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Epstein M, Johnson DA, Hawes R, et al. Long-Term PEG-J Tube Safety in Patients With Advanced Parkinson's Disease. Clin Transl Gastroenterol. 2016;7:e159doi: 10.1038/ctg.2016.19.
Epstein, M., Johnson, D. A., Hawes, R., Schmulewitz, N., Vanagunas, A. D., Gossen, E. R., Robieson, W. Z., Eaton, S., Dubow, J., Chatamra, K., & Benesh, J. (2016). Long-Term PEG-J Tube Safety in Patients With Advanced Parkinson's Disease. Clinical and translational gastroenterology, 7e159. https://doi.org/10.1038/ctg.2016.19
Epstein, Michael, et al. "Long-Term PEG-J Tube Safety in Patients With Advanced Parkinson's Disease." Clinical and translational gastroenterology vol. 7 (2016): e159. doi: https://doi.org/10.1038/ctg.2016.19
Epstein M, Johnson DA, Hawes R, Schmulewitz N, Vanagunas AD, Gossen ER, Robieson WZ, Eaton S, Dubow J, Chatamra K, Benesh J. Long-Term PEG-J Tube Safety in Patients With Advanced Parkinson's Disease. Clin Transl Gastroenterol. 2016 Mar 31;7:e159. doi: 10.1038/ctg.2016.19. PMID: 27030949; PMCID: PMC4822096.
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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.

Clinical and translational gastroenterology

Michael Epstein, David A Johnson, Robert Hawes, Nathan Schmulewitz, Arvydas D Vanagunas, E Roderich Gossen, Weining Z Robieson, Susan Eaton, Jordan Dubow, Krai Chatamra, Janet Benesh

Affiliations

  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.

PMID: 27030949 PMCID: PMC4822096 DOI: 10.1038/ctg.2016.19

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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