From the Guidelines
Farxiga (dapagliflozin) is indicated for adults with type 2 diabetes to improve glycemic control alongside diet and exercise, with a standard starting dose of 5 mg once daily, and is also approved to reduce the risk of hospitalization for heart failure and kidney function decline in patients with chronic kidney disease, as supported by recent studies such as DAPA-HF 1 and DAPA-CKD 1.
Key Points
- The medication works by inhibiting sodium-glucose cotransporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion, thereby lowering blood glucose levels.
- Beyond glycemic control, Farxiga offers additional benefits including weight loss, blood pressure reduction, and cardiovascular protection.
- It's essential to monitor patients for diabetic ketoacidosis, even with normal blood glucose levels, and temporarily discontinue the medication before scheduled surgery or during serious illness.
- Common side effects include genital mycotic infections, urinary tract infections, and volume depletion, particularly in elderly patients or those taking diuretics.
- Farxiga should not be used in patients with type 1 diabetes, severe renal impairment (eGFR <45 mL/min/1.73m²), or end-stage renal disease, as stated in the study by 1.
Usage and Dosage
- The standard starting dose is 5 mg once daily, taken in the morning, with possible increase to 10 mg daily if needed and tolerated.
- For patients with chronic kidney disease, the dose may need to be adjusted based on the eGFR level, as recommended in the study by 1.
Benefits and Risks
- The benefits of Farxiga include improved glycemic control, weight loss, blood pressure reduction, and cardiovascular protection.
- The risks include diabetic ketoacidosis, genital mycotic infections, urinary tract infections, and volume depletion.
- Recent studies such as VERTIS CV 1 and EMPEROR-Preserved 1 have demonstrated the efficacy and safety of SGLT2 inhibitors in reducing the risk of hospitalization for heart failure and cardiovascular death in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
From the FDA Drug Label
1. Indications and Usage
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The indications and usage of Farxiga (dapagliflozin) in patients with type 2 diabetes include:
- Improving glycemic control: Dapagliflozin is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Pediatric use: The safety and effectiveness of dapagliflozin have been established in pediatric patients aged 10 years and older to improve glycemic control in type 2 diabetes mellitus.
- Combination therapy: Dapagliflozin can be used in combination with other antidiabetic agents, such as metformin, sulfonylureas, pioglitazone, and insulin, to improve glycemic control. 2 2
Key points:
- Dapagliflozin is indicated for improving glycemic control in adults with type 2 diabetes mellitus.
- Dapagliflozin can be used in pediatric patients aged 10 years and older with type 2 diabetes mellitus.
- Dapagliflozin can be used in combination with other antidiabetic agents.
From the Research
Indications and Usage of Farxiga (Dapagliflozin)
- Farxiga (dapagliflozin) is indicated for the treatment of type 2 diabetes as an adjunct to diet and exercise to improve glycemic control [ 3 ].
- It is also approved for the treatment of adults with symptomatic heart failure with reduced ejection fraction [ 4 ].
Mechanism of Action
- Dapagliflozin works by inhibiting the sodium-glucose cotransporter-2 (SGLT2) in the renal proximal tubule, increasing urinary glucose excretion and reducing blood glucose levels [ 5 ].
Efficacy and Safety
- Dapagliflozin has been shown to reduce the risk of cardiovascular death or hospitalization for heart failure in patients with type 2 diabetes [ 3 ].
- It has also been shown to reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes and previous myocardial infarction [ 6 ].
- The efficacy and safety of dapagliflozin are consistent across different patient populations, including those with and without background use of cardiovascular medications [ 7 ].
Patient Populations
- Dapagliflozin is effective in patients with type 2 diabetes, including those with established atherosclerotic cardiovascular disease or multiple risk factors for cardiovascular disease [ 3 ].
- It is also effective in patients with symptomatic heart failure with reduced ejection fraction, regardless of the presence or absence of type 2 diabetes [ 4 ].