FDA Approves Dapagliflozin for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Dapagliflozin is indicated for two uses in adults: 1) To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. 2) As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: It is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m², as it is likely to be ineffective in this setting based on its mechanism of action.

Prior to initiation, assess renal function and volume status; correct volume depletion before starting. For glycemic control: The recommended starting dosage is 5 mg orally once daily. Dosage can be increased to 10 mg orally once daily for additional glycemic control. For patients with type 2 diabetes and an eGFR ≥45 mL/min/1.73 m², the dosage is the same as for normal renal function. It is not recommended for glycemic control if eGFR is <45 mL/min/1.73 m². For all other indications (e.g., heart failure risk reduction): The recommended dosage is 10 mg orally once daily. For these indications in patients with an eGFR ≥25 mL/min/1.73 m², the dosage is the same as for normal renal function. Initiation is not recommended if eGFR is <25 mL/min/1.73 m². Withhold dapagliflozin for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting.

Dapagliflozin has been studied in adult patients as monotherapy, in combination with metformin, pioglitazone, sulfonylurea (glimepiride), sitagliptin (with or without metformin), metformin plus a sulfonylurea, or insulin (with or without other oral antidiabetic therapy), compared to a sulfonylurea (glipizide), and in combination with a GLP-1 receptor agonist (exenatide extended-release) added-on to metformin. It has also been studied in adult patients with type 2 diabetes mellitus and moderate renal impairment. Treatment with dapagliflozin as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin produced statistically significant improvements in mean change from baseline at Week 24 in HbA1c compared to con

Not reported in label.

Not reported in label.