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• W2912098476 abstract "Introduction: Patients with advanced Parkinson's disease (APD) experience unpredictable motor complications with oral levodopa therapy exacerbated by fluctuating drug plasma levels, which are due largely to impaired gastric emptying. Motor complications can be reduced by delivering levodopacarbidopa intestinal gel (LCIG, known in the United States as carbidopa-levodopa enteral suspension [CLES]) directly to the jejunum using a percutaneous endoscopic gastrostomy (PEG tube) with jejunal extension tube (J tube). We compared the safety of the LCIG system among ambulatory APD patients who had PEG-J placement in an inpatient setting, with patients who had PEG-J placement in an outpatient setting. Methods: Patients had a 15 French Freka PEG tube and a 9 French J extension tube placed during the same endoscopy. In the phase 3 studies (which consisted of: a pivotal study, an open-label safety study, and extension studies), patients had PEG-J placement as an inpatient procedure (defined as a hospital stay >24 hours). In a phase 3b open-label study, patients had PEG-J tube placement as an outpatient procedure (defined as a hospital stay < 24 hours). Procedure- or device-related treatment-emergent adverse events (AEs), and serious AEs (SAEs) noted during the first 4 weeks were compared between inpatient and outpatient PEG-J placements. Results: Of the 39 patients treated in an outpatient setting, 11 (28%) discontinued before completing the 60-week study, and only 1 patient discontinued (withdrew consent) during the first 4 weeks of the study; 2 patients (5%) discontinued due to a gastrointestinal- or procedure-related AE. Of 395 patients treated in an inpatient setting, 85 patients (22%) discontinued prematurely during an average of 78 weeks of treatment, 7 (2%) of whom discontinued due to a procedure- or device-related AE in the first 4 weeks. The incidence of AEs and SAEs are summarized in the Table and were similar for inpatient or outpatient PEG-J placement. The most common procedure- or device-related AEs were complication of device insertion, procedural pain, and abdominal pain. Incidence of procedure- or device-related AEs decreased within 2 weeks after the PEG-J placement for both inpatient and outpatient placements (Figure).FigureTable: Table. Gastrointestinal-Related Adverse Events and Serious Adverse Events During the First 4 Weeks after Inpatient or Outpatient PEG J PlacementConclusion: Patients undergoing PEG-J placement experienced similar AEs, regardless of the time spent in a hospital setting after procedure completion." @default.
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• W2912098476 date "2017-10-01" @default.
• W2912098476 modified "2023-09-25" @default.
• W2912098476 title "A Comparison of Inpatient and Outpatient Percutaneous Endoscopy Gastrojejunostomy Placement for Treatment With Levodopa-Carbidopa Intestinal Gel in Patients With Advanced Parkinsonʼs Disease" @default.
• W2912098476 doi "https://doi.org/10.14309/00000434-201710001-00839" @default.
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