RT期刊文章SR电子T1 Levodopa-Carbidopa肠凝胶治疗的安全先进的帕金森症患者接受≥2000毫克每日剂量左旋多巴(P2.047)摩根富林明神经病学神经学乔FD Lippincott Williams &威尔金斯SP P2.047 VO 90 15补充A1辛迪Zadikoff A1詹姆斯·博伊德A1斯蒂芬妮Dubow A1 Lars伯格曼A1威宁Robi首页eson A1 Horia Ijacu A1 Janet Benesh年2018 UL //www.ez-admanager.com/content/90/15_Supplement/P2.047.abstract AB目的:检查的安全Levodopa-Carbidopa肠凝胶治疗(LCIG carbidopa-levodopa肠内悬挂在美国)在晚期帕金森病(PD)患者接受≥2000毫克/天的剂量左旋多巴在临床研究期间。背景:LCIG是先进的PD患者的治疗选择电动机严重波动尽管优化药物治疗。发表剂量左旋多巴安全的数据是有限的,特别是对≥2000毫克。设计/方法:不良事件(AEs)病人在三期项目接受非盲LCIG综述了通过10月1日,2016年。事后患者分为2组< 2000毫克剂量(N = 340),≥2000毫克(N = 72)的意思是每天总左旋多巴。设备/过程AEs被排除在分析之外。现实世界安全数据格洛里亚的观察性研究也summarizedResults:大约有17%(72/412)先进的PD患者三期项目要求≥2000毫克/天的左旋多巴症状控制。现实世界的数据格洛丽亚观察研究反映了相似比例的患者接受≥2000毫克每天(100毫升LCIG)左旋多巴(47/356 [13%])。意思是基线(提单)病人剂量组之间是相似的特征。意思是(SD)提单口服左旋多巴剂量≥2000毫克/天组高于病人接受< 2000毫克/天(< 2000 mg: 1000.3[499.6]毫克;≥2000 mg: 1464.8 693.3毫克)。 AEs were reported by 93% of patients in the <2000 mg/day group and 97% of patients in the ≥2000 mg/day group. AEs reported in ≥15% of patients in the ≥2000 mg dose group with incidence rates ≥ twice that of the <2000 mg dose group included PD (return/worsening of PD symptoms) (<2000 mg: 14%, ≥2000 mg: 31%) and vomiting (<2000 mg: 9%, ≥2000 mg: 22%). Serious AEs were reported by 44% of patients in the <2000 mg/day group and 64% of patients receiving ≥2000 mg/day.Conclusions: Patients that required ≥2000 mg/day had higher BL oral levodopa doses and higher rates for some AEs compared to patients who received <2000 mg/day levodopa. However, baseline characteristics and discontinuation due to AE were relatively similar between groups.Study Supported by: AbbVie Inc.Disclosure: Dr. Zadikoff has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, USworldMeds, Acadia, UCB, St Jude, Merz, Teva, Lundbeck. Dr. Boyd has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Teva, Lundbeck, Chrono Therapeutics, Neurocrine and Medical Education Resources. Dr. Boyd has received research support from Michael J. Fox Foundation, NIH/NINDS, Auspex, Biotie, CHDI Foundation, NeuroDerm, Chrono Therapeutics, Vaccinex, AbbVie Inc. Dr. Dubow has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Dubow holds stock and/or stock options in AbbVie Inc. Dr. Bergmann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Bergmann holds stock and/or stock options in AbbVie Inc. Dr. Robieson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Robieson has received research support from AbbVie Inc. Dr. Ijacu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Ijacu holds stock and/or stock options in AbbVie Inc. Dr. Benesh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Benesh holds stock and/or stock options in AbbVie Inc.