Evidence map›Paper›PMID 26695437›Full record

ArticleMovement disorders : official journal of the Movement Disorder Society2016

Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials.

Anthony E Lang, Ramon L Rodriguez, James T Boyd, Sylvain Chouinard, Cindy Zadikoff, Alberto J Espay, John T Slevin, Hubert H Fernandez, Mark F Lew, David A Stein and 11 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Movement disorders : official journal of the Movement Disorder Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 5 pooled it
7.0field-weighted citation impact, top 3% 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

48 citing papers in PubMed, 5 syntheses or guidelines pooled it, 101 citations in OpenAlex.

  1. Interventions for preventing falls in Parkinson's disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Intrajejunal Infusion of Levodopa/Carbidopa for Advanced Parkinson's Disease: A Systematic Review.Movement disorders : official journal of the Movement Disorder Society · 2021
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Observational
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Current and novel infusion therapies for patients with Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2023
    Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Observational
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

21 authors at 14 institutions in 5 countries.

Anthony E LangMorton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.
Ramon L RodriguezUniversity of Florida College of Medicine, Gainesville, Florida, USA.
James T BoydUniversity of Vermont College of Medicine, Burlington, Vermont, USA.
Sylvain ChouinardUniversity of Montreal, Montreal, Quebec, Canada.
Cindy ZadikoffFeinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Alberto J EspayUniversity of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.
John T SlevinUniversity of Kentucky Medical Center, Lexington, Kentucky, USA.
Hubert H FernandezCenter for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.
Mark F LewKeck/University of Southern California School of Medicine, Los Angeles, California, USA.
David A SteinQuintiles, San Diego, California, USA.
Per OdinKlinikim-Bremerhaven, Germany and Skane University Hospital, Lund, Sweden.
Victor S C FungWestmead Hospital and Sydney Medical School, Sydney, Australia.
Fabian KlostermannCharité-University Medicine Berlin, Berlin, Germany.
Alfonso FasanoMorton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.
Peter V DraganovUniversity of Florida College of Medicine, Gainesville, Florida, USA.
Nathan SchmulewitzUniversity of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.
Weining Z RobiesonAbbVie Inc, North Chicago, Illinois, USA.
Susan EatonAbbVie Inc, North Chicago, Illinois, USA.
Krai ChatamraAbbVie Inc, North Chicago, Illinois, USA.
Janet A BeneshAbbVie Inc, North Chicago, Illinois, USA.
Jordan DubowAbbVie Inc, North Chicago, Illinois, USA.
AbbVie (United States) · USUniversity of Cincinnati Medical Center · USUniversity of Florida · USUniversity of Toronto · CACharité - Universitätsmedizin Berlin · DECleveland Clinic · USIQVIA (United States) · USNorthwestern University · USSkåne University Hospital · SEUniversité de Montréal · CAUniversity of Kentucky · USUniversity of Southern California · USUniversity of Vermont · USWestmead Hospital · AU

Funding

Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
NCATS NIH HHS UL1 TR001427
6 · The paper itself

Abstract

backgroundContinuous administration of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.

methodsSafety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device-associated (n = 395) from non-procedure/device adverse events (n = 412).

resultsAt the data cutoff, median exposure to levodopa-carbidopa intestinal gel was 911 days (range, 1-1980 days) with 963 total patient-years of exposure. Procedure/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non-procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non-procedure/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment-emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered "possibly related" to the treatment system.

conclusionIn the largest collection of levodopa-carbidopa intestinal gel safety data from prospective clinical studies, procedure/device events were frequently reported and occasionally life threatening. Most non-procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients.

Indexed as

AgedAntiparkinson AgentsCarbidopaClinical Trials, Phase III as TopicDrug CombinationsFemaleGastric BypassGelsHumansInfusions, ParenteralLevodopaMaleMiddle AgedMulticenter Studies as TopicOutcome Assessment, Health CareParkinson DiseaseAntiparkinson AgentsCarbidopacarbidopa, levodopa drug combinationDrug CombinationsGelsLevodopainfusionLevodopa-carbidopa intestinal gelParkinson's diseasepercutaneous endoscopic gastrojejunostomysafety

Identifiers

PMID26695437
PMCPMC5064722
OpenAlexW2206868244

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.