Dapagliflozin prolonged survival and significantly reduced the risk of kidney failure, heart failure hospitalization and cardiovascular death in chronic kidney disease patients with or without type 2 diabetes, according to findings from the DAPA-CKD trial presented at ESC Congress 2020.

Researchers randomized 4,304 patients from 386 centers in 21 countries to receive either dapagliflozin (10 mg/once daily) or placebo in addition to standard of care. All patients had an estimated glomerular filtration rate (eGFR) of ≥25 and ≤75 mL/min/1.73m2; urinary albumin to creatinine ratio between ≥200 mg/g and ≤5000 mg/g; and were on a stable, maximum tolerated dose of an ACE inhibitor or ARB (unless contraindicated) for at least four weeks. The mean age of participants was 61.8 years and 66.9% were male. A total of 2,906 patients (67.5%) had type 2 diabetes.

The primary composite endpoint was worsening kidney function or onset of end-stage kidney disease, or death due to kidney disease or cardiovascular disease. Secondary endpoints included worsening kidney function or death from kidney failure, heart failure hospitalization or cardiovascular death, and all-cause mortality. Median follow-up was 2.4 years.

Overall results showed 197 primary endpoint events occurred in the dapagliflozin group compared with 312 in the placebo group. The benefit of dapagliflozin on the primary endpoint was consistent in patients with and without type 2 diabetes. Dapagliflozin also reduced all three secondary endpoints compared to placebo. The proportion of patients who discontinued the study drug due to an adverse event or experienced a serious adverse event was similar across both groups. Researchers noted that diabetic ketoacidosis was not reported in any patient randomized to dapagliflozin and occurred in two patients in the placebo group. Neither diabetic ketoacidosis nor severe hypoglycemia were observed in patients without type 2 diabetes.

"DAPA-CKD showed that dapagliflozin reduced the risk of worsening kidney function or death from cardiovascular or kidney disease in patients with chronic kidney disease with and without type 2 diabetes," said Hiddo J.L. Heerspink, PhD, of University Medical Centre Groningen, the Netherlands. "The results highlight the medicine's potential to benefit patients with chronic kidney disease who are in need of improved treatment options."

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Lipid Metabolism, Acute Heart Failure

Keywords: ESC Congress, ESC20, Kidney Failure, Chronic, Diabetes Mellitus, Glomerular Filtration Rate, Heart Failure, Kidney Diseases, Primary Prevention, Sodium-Glucose Transporter 2, Renal Insufficiency, Chronic, Metabolic Syndrome

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