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Dapagliflozin approved in the EU for treatment of CKD in people with and without type 2 diabetes

The sodium–glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin has been approved in the EU for the treatment of chronic kidney disease (CKD) both in people with type 2 diabetes and those without the condition.

The approval is based on positive results from the phase 3 DAPA-CKD trial, in which dapagliflozin significantly reduced the primary composite renal and cardiovascular outcome by 39% compared with placebo, and the secondary renal endpoint (sustained ≥50% decline in eGFR, end-stage renal disease or renal death) by 44%.

Commenting on the approval, Professor Hiddo Heerspink (University Medical Center Groningen, the Netherlands), the co-chair of the DAPA-CKD trial, said: “Today’s approval establishes dapagliflozin as the first SGLT2 inhibitor approved for the treatment of CKD regardless of diabetes status in the EU. Based on the unprecedented results from the DAPA-CKD Phase III trial, dapagliflozin delays disease progression, providing physicians a critical opportunity to improve the prognosis of patients with CKD.”

Dapagliflozin does not require dose adjustment based on kidney function; however, it should not be started in people with an eGFR <15 mL/min/m2. When used in people with type 2 diabetes, its glycaemic-lowering effects are reduced when eGFR is <45 mL/min/1.73 m2, and is likely absent in people with severe renal impairment. Therefore, if eGFR falls below 45 mL/min/1.73 m2, additional glucose-lowering treatment should be considered.

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