Evidence map›Paper›PMID 32843476›Full record

ArticleBMJ (Clinical research ed.)2020

Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study.

Michael Fralick, Seoyoung C Kim, Sebastian Schneeweiss, Brendan M Everett, Robert J Glynn, Elisabetta Patorno

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

Article in BMJ (Clinical research ed.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 7 pooled it
6.5field-weighted citation impact, top 2% 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

27 citing papers in PubMed, 7 syntheses or guidelines pooled it, 63 citations in OpenAlex.

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  7. SGLT2 inhibitors and lower limb complications: an updated meta-analysis.Cardiovascular diabetology · 2021 · on this map
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 2 countries.

Michael FralickDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA mif823@mail.harvard.edu.ORCID 0000-0002-2082-2445
Seoyoung C KimDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA.
Sebastian SchneeweissDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA.
Brendan M EverettDivisions of Cardiovascular and Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Robert J GlynnDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA.
Elisabetta PatornoDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA.
Brigham and Women's Hospital · US

Funding

Novel Approaches to Monitor the Safety and Effectiveness of Newly Marketed Diabetes Medications in Older Adults Considering Frailty and MultimorbidityK08AG055670 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI PATORNO, ELISABETTA · 2018 to 2021
$661k
NIA NIH HHS K08 AG055670
6 · The paper itself

Abstract

objectiveTo estimate the rate of lower limb amputation among adults newly prescribed canagliflozin according to age and cardiovascular disease.

designPopulation based, new user, cohort study. DATA SOURCES: Two commercial and Medicare claims databases, 2013-17.

participantsPatients newly prescribed canagliflozin were propensity score matched 1:1 with patients newly prescribed a glucagon-like peptide-1 (GLP-1) receptor agonist. Hazard ratios and rate differences per 1000 person years were computed for the rate of lower limb amputation in the following four groups: group 1, patients aged less than 65 years without baseline cardiovascular disease; group 2, patients aged less than 65 with baseline cardiovascular disease; group 3, patients aged 65 or older without baseline cardiovascular disease; group 4, patients aged 65 or older with baseline cardiovascular disease. Within each group, pooled hazard ratio and rate difference per 1000 person years were calculated by meta-analysis.

interventionCanagliflozin versus a GLP-1 agonist.

main outcome measuresLower limb amputation requiring surgery.

resultsAcross the three databases, 310 840 propensity score matched adults who started canagliflozin or a GLP-1 agonist were identified. The hazard ratio and rate difference per 1000 person years for amputation in adults receiving canagliflozin compared with a GLP-1 agonist for each group was: group 1, hazard ratio 1.09 (95% confidence interval 0.83 to 1.43), rate difference 0.12 (-0.31 to 0.55); group 2, hazard ratio 1.18 (0.86 to 1.62), rate difference 1.06 (-1.77 to 3.89); group 3, hazard ratio 1.30 (0.52 to 3.26), rate difference 0.47 (-0.73 to 1.67); and group 4, hazard ratio 1.73 (1.30 to 2.29), rate difference 3.66 (1.74 to 5.59).

conclusionsThe increase in rate of amputation with canagliflozin was small and most apparent on an absolute scale for adults aged 65 or older with baseline cardiovascular disease, resulting in a number needed to treat for an additional harmful outcome of 556 patients at six months (that is, 18 more amputations per 10 000 people who received canagliflozin). These results help to contextualize the risk of amputation with canagliflozin in routine care.

Indexed as

AgedAge DistributionAmputation, SurgicalCanagliflozinCardiovascular DiseasesCardiovascular SystemCase-Control StudiesDatabases, FactualDiabetes Mellitus, Type 2FemaleGlucagon-Like Peptide 1HumansLongitudinal StudiesMaleMiddle AgedPropensity ScoreCanagliflozinGlucagon-Like Peptide 1Sodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID32843476
PMCPMC7445737
OpenAlexW3080635855

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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.