Motor and nonmotor symptoms in patients treated with 24-hour daily levodopa-carbidopa intestinal gel infusion: Analysis of the COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS)

Kovács, Norbert; Szász, József Attila; Vela-Desojo, Lydia; Svenningsson, Per; Femia, Samira; Parra, Juan Carlos; Sánchez-Soliño, O.; Bergmann, Lars; Gurevich, Tanya; Fasano, Alfonso

doi:10.1016/j.parkreldis.2022.08.002

Cited by 8 publications

(8 citation statements)

References 20 publications

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“…38,39 In parallel, it allows pill burden to be reduced, thereby increasing treatment compliance. 40,41 Similar benefit was observed in our patients treated with LECIG: a significant reduction of add-on therapeutic options was observed following initiation (Table 3).…”

Section: Discussionsupporting

confidence: 80%

Levodopa–Carbidopa–Entacapone Intestinal Gel in Advanced Parkinson Disease: A Multicenter Real-Life Experience

Szász,

Dulamea,

Constantin

et al. 2024

American Journal of Therapeutics

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Background: For Parkinson disease (PD) patients who have been diagnosed with advanced disease that can no longer be effectively controlled with optimized oral or transdermal medications, a range of device-aided therapies (DAT) are available, comprising either deep brain stimulation or infusion therapies providing continuous dopaminergic stimulation. Levodopa–entacapone–carbidopa intestinal gel (LECIG) infusion is the latest DAT for advanced PD (APD) that was approved in Romania in 2021. Study Question: What is the experience to date in real-world clinical practice in Romania regarding the efficacy and tolerability of LECIG in APD? Study Design: A retrospective evaluation of 74 APD patients treated with LECIG at 12 specialized APD centers in Romania. Measures and Outcomes: Demographic data and various clinical parameters were recorded, including Mini Mental State Evaluation score or Montreal Cognitive Assessment Test score. Levodopa-equivalent daily dose and the administered doses of levodopa and other PD medications were evaluated at baseline and after starting LECIG treatment. The efficacy of LECIG in reducing daily hours of off time, motor fluctuations, and dyskinesias were assessed. Any percutaneous endoscopic gastrojejunostomy system or device complications after starting LECIG treatment were noted. Results: At baseline, patients were taking oral levodopa for a mean of 5.3 times per day, with a high proportion also taking concomitant add-on therapies (dopamine agonists, 86%, monoamine oxidase type-B inhibitors, 53%; catechol-O-methyltransferase inhibitors, 64%). LECIG treatment significantly reduced daily off time versus baseline from 5.7 h/d to 1.7 hours per day (P < 0.01). Duration and severity of dyskinesias was also significantly reduced versus baseline, and improvements were observed in Hoehn and Yahr Scale scores. LECIG treatment also allowed a significant reduction in the use of concomitant oral medications. Conclusions: These findings suggest that LECIG treatment is an effective DAT option in APD that can simplify the treatment regimen.

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Section: Discussionsupporting

confidence: 80%

Levodopa–Carbidopa–Entacapone Intestinal Gel in Advanced Parkinson Disease: A Multicenter Real-Life Experience

Szász,

Dulamea,

Constantin

et al. 2024

American Journal of Therapeutics

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“…The study provides evidence that supports LCIG as an option to maintain adequate symptom control in the long term, despite the continued progression of PD. Adverse events were consistent with the known LCIG safety profile [ 2 , 26 , 41 , 48 ]. Furthermore, LCIG can be a long-term solution for patients with memory or swallowing difficulties associated with APD who follow multi-faceted therapeutic regimens requiring many pills per day and may even eliminate the need to use add-on medications, as monotherapy was an option for many patients.…”

