Levodopa-carbidopa Intestinal Gel Treatment Research Articles

Levodopa‐Carbidopa Intestinal Gel Reduces Dyskinesia in Parkinson's Disease in a Randomized Trial

ABSTRACTBackgroundThere are limited data regarding the effectiveness of levodopa‐carbidopa intestinal gel (LCIG) for dyskinesia.ObjectiveCompare the effectiveness of LCIG versus oral optimized medical treatment (OMT) for dyskinesia in patients with advanced Parkinson's disease (PD) using the Unified Dyskinesia Rating Scale (UDysRS).MethodsThis phase 3b, open‐label, multicenter, 12‐week, interventional study (NCT02799381) randomized 63 LCIG naïve patients with advanced PD (UDysRS ≥30) to LCIG (N = 30) or OMT (N = 33) treatment. Dyskinesia impact was assessed at baseline through week 12 using the UDysRS. PD‐related motor and non‐motor symptoms, and quality of life (QoL) were also assessed.ResultsDyskinesias measured by UDysRS were significantly reduced in the LCIG group (n = 24; −17.37 ± 2.79) compared with the OMT group (n = 26; −2.33 ± 2.56) after 12 weeks (−15.05 ± 3.20; 95% CI, −21.47 to −8.63; P < 0.0001). At week 12, LCIG versus OMT also demonstrated significant improvements in “On” time without troublesome dyskinesia (P = 0.0001), QoL (P < 0.0001), global impression of change (P < 0.0001), activities of daily living (P = 0.0006), and Unified Parkinson's Disease Rating Scale (UPDRS) Part III (P = 0.0762). Treatment‐emergent adverse events were reported in 27 (44.3%) patients (LCIG, 18 [64.3%]; OMT, 9 [27.3%]). Serious adverse events occurred in 2 (7.1%) LCIG‐treated patients.ConclusionsLCIG significantly reduced dyskinesia compared with OMT. LCIG showed efficacy for treatment of troublesome dyskinesia in patients with advanced PD while demonstrating benefits in both motor and non‐motor symptoms and QoL. © 2021 AbbVie Inc. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson Movement Disorder Society

Neskorý vznik tenzného pneumoperitonea cez brušnú stenu po zavedení PEG-J

A 71-year-old woman with Parkinson’s disease underwent elective percutaneous endoscopic gastrojejunostomy due to levodopa-carbidopa intestinal gel treatment. Less than one week after the procedure, the patient developed abdominal distension. X-ray and computed tomography revealed massive pneumoperitoneum. An external binder was dislocated above the abdominal wall. After replacing the binder and fixating it onto the skin, imaging showed no regression of free air. Drainage was performed using a Redon drain, and a gush of free air and ascites leaked out of the abdominal wall. Ventilatory air leakage beside the gastric tube caused permanent massive pneumoperitoneum. After the removal of the PEG tube, the patient fully recovered. In this article, we present a late complication of pneumoperitoneum with air leakage from the abdominal wall stoma. This complication is rarer than air leakage from the visceral wall stoma.

Combining Device‐Aided Therapies in Parkinson's Disease: A Case Series and a Literature Review

Deep brain stimulation (DBS), levodopa-carbidopa intestinal gel (LCIG) and subcutaneous apomorphine infusion are device-aided therapies (DATs) for advanced Parkinson's disease (PD). We present a case series from the Cretan PD Registry who required 2 DATs for optimal management along with a systematic review of similar studies. From 2009 to 2020, we retrospectively studied all PD patients who were simultaneously treated with 2 DATs. Six patients on DBS required an infusion treatment for persisting or re-emergent fluctuations because of disease progression. Two patients on LCIG infusion received DBS as a levodopa-sparing strategy because of drug-induced complications. Fluctuations and quality of life improved in all patients. We identified 4 case series, 1 prospective and 1 retrospective study that included a total of 50 DBS-treated patients who required an infusion therapy. Improvement in motor outcomes, assessed in different ways, was a constant finding. Selected PD patients on 1 DAT may experience additional benefit from a second DAT, for several reasons along the course of their disease. Although infusion therapies optimize dopaminergic drug delivery in fluctuating DBS-treated patients, DBS added on LCIG treatment has an additive symptomatic effect that allows levodopa dose reduction in patients with drug-induced side effects.

