Levodopa‐carbidopa intestinal gel in advanced Parkinson's disease: Final 12‐month, open‐label results. Issue 4 (24th December 2014)

• Record Type: Journal Article
• Authors: Fernandez, Hubert H.; Standaert, David G.; Hauser, Robert A.; Lang, Anthony E.; Fung, Victor S.C.; Klostermann, Fabian; Lew, Mark F.; Odin, Per; Steiger, Malcolm; Yakupov, Eduard Z.; Chouinard, Sylvain; Suchowersky, Oksana; Dubow, Jordan; Hall, Coleen M.; Chatamra, Krai; Robieson, Weining Z.; Benesh, Janet A.; Espay, Alberto J.
• Is Part Of: Movement disorders. Volume 30:Issue 4(2015)
• Page Start: 500
• Page End: 509
• Publication Date: 2014-12-24
• Subjects: Movement disorders -- Periodicals; 610
• DOI: 10.1002/mds.26123
• Languages: English
• ISSNs: 0885-3185

Abstract

<abstract abstract-type="main"> <title>ABSTRACT</title> <p>Motor complications in Parkinson's disease (PD) are associated with long‐term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. <sc>l</sc>‐dopa‐carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG‐J), which reduces <sc>l‐</sc>dopa‐plasma–level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54‐week, open‐label LCIG study. PD patients with severe motor fluctuations (>3 h/day "off" time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post‐LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary‐assessed off time, "on" time with/without troublesome dyskinesia, UPDRS, and health‐related quality‐of‐life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG‐J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty‐seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (<italic>P</italic> < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (<italic>P</italic> < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (<italic>P</italic> = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, <sc>l‐</sc>dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks. © 2014 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</p> </abstract>