Evidence map›Paper›PMID 33903017›Full record

ReviewThe Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation2021

Kinetics of generic tacrolimus in heart transplantation: A cautionary note.

Zachary J Il'Giovine, J Bradley Williams, R Preston Mason, Samuel C R Sherratt, Eileen M Hsich, Harry Lever, Mandeep R Mehra, Randall C Starling

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PubMed Full text at PMC Publisher
In one paragraph

Review in The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.9field-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

0 citing papers in PubMed, 7 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Zachary J Il'GiovineDepartment of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio.
J Bradley WilliamsDepartment of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio.
R Preston MasonDepartment of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Elucida Research LLC, Beverly, Massachusetts.
Samuel C R SherrattElucida Research LLC, Beverly, Massachusetts; Department of Molecular, Cellular, and Biomedical Sciences, University of New Hampshire, Durham, New Hampshire.
Eileen M HsichDepartment of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio.
Harry LeverDepartment of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio.
Mandeep R MehraDepartment of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Randall C StarlingDepartment of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: starlir@ccf.org.
Cleveland Clinic · USBrigham and Women's Hospital · USUniversity of New Hampshire · US

Funding

Impact of Disparities Affecting Survival among Advanced Heart Failure Patients and Transplant RecipientsR01HL141892 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI HSICH, EILEEN MICHELLE, ISHWARAN, HEMANT · 2018 to 2021
$2.8M
NHLBI NIH HHS R01 HL141892
6 · The paper itself

Abstract

Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acute cardiac allograft rejection. Generic samples showed similar API content compared to branded samples with no major impurities. Capsules that underwent uniformity testing had consistent capsule-to-capsule API. Dissolution testing showed similar profiles between branded tacrolimus and Mylan, but notable differences with Dr. Reddy's and Intas. The approximate maximal inhibitory concentration (IC

Indexed as

Heart TransplantationDrugs, GenericGraft RejectionHumansImmunosuppressive AgentsTacrolimusDrugs, GenericImmunosuppressive AgentsTacrolimusImmunosuppressionpharmacologyrejectiontacrolimus

Identifiers

PMID33903017
PMCPMC10257977
OpenAlexW3159469490

What OpenQuestion holds

Textmetadata
LicenceTDM
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.