Buried Bumper Syndrome: A common complication of levodopa intestinal infusion for Parkinson disease

BackgroundPercutaneous endoscopic gastrostomy (PEG) is required for Levodopa/Carbidopa Intestinal Gel (LCIG) delivery in patients with advanced Parkinson's disease (PD) as well as for enteral feeding in a variety of neurological disorders. Buried Bumper Syndrome (BBS) is a serious complication of PEG. The frequency of BBS in patients receiving LCIG treatment has never been reported. ObjectivesTo compare the frequency of BBS in patients on LCIG treatment or on enteral feeding over the past 12 years and identify possible risk factors. MethodsWe reviewed prospectively recorded data from 2009 to 2020 on two case-series: LCIG-treated PD patients and non-PD patients on enteral nutrition. We identified all BBS incidences. Patients’ characteristics, clinical manifestations, BBS management, possible risk factors and outcomes were analyzed. ResultsDuring the 12 years, 35 PD patients underwent PEG insertion for LCIG infusion, and 123 non-PD patients for nutritional support. There were eight cases of BBS in six PD patients (17.1%). Six of them were effectively managed without treatment discontinuation. Of the enteral feeding patients, only one developed BBS (0.8%) (p < 0.001). We identified inappropriate PEG site aftercare, weight gain, early onset PD, longer survival, treatment duration, dementia and PEG system design as potential risk factors for BBS development. ConclusionsBBS occurs more frequently in LCIG patients than in patients receiving enteral feeding. If detected early, it can be successfully managed, and serious sequalae or treatment discontinuation can be avoided. Regular endoscopic follow-up visits of LCIG-treated patients and increased awareness in patients and clinicians are recommended.

The Social Value of Improvement in Activities of Daily Living among the Advanced Parkinson's Disease Population.

Quantify the value of functional status (FS) improvements consistent in magnitude with improvements due to levodopa-carbidopa intestinal gel (LCIG) treatment, among the advanced Parkinson's disease (APD) population. The Health Economic Medical Innovation Simulation (THEMIS), a microsimulation that estimates future health conditions and medical spending, was used to quantify the health and cost burden of disability among the APD population, and the value of quality-adjusted life-years gained from FS improvement due to LCIG treatment compared to standard of care (SoC). A US-representative Parkinson's disease (PD)-comparable cohort was constructed in THEMIS based on observed PD patient characteristics in a nationally representative dataset. APD was defined from the literature and clinical expert input. The PD and APD cohorts were followed from 2010 over their remaining lifetimes. All individuals were ages 65 and over at the start of the simulation. To estimate the value of FS improvement due to LCIG treatment, decreases in activities of daily living (ADL) limitations caused by LCIG treatment were calculated using data from a randomized, controlled, double-blind, double-dummy clinical trial and applied to the APD population in THEMIS. Total burden of disability associated with APD was $17.7 billion (B). From clinical trial data, LCIG treatment versus SoC lowers the odds of difficulties in walking, dressing, and bathing by 76%, 42% and 39%, respectively. Among the APD population, these reductions generated $2.6B in value to patients and cost savings to payers. The added value was 15% of the burden of disability associated with APD and offsets 15% of the cost of LCIG treatment. FS improvements, consistent with improvements due to LCIG treatment, in the APD population created health benefits and reduced healthcare costs in the US.

Levodopa/Carbidopa Intestinal Gel Long-Term Outcome in Parkinson's Disease: Focus on Dyskinesia.

