Evidence map›Paper›PMID 31597667›Full record

ArticleDiabetes care2020

Reports of Lactic Acidosis Attributed to Metformin, 2015-2018.

James H Flory, Sean Hennessy, Clifford J Bailey, Silvio E Inzucchi

Abstract readHistorical Article
In one paragraph

Article in Diabetes care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

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

13 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Therapy of Type 2 Diabetes in Patients with SARS-CoV-2 Infection.International journal of molecular sciences · 2021
    Review
  6. Article
  7. Metformin: A Novel Weapon Against Inflammation.Frontiers in pharmacology · 2021
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

James H FloryMemorial Sloan-Kettering Cancer Center, New York, NY floryj@mskcc.org.ORCID 0000-0002-0259-969X
Sean HennessyUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Clifford J BaileySchool of Life and Health Sciences, Aston University, Birmingham, U.K.ORCID 0000-0002-6998-6811
Silvio E InzucchiYale School of Medicine, New Haven, CT.ORCID 0000-0003-1254-6636

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Richard A Flavell · 1993 to 2026
$44.0M
Improving Metformin Utilization And Diabetes Control Through Patient-Centered Outcomes ResearchK08HS023898 · AHRQ · WEILL MEDICAL COLL OF CORNELL UNIV · PI FLORY, JAMES H · 2015 to 2019
$760k
AHRQ HHS K08 HS023898NCI NIH HHS P30 CA008748NIDDK NIH HHS P30 DK045735
6 · The paper itself

Abstract

objectiveIn 2016, the U.S. Food and Drug Administration (FDA) revised metformin's label to permit use in patients with mild-moderate chronic kidney disease. We sought to determine whether this change was associated with increased reports of metformin-associated lactic acidosis (MALA) to the FDA's Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND

methodsPublicly available FAERS reports were analyzed.

resultsMALA reports increased from 521 in 2015 to 1,939 in 2018. After restriction to U.S. reports, absolute and relative increase in MALA reports was less, from 111 to 243. The proportionate reporting ratio (PRR), a measure adjusted for rates of other adverse event reports, was stable.

conclusionsThe increased reports deserve attention, but the PRR's stability and FAERS's known limitations, including lack of a denominator or control group, do not permit the conclusion that U.S. MALA rates have increased. Further study with more robust data sources is needed.

Indexed as

Acidosis, LacticAdultAdverse Drug Reaction Reporting SystemsAgedDiabetic NephropathiesFemaleHistory, 21st CenturyHumansHypoglycemic AgentsMaleMetforminMiddle AgedRenal Insufficiency, ChronicUnited StatesUnited States Food and Drug AdministrationYoung AdultHypoglycemic AgentsMetformin

Identifiers

PMID31597667
PMCPMC7011199

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.