Evidence map›Paper›PMID 28121741›Full record

Trial reportTransplantation2017

Effect of Early Everolimus-Facilitated Reduction of Tacrolimus on Efficacy and Renal Function in De Novo Liver Transplant Recipients: 24-Month Results for the North American Subpopulation.

William C Chapman, Robert S Brown, Kenneth D Chavin, Debra Sudan, Baburao Koneru, Guido Junge, Gaohong Dong, Dharmesh Patel, Lewis Teperman, John J Fung

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Transplantation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
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

10 authors at 2 institutions in 2 countries.

William C Chapman1 Division of General Surgery, Department of Surgery, Washington University School of Medicine, Saint Louis, MO.2 Division of Gastroenterology and Hepatology, Department of Medicine, Weill Cornell Medical College, New York, NY.3 Division of Transplant Surgery, Department of Surgery, Medical University of South Carolina, Charleston, SC.4 Division of Abdominal Transplant Surgery, Department of Surgery, Duke University Medical Center, Durham, NC.5 Division of Liver Transplant & Hepatobiliary Surgery, Department of Surgery, Rutgers-New Jersey Medical School, Newark, NJ.6 Novartis AG, Basel, Switzerland.7 Novartis Pharmaceuticals Corporation, East Hanover, NJ.8 Transplant Center, Northwell Health, Manhasset, NY.9 Department of Surgery, University of Chicago Medicine Transplant Institute, University of Chicago, Chicago, IL.
Robert S Brown
Kenneth D Chavin
Debra Sudan
Baburao Koneru
Guido Junge
Gaohong Dong
Dharmesh Patel
Lewis Teperman
John J Fung
Association for Language Learning · GBWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA recent randomized phase III study of 719 de novo liver transplant recipients showed that early everolimus plus reduced-dose tacrolimus (EVR + rTAC) led to significantly better kidney function than standard TAC (TAC-C), without compromising efficacy. In that study, patients from North America (n = 211) had increased risk factors for posttransplant renal insufficiency at study start, relative to patients from Europe and rest of world (eg, worse renal function, more diabetes, older age).

methodsA post hoc analysis was performed to assess whether these regional disparities affected study outcomes in North American patients.

resultsIn this subpopulation, estimated glomerular filtration rates at randomization were higher in TAC-C over EVR + rTAC (76.4 vs 69.3 mL/min per 1.73 m). Mean changes in estimated glomerular filtration rate values (mL/min per 1.73 m) favored EVR + rTAC over TAC-C at months 12 (+3.7 vs -4.5; P = 0.032), 24 (+2.7 vs -6.6; P = 0.042), and 36 (+4.3 vs -8.1; P = 0.059). The composite efficacy endpoint of treated biopsy-proven acute rejection, graft loss, or death was 10.9%, 14.1%, and 14.1% for EVR + rTAC and 13.1%, 17.2%, and 19.3% for TAC-C at months 12, 24, and 36, respectively.

conclusionsAlthough the North American cohort had more comorbidities, results were consistent with the overall population for efficacy and renal function.

Indexed as

AdultBiopsyCalcineurin InhibitorsComorbidityDrug Therapy, CombinationEverolimusFemaleGlomerular Filtration RateGraft RejectionGraft SurvivalHealth Status DisparitiesHumansImmunosuppressive AgentsKaplan-Meier EstimateKidneyLiver TransplantationCalcineurin InhibitorsEverolimusImmunosuppressive AgentsTacrolimus

Identifiers

PMID28121741
PMCPMC5265688
OpenAlexW2531139092

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.