Levodopa-carbidopa intestinal gel (LCIG) treatment has shown variable effect on dyskinesia in Parkinson's disease (PD). To identify PD patients who are likely to have troublesome dyskinesia under LCIG treatment and describe the pharmacokinetic-dynamic profile and dyskinesia phenomenology of those patients. PD patients were assessed for clinical and therapeutic variables, before LCIG treatment (T0) and at last outpatient visit (T1). Sub-groups of patients with and without "troublesome dyskinesia" (UPDRS IV, item 33 ≥2), matched for disease and LCIG treatment duration, underwent a pharmacokinetic-dynamic assessment. We included 53 PD patients. After a mean of 51.7 ± 34.1 months of LCIG treatment, "off-time" was significantly reduced, whereas, dyskinesia duration/disability did not change. The multivariate regression model, adjusted for LCIG treatment duration, showed that being female increases the risk of presenting troublesome dyskinesia at T1 (odds ratio [OR] = 9.2; 95% confidence interval [CI] = 2.4-37.4) that was also significantly associated to longer off periods at T1 (OR= 4.4; 95% CI = 1.1-14.3). Female patients showed a higher risk for a higher dyskinesia score at T1 (sum of the items 32 and 33: P = 0.001). Patients with troublesome dyskinesia showed a tendency for a lower motor benefit and the appearance of more severe dyskinesia despite similar levodopa plasma concentration. Dyskinesia should be carefully monitored in patients undergoing LCIG, with particular caution for female patients. Whether combined clinical and pharmacodynamic assessments could be helpful to manage patients with troublesome dyskinesia under LCIG treatment needs further evaluation in a larger group of patients.

Predictors of Response for "Off" Time Improvement With Levodopa-Carbidopa Intestinal Gel Treatment: An Analysis of the GLORIA Registry.

Background: Levodopa-carbidopa intestinal gel (LCIG) is a long-term therapy for motor fluctuations in patients with advanced Parkinson's disease (PD). The aim of this analysis was to identify the baseline characteristics that predict “Off” time reduction in advanced PD patients treated with LCIG under routine clinical care in the GLORIA registry.Methods: Patients were followed under routine care for 24 months (M) with delivery of LCIG via percutaneous gastrojejunostomy. Analysis of covariance (ANCOVA) and logistic regression were performed to identify baseline characteristics that predict “Off” time reduction.Results: Compared to baseline, 86% (n/N = 131/152; mean ± SD baseline “Off” time: 3.4 ± 2.2 h) of M24 completers had ≥ 1 h reduction in “Off” time and 64% (n/N = 97/152; mean ± SD baseline “Off” time: 7.6 ± 2.9 h) had ≥ 3 h “Off” time reduction at M24. Most baseline characteristics were similar across responder subgroups; however, patients with ≥ 3 h “Off” time improvement had more “Off” time and less time with dyskinesia at baseline compared to patients with <3 h “Off” time reduction. Despite having less improvement in absolute “Off” h at M24, patients with <3 h “Off” time reduction experienced a 33% median reduction in “Off” time and a 44% median reduction in dyskinesia duration at M24, which was similar to the dyskinesia improvement observed among patients with ≥ 3 h “Off” time improvement (50% median reduction). Baseline “Off” time was both the best predictor of and the only significant factor associated with “Off” time improvement (P <0.0001).Conclusions: LCIG treatment led to clinically meaningful improvements in “Off” time in 86% of advanced PD patients and those with greater “Off” time are likely to experience the largest absolute reduction in hours “Off.”

Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson\u2019s disease: results of the Italian GLORIA patient population

IntroductionThe GLORIA registry included 375 advanced Parkinson’s disease (PD) patients and evaluated the efficacy and safety of a 24-month levodopa-carbidopa intestinal gel (LCIG) treatment in routine medical care. This analysis focuses on the Italian population, 60 patients treated with LCIG in 7 specialised PD care centres.MethodsHours of “Off” and “On” time were assessed with a modified version of the Unified Parkinson’s Disease Rating Scale (UPDRS) part IV items 39 and 32. Motor fluctuations, dyskinesia, non-motor symptoms, quality of life and safety were evaluated.ResultsOverall, 42 (70%) out of 60 patients completed the registry. LCIG treatment reduced “Off” time (− 3.3 ± 2.7 h at month 24 (M24), P < 0.0001), increased “On” time with dyskinesia (− 2.6 ± 5.2 h at M12, P = 0.0160), and improved UPDRS II and UPDRS III total scores at M24 (− 4.5 ± 10.6, P = 0.0333 and − 4.9 ± 11.7, P = 0.0229, respectively), Non-Motor Symptom Scale (NMSS) total score (− 21.8 ± 28.5, P < 0.0001) and Parkinson’s Disease Questionnaire-8 item (PDQ-8) total score (− 12.5 ± 23.9, P = 0.0173) versus previous oral therapy. Adverse drug reactions (ADR) possibly or probably related to treatment were reported in 16 (28.6%) patients. Decreased weight (7.1%), polyneuropathy (7.1%) and abdominal pain (5.4%) were the most frequent ADRs while device malfunction (5.4%) and medical device change (5.4%) were the most reported device complaints.ConclusionsLCIG improved motor fluctuations, non-motor symptoms and quality of life over 24 months while tolerability was consistent with the established safety profile.

