What is the use of Farxiga (Dapagliflozin)?

From the Guidelines

Farxiga (dapagliflozin) is recommended to reduce the risk of worsening heart failure and cardiovascular death in people with type 2 diabetes and established heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF), as evidenced by the DAPA-HF trial 1. The use of Farxiga has been expanded beyond diabetes management to include the treatment of heart failure and chronic kidney disease, due to its benefits in reducing hospitalization for heart failure and cardiovascular death. Key points about Farxiga include:

• It belongs to a class of medications called SGLT2 inhibitors, which work by causing the kidneys to remove excess sugar from the body through urine.
• The typical dose is 5 mg or 10 mg taken once daily in the morning, with or without food.
• Common side effects include genital yeast infections, urinary tract infections, and increased urination.
• Patients should maintain adequate hydration while taking this medication and be aware that it may cause a slight decrease in blood pressure.
• People with type 1 diabetes or diabetic ketoacidosis should not use Farxiga, and kidney function should be assessed before starting treatment. The DAPA-HF trial 1 demonstrated a lower risk of the primary outcome of a composite of worsening heart failure or cardiovascular death in individuals with New York Heart Association (NYHA) class II, III, or IV heart failure and an ejection fraction of 40% or less, with a hazard ratio (HR) of 0.74 [95% CI 0.65–0.85]. Additionally, the EMPEROR-Reduced trial 1 assessed the effects of empagliflozin on a primary composite outcome of cardiovascular death or hospitalization for worsening heart failure in a population with NYHA class II, III, or IV heart failure and an ejection fraction of 40% or less, showing a 21% reduction (HR 0.79 [95% CI 0.69–0.90]; P < 0.001) of the primary outcome. The DELIVER trial 1 also demonstrated an 18% reduction in the primary outcome of a composite of worsening heart failure, defined as hospitalization or urgent visit for heart failure, or cardiovascular death, in individuals treated with dapagliflozin compared with placebo (HR 0.82 [95% CI 0.73–0.92]; P < 0.001). A large recent meta-analysis 1 of data from multiple trials, including EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF, DELIVER, and the SOLOIST-WHF trial, demonstrated reduced risk for the composite of cardiovascular death or hospitalization for heart failure, cardiovascular death. Therefore, Farxiga is a valuable treatment option for reducing the risk of worsening heart failure and cardiovascular death in people with type 2 diabetes and established heart failure.

From the FDA Drug Label

1 INDICATIONS AND USAGE DAPAGLIFLOZIN TABLETS are indicated:

• To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus

The use of Farxiga (dapagliflozin) is to:

• Reduce the risk of kidney disease progression and cardiovascular events in adults with chronic kidney disease
• Reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure
• Reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors
• Improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus 2

From the Research

Uses of Farxiga

• Farxiga (dapagliflozin) is used for the treatment of adults with symptomatic heart failure with reduced ejection fraction (HFrEF) 3, 4.
• It is also used for the treatment of type 2 diabetes mellitus (T2DM) as monotherapy or in combination with other glucose-lowering agents 5, 6.
• Dapagliflozin has been shown to reduce the risk of cardiovascular (CV) death or hospitalization for heart failure in patients with T2DM who have or are at risk for atherosclerotic CV disease 3, 5.
• It has also been approved for the treatment of chronic kidney disease and heart failure with preserved ejection fraction 7.

Benefits of Farxiga

• Dapagliflozin has been shown to provide effective glycaemic control, reduce body weight and blood pressure, and have a low risk of hypoglycaemia 5, 6.
• It has also been shown to reduce the risk of worsening heart failure or CV death in patients with HFrEF, regardless of the presence or absence of T2DM 3, 4.
• Dapagliflozin has a generally well-tolerated safety profile, with common adverse events including genital infections and urinary tract infections 5, 7, 6.

Patient Populations

• Dapagliflozin is approved for use in adults with symptomatic HFrEF, regardless of the presence or absence of T2DM 3, 4.
• It is also approved for use in patients with T2DM, including those with established atherosclerotic CV disease or multiple risk factors for CV disease 5, 6.
• Dapagliflozin is not recommended for use in patients with type 1 diabetes or end-stage chronic kidney disease 7, 6.