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Ahmed A Othman, Matthew Rosebraugh, Krai Chatamra, Charles Locke, Sandeep Dutta
In a double-blind, double-dummy, double-titration Phase 3 trial in advanced Parkinson's disease (PD) patients, the efficacy and safety of Levodopa-carbidopa intestinal gel (LCIG) infusion were characterized relative to immediate-release oral levodopa-carbidopa (LC-oral) treatment. We present in this report the comparative pharmacokinetic profiles of LCIG and LC-oral from this pivotal study. The results presented in this report clearly demonstrate that LCIG results in lower variability and fluctuations in levodopa and carbidopa plasma concentrations compared to LC-oral...
February 16, 2017: Journal of Parkinson's Disease
Annamária Juhász, Zsuzsanna Aschermann, Péter Ács, József Janszky, Márton Kovács, Attila Makkos, Márk Harmat, Dalma Tényi, Kázmér Karádi, Sámuel Komoly, Annamária Takáts, Adrián Tóth, Helga Nagy, Péter Klivényi, György Dibó, Lívia Dézsi, Dénes Zádori, Ádám Annus, László Vécsei, Lajos Varannai, Norbert Kovács
BACKGROUND: Levodopa/carbidopa intestinal gel therapy (LCIG) can efficiently improve several motor and non-motor symptoms of advanced Parkinson's disease (PD). The recently developed Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) improved the original UPDRS making it a more robust tool to evaluate therapeutic changes. However, previous studies have not used the MDS-UPDRS and the Unified Dyskinesia Rating Scale (UDysRS) to assess the efficacy of LCIG...
February 3, 2017: Parkinsonism & related Disorders
Meloni Mario, Solla Paolo, Mascia Mario Marcello, Marrosu Francesco, Cannas Antonino
OBJECTIVES: Levodopa-carbidopa intestinal gel infusion (LCIG) is indicated in patients with advanced levodopa-responsive Parkinson's disease (PD) for the treatment of motor fluctuations and dyskinesias. Here we describe 4 PD patients who developed disabling diphasic dyskinesias after LCIG initiation. METHODS: The clinical data of 33 PD patients consecutively treated with LCIG therapy were obtained through direct clinical observation and detailed review of medical records...
December 31, 2016: Parkinsonism & related Disorders
Teus van Laar, Robbert Borgemeester
In the course of Parkinson's disease (PD), oral medication may lose its effectiveness due to several reasons, like dysphagia, impaired absorption from the gastro-intestinal tract and delayed emptying of the stomach. If these problems occur, a non-oral therapy should be considered. Examples of non-oral therapies are transdermal patches, (e.g. rotigotine) which may overcome motor and nonmotor nighttime problems, and may serve as well to treat daytime response-fluctuations, if oral therapies fail to do so. Other options are injections with apomorphine to treat early morning dystonia and random off-periods during daytime, as well as continuously infused subcutaneous apomorphine for random fluctuations in PD patients...
December 2016: Parkinsonism & related Disorders
Matteo Bologna, Anna Latorre, Francesca Di Biasio, Antonella Conte, Daniele Belvisi, Nicola Modugno, Antonio Suppa, Alfredo Berardelli, Giovanni Fabbrini
BACKGROUND: By providing a stable and smooth L-dopa plasmatic level, L-dopa/carbidopa intestinal gel reproduces the physiological continuous dopaminergic receptor stimulation in patients with Parkinson disease (PD), and it therefore represents a suitable tool to investigate the role of the altered dopaminergic neurotransmission in the pathophysiology of motor and sensory abnormalities in this condition. METHODS: We studied 11 patients with advanced PD being treated with L-Dopa/carbidopa intestinal gel (LCIG) and 11 age-matched healthy subjects...