The TANDEM investigation: efficacy and tolerability of levodopa-carbidopa intestinal gel in (LCIG) advanced Parkinson's disease patients.

The TANDEM investigation was carried out in 17 Italian Movement Disorder centers on behalf of a joint initiative of neurologist members of the Italian Academy for Parkinson's disease and Movement Disorders (LIMPE-DISMOV Academy) and gastroenterologist members of the Italian Society of Digestive Endoscopy (SIED) to evaluate the efficacy and tolerability of levodopa-carbidopa intestinal gel (LCIG) in patients with advanced Parkinson's disease (PD) in routine medical care. Motor scores in "ON" and OFF" state (UPDRS-III), complications of therapy (UPDRS-IV), activities of daily living, sleep disorders and quality of life were evaluated at baseline and at two follow-up assessments (FUV1 and FUV2) within the initial 12-month LCIG treatment. In 159 patients (55% males) with a mean age of 69.1 ± 6.6years and a diagnosis of PD since 13.6 ± 5.5years, the UPDRS-III total score (in "OFF") decreased from baseline (45.8 ± 13.2) to FUV1 (41.0 ± 17.4; p < 0.001) and FUV2 (40.5 ± 15.5; p < 0.001), the UPDRS-IV total score decreased from baseline (8.8 ± 2.9) to FUV1 (5.1 ± 3.4; p < 0.001) and FUV2 (5.5 ± 3.2; p < 0.001). The percentage of patients exhibiting freezing, dystonia, gait/walking disturbances, falls, pain and sleep disorders was significantly reduced. Twenty-eight device complications were reported and 11 (6.9%) patients prematurely terminated the study. LCIG after 12-month treatment led to sustained improvement of time spent in "OFF", complications of therapy, PD-associated symptoms and sleep disorders. LCIG tolerability was consistent with the established safety profile of LCIG.

Effect of Intestinal Levodopa-Carbidopa Infusion on Pharyngeal Dysphagia: Results from a Retrospective Pilot Study in Patients with Parkinson's Disease.

Background Pharyngeal dysphagia is a common symptom of Parkinson's disease (PD) leading to severe complications. PD-related pharyngeal dysphagia (PDrPD) may significantly improve in up to half of patients following acute oral levodopa challenge. Objective The aim of this study was to investigate the effects of levodopa-carbidopa intestinal gel (LCIG) on PDrPD. Methods Forty-five PD patients under LCIG treatment were available for retrospective analysis. In all patients with PDrPD who underwent flexible endoscopic evaluation of swallowing (FEES) in the clinical “on-state” both before and after implementation of LCIG treatment, FEES videos were systematically reassessed. PDrPD was characterized using a PD-specific FEES score evaluating premature bolus spillage, penetration/aspiration, and pharyngeal residue. Further, the duration of white-out was assessed, as a parameter for pharyngeal bradykinesia. Results Eleven patients with PDrPD (mean age 74.6 ± 4.4 years; mean Hoehn and Yahr stage 3.8 ± 0.6) received FEES both before and after the onset of LCIG treatment. The mean swallowing score improved from 14.9 ± 7.3 to 13.0 ± 6.9 after implementation of LCIG; however, this difference was not significant (p=0.312). Premature bolus spillage decreased significantly (p=0.002) from 5.4 ± 1.1 to 3.6 ± 1.0, and white-out duration decreased significantly (p=0.002) from 984 ± 228 ms to 699 ± 131 ms after implementation of LCIG. Conclusions LCIG may affect PDrPD and reduce premature bolus spillage and pharyngeal bradykinesia. Future studies with larger sample sizes are required to follow-up on these pilot results and identify which factors predict a good response of PDrPD to LCIG treatment.

Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson's Disease Receiving ≥2000 mg Daily Dose of Levodopa.

Background Levodopa-carbidopa intestinal gel (LCIG) provides continuous levodopa administration and clinical benefits to patients with advanced Parkinson's disease (PD). This report evaluates long-term safety and efficacy of high-dose LCIG in PD patients. Methods Data were collected from several prospective, phase III clinical studies and an observational registry. The phase III program (N = 412) included four multicenter studies: a 12-week, randomized, double-blind study and three open-label studies extending ≥12 months. GLORIA (N = 412) included four multicenter studies: a 12-week, randomized, double-blind study and three open-label studies extending ≥12 months. GLORIA (Results A total of 72 of 412 (17.5%) patients required dosages ≥2000 mg/day LCIG in the phase III program and 47 of 375 (12.5%) patients in GLORIA. Baseline demographics and disease severity were similar between dosage groups with more men in the high-dosage group. Compared with the <2000 mg/day dosage group, patients requiring ≥2000 mg/day LCIG had higher rates of AEs/ADRs including polyneuropathy; improvements in “Off” time and discontinuations due to AEs were similar between dosage groups and lower for discontinuations due to ADRs reported in GLORIA. Conclusions Patients who require ≥2000 mg/day LCIG exhibited a safety profile comparable to the established safety/tolerability of LCIG with similar clinical improvements. Higher AEs were noted but within what is accepted for LCIG. Continuous administration of LCIG is beneficial to advanced PD patients who require very high doses of levodopa.

Multicenter study of levodopa carbidopa intestinal gel in Parkinson’s disease: the Turkish experience

Background/aim Our purpose was to determine the efficacy of levodopa carbidopa intestinal gel (LCIG) in a series of Turkish patients with Parkinson’s disease (PD). Materials and methods We had telephone calls with 54 patients from 11 neurology centers who were on LCIG treatment, and 44 patients or their caregivers were included in an eight-item survey between September 2015 and June 2016. The reliability and validity of the survey were evaluated with intraclass correlation coefficients for every question separately.Results Average age of the patients were 63.48 and the duration of PD was 12.79 years. Average LCIG treatment period was 15.63 months. Percentages of the patients who reported they were ‘better’ after LCIG treatment were as follows: 80% for time spent off, 55% for dyskinesia, 65% for tremor, 85% for gait disorder, 50% for pain, 50% for sleep disorders, 42.5% for depression, 32.5% for incontinence, and 70% for activities of daily living. Cronbach’s alpha was 0.795 and the intraclass correlation coefficient was reliable for the items.Conclusion As detected by a survey performed by telephone calls with good interrater reliability, patients with PD improve with LCIG treatment in many aspects of the disease.

The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson’s disease

Aims: To estimate the relationship between functional status (FS) impairment and nursing home admission (NHA) risk in Parkinson’s disease (PD) patients, and quantify the effect of advanced PD (APD) treatment on NHA risk relative to standard of care (SoC).Materials and methods: PD patients were identified in the Medicare Current Beneficiary Survey (MCBS) (1992–2010). A working definition based on the literature and clinical expert input determined APD status. A logit model estimated the relationship between FS impairment and NHA risk. The effect of levodopa-carbidopa intestinal gel (LCIG) on NHA risk relative to SoC was simulated using clinical trial data (control: optimized oral levodopa-carbidopa IR, ClinicalTrials.gov NCT00660387 and NCT0357994).Results: Non-advanced PD and APD significantly increased NHA risk when controlling for demographics (p < 0.01). APD status was no longer significant after controlling for FS limitations, implying that FS limitations explain the increased NHA risk in APD patients. Reduced impairment in FS in patients with APD treated with LCIG reduced risk of NHA by 13.5% relative to SoC.Limitations: This study applies clinical trial results to real-world data. LCIG treatment might have a different effect on NHA risk for the nationally representative population than the effect measured in the trial. Both data sources employ different instruments to measure FS, instrument wording and study follow-up differed, which might bias our estimates. Finally, there lacks consensus on a definition of APD. The prevalence of APD in this study is high, perhaps due to the specific definition used.Conclusions: Patients with APD experience a higher risk in NHA than those with non-advanced disease. This increased risk in NHA in patients with APD is explained by greater limitations in FS. The relative reduction in risk of NHA for the APD population treated with LCIG is quantitatively similar to doubling Medicaid home care services.

