Levodopa‐carbidopa intestinal gel in advanced Parkinson's disease: Final 12‐month,open‐label results |
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| Authors: | Hubert H. Fernandez MD David G. Standaert MD PhD Robert A. Hauser MD Anthony E. Lang MD FRCPC Victor S.C. Fung PhD FRACP Fabian Klostermann PhD Mark F. Lew MD Per Odin MD PhD Malcolm Steiger MBBS MD FRCP Eduard Z. Yakupov MD PhD DMSc Sylvain Chouinard MD FRCPC Oksana Suchowersky MD FRCPC FCCMG Jordan Dubow MD Coleen M. Hall MS Krai Chatamra PhD Weining Z. Robieson PhD Janet A. Benesh BSMT Alberto J. Espay MD MSc |
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| Affiliation: | 1. Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA;2. University of Alabama at Birmingham, Birmingham, Alabama, USA;3. Department of Neurology, University of South Florida, Tampa, Florida, USA;4. University of Toronto, Toronto, Ontario, Canada;5. Movement Disorders Unit, Westmead Hospital and Sydney Medical School, Sydney, Australia;6. Charité‐University Medicine Berlin, Berlin, Germany;7. Keck/USC School of Medicine, Los Angeles, California, USA;8. Klinikum‐Bremerhaven, Bremerhaven, Germany and Skane University Hospital, Lund, Sweden;9. Walton Center for Neurology and Neurosurgery, Liverpool, United Kingdom;10. Kazan State Medical University, Kazan, Russia;11. University of Montreal, Montreal, Quebec, Canada;12. University of Alberta, Edmonton, Alberta, Canada;13. AbbVie Inc., North Chicago, Illinois, USA;14. University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA |
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| Abstract: | Motor complications in Parkinson's disease (PD) are associated with long‐term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. l ‐dopa‐carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG‐J), which reduces l‐ 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% (P < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (P < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (P = 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, l‐ 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. |
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| Keywords: | dyskinesia infusion levodopa‐carbidopa intestinal gel “ off” time percutaneous endoscopic gastrojejunostomy |
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