Can Farxiga (dapagliflozin) be initiated in patients with diabetes mellitus and Chronic Kidney Disease (CKD) stage 3b, characterized by Impaired Renal Function?

From the Guidelines

Farxiga (dapagliflozin) can be initiated in patients with diabetes mellitus and Chronic Kidney Disease (CKD) stage 3b, characterized by Impaired Renal Function, as it has shown to provide both kidney and cardiovascular protective benefits, according to the latest clinical guidelines 1. The recommended starting dose is 10 mg once daily, and it's essential to closely monitor kidney function, volume status, and electrolytes in these patients. Key considerations for initiating Farxiga in patients with CKD stage 3b include:

• Estimated glomerular filtration rate (eGFR) should be 30-44 mL/min/1.73m2, as Farxiga is not recommended for initiation if eGFR is below 25 mL/min/1.73m2 1.
• Patients should be educated about the potential risks, including volume depletion and urinary tract infections, and advised to maintain adequate hydration.
• The medication should be discontinued if eGFR persistently falls below 25 mL/min/1.73m2. The use of sodium-glucose cotransporter 2 inhibitors, such as Farxiga, has changed the therapeutic landscape for patients with diabetic kidney disease, offering unprecedented opportunities to reduce the risk of progression of kidney disease and death 1. As such, the American Diabetes Association, the Kidney Disease: Improving Global Outcomes, and the European Association for the Study of Diabetes now recommend the use of these therapies for patients with diabetic kidney disease to provide both kidney and cardiovascular protective benefits 1.

From the FDA Drug Label

In patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating DAPAGLIFLOZIN TABLETS in patients with one or more of these characteristics, assess volume status and renal function. Patients with type 2 diabetes mellitus and mild, moderate, or severe renal impairment (as determined by eGFR) had geometric mean systemic exposures of dapagliflozin that were 45%, 100%, and 200% higher, respectively, as compared to patients with type 2 diabetes mellitus with normal renal function

Initiation of Farxiga (dapagliflozin) in patients with diabetes mellitus and Chronic Kidney Disease (CKD) stage 3b:

• The FDA drug label recommends assessing volume status and renal function before initiating DAPAGLIFLOZIN TABLETS in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2) 2.
• Patients with CKD stage 3b have an eGFR between 30-44 mL/min/1.73 m2, which is considered moderate renal impairment.
• The label states that patients with moderate renal impairment had a geometric mean systemic exposure of dapagliflozin that was 100% higher compared to patients with normal renal function 3.
• It is recommended to assess volume status and renal function before initiating Farxiga (dapagliflozin) in patients with CKD stage 3b, and to monitor for signs and symptoms of hypotension and renal function after initiating therapy.

From the Research

Initiation of Farxiga (Dapagliflozin) in Patients with Diabetes Mellitus and CKD Stage 3b

• Dapagliflozin (Farxiga) has been approved to reduce the risk of declining kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease with or without type 2 diabetes 4.
• The efficacy and safety of dapagliflozin have been studied in patients with type 2 diabetes and Stages 3b-4 chronic kidney disease, showing that it decreases urinary albumin:creatinine ratio (UACR), blood pressure (BP), and body weight to a clinically meaningful extent 5.
• Real-world data on the efficacy and safety of dapagliflozin in CKD patients followed in nephrology settings have shown that it significantly reduces body weight, eGFR, and blood pressure, and declines albuminuria by 25.1% 6.
• A randomized controlled trial has demonstrated that dapagliflozin reduces 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 chronic kidney disease, with or without type 2 diabetes 7.

Key Findings

• Dapagliflozin can be initiated in patients with diabetes mellitus and CKD stage 3b, as it has been shown to be effective in reducing kidney and cardiovascular risk in this population 5, 7.
• The drug has a good safety profile, with the most frequent adverse events being acute kidney injury and urinary tract infection 6.
• Dapagliflozin has been approved for the management of CKD in patients with or without type 2 diabetes, and its use is recommended in clinical practice guidelines 4, 8.