title: Long-Term PEG-J Tube Safety in Patients With Advanced Parkinson's Disease.
abstract: OBJECTIVE
  The objectives of this study were to present procedure- and device-associated adverse events (AEs) identified with long-term drug delivery via percutaneous endoscopic gastrojejunostomy (PEG-J). Levodopa-carbidopa intestinal gel (LCIG, also known in US as carbidopa-levodopa enteral suspension, CLES) is continuously infused directly to the proximal small intestine via PEG-J in patients with advanced Parkinson's disease (PD) to overcome slow and erratic gastric emptying and treat motor fluctuations that are not adequately controlled by oral or other pharmacological therapy.
  
  
  METHODS
  An independent adjudication committee of three experienced (>25 years each) gastroenterologists reviewed gastrointestinal procedure- and device-associated AEs reported for PD patients (total n=395) enrolled in phase 3 LCIG studies. The rate, clinical significance, and causality of the procedure/device events were determined.
  
  
  RESULTS
  The patient median exposure to PEG-J at the data cutoff was 480 days. Procedure- and device-associated serious AEs (SAEs) occurred in 67 (17%) patients. A total of 42% of SAEs occurred during the first 4 weeks following PEG-J placement. SAEs of major clinical significance with the highest procedural incidence were peritonitis (1.5%), pneumonia (1.5%), and abdominal pain (1.3%). The most common non-serious procedure- and device-associated AEs were abdominal pain (31%), post-operative wound infection (20%), and procedural pain (23%). In all, 17 (4.3%) patients discontinued treatment owing to an AE.
  
  
  CONCLUSIONS
  In conclusion, incidences of PEG-J AEs with the LCIG delivery system and PEG-J longevity were compared favorably with ranges described in the PEG/PEG-J literature. A low discontinuation rate in this study suggests acceptable procedural outcomes and AE rates in PD patients treated with this PEG-J drug delivery system.
authors.affiliation: Digestive Disorders Associates, Annapolis, Maryland, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Epstein
authors.affiliation: Department of Internal Medicine, Eastern Virginia Medical School, Norfolk, Virginia, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Johnson
authors.affiliation: Department of Internal Medicine, University of Central Florida College of Medicine, Orlando, Florida, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Hawes
authors.affiliation: Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
authors.forename: Nathan
authors.initials: N
authors.lastname: Schmulewitz
authors.affiliation: Department of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Arvydas D
authors.initials: AD
authors.lastname: Vanagunas
authors.affiliation: OptumInsight, Saint-Laurent, Quebec, Canada.
authors.forename: E Roderich
authors.initials: ER
authors.lastname: Gossen
authors.affiliation: Department of Statistics, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Weining Z
authors.initials: WZ
authors.lastname: Robieson
authors.affiliation: Department of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Eaton
authors.affiliation: Department of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Jordan
authors.initials: J
authors.lastname: Dubow
authors.affiliation: Department of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Krai
authors.initials: K
authors.lastname: Chatamra
authors.affiliation: Department of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Benesh