November 2016: Clinical Neuropharmacology
Maria Eliza Freitas, Marta Ruiz-Lopez, Susan H Fox
Levodopa remains the most effective treatment for Parkinson's disease and is considered the gold standard therapy. However, disease progression and changes in the gastrointestinal tract result in a declining window of treatment response in a majority of patients. Efforts have been made recently to improve levodopa bioavailability either by developing more effective oral formulations or by innovating routes of administration (intestinal infusion, transcutaneous or inhaled levodopa). IPX066 is a novel levodopa-carbidopa (LD/CD) oral formulation combining immediate-release (IR) and extended-release (ER) LD/CD recently approved in the USA and the EU...
October 14, 2016: CNS Drugs
Tommaso Martino, Donato Melchionda, Paolo Tonti, Vincenzo De Francesco, Alessandra Lalla, Luigi Maria Specchio, Carlo Avolio
Apparently, unexplained weight loss is a common symptom experienced by patients affected by Parkinson's disease, especially in those treated by levodopa-carbidopa infusion gel (LCIG) with a poor control of dyskinesias. Weight loss is considered part of gastrointestinal dysfunction seen in patients affected by Parkinson's disease, along with gastroparesis and reduced bowel peristalsis. In patients treated with LCIG, weight loss needs to be accurately evaluated, because of possible underlying life-threatening adverse events, like duodenum decubitus ulcer...
December 2016: Journal of Neural Transmission
Grazia Devigili, Sara Rinaldo, Christian Lettieri, Roberto Eleopra
INTRODUCTION: Peripheral neuropathy related to levodopa/carbidopa intestinal gel (LCIG) therapy for advanced Parkinson disease (PD) is under investigation and is debated in the literature. The purpose of the study was to detect whether small nerve fibers are damaged during LCIG infusion. METHODS: Five advanced PD patients were enrolled prior to starting LCIG infusion. Six PD patients on oral levodopa (LD) treatment and 6 PD patients naïve to LD were also enrolled...
August 12, 2016: Muscle & Nerve
Francesc Valldeoriola, Francisco Grandas, Diego Santos-García, Ignacio Regidor, María José Catalán, José Matías Arbelo, Víctor Puente, Pablo Mir, Juan Carlos Parra
AIM: To assess long-term effectiveness and tolerability of levodopa-carbidopa intestinal gel (LCIG) in Spanish patients with advanced Parkinson's disease. PATIENTS & METHODS: This was an observational, multicenter, cross-sectional, retrospective study. RESULTS: Data of 177 patients were analyzed. LCIG treatment led to a reduction in the percentage of daily 'off' time (16.2 vs 47.6% before LCIG), an increase in the percentage of daily 'on' time without disabling dyskinesia (55...
August 2016: Neurodegenerative Disease Management
Leonardo Lopiano, Nicola Modugno, Pietro Marano, Mariachiara Sensi, Giuseppe Meco, Antonino Cannas, Graziano Gusmaroli, Filippo Tamma, Francesca Mancini, Rocco Quatrale, Anna Maria Costanzo, Giuliana Gualberti, Gabriella Melzi, Umberto di Luzio Paparatti, Angelo Antonini
Several levodopa/carbidopa intestinal gel (LCIG) studies showed a significant reduction of OFF time and a significant increase of ON time, as well as a reduction of dyskinesia, and improvement of non-motor symptoms and quality of life. However, few studies have been conducted in a large population for more than 3 years. Interim outcomes from GREENFIELD observational study on a large Italian cohort of advanced PD patients who started LCIG in routine care between 2007 and 2014, still on treatment at the enrollment, are presented...
November 2016: Neurological Sciences
C Zulli, M Sica, R De Micco, A Del Prete, M R Amato, A Tessitore, F Ferraro, P Esposito
OBJECTIVE: Levodopa is the gold standard in the pharmacological treatment of Parkinson's disease (PD) and its oral administration is associated with the development of disabling motor and non-motor complications in advanced disease. Levodopa is rapidly metabolized and has a short plasma half-life thus requiring frequent, repeated dosing. Impaired gastric emptying is common in PD, and likely contributes to the unpredictable motor responses observed with orally-dosed levodopa. A new therapeutic protocol for patients with advanced PD include a carbidopa/levodopa combination using continuous, modulated enteral administration achieved inserting a Jejunal Extension Tube Placement through Percutaneous Endoscopic Gastrostomy (PEG-J)...
