What is the indication and usage of Farxiga (dapagliflozin) in patients with type 2 diabetes and heart failure?

Indications and Usage of Farxiga (Dapagliflozin) in Type 2 Diabetes and Heart Failure

Farxiga (dapagliflozin) is strongly recommended as first-line therapy for heart failure across all ejection fraction ranges, regardless of diabetes status, reducing the composite outcome of cardiovascular death or hospitalization for heart failure by 18% (HR 0.82 [95% CI 0.73–0.92]; P < 0.001). 1

Indications in Type 2 Diabetes and Heart Failure

Heart Failure Indications

• Approved for treatment of adults with symptomatic heart failure with reduced ejection fraction (HFrEF) 2
• Recommended for heart failure across all ejection fraction ranges (HFrEF and HFpEF) 1
• Benefits observed regardless of diabetes status 1
• Greatest benefit seen in NYHA class II-III patients with frequent symptoms or hospitalizations 1

Type 2 Diabetes Indications

• Used for glycemic control in type 2 diabetes as:
  • Monotherapy in previously untreated patients
  • Add-on therapy with metformin, glimepiride, pioglitazone, or insulin-based regimens 3, 4

Dosage and Administration

• Standard dose: 10 mg once daily 1
• Renal function considerations:
  • No dose adjustment required for eGFR ≥45 mL/min/1.73 m² 1
  • Not recommended for initiation if eGFR <25 mL/min/1.73 m² 1
  • May continue at 10 mg daily in patients already receiving treatment even with lower eGFR 1

Clinical Benefits

Cardiovascular Outcomes

• Reduces primary composite outcome of cardiovascular death or hospitalization for heart failure by 18% (HR 0.82 [95% CI 0.73–0.92]; P < 0.001) 1
• In patients with HFrEF, dapagliflozin significantly reduces:
  • Hospitalization risk for heart failure (30% relative risk reduction) 5
  • Urgent heart failure visits (57% relative risk reduction) 5
  • Cardiovascular death (18% relative risk reduction) 5

Additional Benefits

• Weight reduction in most clinical trials 3, 4, 6
• Low risk of hypoglycemia when used alone or with metformin 1, 7, 4
• Efficacy maintained for up to 2-4 years in extension studies 3, 6

Precautions and Monitoring

Common Adverse Effects

• Genital mycotic infections (most common, particularly in women) 1, 7
• Urinary tract infections 1, 7
• Volume depletion/hypotension 1, 7

Serious Adverse Effects to Monitor

• Euglycemic diabetic ketoacidosis (rare but serious) 1, 7
• Necrotizing fasciitis of the perineum (Fournier's gangrene) 7
• Urosepsis and pyelonephritis 7

Perioperative Management

• Withhold for at least 3 days before major surgery or procedures requiring prolonged fasting 1
• Resume when patient is clinically stable and has resumed oral intake 1

Hypoglycemia Risk

• Increased risk when combined with insulin or insulin secretagogues 7
• Lower doses of insulin or insulin secretagogues may be required when used in combination 7

Practical Considerations

• Should be used as part of comprehensive heart failure management alongside:

  • Diuretics (as needed for congestion)
  • RAAS antagonists (ACE inhibitors, ARBs, or ARNI)
  • Mineralocorticoid receptor antagonists (MRAs)
  • Evidence-based beta blockers 1

• Avoid thiazolidinediones in patients with symptomatic heart failure 1

• Continue indefinitely as part of heart failure management 1

• Benefits appear greatest in patients with LVEF between 41% and 65% 1

Monitoring Recommendations

• Assess renal function and volume status before initiation 1
• Monitor for signs and symptoms of urinary tract infections 7
• Evaluate for genital mycotic infections, especially in patients with history of such infections 7
• Watch for symptoms of ketoacidosis, particularly in type 1 diabetes patients 7