Maríateresa Buongiorno1, Francesca Antonelli1, Ana Cámara1, Victor Puente2, Oriol de Fabregues-Nebot3, Jorge Hernandez-Vara3, Matilde Calopa4, Berta Pascual-Sedano5, Antonia Campolongo5, Francesc Valldeoriola1, Eduardo Tolosa1, Jaime Kulisevsky6, Maria Jose Martí7. 1. Parkinson's Disease and Movement Disorders Unit, Neurology Service, Hospital Clínic, University of Barcelona, Spain; Instituto de Investigaciones Biomédicas August Pi I Sunyer - IDIBAPS, Barcelona, Spain; CIBERNED Carlos III Health Institute, Spain. 2. Neurology Service, Institut Municipal d'Investigacio Medica, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain. 3. Movement Disorders Unit, Department of Neurology, Institut de Recerca Vall d'Hebron, Hospital Universitari Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain. 4. Neurology Service, Hospital de Bellvitge, University of Barcelona, l'Hospitalet de Llobregat, Spain. 5. CIBERNED Carlos III Health Institute, Spain; Movement Disorders Unit, Neurology Service, Sant Pau Hospital, Autonomous University of Barcelona, Spain. 6. CIBERNED Carlos III Health Institute, Spain; Movement Disorders Unit, Neurology Service, Sant Pau Hospital, Autonomous University of Barcelona, Spain; Health Sciences Department, Universitat Oberta de Catalunya, Spain. 7. Parkinson's Disease and Movement Disorders Unit, Neurology Service, Hospital Clínic, University of Barcelona, Spain; Instituto de Investigaciones Biomédicas August Pi I Sunyer - IDIBAPS, Barcelona, Spain; CIBERNED Carlos III Health Institute, Spain. Electronic address: MJMARTI@clinic.ub.es.
Abstract
INTRODUCTION: Continuous infusion of levodopa/carbidopa intestinal gel (LCIG) is an effective treatment for patients with advanced Parkinson Disease (PD) that cannot be further improved by oral therapy. METHODS: We conducted an observational, prospective, and multicenter study to collect, in a large sample of PD treated with LCIG, long-term information about the outcome and safety of the treatment. The assessments were performed before LCIG, 1, 3, 6 months after, and ever since, every 6 months. RESULTS: We studied 72 patients with a mean observation time of 22 months and a maximum of 48 months. During follow-up 28 patients discontinued the treatment, especially for lack of efficacy or adverse events related to the drug. We obtained a significant improvement of motor and non-motor fluctuations, mean off time and some non-motor symptoms. A significant increase in the percentage of time with dyskinesias was found in patients having less than 50% of the day with dyskinesias before LCIG. However, patients having already many dyskinesias before LCIG experienced a significant decrease of the troublesome dyskinesias, meaning that outcomes might be different depending on specific clinical characteristics. Adverse effects were in general minor but one case of intestinal perforation and one of abdominal cellulite were observed. CONCLUSIONS: We confirmed that LCIG is a very effective treatment option for advanced PD; however considering the findings that dyskinesia can increase and the potential for serious side effects, we suggest the necessity for development of guidelines that better define the profile of responders.
INTRODUCTION: Continuous infusion of levodopa/carbidopa intestinal gel (LCIG) is an effective treatment for patients with advanced Parkinson Disease (PD) that cannot be further improved by oral therapy. METHODS: We conducted an observational, prospective, and multicenter study to collect, in a large sample of PD treated with LCIG, long-term information about the outcome and safety of the treatment. The assessments were performed before LCIG, 1, 3, 6 months after, and ever since, every 6 months. RESULTS: We studied 72 patients with a mean observation time of 22 months and a maximum of 48 months. During follow-up 28 patients discontinued the treatment, especially for lack of efficacy or adverse events related to the drug. We obtained a significant improvement of motor and non-motor fluctuations, mean off time and some non-motor symptoms. A significant increase in the percentage of time with dyskinesias was found in patients having less than 50% of the day with dyskinesias before LCIG. However, patients having already many dyskinesias before LCIG experienced a significant decrease of the troublesome dyskinesias, meaning that outcomes might be different depending on specific clinical characteristics. Adverse effects were in general minor but one case of intestinal perforation and one of abdominal cellulite were observed. CONCLUSIONS: We confirmed that LCIG is a very effective treatment option for advanced PD; however considering the findings that dyskinesia can increase and the potential for serious side effects, we suggest the necessity for development of guidelines that better define the profile of responders.