The U.S. Food and Drug Administration (FDA) has approved a prescription medicine called dapagliflozin for adults with type 2 diabetes. This drug works to lower blood sugar levels. It has also been approved for a second, important use: to reduce the chance of being hospitalized for heart failure in people who already have heart disease or have several risk factors for it. This means doctors now have a single medication option that can address both blood sugar management and certain heart-related risks for their patients. The approval is specifically for adults with type 2 diabetes. It is not for people with type 1 diabetes. The drug's effectiveness for blood sugar control is also limited for patients with more advanced kidney disease. As with any new treatment option, this approval provides doctors with another tool to consider for their patients' overall care. It is important to remember that every person's health situation is unique. The most important step for anyone interested in this news is to have an open conversation with their own doctor about what treatments are right for them.
FDA Approves Dapagliflozin Tablets (dapagliflozin) to Reduce Heart Failure Hospitalization Risk in Adults with Type 2 DiabetesFDA approves a diabetes drug that also helps protect the heart
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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.
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