Safety and effectiveness of levodopa-carbidopa intestinal gel for advanced Parkinson's disease: A large single-center study

BackgroundTreatment with levodopa-carbidopa intestinal gel (LCIG) can effectively relieve motor and non-motor symptoms in advanced Parkinson's disease (PD). However, adverse events (AEs) are frequent. ObjectiveTo describe AEs associated with LCIG treatment and the main reasons for treatment discontinuation. We also looked for factors that were potentially predictive of serious AEs and assessed the effectiveness of and satisfaction with LCIG. MethodWe retrospectively analyzed data on AEs in patients treated with LCIG at a French university medical center. For patients still receiving treatment at last follow-up, effectiveness was assessed according to the Clinical Global Impression (CGI) scale and the Movement Disorders Society – Unified Parkinson's Disease Rating Scale motor score. ResultsOf the 63 patients treated with LCIG for a mean (range) of 19 months (8–47), 57 (90%) experienced at least one AE (340 AEs in total). Most of the AEs (in 69.8% of the patients) were related to percutaneous endoscopic gastrostomy with a jejunal tube (PEG-J) or affected the gastrointestinal tract (granuloma, leakage, or a local infection). Device-related AEs (such as PEG-J removal and device occlusion) were frequent (in 63.5% of patients). Forty-three patients (68%) required at least one additional endoscopic procedure. Dopatherapy-related AEs occurred in 30 patients (48%). Most of the AEs occurred long after treatment initiations, and only a small proportion led to discontinuation. On the CGI scale, 53 patients (84.4%) considered that their condition had improved during LCIG treatment. ConclusionDespite the high frequency of AEs, patients with advanced PD gain clinical benefit from treatment with LCIG. This treatment requires a competent, multidisciplinary team on site.

Utilization of COMT inhibitors, dopamine agonists, and MAO-B inhibitors with levodopa-carbidopa instestinal gel in advanced Parkinson's disease patients: Summary of phase 3 and real-world studies

Levodopa remains the most effective treatment for Parkinson's disease (PD); however, as disease evolves, uncontrolled motor and non-motor symptoms with chronic oral therapy may necessitate the use of advanced therapies. Continuous levodopa delivery with levodopa-carbidopa intestinal gel (LCIG) improves motor fluctuations and may reduce the need for concomitant dopamine replacement therapies (DRT). This analysis summarizes add-on medication use in advanced PD patients before and after LCIG treatment from a phase 3 study and real-world observations. Add-on PD medication use including catechol-O-methyl transferase (COMT) inhibitors, dopamine agonists (DAs), and monoamine oxidase (MAO)-B inhibitors was determined at baseline (recent use before LCIG) and after approximately 1 year of LCIG treatment from a phase 3 study (NCT00335153), UK-based retrospective chart review (IRAS ID: 135453), and GLORIA observational registry. The phase 3 trial required LCIG monotherapy (no concomitant PD medications) from LCIG initiation to treatment week 4, after which adjunctive medication use was permitted. In the phase 3 study, patients using COMT inhibitors decreased from 28% to 1%, representing a 96% reduction. Under real-world conditions, patients using COMT inhibitors decreased from 23% to 2% in the retrospective chart review and from 57% to 9% in the GLORIA registry, representing 91% and 84% reductions, respectively. Decreased DA and MAO-B inhibitor use after LCIG therapy were observed in all three studies (Fig. 1). This summary of 840 advanced PD patients treated in a controlled clinical trial setting or during routine clinical care highlights reductions in add-on DRT use following 12 months of LCIG treatment.

