
| Cites_doi | 10.1002/mds.21500 10.1016/S1353-8020(09)70844-2 10.1002/mds.26123 10.1097/WNF.0b013e3180ed449f 10.1016/j.parkreldis.2012.11.020 10.2165/11310940-000000000-00000 10.2165/00003088-200241040-00003 10.1097/00002826-200003000-00003 10.1097/wnf.0b013e31814b113e 10.1034/j.1600-0404.2001.00153.x 10.1002/mds.22112 10.1016/j.parkreldis.2010.11.009 10.1007/s00702-013-0981-5 10.1097/00002826-200305000-00010 10.1212/01.WNL.0000149637.70961.4C 10.2165/00003495-199855001-00001 10.1007/s00228-009-0622-y 10.1111/ene.12309 10.1016/S1474-4422(06)70521-X 10.1111/j.1468-1331.2012.03679.x 10.1016/j.parkreldis.2009.07.015 10.1016/S1474-4422(13)70293-X |
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| Copyright | 2015 AbbVie Inc, employer of authors K. Chatamra,W. Robieson, and J. Benesh AbbVie Inc, employer of authors K. Chatamra,W. Robieson, and J. Benesh Copyright © 2015 AbbVie Inc, employer of authors K. Chatamra,W. Robieson, and J. Benesh. Published by Elsevier Ltd.. All rights reserved. |
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| Keywords | Motor fluctuations Dosing PEG-J procedure Levodopa-carbidopa intestinal gel Parkinson's disease |
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| Snippet | Levodopa-carbidopa intestinal gel (LCIG) provides continuous infusion and reduces “off” time in advanced Parkinson's disease (PD) patients with motor... Abstract Background Levodopa-carbidopa intestinal gel (LCIG) provides continuous infusion and reduces “off” time in advanced Parkinson's disease (PD) patients... Levodopa-carbidopa intestinal gel (LCIG) provides continuous infusion and reduces "off" time in advanced Parkinson's disease (PD) patients with motor... |
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| Title | Initiation and dose optimization for levodopa-carbidopa intestinal gel: Insights from phase 3 clinical trials |
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