Adverse effects of levodopa/carbidopa intrajejunal gel treatment: A single-center long-term follow-up study.

OBJECTIVES: Levodopa/carbidopa intrajejunal gel (LCIG) is an effective therapeutic strategy to overcome levodopa-induced motor complications in advanced Parkinson's disease (PD). However, it requires invasive percutaneous endoscopic gastrojejunostomy (PEG-J) and may be associated with serious adverse effects (AE). In this study, we aimed to evaluate long-term AEs related to LCIG treatment in a large homogenous cohort of advanced PD patients. METHODS: One hundred three consecutive PD patients were regularly monitored for LCIG-related, PEG-J-related, and device-related AEs up to 14 years. Incidence of AEs was studied in time applying a time-to-event analysis and Cox proportional hazard model with age, disease duration, gender, and recurrent AE as covariates. Health-related quality of life (HRQoL) was estimated at each visit and compared to HRQoL before the LCIG treatment. RESULTS: Among 296 AEs noted, 48.8% were LCIG-related, 32.4% PEG-J-related, and 19.6% device-related. While most of the studied AEs steadily accumulated throughout the follow-up period, 24.3% of the patients (95% CI 10.1%-36.3%) experienced PEG-J-related AE already within the first days after the PEG-J insertion. Cox model revealed that older patients had higher probability of psychosis, PEG-J- and device-related AEs (p < .05, p < .05, and p = .02) and suggested increased recurrence risk in those with early PEG-J and device-related AEs. Despite relatively high incidence of AEs, HRQoL significantly increased in the follow-up period (p < .0001). CONCLUSION: AEs related to LCIG treatment are common. Therefore, careful patient selection and monitoring throughout the treatment is recommended, especially in those with early side effects. Nevertheless, LCIG significantly improves HRQoL in advanced PD patients on a long term.

Long-term effect of bilateral STN-DBS on non-motor symptoms in Parkinson's disease: A four-year observational, prospective study.

BACKGROUND: Several studies have shown beneficial effects of bilateral stimulation of the subthalamic nucleus (STN-DBS) on motor as well as on non-motor symptoms (NMS) up to 36 months post-surgery in advanced Parkinson's disease (PD) patients. We set to explore the long-term effect of STN-DBS on NMS in a four-year follow-up, prospective, observational study. METHODS: Forty patients were enrolled and assessed at baseline. Twenty-eight were followed-up at 6, 12, 24, 36 and 48 months after the operation. The effect of post-operative time on NMS was analyzed by six-level repeated measures ANOVA. In a post-hoc analysis the follow-up scores were compared to baseline using a paired t-test. RESULTS: The following scores stayed improved up to 24 months after surgery, presented as baseline/24 months, p-value (t-test): total Non-Motor Symptoms Scale score (54.0 ± 5.6/44.9 ± 5.0, p = 0.029), Hamilton Anxiety Scale (14.3 ± 1.3/11.3 ± 1.2, p = 0.019) and PDQ39 (53.4 ± 4.5/40.2 ± 2.9, p = 0.012). PD Sleep Scale 2 remained improved throughout the study (17.4 ± 2.0/12.8 ± 1.3 at 48 months, p = 0.032), while Beck Depression Inventory only at six months post-surgery (9.5 ± 1.2/6.7 ± 0.7 at 6 months, p = 0.006). Montreal Cognitive Assessment remained stable up to 24 months and then declined at 36 months (26.3 ± 0.5/25.4 ± 0.5 at 36 months, p = 0.003), Starkstein Apathy Scale deteriorated throughout the study (7.6 ± 0.7/12.7 ± 0.9 at 48 months, p = 0.006). CONCLUSIONS: We observed beneficial effect of STN-DBS in several but not all domains of NMS at least up to 24 months post-op in advanced PD. Further long-term studies on larger cohorts of PD patients and longer follow-up need to be conducted to better understand the long-term effect of STN-DBS on NMS.