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Ertugliflozin gets FDA thumbs-up for glucose control


The Food and Drug Administration has approved ertugliflozin for use both as monotherapy and in combination with sitagliptin or metformin to control blood glucose in patients with type 2 diabetes.

The FDA approval covers ertugliflozin monotherapy (Steglatro, Merck and Pfizer) and ertugliflozin plus sitagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, as a fixed-dose combination (Steglujan, Merck) and ertugliflozin plus metformin (Segluromet, Merck).

Ertugliflozin is the third sodium glucose cotransporter 2 (SGLT2) inhibitor to win FDA approval. Another such agent, empagliflozin, recently won a second indication for lowering the risk for cardiovascular death in adults with type 2 diabetes and established heart disease.

The American Diabetes Association recognized the value of SGLT2 inhibitors in patients with type 2 diabetes in its 2018 Standards of Care in Diabetes, now recommending that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the SGLT2 inhibitor empagliflozin or the glucagonlike peptide–1 agonist liraglutide – to the regimens of patients with diabetes and atherosclerotic cardiovascular disease (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).

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