Evidence map›Paper›PMID 32660971›Full record

ArticleJournal of the American Society of Nephrology : JASN2020

The FDA Metformin Label Change and Racial and Sex Disparities in Metformin Prescription among Patients with CKD.

Jung-Im Shin, Yingying Sang, Alex R Chang, Stephan C Dunning, Josef Coresh, Lesley A Inker, Elizabeth Selvin, Shoshana H Ballew, Morgan E Grams

Open access · greenAbstract read
In one paragraph

Article in Journal of the American Society of Nephrology : JASN, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 5% 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, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Metformin treatment reduces the incidence of osteoporosis: a two-sample Mendelian randomized study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
    Article
  7. Article
  8. Review
  9. Estimating glomerular filtration rate with new equations: can one size ever fit all?Critical reviews in clinical laboratory sciences · 2023
    Review
  10. Using measures of race to make clinical predictions: Decision making, patient health, and fairness.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Article
  11. Review
  12. KDOQI US Commentary on the KDIGO 2020 Clinical Practice Guideline for Diabetes Management in CKD.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2022
    Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Race, Genetic Ancestry, and Estimating Kidney Function in CKD.The New England journal of medicine · 2021
    Article
  18. Review
  19. Reassessing the Inclusion of Race in Diagnosing Kidney Diseases: An Interim Report From the NKF-ASN Task Force.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Jung-Im ShinDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland jshin19@jhmi.edu.ORCID 0000-0003-0374-6927
Yingying SangDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Alex R ChangKidney Health Research Institute, Geisinger, Danville, Pennsylvania.ORCID 0000-0002-8114-7447
Stephan C DunningOptumLabs, Cambridge, Massachusetts.
Josef CoreshDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.ORCID 0000-0002-4598-0669
Lesley A InkerDivision of Nephrology, Tufts Medical Center, Boston, Massachusetts.
Elizabeth SelvinDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Shoshana H BallewDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Morgan E GramsDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Johns Hopkins University · USGeisinger Neuroscience Institute · USOptum (United States) · USTufts Medical Center · US

Funding

Medication Use and Adverse Events in CKDR01DK115534 · NIDDK · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Alexander R Chang, Morgan Erika Grams · 2018 to 2026
$5.7M
The Comparative Effectiveness and Safety of Second-line Therapy in Patients with Type 2 DiabetesK01DK121825 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI SHIN, JUNG-IM · 2019 to 2022
$615k
Research and Mentoring in the Clinical Epidemiology of Cardiovascular Disease and Type 2 DiabetesK24HL152440 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI SELVIN, ELIZABETH · 2020 to 2024
$612k
NHLBI NIH HHS K24 HL152440NIDDK NIH HHS K01 DK121825NIDDK NIH HHS R01 DK115534
6 · The paper itself

Abstract

backgroundIn 2016, the Food and Drug Administration (FDA) changed labeling regarding metformin contraindications in patients with diabetes and CKD from using serum creatinine-based thresholds to using eGFR-based thresholds. Because race and sex affect serum creatinine levels independently of GFR, the earlier creatinine-based contraindication may have inadvertently caused racial and sex disparities in metformin prescription among patients with low eGFR.

methodsIn an analysis of 15,946 Black and White primary care patients with diabetes and eGFR≥30 ml/min per 1.73 m

resultsIn the primary cohort, before the label change, Black patients with eGFR of 30-44 ml/min per 1.73 m

conclusionsThe metformin label change to an eGFR-based contraindication may have reduced racial and sex disparities in metformin prescription in moderate kidney dysfunction.

Indexed as

Drug LabelingAdultAgedBlack or African AmericanCreatinineDiabetes MellitusDrug PrescriptionsFemaleGlomerular Filtration RateHumansHypoglycemic AgentsMaleMetforminMiddle AgedRenal Insufficiency, ChronicSex CharacteristicsCreatinineHypoglycemic AgentsMetforminchronic kidney diseaseclinical epidemiologycreatininedisparitiesestimated glomerular filtration rateFDA drug labelglomerular filtration ratemetformin

Identifiers

PMID32660971
PMCPMC7460896
OpenAlexW3042894330

What OpenQuestion holds

Texttitle and abstract
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.