Indications and Usage of Farxiga (Dapagliflozin) in Type 2 Diabetes and Heart Failure
Farxiga (dapagliflozin) is indicated for improving glycemic control in adults with type 2 diabetes, reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple risk factors, and reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF), regardless of diabetes status. 1, 2
Approved Indications for Farxiga (Dapagliflozin)
Farxiga has multiple FDA-approved indications:
Type 2 Diabetes Management:
- As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes 1
Cardiovascular Risk Reduction in Type 2 Diabetes:
- Reduces risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors 1
Heart Failure Treatment:
Dosing and Administration
- Standard dose: 10 mg orally once daily 1, 2
- Renal considerations:
- eGFR <45 ml/min/1.73 m²: Not recommended for glycemic control
- eGFR <30 ml/min/1.73 m²: Contraindicated for diabetes management
- For heart failure: Dapagliflozin remains the only SGLT2 inhibitor option for patients with eGFR 20-30 mL/min/1.73m² 2
Clinical Evidence Supporting Heart Failure Indications
Heart Failure with Reduced Ejection Fraction (HFrEF)
- The DAPA-HF trial demonstrated that dapagliflozin 10 mg daily reduced the risk of worsening heart failure or cardiovascular death by 26% (HR: 0.74; 95% CI: 0.65 to 0.85) in patients with HFrEF, regardless of diabetes status 1, 3
- Benefits were consistent across subgroups and independent of background heart failure therapies 3
Heart Failure with Preserved Ejection Fraction (HFpEF)
- The DELIVER trial showed an 18% reduction in the composite risk of worsening heart failure or cardiovascular death (HR 0.82 [95% CI 0.73–0.92]; P < 0.001) 2
- Dapagliflozin improved symptoms and physical function, with an improvement in the Kansas City Cardiomyopathy Questionnaire Clinical Summary score by 5.8 points at 12 weeks 2
Mechanism of Action
Dapagliflozin works by:
- Inhibiting sodium-glucose co-transporter-2 (SGLT2) in the renal proximal tubule
- Reducing renal glucose reabsorption, leading to increased urinary glucose excretion
- Functioning independently of insulin secretion or action, making it complementary to other antihyperglycemic medications 4, 5
Safety Considerations
Contraindications
- History of serious hypersensitivity reaction to dapagliflozin
- eGFR <30 mL/min/1.73 m² (for diabetes management)
- Pregnancy or breastfeeding 1
Monitoring and Adverse Effects
Common adverse events:
Rare but serious adverse events:
- Euglycemic diabetic ketoacidosis (particularly with insulin dose reduction, prolonged fasting, or carbohydrate restriction) 2
Perioperative considerations:
- Discontinue at least 3 days before planned surgery to prevent postoperative ketoacidosis 1
Clinical Pearls
- Dapagliflozin provides cardiovascular benefits regardless of diabetes status in heart failure patients 3, 6
- When used in patients with well-controlled HbA1c or history of hypoglycemic events, consider weaning or stopping sulfonylureas or glinides 1
- The cardiovascular benefits of dapagliflozin were first observed in the DECLARE-TIMI 58 trial in patients with type 2 diabetes 3
- Weight reduction is a consistent beneficial effect of dapagliflozin treatment 4, 7
- Efficacy on glycemic control and weight reduction is maintained for up to 2-4 years 7