June 2016: European Review for Medical and Pharmacological Sciences
Sven E Pålhagen, Olof Sydow, Anders Johansson, Dag Nyholm, Bjorn Holmberg, Hakan Widner, Nil Dizdar, Jan Linder, Tove Hauge, Rasmus Jansson, Lars Bergmann, Susanna Kjellander, Thomas S Marshall
BACKGROUND: Continuous infusion of levodopa-carbidopa intestinal gel (LCIG) can effectively manage motor and non-motor complications in advanced Parkinson's disease (PD). Healthcare costs, quality of life (QoL), effectiveness, and tolerability were assessed in routine care treatment with LCIG. METHODS: The seventy-seven patients enrolled in this prospective, open-label, 3-year study in routine medical care were LCIG-naïve (N = 37), or had previous LCIG treatment for <2 (N = 22), or ≥2 (N = 18) years...
August 2016: Parkinsonism & related Disorders
Aristide Merola, Alberto J Espay, Alberto Romagnolo, Andrea Bernardini, Laura Rizzi, Michela Rosso, Kristy J Espay, Maurizio Zibetti, Michele Lanotte, Leonardo Lopiano
BACKGROUND: Levodopa/carbidopa intestinal gel infusion (LCIG) and subthalamic nucleus deep brain stimulation (STN-DBS) are approved therapies for advanced Parkinson's disease (PD) whose long-term comparability remains unclear. METHODS: We reviewed the 5-year data on activities of daily living (ADL) and motor complications (OFF time, dyskinesia duration, and dyskinesia severity), as measured by the Unified Parkinson Disease Rating Scale (UPDRS) section-II and section-IV (items 39, 32, and 33, respectively) in 60 PD patients exposed to STN-DBS (n = 20), LCIG (n = 20), and oral medical therapy (OMT) (n = 20) at similar baseline disability and cognitive state...
August 2016: Parkinsonism & related Disorders
Karin Wirdefeldt, Per Odin, Dag Nyholm
BACKGROUND: Levodopa-carbidopa intestinal gel (LCIG) is available in several countries for the treatment of advanced levodopa-responsive Parkinson's disease (PD) with severe motor fluctuations and dyskinesia when other treatments have not given satisfactory results. OBJECTIVE: Our objective was to summarize the present evidence base for LCIG therapy through a systematic review of the literature. METHODS: Studies were identified from the PubMed and EMBASE databases up to 12 March 2016 using the following search terms: Parkinson disease, duodopa, levodopa/carbidopa intestinal gel, levodopa-carbidopa intestinal gel, LCIG, l-dopa infusion, levodopa infusion, duodenal l-dopa infusion, and duodenal levodopa infusion...
May 2016: CNS Drugs
Diego Santos García, Juan Carlos Martínez Castrillo, Víctor Puente Périz, Agustín Seoane Urgorri, Servando Fernández Díez, Vicente Benita León, Beatriz Udaeta Baldivieso, Antonia Campolongo Perillo, Natividad Mariscal Pérez
Patients with Parkinson's disease often have a good initial response to dopaminergic therapy but later usually develop motor fluctuations and dyskinesia. In these patients, continuous infusion of levodopa-carbidopa intestinal gel (LCIG) allows for maintaining adequate dopamine levels and for improving motor and nonmotor symptoms, as well as quality of life and autonomy. Adequate candidate selection and follow-up are crucial for treatment success. Management should be multidisciplinary, and patient and caregiver education is a priority...
