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 [F] Diseases Research  / PubMed Research Articles  /
Risk of Lower Extremity Amputations in Patients With Type 2 Diabetes Mellitus Treated With SGLT2 Inhibitors in the United States: A Retrospective Cohort Study.




Diabetes, obesity & metabolism 2017 Sep 12; ()


Yuan Z1; DeFalco FJ2; Ryan PB3; Schuemie MJ4; Stang PE5; Berlin JA6; Desai M7; Rosenthal N8;

Author Information
  • 1Janssen Research & Development, LLC, Titusville, NJ.
  • 2Janssen Research & Development, LLC, Raritan, NJ.
  • 3Janssen Research & Development, LLC, Titusville, NJ.
  • 4Janssen Research & Development, LLC, Titusville, NJ.
  • 5Janssen Research & Development, LLC, Titusville, NJ.
  • 6Johnson & Johnson, Titusville, NJ.
  • 7Janssen Research & Development, LLC, Raritan, NJ.
  • 8Janssen Research & Development, LLC, Raritan, NJ.


AIMS: To examine the incidence of amputation in patients with type 2 diabetes mellitus (T2DM) treated with sodium glucose co-transporter 2 inhibitors (SGLT2i) overall, and canagliflozin specifically, compared with non-SGLT2i antihyperglycemic agents (AHAs).

MATERIALS AND METHODS: Patients with T2DM newly exposed to SGLT2i or non-SGLT2i AHAs were identified using the Truven MarketScan database. The incidence of below-knee lower extremity (BKLE) amputation was calculated for patients treated with SGLT2i, canagliflozin, or non-SGLT2i AHAs. Patients newly exposed to canagliflozin and non-SGLT2i 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.

RESULTS: Between April 1, 2013-October 31, 2016, 118,018 new users of SGLT2i, including 73,024 of canagliflozin, and 226,623 new users of non-SGLT2i AHAs were identified. The crude incidence rate of BKLE amputation was 1.22, 1.26, and 1.87 events per 1,000 person-years with SGLT2i, canagliflozin, and non-SGLT2i AHAs, respectively. For the comparative analysis, 63,845 new users of canagliflozin were matched with 63,845 new users of non-SGLT2i AHAs, resulting in well-balanced baseline covariates. The incidence rate of BKLE amputation was 1.18 and 1.12 events per 1,000 person-years with canagliflozin and non-SGLT2i AHAs, respectively; the hazard ratio (95% confidence interval) was 0.98 (0.68-1.41; P=0.92, calibrated P=0.95).

CONCLUSIONS: This real-world study observed no evidence of increased risk of BKLE amputation for new users of canagliflozin compared with non-SGLT2i AHAs in a broad population of patients with T2DM.

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Publication Type: Journal Article

This article is licensed under the the National Library of Medicine License. It uses material from the PubMed National Library of Medicine Data.

Last Modified:   2016-03-27

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