Angelo Antonini1, Werner Poewe2, K Ray Chaudhuri3, Robert Jech4, Barbara Pickut5, Zvezdan Pirtošek6, Jozsef Szasz7, Francesc Valldeoriola8, Christian Winkler9, Lars Bergmann10, Ashley Yegin10, Koray Onuk10, David Barch10, Per Odin11. 1. Department of Neurosciences, University of Padua, Italy. Electronic address: angelo3000@yahoo.com. 2. Medical University of Innsbruck, Innsbruck, Austria. Electronic address: werner.poewe@i-med.ac.at. 3. King's College and King's College Hospital, London, United Kingdom. 4. Department of Neurology, Center of Clinical Neurosciences, Charles University in Prague, General University Hospital in Prague, Prague, Czech Republic. 5. University Hospital Antwerp, Antwerp, Belgium; Michigan State University, Mercy Health Hauenstein Neurosciences, Grand Rapids, MI, USA. 6. University Medical Center Ljubljana, Ljubljana, Slovenia. 7. University of Medicine and Pharmacy Tirgu-Mures, Emergency Clinical County Hospital Mures, Tîrgu Mureş, Romania. 8. Clinical and Provincial Hospital of Barcelona, Barcelona, Spain. 9. Lindenbrunn Hospital, Coppenbrügge, Germany. 10. AbbVie Inc., North Chicago, IL, USA. 11. Lund University, Lund, Sweden.
Abstract
INTRODUCTION: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. METHODS: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naïve patients (60% of patients) and partially retrospective for patients with ≤12 months of pre-treatment with LCIG (40% of patients). Hours of "On" and "Off" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. RESULTS: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in "Off" time (hours/day) (mean ± SD = -4.1 ± 3.5, P < 0.001), "On" time with dyskinesia (hours/day) (-1.1 ± 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 ± 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 ± 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). CONCLUSIONS: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG.
INTRODUCTION: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. METHODS: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naïve patients (60% of patients) and partially retrospective for patients with ≤12 months of pre-treatment with LCIG (40% of patients). Hours of "On" and "Off" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. RESULTS: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in "Off" time (hours/day) (mean ± SD = -4.1 ± 3.5, P < 0.001), "On" time with dyskinesia (hours/day) (-1.1 ± 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 ± 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 ± 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). CONCLUSIONS:LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PDpatients over 24 months. Safety events were consistent with the established safety profile of LCIG.
Authors: Vili Viljaharju; Tuomas Mertsalmi; K Amande M Pauls; Maija Koivu; Johanna Eerola-Rautio; Marianne Udd; Eero Pekkonen Journal: Mov Disord Clin Pract Date: 2021-11-04
Authors: Pablo Martinez-Martin; Anette Schrag; Daniel Weintraub; Alexandra Rizos; Carmen Rodriguez-Blazquez; Kallol Ray Chaudhuri Journal: Mov Disord Clin Pract Date: 2019-02-05