Evidence map›Paper›PMID 36964312›Full record

ArticleInternational journal of clinical pharmacy2023

Remdesivir for COVID-19 and acute kidney injury: disproportionality analysis of data from the U.S. Food and Drug Administration Adverse Event Reporting System.

Xiaotong Li, Liyuan Zhou, Martina Gaggl, Alan C Kinlaw, Zhuoyue Gou, Yang Xu, Jingkai Wei, Tiansheng Wang

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of clinical pharmacy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

8 citing papers in PubMed, 11 citations in OpenAlex.

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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

8 authors at 5 institutions in 4 countries.

Xiaotong Li *School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA.
Liyuan Zhou *Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Martina GagglDepartment of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.
Alan C KinlawDivision of Pharmaceutical Outcomes and Policy, University of North Carolina School of Pharmacy, Chapel Hill, NC, USA.
Zhuoyue GouInstitute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
Yang XuPeking University Clinical Research Institute, Peking University First Hospital, Beijing, China.
Jingkai WeiDepartment of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.
Tiansheng WangDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 2101 McGavran-Greenberg Hall, Campus, Box 7453, Chapel Hill, NC, 27599, USA. tianwang@unc.edu.ORCID http://orcid.org/0000-0002-0980-8896
University of North Carolina at Chapel Hill · USPeking University · CNMedical University of Vienna · ATUniversity of Pittsburgh · USUniversity of South Carolina · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence about remdesivir-associated acute kidney injury (AKI) among patients with novel coronavirus disease 2019 (COVID-19) was controversial.

aimTo investigate the signal of disproportionate reporting of remdesivir-related AKI in COVID-19 patients over time with data from US Food and Drug Administration Adverse Event Reporting System.

methodAdverse events in COVID-19 patients reported between April 2020 and September 2022 were included. Reporting odds ratios (RORs) of AKI and renal disorders (a more sensitive definition for AKI) were estimated to compare remdesivir with other medications prescribed in comparable situations of COVID-19.

resultsDuring the entire study period, significant signals were identified for remdesivir-related AKI (ROR 2.00, 95% CI: 1.83-2.18) and renal disorder (ROR 2.35, 95% CI: 2.17-2.54) when compared to all comparable drugs. However, in the third quarter of 2022 (the most recent quarter) signals disappeared as the ROR of AKI was 1.50 (95% CI 0.91-2.45) and ROR of renal disorder was 1.69 (95% CI 1.06-2.70). Number of signals in sensitivity analyses and the proportion of AKI in remdesivir-associated events decreased over time.

conclusionIn COVID-19 patients, we observed diminishing signals of remdesivir-associated AKI over time and no significant signal in the most recent quarter, suggesting remdesivir might not be nephrotoxic.

Indexed as

Acute Kidney InjuryCOVID-19Drug-Related Side Effects and Adverse ReactionsAdenosine MonophosphateAdverse Drug Reaction Reporting SystemsAlanineCOVID-19 Drug TreatmentHumansUnited StatesUnited States Food and Drug AdministrationAdenosine MonophosphateAlanineremdesivirAcute kidney injuryCOVID-19Disproportionality analysisRemdesivir

Identifiers

PMID36964312
PMCPMC10038360
OpenAlexW4360824216

What OpenQuestion holds

Textmetadata
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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.