Angelo Antonini1, Ashley Yegin2, Cornelia Preda2, Lars Bergmann2, Werner Poewe3. 1. Parkinson and Movement Disorders Unit, IRCCS Hospital San Camillo, Venice, Italy. Electronic address: angelo3000@yahoo.com. 2. AbbVie, Inc., USA. 3. Dept of Neurology, Innsbruck Medical University, Austria.
Abstract
INTRODUCTION: Intermittent oral delivery of levodopa is a major contributing factor for motor complications in Parkinson's disease (PD). Continuous infusion of levodopa-carbidopa intestinal gel (LCIG) into the jejunum using a portable pump via percutaneous endoscopic gastrostomy (PEG) improves motor complications and quality of life (QoL). OBJECTIVES: To record long-term effectiveness of advanced PD patients undergoing LCIG infusion in routine care, by Unified Parkinson's Disease Rating Scale (UPDRS), Non-Motor Symptoms Scale (NMSS), PDQ-8 and EQ-5D questionnaires. METHODS: Overall, 375 patients from 75 movement disorder centers in 18 countries were enrolled in this prospective non-interventional study. The 12-month interim outcomes of the first 172 included patients are presented here. RESULTS: There were reductions of mean daily "Off" time from baseline (BL) (7.1 ± 3.5 h) and "On" time with dyskinesias (5.2 ± 4.5 h) at month 12 (M12) of -4.7 ± 3.4 and -1.7 ± 5.0 h respectively (p < 0.0001; p = 0.0228). UPDRS II and III "On" scores decreased from BL to M12 (p = 0.0107 and p = 0.0128). Total NMSS and PDQ-8 scores improved at M12 (p = 0.0014 and p = 0.0100). Mean LCIG dose administered through PEG at first visit (day after implantation) was 1304 ± 618 mg/day and remained stable through M12. Continuous LCIG infusion tolerability and adverse drug reactions were consistent with the known safety profile of previous studies. CONCLUSIONS: This observational, routine-care study supports long-term safety and efficacy of LCIG infusion in advanced PD including motor, non-motor and QoL improvements.
INTRODUCTION: Intermittent oral delivery of levodopa is a major contributing factor for motor complications in Parkinson's disease (PD). Continuous infusion of levodopa-carbidopa intestinal gel (LCIG) into the jejunum using a portable pump via percutaneous endoscopic gastrostomy (PEG) improves motor complications and quality of life (QoL). OBJECTIVES: To record long-term effectiveness of advanced PDpatients undergoing LCIG infusion in routine care, by Unified Parkinson's Disease Rating Scale (UPDRS), Non-Motor Symptoms Scale (NMSS), PDQ-8 and EQ-5D questionnaires. METHODS: Overall, 375 patients from 75 movement disorder centers in 18 countries were enrolled in this prospective non-interventional study. The 12-month interim outcomes of the first 172 included patients are presented here. RESULTS: There were reductions of mean daily "Off" time from baseline (BL) (7.1 ± 3.5 h) and "On" time with dyskinesias (5.2 ± 4.5 h) at month 12 (M12) of -4.7 ± 3.4 and -1.7 ± 5.0 h respectively (p < 0.0001; p = 0.0228). UPDRS II and III "On" scores decreased from BL to M12 (p = 0.0107 and p = 0.0128). Total NMSS and PDQ-8 scores improved at M12 (p = 0.0014 and p = 0.0100). Mean LCIG dose administered through PEG at first visit (day after implantation) was 1304 ± 618 mg/day and remained stable through M12. Continuous LCIG infusion tolerability and adverse drug reactions were consistent with the known safety profile of previous studies. CONCLUSIONS: This observational, routine-care study supports long-term safety and efficacy of LCIG infusion in advanced PD including motor, non-motor and QoL improvements.
Authors: Joseph Classen; Jiri Koschel; Christian Oehlwein; Klaus Seppi; Peter Urban; Christian Winkler; Ullrich Wüllner; Alexander Storch Journal: J Neural Transm (Vienna) Date: 2017-07-12 Impact factor: 3.575