Utilization of monotherapy and combination therapies in advanced Parkinson's disease patients during levodopa-carbidopa intestinal gel treatment from the cosmos study

Utilization of monotherapy and combination therapies in advanced Parkinson's disease patients during levodopa-carbidopa intestinal gel treatment from the cosmos study

Levodopa-carbidopa intestinal gel treatment of motor fluctuations and dyskinesia in advanced Parkinson’s disease patients in a ‘real world’ setting: Interim results from the DUOGLOBE study

Levodopa-carbidopa intestinal gel treatment of motor fluctuations and dyskinesia in advanced Parkinson’s disease patients in a ‘real world’ setting: Interim results from the DUOGLOBE study

Long-term effect of levodopa-carbidopa intestinal gel on axial signs in Parkinson's disease.

Few studies have suggested that levodopa-carbidopa intestinal gel (LCIG) may have a benefit on Parkinson's disease (PD) axial signs. To investigate the long-term effect of LCIG on axial signs and the related prognostic factors. A retrospective study on 49 PD patients treated with LCIG. Axial signs as per the Unified Parkinson Disease Rating Scale axial score (AS), Hoehn and Yahr (H&Y) scale, and levodopa equivalent daily dose (LEDD) were assessed at baseline (before starting LCIG treatment) and at the last follow-up (FU). After 47.6±30months of treatment, total AS deteriorated while motor complications still improved, in spite of a significant LEDD/Kg increment. When adjusted for LCIG treatment duration, a higher AS and freezing of gait severity at FU were predicted by a baseline lower response to l-dopa and higher H&Y (P<0.01) and they were related to a lower independency in activity of daily life at FU (P<0.001). Single axial items remain stable up to one year and postural instability up to four years. Baseline disease severity and the magnitude of l-dopa response predict axial signs' severity after around four years of LCIG treatment, with consequent implication on patients' functional independence.

Psychometric Properties of the Apathy Scale in Advanced Parkinson's Disease.

Objectives To assess the psychometric attributes of the Apathy Scale- (AS-) Spanish version in patients with advanced Parkinson's disease (APD). Materials and Methods Over 6 months, 61 patients participated in a clinical study of levodopa-carbidopa intestinal gel (LCIG) and were evaluated using the AS and other clinical tools. Various psychometric attributes of the AS were assessed. Results Patients (60.7% men) were aged 68.02 ± 7.43 years, with 12.57 ± 5.97 years from PD diagnosis. Median HY of patients in “on state” was 2 (range, 1–4), and mean levodopa equivalent daily dose was 1455.98 ± 456.00 mg. Overall, the parameters of feasibility/acceptability were satisfactory, except for a moderate-to-high floor effect in AS items but not in its total score (both 3.3%). Cronbach's alpha was 0.78, while item homogeneity coefficient was 0.21. Almost all items (11/14) reached acceptable item-total corrected correlations (rS = 0.16–0.50). AS total score was moderately correlated with Beck Depression Inventory (0.34) and with Non-Motor Symptoms Scale domains 2 (sleep/fatigue, 0.35), 3 (mood/apathy, 0.56), and 5 (attention/memory, 0.41). There were no significant differences between AS total scores by established groups of sex, time from diagnosis, HY, and Clinical Global Impression-Severity Scale. Following LCIG treatment, there was no significant change in the AS total score. The relative change was 5.56%, the standard error of the difference was 4.17, and Cohen's d effect was 0.10. Conclusions The AS showed satisfactory feasibility, acceptability, scaling assumptions, internal consistency, and convergent validity. Responsiveness parameters were poor, probably due to the characteristics of the clinical study from which these data came. This trial is registered with NCT02289729.

Analysis of PEG-J associated complications in 14 adult patients treated with levodopa-carbidopa intestinal gel

We analyzed 14 patients in our hospital, who underwent levodopa-carbidopa intestinal gel (LCIG) treatment through a percutaneous endoscopic gastrojejunostomy (PEG-J). The PEG-J related complications were observed in 10 patients (71.4%). Detailed complications are as followings: J-tube related complications such as kinking (3 cases, 21.4%), pump malfunctions (3 cases, 21.4%), skin troubles in the gastrostoma (7 cases, 50.0%), duodenal perforation, peritonitis, and ulcers (2 cases, 14.3%). These results indicated that the sufficient care for PEG-J associated complications are important in LCIG treatment.