FDA Approves Dapagliflozin Tablets (dapagliflozin) to Reduce Heart Failure Hospitalization Risk in Adults with Type 2 Diabetes
The FDA has approved dapagliflozin tablets, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for two indications in adults with type 2 diabetes mellitus. The approval includes its use to reduce the risk of hospitalization for heart failure in patients who have either established cardiovascular disease or multiple cardiovascular risk factors. It is also approved as an adjunct to diet and exercise to improve glycemic control.
This approval provides clinicians with an SGLT2 inhibitor option for managing both glycemic control and cardiovascular risk in this patient population. The label specifies important limitations, including that it is not recommended for glycemic control in patients with type 1 diabetes or in patients with type 2 diabetes and an eGFR less than 45 mL/min/1.73 m², where it is likely to be ineffective for that purpose. Clinicians should assess renal function and volume status prior to initiation.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Dapagliflozin tablets are 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: Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. They are 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 they are likely to be ineffective in this setting based on the mechanism of action.
Prior to initiation, assess renal function and volume status; correct volume depletion before starting. For improving glycemic control in adults with type 2 diabetes, the recommended starting dosage is 5 mg orally once daily. The dosage can be increased to 10 mg orally once daily for additional glycemic control. For the indication of reducing the risk of hospitalization for heart failure, the recommended dosage is 10 mg orally once daily.
For glycemic control in patients with type 2 diabetes and renal impairment: The recommended dosage is the same as for normal renal function for patients with eGFR ≥45 mL/min/1.73 m². It is not recommended for glycemic control in patients with eGFR <45 mL/min/1.73 m². For the heart failure hospitalization risk reduction indication in patients with renal impairment: The recommended dosage is the same as for normal renal function for patients with eGFR ≥25 mL/min/1.73 m². Initiation is not recommended in patients with eGFR <25 mL/min/1.73 m².
Withhold dapagliflozin tablets 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.
Trial data not available in label.
Not reported in label.
Not reported in label.
More on Type 2 Diabetes
View Original Abstract ↓
Tirzepatide MTD Demonstrates Cost-Effectiveness Versus Semaglutide MTD in Obesity Simulation Modeling Study
Tirzepatide Saves Money and Health Over Semaglutide
Related in Diabetes & Endocrinology
From Other Specialties
