Current Practices for Outpatient Initiation of Levodopa-Carbidopa Intestinal Gel for Management of Advanced Parkinson's Disease in the United States.
In 2015, the US Food and Drug Administration approved levodopa-carbidopa intestinal gel (LCIG; also known as carbidopa-levodopa enteral suspension in the US) for the treatment of motor fluctuations in patients with advanced Parkinson's disease. LCIG provides a continuous infusion of levodopa and carbidopa by means of a portable pump and percutaneous endoscopic gastrojejunostomy tube. The delivery system has a two-fold pharmacokinetic advantage over orally administered carbidopa/levodopa. First, levodopa is delivered in a continuous rather than intermittent, pulsatile fashion. Second, delivery to levodopa's site of absorption in the jejunum bypasses the stomach, thereby avoiding issues with erratic gastric emptying. In blinded prospective clinical trials and observational studies, LCIG has been shown to significantly decrease "off" time, increase "on" time without troublesome dyskinesia, and reduce dyskinesia. Consistent with procedures in previous studies, LCIG initiation and titration in the pivotal US clinical trial were performed in the inpatient setting and followed a standardized protocol. In clinical practice, however, initiation and titration of LCIG have a great degree of flexibility and, in the US, almost always take place in the outpatient setting. Nonetheless, there remains a significant amount of clinician uncertainty regarding titration in outpatient clinical practice. This review aims to shed light on and provide guidance as to the current methods of titration in the outpatient setting, as informed by the medical literature and the authors' experiences. FUNDING: AbbVie, Inc. Plain language summary available for this article.
['Amjad|Fahd|F|', 'Bhatti|Danish|D|', 'Davis|Thomas L|TL|', 'Oguh|Odinachi|O|', 'Pahwa|Rajesh|R|', 'Kukreja|Pavnit|P|', 'Zamudio|Jorge|J|', 'Metman|Leonard Verhagen|LV|']
D000368:Aged D000978:Antiparkinson Agents D002230:Carbidopa D004338:Drug Combinations D005260:Female D005782:Gels D006801:Humans D007263:Infusions, Parenteral D007980:Levodopa D008297:Male D008875:Middle Aged D064887:Observational Studies as Topic D010300:Parkinson Disease D057285:Precision Medicine D011446:Prospective Studies D014481:United States
LCIG Carbidopa/levodopa enteral suspension Continuous dopaminergic stimulation Device-aided therapy Duodopa Duopa Neurology