What are the recommendations for using Farxiga (Dapagliflozin) in patients with Chronic Kidney Disease (CKD)?

From the Guidelines

Farxiga (dapagliflozin) is recommended for adults with chronic kidney disease (CKD) at a dose of 10 mg once daily, regardless of whether they have type 2 diabetes, as it has been shown to significantly reduce the risk of kidney function decline, end-stage kidney disease, and cardiovascular death in CKD patients, as demonstrated in the DAPA-CKD study 1.

Key Considerations

• The medication is specifically indicated for CKD patients with an eGFR of 25 mL/min/1.73m² or higher and urinary albumin-to-creatinine ratio (UACR) ≥200 mg/g.
• Patients should continue taking their standard CKD treatments like ACE inhibitors or ARBs alongside Farxiga.
• The medication should be taken in the morning with or without food, and kidney function should be monitored regularly, especially when initiating treatment.
• Farxiga works by inhibiting SGLT2 receptors in the kidneys, which reduces glucose reabsorption and increases glucose excretion in urine.
• In CKD patients, it provides kidney protection by reducing intraglomerular pressure, decreasing albuminuria, and improving other pathways that contribute to kidney damage.

Benefits and Risks

• The DAPA-CKD study showed that dapagliflozin significantly reduced the risk of kidney function decline, end-stage kidney disease, and cardiovascular death in CKD patients, with a hazard ratio (HR) of 0.61 for the primary end point 1.
• Common side effects include genital yeast infections, urinary tract infections, and volume depletion, so adequate hydration should be maintained.

Monitoring and Follow-up

• Kidney function should be monitored regularly, especially when initiating treatment, to assess the effectiveness of Farxiga and adjust the dose as needed.
• Patients should be educated on the importance of adequate hydration and the potential risks of volume depletion.

Comparison with Other Studies

• The CREDENCE trial also demonstrated the benefits of SGLT2 inhibitors in CKD patients, with canagliflozin reducing the risk of kidney function decline and cardiovascular events 1.
• The EMPA-REG OUTCOME and CANVAS trials also showed benefits of SGLT2 inhibitors in reducing cardiovascular events in patients with type 2 diabetes and CKD 1.

From the FDA Drug Label

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 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. Initiation with DAPAGLIFLOZIN TABLETS is not recommended in patients with an eGFR less than 25 mL/min/1.73 m2. If the eGFR falls below 25 mL/min/1. 73 m2 while receiving treatment with DAPAGLIFLOZIN TABLETS, patients may continue DAPAGLIFLOZIN TABLETS 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.

Key Points:

• Dapagliflozin is 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.
• The recommended dosage for adults with CKD is 10 mg orally once daily.
• Initiation is not recommended in patients with an eGFR less than 25 mL/min/1.73 m2.
• Patients with an eGFR greater than or equal to 25 mL/min/1.73 m2 can continue treatment if their eGFR falls below 25 mL/min/1.73 m2 while receiving dapagliflozin 2.

From the Research

Farxiga and CKD Recommendations

• Dapagliflozin (Farxiga) is approved to reduce the risk of declining kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) with or without type 2 diabetes 3.
• The use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs) is recommended in patients with CKD, as they have been shown to reduce the risk of kidney failure and cardiovascular events 4, 5, 6.
• A study found that dapagliflozin reduced the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes in patients with CKD, regardless of the presence or absence of diabetes 7.
• The effects of dapagliflozin on CKD were similar in participants with type 2 diabetes and in those without type 2 diabetes, and the known safety profile of dapagliflozin was confirmed 7.
• The prescription rates of ARBs and ACEIs were found to be lower in patients with CKD stage G1-G5, and the use of these agents was insufficient in patients with hypertension associated with CKD and proteinuria 6.