June 2016: Neurodegenerative Disease Management
Michael Epstein, David A Johnson, Robert Hawes, Nathan Schmulewitz, Arvydas D Vanagunas, E Roderich Gossen, Weining Z Robieson, Susan Eaton, Jordan Dubow, Krai Chatamra, Janet Benesh
OBJECTIVES: The objectives of this study were to present procedure- and device-associated adverse events (AEs) identified with long-term drug delivery via percutaneous endoscopic gastrojejunostomy (PEG-J). Levodopa-carbidopa intestinal gel (LCIG, also known in US as carbidopa-levodopa enteral suspension, CLES) is continuously infused directly to the proximal small intestine via PEG-J in patients with advanced Parkinson's disease (PD) to overcome slow and erratic gastric emptying and treat motor fluctuations that are not adequately controlled by oral or other pharmacological therapy...
March 31, 2016: Clinical and Translational Gastroenterology
Florence C F Chang, Vu Kwan, David van der Poorten, Neil Mahant, Nigel Wolfe, Ainhi D Ha, Jane M Griffith, David Tsui, Samuel D Kim, Victor S C Fung
We report the efficacy and adverse effect profile of intraduodenal levodopa-carbidopa intestinal gel (LCIG) infusion from patients treated in a single Australian movement disorder centre. We conducted an open-label, 12 month prospective study of treatment with LCIG in patients with advanced Parkinson's disease in a single tertiary referral hospital unit specialising in movement disorders. Patients with levodopa-responsive, advanced Parkinson's disease with motor fluctuations despite optimal pharmacological treatment were enrolled and underwent a 16 hour daily infusion of LCIG for 12 months...
March 2016: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
O Băjenaru, A Ene, B O Popescu, J A Szász, M Sabău, D F Mureşan, L Perju-Dumbrava, C D Popescu, A Constantinescu, I Buraga, M Simu
Chronic treatment with oral levodopa is associated with an increased frequency of motor complications in the late stages of Parkinson's disease (PD). Continuous administration of levodopa-carbidopa intestinal gel (LCIG-Duodopa(®), Abbott Laboratories), which has been available in Romania since 2009, represents an option for treating patients with advanced PD. Our primary objective was to report changes in motor complications after initiation of LCIG therapy. The secondary objectives were as follows: to determine the impact of LCIG therapy on the daily levodopa dose variation before/and after LCIG, to collect patient self-assessments of quality of life (QoL), and to study the overall tolerability and safety of LCIG administration...
April 2016: Journal of Neural Transmission
Saeed Bohlega, Hussam Abou Al-Shaar, Thamer Alkhairallah, Fahad Al-Ajlan, Nael Hasan, Khalid Alkahtani
BACKGROUND: Levodopa therapy in Parkinson's disease (PD) is often associated with disabling motor and non-motor complications in patients with advanced disease due to the variable absorption of levodopa because of an irregular or erratic emptying of the gastric content. METHODS: Prospective single movement disorder center study using pre-set selection criteria, unified PD scale (UPDRS III), non-motor symptoms scale (NMSS), and PD questionnaire-8 (PDQ-8) to evaluate the efficacy, safety, and long-term treatment outcomes using levodopa-carbidopa intestinal gel (LCIG) infusion in patients with advanced PD, who were followed up every 6 months...
2015: European Neurology
J Timpka, T Fox, K Fox, H Honig, P Odin, P Martinez-Martin, A Antonini, K Ray Chaudhuri
OBJECTIVES: We wanted to investigate whether continuous intrajejunal levodopa-carbidopa intestinal gel (LCIG) therapy has an antidyskinetic effect in patients with Parkinson's disease (PD) and troublesome dyskinesias. We also sought to examine the effect of LCIG therapy on motor function and health-related quality of life (HRQoL). MATERIALS AND METHODS: This open-label pilot study used a single group pre-post design with follow-up at 6 months. Nine patients with PD who reported to spend at least 3 h per day in on with troublesome dyskinesia were included...
June 2016: Acta Neurologica Scandinavica
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