Evidence map›Paper›PMID 39601981›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2025

Evaluation of the Clinical Outcomes of Cyclosporine Short Infusion Versus Continuous Infusion Postallogenic Stem Cell Transplantation.

Shaymaa M M El-Awady, Amal M El Afifi, Rania Afifi, Nagwa A Sabri, Marwa Adel Ahmed

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04575779 (Evaluation of the Clinical Outcome of Cyclosporine Short Infusion Versus Continuous Infusion Post Allogenic Stem Cell Transplantation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04575779 completednot on this map

Evaluation of the Clinical Outcome of Cyclosporine Short Infusion Versus Continuous Infusion Post Allogenic Stem Cell Transplantation

TypeobservationalSponsorShaymaa Mohammed El-AwadyRan2018 to 2022Enrolled31ConditionsAllogenic Bone Marrow TransplantationArmsCyclosporin with a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

5 authors.

Shaymaa M M El-AwadyClinical Pharmacy Department, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt. shaymaa.elawady@pharma.asu.edu.eg.ORCID http://orcid.org/0000-0003-0020-7514
Amal M El AfifiClinical Hematology and Bone Marrow Transplantation Unit, Department of Internal Medicine, Faculty of Medicine, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.ORCID http://orcid.org/0009-0003-7032-0413
Rania AfifiInternal Medicine-Hematology Department, Faculty of Medicine, Helwan University, Cairo, Egypt.ORCID http://orcid.org/0000-0002-8632-0608
Nagwa A SabriClinical Pharmacy Department, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt.ORCID http://orcid.org/0000-0002-2611-4853
Marwa Adel AhmedClinical Pharmacy Department, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt.ORCID http://orcid.org/0000-0002-5193-9523

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveCyclosporin A (CsA) exhibits a narrow therapeutic index and large inter-individual variation in pharmacokinetics. Two intermittent and 24-h continuous infusions (CI) are both commonly used regimens in hematopoietic stem cell transplantation (HSCT), with no universal consensus. The objective of this study was to assess whether CsA as a 2-h, twice-daily intravenous infusion (2 h/12 h) is non-inferior to 22 h CI every 24 h (22 h-CI/24 h) in terms of acute graft-versus-host disease (aGVHD) incidence and adverse events in allogeneic HSCT adult patients.

methodsAn open-label randomized trial recruited 31 allogeneic HSCT patients to receive the 2 h/12 h or 22 h-CI/24 h regimen. The primary outcomes were the incidence of aGVHD and CsA-related adverse events. The secondary outcomes included the correlation between the time concentration and area under the concentration-time curve (AUC) of 2 h/12 h versus 22 h-CI/24 h regimens.

resultsSix (19.4%) patients developed aGVHD. There was no statistically significant difference between the two groups concerning the incidence of aGVHD (13.3% in 2 h/12 h vs. 25% in 22 h-CI/24 h; p = 0.359). The distribution of different aGVHD types (p = 0.20) and mortality (p = 0.9) were not significantly different between the two groups. The two groups did not differ at any time with respect to AUCs, nephrotoxicity, hepatotoxicity, or electrolyte disturbance.

conclusionThe study suggested that the 2 h/12 h regimen is non-inferior to the conventional regimen (22 h CI/24 h) in terms of aGVHD incidence and adverse events. Further research is necessary to validate these findings and to guide practice, considering the small sample size of this study.

trial registrationClinicalTrials.gov identifier NCT04575779 with initial release on 19 September 2020-Retrospectively registered, https://clinicaltrials.gov/study/NCT04575779 .

Indexed as

CyclosporineGraft vs Host DiseaseHematopoietic Stem Cell TransplantationImmunosuppressive AgentsAdultArea Under CurveDrug Administration ScheduleFemaleHumansIncidenceInfusions, IntravenousMaleMiddle AgedTreatment OutcomeYoung AdultCyclosporineImmunosuppressive Agents

Identifiers

PMID39601981

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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.