Abstract
BackgroundLevodopa–carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson’s disease (PD), is covered by health insurance in Japan since September 2016. Various LCIG procedure/device-associated adverse events (AEs) have been reported; however, reports on their treatment have been limited. This is the first multicenter study to clarify the frequency and timing of device-related AEs.MethodsBetween September 2016 and December 2018, 104 patients introduced to the LCIG treatment for advanced PD in 11 hospitals were included. The patients’ characteristics, AEs incidence, AEs time, and tube exchange time were investigated.ResultsThe median follow-up period was 21.5 months. Minor AE cases were 29.4%, whereas major AE cases were 43.1%. Majority of major AEs (n = 55, 94.8%) were managed with endoscopic treatment, such as tube exchange. Few severe AEs required surgical treatment (n =3, 5.2%). The mean (range) exposure to percutaneous endoscopic gastrojejunostomy (PEG-J) was 14.7 (0–33) months. One year after the LCIG treatment introduction, 55 patients (54.0%) retained the original PEG-J tube. The mean PEG-J tube exchange time was 10.8 ± 7.0 months in all patients, 11.6 ± 4.7 and 10.5 ± 7.7 months in patients with scheduled exchange and who underwent exchange due to AEs, respectively.ConclusionsSome device-related AEs occurred during the LCIG treatment; however, only few were serious, most of which could be treated with simple procedures or tube replacement with endoscopy. Therefore, the LCIG treatment is feasible and safe and is a unique treatment option for PD, requiring endoscopists’ understanding and cooperation.
Highlights
Levodopa–carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson’s disease (PD), is covered by health insurance in Japan since September 2016
Device-related Adverse event (AE) were defined as cases that required any tube adjustment or replacement, deficiency of a portable infusion pump, breakage of percutaneous endoscopic gastrostomy (PEG)/percutaneous endoscopic gastrojejunostomy (PEG-J) tube, any symptoms related to PEG/PEG-J tube placement, skin symptom around PEG
A total of 104 patients who underwent LCIG treatment for advanced PD were included in this study
Summary
Levodopa–carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson’s disease (PD), is covered by health insurance in Japan since September 2016. Various LCIG procedure/device-associated adverse events (AEs) have been reported; reports on their treatment have been limited This is the first multicenter study to clarify the frequency and timing of device-related AEs. As the risk of development of Parkinson’s disease (PD) sharply increases with age and due to the world’s aging population, the number of individuals affected is poised for exponential growth [1]. LCIG helps maintain higher therapeutic plasma concentrations of levodopa than standard oral levodopa therapy [4, 9] It has been covered by insurance in Japan since September 2016. This is the first multicenter study on the frequency of LCIG procedure/device-associated AEs and the timing of tube replacement in Japan
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