FDA Approves Dapagliflozin for Reducing Heart Failure Hospitalization Risk and Improving Glycemic Control in Adults with Type 2 Diabetes

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

Dapagliflozin is indicated: 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: Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It is also 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.

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 reducing the risk of hospitalization for heart failure: The recommended dosage is 10 mg orally once daily. Prior to initiation: Assess renal function and volume status. Correct volume depletion before initiating. For glycemic control in patients with type 2 diabetes and renal impairment: The recommended dosage for patients with an eGFR ≥45 mL/min/1.73 m² 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 indications other than glycemic control (e.g., heart failure risk reduction) in patients with renal impairment: The recommended dosage for patients with an eGFR ≥25 mL/min/1.73 m² is the same as for normal renal function. Initiation is not recommended if eGFR is <25 mL/min/1.73 m². Temporary interruption: Withhold dapagliflozin for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume when the patient is clinically stable and has resumed oral intake.

Treatment with dapagliflozin as monotherapy and in combination with other agents (metformin, glimepiride, pioglitazone, sitagliptin, or insulin) produced statistically significant improvements in mean change from baseline at Week 24 in HbA1c compared to control. Reductions in HbA1c were seen across subgroups including gender. Trial data for the heart failure hospitalization risk reduction indication is not available in the provided label text.

Not reported in label.

Not reported in label.