Section: Discussionsupporting

confidence: 72%

Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS

et al. 2023

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Background While immediate benefits of levodopa–carbidopa intestinal gel (LCIG) are evident in patients with Parkinson’s disease (PD), long-term LCIG effects require further study. Objectives We explored long-term LCIG on motor symptoms, nonmotor symptoms (NMS), and LCIG treatment settings in patients with advanced PD (APD). Methods Data were obtained (medical records and patient visit) from COSMOS, a multinational, retrospective, cross-sectional post-marketing observational study in patients with APD. Patients were stratified into 5 groups based on LCIG treatment duration at the patient visit, from 1–2 to > 5 years LCIG. Between-group differences were assessed for changes from baseline in LCIG settings, motor symptoms, NMS, add-on medications, and safety. Results Out of 387 patients, the number of patients per LCIG group was: > 1– ≤ 2 years LCIG (n = 156); > 2– ≤ 3 years LCIG (n = 80); > 3– ≤ 4 years LCIG (n = 61); > 4– ≤ 5 years LCIG (n = 30); > 5 years LCIG (n = 60). Baseline values were similar; data reported are changes from the baseline. There were reductions in “off” time, dyskinesia duration, and severity across LCIG groups. Prevalence, severity, and frequency of many individual motor symptoms and some NMS were reduced amongst all LCIG groups, with few differences between groups. Doses for LCIG, LEDD and LEDD for add-on medications were similar across groups both at LCIG initiation and patient visit. Adverse events were similar across all LCIG groups and consistent with the established safety profile of LCIG. Conclusions LCIG may provide sustained, long-term symptom control, while potentially avoiding increases in add-on medication dosages. Trial registration ClinicalTrials.gov Identifier: NCT03362879. Number and date: P16-831, November 30, 2017.

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“…However, a comprehensive expert opinion report on the practical aspects of 24-h LCIG administration was only published in 2021 37 . The recently published sub-analysis of the COSMOS study (COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel) demonstrated that 24-h LCIG led to improvements in specific motor symptoms, as well as non-motor symptoms and treatment-related symptoms in patients with APD who were treated with LCIG for ≥ 12 months, with safety findings consistent within the known LCIG profile 38 .…”

Section: Discussionmentioning

confidence: 74%

Starting with 24-h levodopa carbidopa intestinal gel at initiation in a large cohort of advanced Parkinson’s disease patients

Szatmári,

Szász,

Orbán-Kis

et al. 2024

Sci Rep

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Continuous intra-jejunal infusion of levodopa-carbidopa intestinal gel (LCIG) is a long-term proven and effective treatment in advanced Parkinson’s Disease (APD). Efficacy and safety of 16-h administration of LCIG has already been established. Additional benefits of 24-h LCIG administration have been reported in several case series and small clinical studies. The aim of this retrospective study was to compare the characteristics of patients who needed 24-h LCIG from the beginning of the DAT (device-aided treatment) with those who remained with the standard 16-h LCIG treatment and to identify particular motives if any. We initiated LCIG in 150 patients out of which in case of 62 patients (41,3%) due to unsatisfactory initial clinical benefits continuous 24-h LCIG was deemed necessary. Despite the subjective complaints and more severe clinical condition, at baseline evaluation we found statistically significant differences between 16-h LCIG cohort and 24-h LCIG cohort only in case of incidence of freezing (47% vs 65%, p = 0.03) and sudden off (32% vs 48%, p = 0.04). Wake hours/daytime LCIG does not always sufficiently improve the patient's quality of life in some patients due to persistent nighttime troublesome symptoms. Instead of labeling the patient as a non-responder, it is worth trying the 24-h LCIG dosage in a carefully selected group of patients, as there is currently no consensus on reliable criteria that serve the decision in these patients.

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Motor and nonmotor symptoms in patients treated with 24-hour daily levodopa-carbidopa intestinal gel infusion: Analysis of the COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS)

Cited by 8 publications

References 20 publications

Levodopa–Carbidopa–Entacapone Intestinal Gel in Advanced Parkinson Disease: A Multicenter Real-Life Experience

Levodopa–Carbidopa–Entacapone Intestinal Gel in Advanced Parkinson Disease: A Multicenter Real-Life Experience

Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS

Starting with 24-h levodopa carbidopa intestinal gel at initiation in a large cohort of advanced Parkinson’s disease patients

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