What is the current National Institute for Health and Care Excellence (NICE) guidance regarding Dapagliflozin (Forxiga) in Chronic Kidney Disease (CKD)?

From the Guidelines

NICE recommends dapagliflozin as an option for treating chronic kidney disease (CKD) in adults with specific criteria, as evidenced by the most recent study in 2025 1.

Key Criteria for Dapagliflozin Use in CKD

• The patient should have an estimated glomerular filtration rate (eGFR) of 25 to 75 ml/min/1.73m².
• The patient should have a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more.
• The patient should already be receiving standard care with the maximum tolerated dose of an ACE inhibitor or ARB.

Dosing and Administration

• The recommended dose of dapagliflozin is 10mg once daily, taken orally.
• Treatment should be initiated by specialists experienced in kidney disease management, though ongoing prescribing can be managed in primary care.

Mechanism of Action and Benefits

• Dapagliflozin works by inhibiting sodium-glucose co-transporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and promoting glucose excretion in urine.
• In CKD, it provides renoprotective effects by reducing intraglomerular pressure, decreasing albuminuria, and improving other pathophysiological mechanisms, as supported by studies such as DAPA-CKD 1.

Monitoring and Side Effects

• Common side effects include genital infections and urinary tract infections.
• Patients should be monitored for acute kidney injury, particularly during illness that may cause dehydration, as advised in guidelines 1.
• Blood glucose monitoring is important for patients with diabetes, as dose adjustments of other glucose-lowering medications may be needed, considering the findings from recent studies like EMPA-KIDNEY 1.

Recent Evidence and Guidelines

• Recent studies, including the DAPA-CKD trial 1 and EMPA-KIDNEY trial, have provided clear evidence of the efficacy and safety of dapagliflozin in patients with CKD.
• Guidelines from reputable organizations, such as the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO), support the use of SGLT2 inhibitors like dapagliflozin in patients with CKD, as outlined in the 2022 consensus report 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 FDA drug label does not answer the question about the current National Institute for Health and Care Excellence (NICE) guidance regarding Dapagliflozin (Forxiga) in Chronic Kidney Disease (CKD).

From the Research

Current NICE Guidance on Dapagliflozin (Forxiga) in Chronic Kidney Disease (CKD)

• The current National Institute for Health and Care Excellence (NICE) guidance regarding Dapagliflozin (Forxiga) in Chronic Kidney Disease (CKD) is based on several studies, including the DAPA-CKD trial 2, 3, 4, 5, 6.
• Dapagliflozin has been shown to reduce the risk of kidney failure and cardiovascular events in patients with CKD, with or without type 2 diabetes 3, 5.
• The DAPA-CKD trial demonstrated that dapagliflozin reduced the risk of a composite of sustained decline in estimated glomerular filtration rate (eGFR) of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes by 39% compared to placebo 5.
• The effects of dapagliflozin were consistent across different CKD risk categories, including moderately high risk, high risk, and very high risk patients 4.
• In patients with stage 4 CKD, dapagliflozin reduced the risk of a composite of time to ≥50% sustained decline in eGFR, end-stage kidney disease, or kidney or cardiovascular death by 27% compared to placebo 6.

Key Findings

• Dapagliflozin reduces the risk of kidney failure and cardiovascular events in patients with CKD, with or without type 2 diabetes 3, 5.
• The effects of dapagliflozin are consistent across different CKD risk categories 4.
• Dapagliflozin is efficacious and safe in patients with stage 4 CKD 6.
• The eGFR slope declined by 2.15 and 3.38 ml/min per 1.73 m2 per year in the dapagliflozin and placebo groups, respectively (P=0.005) 6.

Safety and Efficacy

• The known safety profile of dapagliflozin was confirmed in the DAPA-CKD trial 5.
• Patients treated with dapagliflozin or placebo had similar rates of serious adverse events and adverse events of interest 6.
• Dapagliflozin reduced the risk of death from cardiovascular causes or hospitalization for heart failure by 29% compared to placebo 5.