Long‐term safety and effectiveness of levodopa‐carbidopa intestinal gel infusion

Abstract

IntroductionLevodopa‐carbidopa intestinal gel (LCIG) infusion has demonstrated to improve motor fluctuations. The aim of this study is to assess the long‐term safety and effectiveness of LCIG infusion in advanced Parkinson's disease (PD) patients with motor fluctuations and its effect in nonmotor symptoms.MethodsAdverse events (AE) and their management, clinical motor, and nonmotor aspects were assessed up to 10 years. Thirty‐seven patients were treated with LGIC; in three subsets of patients, specific batteries of tests were used to assess cognitive and behavior assessment for 6 months, quality of sleep for 6 months, and quality of life and caregiver burden for 1 year.ResultsThere was a high number of AE, but manageable, most of mild and moderate severity. All patients experienced significant improvement in motor fluctuations with a reduction in mean daily off time of 4.87 hr after 3 months (n = 37) to 6.25 hr after 9 years (n = 2). Diskynesias remained stables in 28 patients (75.7%) and improved in 5 patients (13.5%). There was no neuropsychological deterioration, but an improvement in attentional functions, voluntary motor control, and semantic fluency. Quality of sleep did not worsen, and there was an improvement in the subjective parameters, although overnight polysomnography did not change. There was a significant sustained improvement of 37% in PD‐Q39 after 3 months and to 1 year, and a significant reduction in caregiver burden of 10% after 3 months.Conclusion LCIG infusion is a safe and efficacious treatment for the control of motor fluctuations, and for improvement or nonworsening of nonmotor aspects, long‐term sustained, and feasible for use in routine care.

EuroInf 2: Subthalamic stimulation, apomorphine, and levodopa infusion in Parkinson's disease

“…Furthermore, as expected, we found no significant changes of UPDRS‐III between preinterventional MedON and postinterventional MedON(/StimON) for all three groups . Our results also confirm studies that reported an improvement of ON‐state Hoehn and Yahr scale for STN‐DBS, IJLI, and APO . Based on dyskinesia/motor fluctuation ratios, treatments were chosen independently from these motor complication profiles.…”

Long‐term safety and efficacy of levodopa‐carbidopa intestinal gel in advanced Parkinson's disease

“…Frequently reported AEs were associated with PEG‐J complications (mainly related to stoma‐site maintenance), comorbidities associated with advanced PD (eg, fall, fracture), aging (eg, fractures, osteoarthritis), or dopaminergic therapy (eg, dyskinesia, insomnia). The overall safety profile was like that reported in a recent integrated summary of safety of an average LCIG exposure of just more than 2 years, as well as prospective open‐label and retrospective observational studies . A total of 36 patients (14%) reported AEs related to weight loss, as was also reported in the integrated safety study (59 patients [14%]) and was similar to rates reported in a retrospective survey of more than 900 patients and a prospective open‐label routine‐care study of 59 patients .…”

“…Despite these limitations, this is the longest prospective study to date evaluating the safety and efficacy of LCIG, with an average infusion of 4.1 years. Although a high incidence of AEs was noted, long‐term use was associated with a relatively low annual discontinuation rate (average, 10% per year), with overall discontinuation rates similar to other long‐term follow‐up studies and low incidence of serious AEs.…”

Sleep Quality and Levodopa Intestinal Gel Infusion in Parkinson’s Disease: A Pilot Study

“…Patients started LCIG infusion after receiving an implant of percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) following a previously described procedure used in our center [ 14 ]. The initial LCIG maintenance dose was calculated according to the levodopa equivalent daily dose; the optimal dose was titrated individually until reaching the best motor performance, controlling motor fluctuations without causing annoying dyskinesia, and getting a stable infusion for less than 16 hours a day, stopped at night, when patients received an oral nocturnal dose of levodopa.…”