Evidence map›Paper›PMID 32759360›Full record

Observational studyDiabetes care2020

Sodium-Glucose Cotransporter 2 Inhibitors and the Risk of Below-Knee Amputation: A Multicenter Observational Study.

Oriana Hoi Yun Yu, Sophie Dell'Aniello, Baiju R Shah, Vanessa C Brunetti, Jean-Marc Daigle, Michael Fralick, Antonios Douros, Nianping Hu, Silvia Alessi-Severini, Anat Fisher and 6 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Diabetes care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT04017221. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.1field-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.

NCT04017221 completed

Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes: a Multicenter Cohort Study

Ran2018Enrolled1,249,636Registered outcomes4Posted comparisons0ConditionsDiabetes Mellitus, Type 2, Diabetic Ketoacidosis, Lower Extremity Amputation, UrosepsisArmsDipeptidyl Peptidase-4 (DPP-4) Inhibitors, Other treatment combinations, Sodium-glucose cotransporter 2 (SGLT2) inhibitors
PMID 32716707PMID 32383792other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Innovations in pharmacovigilance studies of medicines in older people.British journal of clinical pharmacology · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Chronic Lower Extremity Ischemia and Its Association with the Frailty Syndrome in Patients with Diabetes.International journal of environmental research and public health · 2020
    Review
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

16 authors at 10 institutions in 2 countries.

Oriana Hoi Yun YuCenter for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.
Sophie Dell'AnielloCenter for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.
Baiju R ShahDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0003-3598-3628
Vanessa C BrunettiCenter for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.
Jean-Marc DaigleInstitut national d'excellence en santé et en services sociaux (INESSS), Québec City, Québec, Canada.
Michael FralickDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.
Antonios DourosCenter for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.ORCID 0000-0002-6005-4006
Nianping HuThe Health Quality Council, Saskatoon, Saskatchewan, Canada.
Silvia Alessi-SeveriniCollege of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
Anat FisherDepartment of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, Canada.
Shawn C BugdenCollege of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
Paul E RonksleyDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Kristian B FilionCenter for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.ORCID 0000-0001-6055-0088
Pierre ErnstCenter for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.
Canadian Network for Observational Drug Effect Studies (CNODES) Investigators
Jewish General Hospital · CAUniversity of Manitoba · CAInstitut National d'Excellence en Santé et en Services Sociaux · CAManitoba Health · CAMemorial University of Newfoundland · CASaskatchewan Health Quality Council · CASunnybrook Health Science Centre · CAUniversity of British Columbia · CAUniversity of Calgary · CAUniversity of Toronto · CA

Funding

Canadian Institutes of Health Research DSE-146021
6 · The paper itself

Abstract

objectiveReports of amputations associated with sodium-glucose cotransporter 2 (SGLT2) inhibitors have been inconsistent. We aimed to compare the risk of below-knee amputation with SGLT2 inhibitors versus dipeptidyl peptidase 4 (DPP-4) inhibitors among patients with type 2 diabetes. RESEARCH DESIGN AND

methodsThis multicenter observational study used administrative health care databases from seven Canadian provinces and the U.K. Incident SGLT2 inhibitor users were matched to DPP-4 inhibitor users using a prevalent new-user design and time-conditional propensity scores. Cox proportional hazards models were used to estimate site-specific adjusted hazard ratios (HR) and corresponding 95% CIs of incident below-knee amputation for SGLT2 inhibitor versus DPP-4 inhibitor users. Random effects meta-analyses were used to pool the site-specific results.

resultsThe study cohort included 207,817 incident SGLT2 inhibitor users matched to 207,817 DPP-4 inhibitor users. During a mean exposed follow-up time of 11 months, the amputation rate was 1.3 per 1,000 person-years among SGLT2 inhibitor users and 1.5 per 1,000 person-years among DPP-4 inhibitor users. The adjusted HR of below-knee amputations associated with SGLT2 inhibitor use compared with DPP-4 inhibitor use was 0.88 (95% CI 0.71-1.09). Similar results were obtained in stratified analyses by specific SGLT2 inhibitor molecule.

conclusionsIn this large multicenter observational study, there was no association between SGLT2 inhibitor use and incident below-knee amputations among patients with type 2 diabetes compared with DPP-4 inhibitor use. While these findings provide some reassurance, studies with a longer duration of follow-up are needed to assess potential long-term effects.

Indexed as

AdolescentAdultAgedAmputation, SurgicalCanadaCase-Control StudiesCohort StudiesDatabases, FactualDiabetes Mellitus, Type 2Diabetic FootDipeptidyl-Peptidase IV InhibitorsFemaleHumansHypoglycemic AgentsKneeMaleDipeptidyl-Peptidase IV InhibitorsHypoglycemic AgentsSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID32759360
OpenAlexW3047040213

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.