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Latest evidence from real-world study on rates of amputations in T2DM

Latest evidence from real-world study on rates of amputations in T2DM

A real-world study of more than 3 million type 2 diabetes (T2DM) patients shows rates of lower limb amputations (LLA) were similar in patients treated with canagliflozin, empagliflozin, or dapagliflozin. The researchers suggest that the largest contributor to amputations was prior history of peripheral artery disease (PAD), with a larger than fourfold increased LLA risk.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been shown to have additional benefits beyond glycaemic control in terms of cardiovascular and renal benefits, but there has been controversy in relation to the possible association of SGLT2i with increased LLA risk.

This retrospective study utilises nationally representative electronic medical records data from the US. The researchers provide an up-to-date exploration of

  • temporal pattern of LLA and PAD;
  • amputation risks by classes of anti-diabetic drugs (ADD) and by individual sub-classes of SGLT2 inhibitors;
  • and interplay of PAD in the association of therapy exposure with the risk of amputations.

The analysis looked at patients in 5 non-overlapping groups based on treatment with ADD:

1) SGLT2i – exposed to SGLT2i with or without use of glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dipeptidyl peptidase-4 inhibitor (DPP-4i);

2) GLP-1 RA – exposed to GLP-1 RA but never exposed to SGLT2i nor DPP-4i;

3) DPP-4i – exposed to DPP-4i but never exposed to SGLT2i nor GLP-1 RA;

4) other ADD – exposed to an ADD other than SGLT2i, GLP-1 RA, or DPP-4i;

5) no ADD – never initiated ADD.

This large cohort study suggests that there were no SGLT2i drug-specific increases in LLA risk in T2DM patients. These results provide further context to the signals seen in the randomised clinical trials and epidemiological studies of SGLT2 inhibitors.

Prescribing information for Invokana (canagliflozin)

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Editorial Board

Image
Dr. Salvatore A. De Cosmo's image

Dr. Salvatore A. De Cosmo

Head of Unit of Internal Medicine and Endocrinology, Scientific Institute “Casa Sollievo della Sofferenza” San Giovanni, Rotondo, Italy
,
Image
Dr. Juan José Gorgojo Martínez's image

Dr. Juan José Gorgojo Martínez

Head of Department of Endocrinology and Nutrition, University Hospital Fundación, Alcorcon, Madrid, Spain
,
Image
Dr. Patrick Holmes' image

Dr. Patrick Holmes

General Practitioner, St. George's Medical Practice, Darlington, UK

Editorial Board

Image
Dr. Salvatore A. De Cosmo's image

Dr. Salvatore A. De Cosmo

Head of Unit of Internal Medicine and Endocrinology, Scientific Institute “Casa Sollievo della Sofferenza” San Giovanni, Rotondo, Italy
Image
Dr. Juan José Gorgojo Martínez's image

Dr. Juan José Gorgojo Martínez

Head of Department of Endocrinology and Nutrition, University Hospital Fundación, Alcorcon, Madrid, Spain
Image
Dr. Patrick Holmes' image

Dr. Patrick Holmes

General Practitioner, St. George's Medical Practice, Darlington, UK

Publication under Spotlight

The Association of Amputations and Peripheral Artery Disease in Patients With Type 2 Diabetes Mellitus Receiving SodiumGlucose Cotransporter Type 2 Inhibitors: Real-World Study

Eur Heart J

2021;42(18):1728-1738.

Authors: Sanjoy K Paul, Deepak L Bhatt and Olga Montvida

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