Evidence map›Paper›PMID 27104933›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2016

Everolimus Versus Mycophenolate Mofetil De Novo After Lung Transplantation: A Prospective, Randomized, Open-Label Trial.

M Strueber, G Warnecke, J Fuge, A R Simon, R Zhang, T Welte, A Haverich, J Gottlieb

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
8.2field-weighted citation impact, top 2% 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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Guideline
  2. Systemic safety analysis of mycophenolate in Graves' orbitopathy.Journal of endocrinological investigation · 2020
    Pooled it
  3. A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2019
    Trial
  4. Article
  5. Interactions Between Immunosuppressive Regimens and Cytomegalovirus Infection After Solid-Organ Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Review
  6. Article
  7. Kidney Biopsy Findings After Lung Transplantation.Kidney international reports · 2024
    Article
  8. Article
  9. Review
  10. Article
  11. Rescue Everolimus Post Lung Transplantation is Not Associated With an Increased Incidence of CLAD or CLAD-Related Mortality.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  12. Article
  13. Kidney disease in non-kidney solid organ transplantation.World journal of transplantation · 2022
    Review
  14. Immunosuppression in Lung Transplantation.Handbook of experimental pharmacology · 2022
    Review
  15. Antiproliferatives and Transplantation.Handbook of experimental pharmacology · 2022
    Article
  16. Article
  17. Article
  18. Bronchiolitis obliterans syndrome-free survival after lung transplantation: An International Society for Heart and Lung Transplantation Thoracic Transplant Registry analysis.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2019
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

M StrueberRichard DeVos Heart & Lung Transplant Program, Frederik Meijer Heart & Vascular Institute, Grand Rapids, MI. strueber@msu.edu.
G WarneckeDepartment of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
J FugeDepartment of Respiratory Medicine, Hannover Medical School, Hannover, Germany.
A R SimonDepartment of Heart and Lung Transplantation/VAD, Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.
R ZhangDepartment of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
T WelteGerman Centre of Lung Research (DZL/BREATH), Hannover Medical School, Hannover, Germany.
A HaverichDepartment of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
J GottliebGerman Centre of Lung Research (DZL/BREATH), Hannover Medical School, Hannover, Germany.
Medizinische Hochschule Hannover · DERoyal Brompton & Harefield NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The role of mammalian target of rapamycin (mTOR) inhibitors in de novo immunosuppression after lung transplantation is not well defined. We compared Everolimus versus mycophenolate mofetil in an investigator-initiated single-center trial in Hannover, Germany. A total of 190 patients were randomly assigned 1:1 on day 28 posttransplantation to mycophenolate mofetil (MMF) or Everolimus combined with cyclosporine A (CsA) and steroids. Patients were followed up for 2 years. The primary endpoint was freedom from bronchiolitis obliterans syndrome (BOS). The secondary endpoints were incidence of acute rejections, infections, treatment failure and kidney function. BOS-free survival in intention-to-treat (ITT) analysis was similar in both groups (p = 0.174). The study protocol was completed by 51% of enrolled patients. The per-protocol analysis shows incidence of bronchiolitis obliterans syndrome (BOS): 1/43 in the Everolimus group and 8/54 in the MMF group (p = 0.041). Less biopsy-proven acute rejection (AR) (p = 0.005), cytomegalovirus (CMV) antigenemia (p = 0.005) and lower respiratory tract infection (p = 0.003) and no leucopenia were seen in the Everolimus group. The glomerular filtration rate (GFR) decreased in both groups about 50% within 6 months. Due to a high withdrawal rate, the study was underpowered to prove a difference in BOS-free survival. The dropout rate was more pronounced in the Everolimus group. Secondary endpoints indicate potential advantages of Everolimus-based protocols but also a potentially higher rate of drug-related serious adverse events.

Indexed as

AdolescentAdultAgedAntibiotics, AntineoplasticEverolimusFemaleFollow-Up StudiesGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsLung DiseasesLung TransplantationMaleMiddle AgedMycophenolic AcidAntibiotics, AntineoplasticEverolimusImmunosuppressive AgentsMycophenolic Acidantiproliferative agent: mycophenolate mofetil (MMF)bronchiolitis obliterans (BOS)calcineurin inhibitor: cyclosporine A (CsA)clinical research/practiceclinical trialimmunosuppressantimmunosuppression/immune modulationlung transplantation/pulmonologymechanistic target of rapamycin (mTOR)pharmacology

Identifiers

PMID27104933
OpenAlexW2336858001

What OpenQuestion holds

Textmetadata
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.