Evidence map›Paper›PMID 31691256›Full record

ArticleDrug safety2020

Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).

Taylor M Patek, Chengwen Teng, Kaitlin E Kennedy, Carlos A Alvarez, Christopher R Frei

Erratum issuedAbstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 7% 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, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Taylor M PatekPharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA.
Chengwen TengPharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. tengc3@livemail.uthscsa.edu.ORCID http://orcid.org/0000-0001-9239-2125
Kaitlin E KennedyPharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA.
Carlos A AlvarezDivision of Clinical/Translational Research, Hodge School of Pharmacy, Texas Tech University Health Sciences Center, Dallas, TX, USA.
Christopher R FreiPharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA.ORCID http://orcid.org/0000-0002-0692-4787
The University of Texas Health Science Center at San Antonio · USAustin College · USTexas Tech University · US

Funding

Institute for Integration of Medicine & Science: A Partnership to Improve HealthUL1TR002645 · NCATS · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI CLARK, ROBERT A, HARGREAVES, KENNETH M · 2018 to 2022
$20.4M
Institute for Integration of Medicine & Science: A Partnership to Improve HealthUL1TR001120 · NCATS · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI CLARK, ROBERT A, HARGREAVES, KENNETH M · 2013 to 2017
$16.5M
NRSA Training Core (TL1)TL1TR002647 · NCATS · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI CHUN, YONG-HEE PATRICIA, FREI, CHRISTOPHER R. · 2018 to 2022
$1.8M
Safety and Effectiveness of Metformin Therapy in Patients with Type 2 Diabetes anK08DK101602 · NIDDK · TEXAS TECH UNIVERSITY HEALTH SCIS CENTER · PI ALVAREZ, CARLOS A · 2014 to 2017
$536k
Agency for Healthcare Research and Quality R24HS022418NCATS NIH HHS TL1 TR002647NCATS NIH HHS UL1 TR001120NCATS NIH HHS UL1 TR002645NIDDK NIH HHS K08 DK101602
6 · The paper itself

Abstract

backgroundA study using the US FDA Adverse Event Reporting System (FAERS) found significant acute kidney injury (AKI) reporting associations with vancomycin, fluoroquinolones, penicillin combinations, and trimethoprim-sulfamethoxazole. Other antibiotics may also lead to AKI, but no study has systemically compared AKI reporting associations for many available antibiotics.

objectiveThe objective of this study was to evaluate the reporting associations between AKI and many available antibiotics using FAERS.

methodsFAERS reports from 1 January 2015 to 31 December 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify AKI cases. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) for the reporting associations between antibiotics and AKI were calculated. A reporting association was considered statistically significant when the lower limit of the 95% CI was > 1.0.

resultsA total of 2,042,801 reports (including 20,138 AKI reports) were considered. Colistin had the greatest proportion of AKI reports, representing 25% of all colistin reports. AKI RORs (95% CI) for antibiotics were, in descending order: colistin 33.10 (21.24-51.56), aminoglycosides 17.41 (14.49-20.90), vancomycin 15.28 (13.82-16.90), trimethoprim-sulfamethoxazole 13.72 (11.94-15.76), penicillin combinations 7.95 (7.09-8.91), clindamycin 6.46 (5.18-8.04), cephalosporins 6.07 (5.23-7.05), daptomycin 6.07 (4.61-7.99), macrolides 3.60 (3.04-4.26), linezolid 3.48 (2.54-4.77), carbapenems 3.31 (2.58-4.25), metronidazole 2.55 (1.94-3.36), tetracyclines 1.73 (1.26-2.36), and fluoroquinolones 1.71 (1.49-1.97).

conclusionThis study found 14 classes of antibiotics having significant reporting associations with AKI. Among the antibiotics evaluated in this study, colistin had the highest AKI ROR and moxifloxacin had the lowest.

Indexed as

Acute Kidney InjuryAdverse Drug Reaction Reporting SystemsAnti-Bacterial AgentsDrug-Related Side Effects and Adverse ReactionsHumansPharmacovigilanceUnited StatesUnited States Food and Drug AdministrationAnti-Bacterial Agents

Identifiers

PMID31691256
OpenAlexW2986534514

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.