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. 2016 Mar 31;7(3):e159.
doi: 10.1038/ctg.2016.19.

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

Michael Epstein  1 , David A Johnson  2 , Robert Hawes  3 , Nathan Schmulewitz  4 , Arvydas D Vanagunas  5 , E Roderich Gossen  6 , Weining Z Robieson  7 , Susan Eaton  8 , Jordan Dubow  8 , Krai Chatamra  8 , Janet Benesh  8
Affiliations

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

Michael Epstein et al. Clin Transl Gastroenterol. .

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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Conflict of interest statement

Guarantor of the article: Michael Epstein, MD.

Specific author contributions: Design and execution of the adjudication: Michael Epstein, David A. Johnson, and Robert Hawes; performance of literature review: Michael Epstein, David A. Johnson, Robert Hawes, and Arvydas D. Vanagunas; organization and analysis of adjudication data: E. Roderich Gossen; original research project conception, organization and execution: Weining Z. Robieson, Krai Chatamra, Jordan Dubow, and Janet Benesh; design and execution of statistical analysis: Weining Z. Robieson, Susan Eaton, Krai Chatamra, Jordan Dubow, and Janet Benesh; organization, review, and analysis of the adjudication data: Susan Eaton. All the authors reviewed and critiqued the statistical analysis and the manuscript throughout the editorial process. All the authors approved of the final manuscript draft submitted for publication.

Financial support: This study was sponsored by AbbVie, North Chicago, IL, which participated in the study design, research, data collection, analysis and interpretation of data, writing, reviewing, and approving the manuscript for publication. The work of the data adjudication committee was funded by, but performed independently of, the study sponsor.

Potential competing interests: Michael Epstein has received compensation from AbbVie for serving as a consultant and lecturer. He also receives compensation for advisory boards from Zx Pharma and Aspire Bariatrics, and for speaking services from Otsuka and Ferring. David A. Johnson has received compensation from AbbVie for serving as a consultant. He has also received compensation for advisory board/consultant services from Pfizer, Takeda Pharmaceuticals, Abbott Laboratories (now AbbVie), Given Imaging, CRH Medical Corporation, and Janssen Biotech, and for speaking services from Takeda Pharmaceuticals and AstraZeneca. He has served on the editorial boards of WebMD/Medscape, Journal Watch Gastro (New England Journal of Medicine), Frontiers in Endocrinology, American College of Gastroenterology Education Universe, and World Journal of Gastroenterology and Hepatology. He has received clinical research grants from Epigenomics AG and Exact Sciences Corporation, and he holds stock options/ownership in CRH Medical Corporation. Robert Hawes has received compensation from AbbVie for serving as a consultant. He has also received compensation for advisory board/consultancy services from Boston Scientific, Olympus, and Abbott Laboratories (now AbbVie), and for speaking services from Cook. He holds stock options/ownership in Apollo Endosurgery. Nathan Schmulewitz has received compensation from AbbVie for advisory board and speaking services. Arvydas D. Vanagunas has received compensation from AbbVie for consultancy and advisory board services. He has also received compensation for consultancy services from CVS/Caremark Pharmacy and Therapeutics and for speaking services from Forest Laboratories. E. Roderich Gossen served as executive secretary on the adjudication committee through a contract between his former employer, OptumInsight, and AbbVie; he is currently employed by Veristat. Weining Z. Robieson is an employee of AbbVie with stock and/or stock options at the time of the study and is currently employed by ZS pharma. Susan Eaton is a former employee of AbbVie and holds stock and/or stock options. Jordan Dubow was an employee of AbbVie with stock/stock options at the time of the study and is currently employed with stock options by Marathon Pharmaceuticals. Krai Chatamra is an employee of AbbVie and holds stock and/or stock options. Janet Benesh is an employee of AbbVie and holds stock and/or stock options.

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