The effect of levodopa–carbidopa intestinal gel infusion long-term therapy on motor complications in advanced Parkinson’s disease: a multicenter Romanian experience

Journal of Neural Transmission, Dec 2015

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. A retrospective analysis (2009–2013) of LCIG therapy and the experience in nine neurology centers in Romania was performed. The impact of LCIG therapy was evaluated by analyzing changes in motor fluctuations, dyskinesia and the patients’ QoL after initiating therapy. The safety of LCIG therapy was estimated by noting agent-related adverse events (AEs) and medical device-related AEs. In the 113 patients included, we observed a significant improvement in PD symptoms after initiation of LCIG therapy. The “on” period increased, with a mean value of 6.14 h, and the dyskinesia period was reduced, with a mean value of 29.4 %. The quantified non-motor symptoms subsided. The patients exhibited significant improvements in QoL scores. There were few AEs and few cases of LCIG therapy discontinuation. LCIG is an important and available therapeutic option for managing patients with advanced PD.

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The effect of levodopa–carbidopa intestinal gel infusion long-term therapy on motor complications in advanced Parkinson’s disease: a multicenter Romanian experience

J Neural Transm The effect of levodopa-carbidopa intestinal gel infusion long-term therapy on motor complications in advanced Parkinson's disease: a multicenter Romanian experience O. Ba˘ jenaru 0 1 2 3 4 5 6 7 A. Ene 0 1 2 3 4 5 6 7 B. O. Popescu 0 1 3 4 5 6 7 J. A. Sza´ sz 0 1 3 4 5 6 7 M. Saba˘ u 0 1 3 4 5 6 7 D. F. Mures¸an 0 1 3 4 5 6 7 L. Perju-Dumbrava 0 1 3 4 5 6 7 C. D. Popescu 0 1 3 4 5 6 7 A. Constantinescu 0 1 3 4 5 6 7 I. Buraga 0 1 3 4 5 6 7 M. Simu 0 1 3 4 5 6 7 0 Department of Neurology, University of Medicine and Pharmacy ''Carol Davila'' Bucharest, Colentina Hospital , 19-21 Stefan cel Mare Street, Sector 2, 020125 Bucharest , Romania 1 Department of Neurology, University of Medicine and Pharmacy ''Carol Davila'' Bucharest, University Emergency Hospital Bucharest , 169 Splaiul Independentei, Sector 5, Bucharest , Romania 2 0 Iosif Bulbuca Street, 300736 Timisoara , Timis , Romania 3 Department of Neurology, University of Medicine and Pharmacy ''Victor Babes,'' Timisoara County Hospital 4 Neurology Rehabilitation Department, University of Medicine and Pharmacy ''Gr. T. Popa'' Iasi, Clinical Rehabilitation Hospital , 14 Pantelimon Halipa Street, 700661 Iasi , Romania 5 Department of Neurology, University of Medicine and Pharmacy ''Iuliu Hatieganu'' Cluj Napoca, Cluj County Hospital , 3-5 Clinicilor Street, 400006 Cluj-Napoca , Romania 6 Department of Neurology, Emergency Clinical Hospital Oradea , 65 Gh Doja Street, 410169 Oradea, Bihor , Romania 7 Department of Neurology, University of Medicine and Pharmacy Targu Mures , 38 Gh Marinescu Street, 540139 Targu Mures, Mures , Romania 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. A retrospective analysis (2009-2013) of LCIG therapy and the experience in nine neurology centers in Romania was performed. The impact of LCIG therapy was evaluated by analyzing changes in motor fluctuations, dyskinesia and the patients' QoL after initiating therapy. The safety of LCIG therapy was estimated by noting agentrelated adverse events (AEs) and medical device-related AEs. In the 113 patients included, we observed a significant improvement in PD symptoms after initiation of LCIG therapy. The ''on'' period increased, with a mean value of 6.14 h, and the dyskinesia period was reduced, with a mean value of 29.4 %. The quantified non-motor symptoms subsided. The patients exhibited significant improvements in QoL scores. There were few AEs and few cases of LCIG therapy discontinuation. LCIG is an important and available therapeutic option for managing patients with advanced PD. Parkinson's disease; Motor complications; Levodopa-carbidopa intestinal gel (LCIG); Quality of life Introduction Levodopa is currently the most effective agent for symptomatic treatment of PD, particularly when bradykinetic symptoms become intrusive with respect to a patient’s motor abilities. However, while the exact percentage is difficult to estimate (Ahlskog and Muenter 2001) , somewhere between 50 and 90 % of patients with PD develop motor complications and dyskinesia within 5–10 years of levodopa treatment (Olanow et al. 2001) . Dyskinesia, the most invalidating side effect of oral L-dopa therapy, becomes increasingly frequent with long-term treatment and advanced disease and is one of the greatest disadvantages of the oral levodopa treatment for Parkinson’s disease. As the therapeutic window becomes narrower, finetuning between the ‘‘off’’ time and dyskinesia becomes more difficult with the use of oral therapies partly because the gastric passage severely interferes with the process. Furthermore, motor fluctuations represent the other end of the problem, also highlighting the relatively short half-life of levodopa. Therefore, these side-effects of levodopa therapy are likely due to both the pulsatile dopaminergic substitution pharmacological characteristics of all available oral levodopa formulations (immediate or extended release) and the potential gastric barrier to its absorption. Continuous administration of LCIG through intestinal infusion represents a therapeutic option for advanced PD. Studies have demonstrated that the levodopa plasma concentration is less time variable with LCIG than with tablets (Nyholm et al. 2003) . Data regarding its effects have been systematically collected in cou (...truncated)


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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. The effect of levodopa–carbidopa intestinal gel infusion long-term therapy on motor complications in advanced Parkinson’s disease: a multicenter Romanian experience, Journal of Neural Transmission, 2016, pp. 407-414, Volume 123, Issue 4, DOI: 10.1007/s00702-015-1496-z