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 for patients with type 2 diabetes and heart failure, regardless of ejection fraction, to reduce the risk of worsening heart failure, cardiovascular death, and to improve symptoms and quality of life.

Primary Indications

• Farxiga is indicated to improve glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise 1
• Farxiga is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors 2
• Farxiga is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF) 2, 1
• Farxiga is effective in heart failure patients regardless of diabetes status, showing consistent benefits in patients with and without type 2 diabetes 2

Evidence for Heart Failure Benefits

• In the DAPA-HF trial, dapagliflozin demonstrated a 26% reduction in the primary composite outcome of worsening heart failure or cardiovascular death (HR 0.74 [95% CI 0.65–0.85]) in patients with NYHA class II-IV heart failure and ejection fraction ≤40% 2
• Dapagliflozin reduced the risk of first worsening heart failure event by 30% (HR 0.70 [95% CI 0.59–0.83]) and cardiovascular death by 18% (HR 0.82 [95% CI 0.69–0.98]) compared to placebo 2
• The DELIVER trial showed dapagliflozin reduced the risk of worsening heart failure or cardiovascular death by 18% (HR 0.82 [95% CI 0.73–0.92]) in patients with heart failure with preserved ejection fraction (HFpEF, EF >40%) 2
• Benefits were consistent regardless of baseline diabetes status, with approximately 45% of DAPA-HF participants and 44% of DELIVER participants having type 2 diabetes 2

Dosing and Administration

• The recommended dose of Farxiga is 10 mg orally once daily 1, 3
• Dose modifications:
  • For patients with eGFR <45 mL/min/1.73 m², Farxiga is not recommended for glycemic control 2
  • For patients with eGFR <30 mL/min/1.73 m², Farxiga use is contraindicated 2
  • No dose adjustment is needed specifically for heart failure indication across different eGFR levels, though monitoring is recommended 1

Safety Considerations

• Common adverse reactions include:
  • Genital mycotic infections (monitor and treat appropriately) 1
  • Urinary tract infections (evaluate and treat promptly if indicated) 1
  • Volume depletion (monitor for signs of hypotension, especially in elderly, those with renal impairment, or on diuretics) 1
• Serious but rare adverse events include:
  • Diabetic ketoacidosis, including euglycemic ketoacidosis (monitor, particularly during illness or fasting) 1
  • Necrotizing fasciitis of the perineum (Fournier's gangrene) - rare but serious infection requiring urgent treatment 1
• Risk of hypoglycemia is increased when used with insulin or insulin secretagogues - consider reducing doses of these medications when adding Farxiga 1

Clinical Implementation

• Farxiga should be considered for all patients with symptomatic heart failure (NYHA class II-IV), regardless of ejection fraction or diabetes status 2
• The benefits of Farxiga appear to be independent of its glucose-lowering effects, as evidenced by similar outcomes in patients with and without diabetes 2
• Farxiga can be used in combination with standard heart failure therapies, including ACE inhibitors/ARBs, beta-blockers, and mineralocorticoid receptor antagonists 3
• Monitor renal function, volume status, and signs/symptoms of adverse effects, particularly when initiating therapy 1

Farxiga represents an important therapeutic option for patients with type 2 diabetes and heart failure, offering benefits on cardiovascular outcomes, heart failure hospitalizations, and mortality that extend beyond its glucose-lowering effects.