The U.S. Food and Drug Administration (FDA) has approved a drug called dapagliflozin for adults with type 2 diabetes. This drug, taken as a once-daily pill, has two main uses. It is approved to help lower blood sugar levels along with diet and exercise. It is also approved to reduce the risk of hospitalization for heart failure in patients who have heart disease or are at high risk for it. This approval is for adults with type 2 diabetes. It is specifically for those who have known heart disease or several risk factors for heart problems, where the goal is to protect against heart failure. The drug is not for people with type 1 diabetes. It is also not recommended for controlling blood sugar in patients with more advanced kidney disease, as it may not work well for that purpose in those cases. This approval means doctors now have a medication option that can address two important health concerns for many people with type 2 diabetes: managing blood sugar and protecting heart health. It highlights a growing understanding of the link between diabetes and heart complications. The most important step for any patient is to have an honest conversation with their own doctor. A doctor can review a person's full health history to see if this new option might be a good fit for their individual care plan.
FDA Approves Dapagliflozin for Heart Failure Risk Reduction and Glycemic Control in Type 2 DiabetesFDA approves a diabetes drug that also helps protect the heart from failure
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The FDA has approved dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for two indications in adults with type 2 diabetes mellitus. The drug is now indicated 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 a medication option that addresses both glycemic management and cardiovascular risk, specifically heart failure hospitalization, in a high-risk patient population. The drug is not recommended for patients with type 1 diabetes or for glycemic control in patients with type 2 diabetes and an eGFR less than 45 mL/min/1.73 m², where it is likely ineffective. Dosing varies by indication, with 10 mg once daily for heart failure risk reduction and a starting dose of 5 mg once daily for glycemic control.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
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.
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