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Clin Transl Gastroenterol. 2016 Mar 31;7:e159. doi: 10.1038/ctg.2016.19.

Long-Term PEG-J Tube Safety in Patients With Advanced Parkinson's Disease.

Author information

1
Digestive Disorders Associates, Annapolis, Maryland, USA.
2
Department of Internal Medicine, Eastern Virginia Medical School, Norfolk, Virginia, USA.
3
Department of Internal Medicine, University of Central Florida College of Medicine, Orlando, Florida, USA.
4
Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
5
Department of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
6
OptumInsight, Saint-Laurent, Quebec, Canada.
7
Department of Statistics, AbbVie Inc., North Chicago, Illinois, USA.
8
Department of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.

Abstract

OBJECTIVES:

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.

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