From the Guidelines
Dapagliflozin should be dosed at 10 mg once daily for patients with type 2 diabetes, heart failure, or chronic kidney disease, with the exception of those with severe kidney impairment (eGFR less than 25 mL/min/1.73m²) where initiation is not recommended, as stated in the Mayo Clinic Proceedings 1.
Key Considerations
- The dosing of dapagliflozin is crucial for its efficacy and safety, and it is essential to consider the patient's kidney function when initiating or adjusting the dose.
- For patients with an eGFR of 25 to <45 mL/min/1.73m², the dose of dapagliflozin should be 10 mg once daily, as approved for use in this range of eGFR 1.
- The glucose-lowering efficacy of dapagliflozin is reduced with declining eGFR, but its kidney and cardiovascular benefits are preserved, making it a valuable treatment option for patients with heart failure or chronic kidney disease, regardless of their diabetic status.
Monitoring and Precautions
- Patients starting dapagliflozin should be monitored for volume depletion, especially if they are elderly, on diuretics, or have low blood pressure.
- Adequate hydration is essential, and temporary dose interruption may be necessary during acute illness or fasting.
- The mechanism of action of dapagliflozin, inhibiting sodium-glucose cotransporter-2 (SGLT2) in the kidneys, not only lowers blood glucose levels but also provides cardiovascular and renal benefits beyond glucose control.
Clinical Implications
- Dapagliflozin is a valuable treatment option for patients with type 2 diabetes, heart failure, or chronic kidney disease, offering benefits beyond glucose control.
- Its use should be guided by the patient's kidney function, and dose adjustments should be made accordingly to ensure efficacy and safety.
- As stated in the Kidney International consensus report, dapagliflozin is approved for use at 10 mg once daily with an eGFR of 25 to <45 mL/min/1.73m², and its initiation is not recommended with an eGFR <25 mL/min/1.73m² 1.
From the FDA Drug Label
• To improve 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 all other indications, the recommended dosage is 10 mg orally once daily. • The recommended dosage of DAPAGLIFLOZIN TABLETS in patients with an eGFR greater than or equal to 45 mL/min/1. 73 m2 is the same as the recommended dosage in patients with normal renal function. • The recommended dosage of DAPAGLIFLOZIN TABLETS in patients with an eGFR greater than or equal to 25 mL/min/1. 73 m2 is the same as the recommended dosage in patients with normal renal function.
The recommended dosage of dapagliflozin is:
- 5 mg orally once daily to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, which can be increased to 10 mg orally once daily for additional glycemic control.
- 10 mg orally once daily for all other indications. The dosage may need to be adjusted based on renal function, with a recommended dosage of 10 mg orally once daily in patients with an eGFR greater than or equal to 25 mL/min/1.73 m2 2 2.
From the Research
Dapagliflozin Dosing Information
- Dapagliflozin is indicated for the treatment of type 2 diabetes and is also used in patients with heart failure and reduced ejection fraction 3, 4, 5, 6.
- The approved dose of dapagliflozin is 10 mg once daily, which can be used as monotherapy or in combination with other glucose-lowering agents, including insulin 3.
- In clinical trials, dapagliflozin has been shown to be effective in reducing the risk of worsening heart failure and cardiovascular death in patients with heart failure and reduced ejection fraction, regardless of the presence or absence of type 2 diabetes 4, 5.
Efficacy and Safety of Dapagliflozin
- Dapagliflozin has been shown to be effective in improving cardiac and renal function, as well as reducing the risk of adverse outcomes, in patients with heart failure and type 2 diabetes 6.
- The safety profile of dapagliflozin is generally favorable, with a low risk of hypoglycemia and no increased risk of adverse effects or outcomes in patients with heart failure and type 2 diabetes 3, 6.
- Dapagliflozin has also been shown to slow the rate of decline in estimated glomerular filtration rate (eGFR) in patients with heart failure and reduced ejection fraction, regardless of the presence or absence of type 2 diabetes 7, 5.
Renal Effects of Dapagliflozin
- Dapagliflozin has been shown to have a beneficial effect on renal function, slowing the rate of decline in eGFR in patients with heart failure and reduced ejection fraction 7, 5.
- The effect of dapagliflozin on renal function is not modified by baseline kidney function, and dapagliflozin has been shown to be effective in patients with chronic kidney disease 7, 5.