Evidence map›Paper›PMID 30231851›Full record

SynthesisBMC nephrology2018

Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials.

Claudia Sommerer, Oliver Witzke, Frank Lehner, Wolfgang Arns, Petra Reinke, Ute Eisenberger, Bruno Vogt, Katharina Heller, Johannes Jacobi, Markus Guba and 12 more

2 registry-linked trialsOpen access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in BMC nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

NCT00154310 phase4completednot on this map

Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Everolimus in Comparison to Standard Therapy With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Cyclosporine Microemulsion in de Novo Renal Transplant Patients

TypeinterventionalSponsorNovartisRan2005 to 2008Enrolled300ConditionsRenal TransplantationArmsEverolimus, Cyclosporine, Enteric-coated mycophenolate sodium, Corticosteroids
NCT00514514 phase3completednot on this map

Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen

TypeinterventionalSponsorNovartis PharmaceuticalsRan2007 to 2015Enrolled802ConditionsKidney TransplantationArmsEverolimus, Myfortic, Sandimmun Optoral, Simulect®
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Diabetes and Cardiovascular Risk in Renal Transplant Patients.International journal of molecular sciences · 2021
    Review
  6. Review
  7. Post-Transplantation Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  8. Observational
  9. 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

22 authors at 10 institutions in 2 countries.

Claudia SommererDepartment of Nephrology, University of Heidelberg, Im Neuenheimer Feld 162, 69120, Heidelberg, Germany. claudia.sommerer@med.uni-heidelberg.de.
Oliver WitzkeDepartment of Infectious Diseases, University Duisburg-Essen, Essen, Germany.
Frank LehnerDepartment of General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany.
Wolfgang ArnsDepartment of Nephrology and Transplantation, Cologne Merheim Medical Center, Cologne, Germany.
Petra ReinkeDepartment of Nephrology and Intensive Care, Charité Campus Virchow, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Ute EisenbergerDepartment of Nephrology and Hypertension, University of Bern, Inselspital, Bern, Switzerland.
Bruno VogtDepartment of Nephrology and Hypertension, University of Bern, Inselspital, Bern, Switzerland.
Katharina HellerDepartment of Nephrology and Hypertension, University of Erlangen-Nuremberg, Erlangen, Germany.
Johannes JacobiDepartment of Nephrology and Hypertension, University of Erlangen-Nuremberg, Erlangen, Germany.
Markus GubaDepartment of General-, Visceral- and Transplantation Surgery, Munich University Hospital, Campus Grosshadern, Munich, Germany.
Rolf StahlDivision of Nephrology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Ingeborg A HauserMed. Klinik III, Department of Nephrology, UKF, Goethe University, Frankfurt, Germany.
Volker KliemDepartment of Internal Medicine and Nephrology, Kidney Transplant Center, Nephrological Center of Lower Saxony, Klinikum Hann, Münden, Germany.
Rudolf P WüthrichDivision of Nephrology, University Hospital, Zürich, Switzerland.
Anja MühlfeldDivision of Nephrology and Immunology, University Hospital RWTH Aachen, Aachen, Germany.
Barbara SuwelackDepartment of Internal Medicine - Transplant Nephrology, University Hospital of Münster, Münster, Germany.
Michael DuerrDepartment of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Eva-Maria PaulusNovartis Pharma GmbH, Nürnberg, Germany.
Martin ZeierDepartment of Nephrology, University of Heidelberg, Im Neuenheimer Feld 162, 69120, Heidelberg, Germany.
Martina PorstnerNovartis Pharma GmbH, Nürnberg, Germany.
Klemens BuddeDepartment of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.
ZEUS and HERAKLES study investigators
Heidelberg University · DEUniversity of Bern · CHCharité - Universitätsmedizin Berlin · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGoethe University Frankfurt · DEMedizinische Hochschule Hannover · DENovartis (Germany) · DEUniversity Hospital Münster · DEUniversity Hospital of Zurich · CHUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes.

methodsPTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497).

resultsThere were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes).

conclusionsWithin the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes.

trial registrationclinicaltrials.gov , NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT ( 2006-007021-32 and 2004-004346-40 ).

Indexed as

AgedCyclosporineDiabetes MellitusDisease ProgressionEverolimusFemaleGraft RejectionHumansImmunosuppressive AgentsKidney TransplantationMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicCyclosporineEverolimusImmunosuppressive AgentsDiabetesEverolimusKidney transplantationPost-transplantPTDMTOR inhibitor

Identifiers

PMID30231851
PMCPMC6146542
OpenAlexW2890988561

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.