Evidence map›Paper›PMID 38165971›Full record

Observational studyPloS one2024

Effectiveness and safety of immunosuppressive regimens used as maintenance therapy in kidney transplantation: The CESIT study.

Arianna Bellini, Marco Finocchietti, Alessandro Cesare Rosa, Maurizio Nordio, Eliana Ferroni, Marco Massari, Stefania Spila Alegiani, Lucia Masiero, Gaia Bedeschi, Massimo Cardillo and 10 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Observational
  5. Article
  6. Review
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

20 authors.

Arianna BelliniDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.ORCID 0000-0002-4558-0921
Marco FinocchiettiDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Alessandro Cesare RosaDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Maurizio NordioAzienda Zero of the Veneto Region, Padua, Italy.
Eliana FerroniAzienda Zero of the Veneto Region, Padua, Italy.
Marco MassariNational Centre for Drug Research and Evaluation, Istituto Superiore Di Sanità, Rome, Italy.
Stefania Spila AlegianiNational Centre for Drug Research and Evaluation, Istituto Superiore Di Sanità, Rome, Italy.
Lucia MasieroItalian National Transplant Centre, Istituto Superiore di Sanità, Rome, Italy.
Gaia BedeschiItalian National Transplant Centre, Istituto Superiore di Sanità, Rome, Italy.
Massimo CardilloItalian National Transplant Centre, Istituto Superiore di Sanità, Rome, Italy.
Ersilia LucenteforteDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Giuseppe PiccoloRegional Transplant Coordination, Lombardy Region, Milan, Italy.
Olivia LeoniDepartment of Health of Lombardy Region, Epidemiology Observatory, Milan, Italy.
Silvia PierobonAzienda Zero of the Veneto Region, Padua, Italy.
Stefano LeddaGeneral Directorate for Health, Sardinia Region, Italy.
Donatella GarauGeneral Directorate for Health, Sardinia Region, Italy.
Marina DavoliDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Antonio AddisDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Valeria BelleudiDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.ORCID 0000-0002-8286-443X
CESIT study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Maintenance immunosuppressive therapy used in kidney transplantation typically involves calcineurin inhibitors, such as tacrolimus or cyclosporine, in combination with mycophenolate or mechanistic target of rapamycin (mTORi) with or without corticosteroids. An Italian retrospective multicentre observational study was conducted to investigate the risk-benefit profile of different immunosuppressive regimens. We identified all subjects who underwent kidney transplant between 2009 and 2019, using healthcare claims data. Patients on cyclosporine and tacrolimus-based therapies were matched 1:1 based on propensity score, and effectiveness and safety outcomes were compared using Cox models (HR; 95%CI). Analyses were also conducted comparing mTORi versus mycophenolate among tacrolimus-treated patients. Patients treated with cyclosporine had a higher risk of rejection or graft loss (HR:1.69; 95%CI:1.16-2.46) and a higher incidence of severe infections (1.25;1.00-1.55), but a lower risk of diabetes (0.66;0.47-0.91) compared to those treated with tacrolimus. Among tacrolimus users, mTORi showed non-inferiority to MMF in terms of mortality (1.01;0.68-1.62), reject/graft loss (0.61;0.36-1.04) and severe infections (0.76;0.56-1.03). In a real-life setting, tacrolimus-based immunosuppressive therapy appeared to be superior to cyclosporine in reducing rejection and severe infections, albeit with an associated increased risk of diabetes. The combination of tacrolimus and mTORi may represent a valid alternative to the combination with mycophenolate, although further studies are needed to confirm this finding.

Indexed as

Immunosuppressive AgentsKidney TransplantationCyclosporineDiabetes MellitusDrug Therapy, CombinationHumansMycophenolic AcidTacrolimusCyclosporineImmunosuppressive AgentsMycophenolic AcidTacrolimus

Identifiers

PMID38165971
PMCPMC10760756

What OpenQuestion holds

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Registered trials

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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.