Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
Por:
Antonini, A, Poewe, W, Chaudhuri, KR, Jech, R, Pickut, B, Pirtosek, Z, Szasz, J, Valldeoriola, F, Winkler, C, Bergmann, L, Yegin, A, Onuk, K, Barch, D, Odin, P, Kulisevsky J., van Zandijcke, Michel
Publicada:
1 dic 2017
Resumen:
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-naive 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. (C) 2017 The Authors. Published by Elsevier Ltd.
Filiaciones:
Antonini, A:
Univ Padua, Dept Neurosci, Via Giustiniani 5, Padua, Italy
Poewe, W:
Med Univ Innsbruck, Innsbruck, Austria
Chaudhuri, KR:
Kings Coll London, London, England
Kings Coll Hosp London, London, England
Jech, R:
Charles Univ Prague, Gen Univ Hosp Prague, Ctr Clin Neurosci, Dept Neurol, Prague, Czech Republic
Pickut, B:
Univ Hosp Antwerp, Antwerp, Belgium
Michigan State Univ, Mercy Hlth Hauenstein Neurosci, Grand Rapids, MI USA
Pirtosek, Z:
Univ Med Ctr Ljubljana, Ljubljana, Slovenia
Szasz, J:
Univ Med & Pharm Tirgu Mures, Emergency Clin Cty Hosp Mures, Targu Mures, Romania
Valldeoriola, F:
Clin & Prov Hosp Barcelona, Barcelona, Spain
Winkler, C:
Lindenbrunn Hosp, Coppenbrugge, Germany
Bergmann, L:
AbbVie Inc, N Chicago, IL USA
Yegin, A:
AbbVie Inc, N Chicago, IL USA
Onuk, K:
AbbVie Inc, N Chicago, IL USA
Barch, D:
AbbVie Inc, N Chicago, IL USA
Odin, P:
Lund Univ, Lund, Sweden
Kulisevsky J.:
Sant Pau Hospital, Barcelona, Spain
van Zandijcke, Michel :
AZ Sint-Jan Brugge, Brugge, Belgium
Green Submitted, Green Published, hybrid
|