Evidence map›Paper›PMID 27030949›Full record

ArticleClinical and translational gastroenterology2016

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

Michael Epstein, David A Johnson, Robert Hawes, Nathan Schmulewitz, Arvydas D Vanagunas, E Roderich Gossen, Weining Z Robieson, Susan Eaton, Jordan Dubow, Krai Chatamra and 1 more

Open access · goldAbstract read
In one paragraph

Article in Clinical and translational gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Transgastric Jejunostomy (PEG-J) for Continuous Infusion of Levodopa-Carbidopa Intestinal Gel: An Approach for Parkinson's Disease Treatment.Medical science monitor : international medical journal of experimental and clinical research · 2023
    Article
  6. Review
  7. Article
  8. Article
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  10. Review
  11. Article
  12. Observational
  13. Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease: results of the Italian GLORIA patient population.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
    Article
  14. Infusion Therapies for Parkinson's Disease.Current neurology and neuroscience reports · 2020
    Review
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  16. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Michael EpsteinDigestive Disorders Associates, Annapolis, Maryland, USA.
David A JohnsonDepartment of Internal Medicine, Eastern Virginia Medical School, Norfolk, Virginia, USA.
Robert HawesDepartment of Internal Medicine, University of Central Florida College of Medicine, Orlando, Florida, USA.
Nathan SchmulewitzDepartment of Internal Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
Arvydas D VanagunasDepartment of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
E Roderich GossenOptumInsight, Saint-Laurent, Quebec, Canada.
Weining Z RobiesonDepartment of Statistics, AbbVie Inc., North Chicago, Illinois, USA.
Susan EatonDepartment of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
Jordan DubowDepartment of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
Krai ChatamraDepartment of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
Janet BeneshDepartment of Pharmaceutical Development, AbbVie Inc., North Chicago, Illinois, USA.
AbbVie (United States) · USDigestive Care (United States) · USEastern Virginia Medical School · USNorthwestern University · USUniversity of Central Florida · USUniversity of Cincinnati · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe 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.

methodsAn 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.

resultsThe 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.

conclusionsIn 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.

Identifiers

PMID27030949
PMCPMC4822096
OpenAlexW2319834059

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.