Observational studyDiabetes, obesity & metabolism2018
Risk of lower extremity amputations in people with type 2 diabetes mellitus treated with sodium-glucose co-transporter-2 inhibitors in the USA: A retrospective cohort study.
Observational study in Diabetes, obesity & metabolism, 2018. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. Cited by 53 papers, 6 of them syntheses that pooled it.
What it found
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The incidence rates of BKLE amputation were 1.18 and 1.12 events per 1000 person-years with canagliflozin and non-SGLT2 inhibitor AHAs, respectively; the hazard ratio was 0.98 (95% confidence interval 0.68-1.41; P = .92, calibrated P = .95).
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SGLT2 inhibitors×cardiovascular events
No readable resultOpen on the map →What to test next →22 readable studies in this cell: 9 favour the treatment, 11 find no difference, 2 favour the comparator.
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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.
Who cites it
53 citing papers in PubMed, 6 syntheses or guidelines pooled it, 119 citations in OpenAlex.
- Sodium-glucose Cotransporter 2 Inhibitors Association with Risk of Heart Failure Hospitalization in Preserved and Mildly Reduced Ejection Fraction, Regardless of Diabetes Mellitus: A Systematic Review and Meta-Analysis.Current cardiology reviews · 2026Pooled it
- Safety of sodium-glucose transporter 2 (SGLT-2) inhibitors in patients with type 2 diabetes: a meta-analysis of cohort studies.Frontiers in pharmacology · 2023Pooled it
- Effects of Sodium-Glucose Cotransporter 2 on Amputation Events: A Systematic Review and Meta-Analysis of Randomized-Controlled Trials.Pharmacology · 2022Pooled it
- Pooled it
- Comparative effectiveness of canagliflozin, SGLT2 inhibitors and non-SGLT2 inhibitors on the risk of hospitalization for heart failure and amputation in patients with type 2 diabetes mellitus: A real-world meta-analysis of 4 observational databases (OBSERVE-4D).Diabetes, obesity & metabolism · 2018 · on this mapPooled it
- Cardiovascular Safety, Long-Term Noncardiovascular Safety, and Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Systemic Review and Meta-Analysis With Trial Sequential Analysis.Journal of the American Heart Association · 2018Pooled it
- Effects of canagliflozin on amputation risk in type 2 diabetes: the CANVAS Program.Diabetologia · 2019 · on this mapTrial
- Comparative analysis of serious adverse effects of antidiabetic drugs and complications associated with type II diabetes mellitus.BMC pharmacology & toxicology · 2026Observational
- The Potential Impact of SGLT2-I in Diabetic Foot Prevention: Promising Pathophysiologic Implications, State of the Art, and Future Perspectives-A Narrative Review.Medicina (Kaunas, Lithuania) · 2024Review
- Liraglutide Promotes Diabetic Wound Healing via Myo1c/Dock5.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes: A Multinational, Federated Analysis of LEGEND-T2DM.Journal of the American College of Cardiology · 2024Article
- The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.American journal of epidemiology · 2024Review
- Sodium-glucose co-transporter 2 inhibitor use in patients with diabetes mellitus undergoing endovascular therapy for symptomatic peripheral artery disease.Cardiovascular diabetology · 2023Article
- Safety of sodium-glucose cotransporter 2 inhibitors in Asian type 2 diabetes populations.Journal of diabetes investigation · 2023Review
- Risk of lower limb amputation in diabetic patients using SGLT2 inhibitorsTherapeutic advances in drug safety · 2023Article
- Article
- Sodium-glucose co-transporter 2 inhibitors: game changers when handled with care?Journal of the Royal Society of Medicine · 2021Review
- Comprehensive evaluation of cardiovascular efficacy and safety outcomes of SGLT2 inhibitors in high risk patients of cardiovascular disease: systematic review and meta-analysis.Cardiovascular endocrinology & metabolism · 2021Article
- Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) Exposure and Outcomes in Type 2 Diabetes: A Systematic Review of Population-Based Observational Studies.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021Review
- Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus treated in real-world clinical practice: Results of a 36-month post-marketing surveillance study (J-STEP/LT).Journal of diabetes investigation · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The marked sentences are the ones the graph read a number from.
aimsTo examine the incidence of amputation in patients with type 2 diabetes mellitus (T2DM) treated with sodium glucose co-transporter 2 (SGLT2) inhibitors overall, and canagliflozin specifically, compared with non-SGLT2 inhibitor antihyperglycaemic agents (AHAs). MATERIALS AND
methodsPatients with T2DM newly exposed to SGLT2 inhibitors or non-SGLT2 inhibitor AHAs were identified using the Truven MarketScan database. The incidence of below-knee lower extremity (BKLE) amputation was calculated for patients treated with SGLT2 inhibitors, canagliflozin, or non-SGLT2 inhibitor AHAs. Patients newly exposed to canagliflozin and non-SGLT2 inhibitor AHAs were matched 1:1 on propensity scores, and a Cox proportional hazards model was used for comparative analysis. Negative controls (outcomes not believed to be associated with any AHA) were used to calibrate P values.
resultsBetween April 1, 2013 and October 31, 2016, 118 018 new users of SGLT2 inhibitors, including 73 024 of canagliflozin, and 226 623 new users of non-SGLT2 inhibitor AHAs were identified. The crude incidence rates of BKLE amputation were 1.22, 1.26 and 1.87 events per 1000 person-years with SGLT2 inhibitors, canagliflozin and non-SGLT2 inhibitor AHAs, respectively. For the comparative analysis, 63 845 new users of canagliflozin were matched with 63 845 new users of non-SGLT2 inhibitor AHAs, resulting in well-balanced baseline covariates. The incidence rates of BKLE amputation were 1.18 and 1.12 events per 1000 person-years with canagliflozin and non-SGLT2 inhibitor AHAs, respectively; the hazard ratio was 0.98 (95% confidence interval 0.68-1.41; P = .92, calibrated P = .95).
conclusionsThis real-world study observed no evidence of increased risk of BKLE amputation for new users of canagliflozin compared with non-SGLT2 inhibitor AHAs in a broad population of patients with T2DM.
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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.