Dapagliflozin reduces Renal Risk in CKD, irrespective of Diabetes Status: NEJM
The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin reduces the risk for kidney disease progression and death in patients with chronic kidney disease (CKD) — whether or not they have type 2 diabetes — according to a multinational, industry-sponsored study. The findings of this DAPA-CKD Clinical Trials were presented at the annual meeting of the European Association for the Study of Diabetes and published in the New England Journal of Medicine.
"Among patients with chronic kidney disease, regardless of the presence or absence of diabetes, 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 was significantly lower with dapagliflozin than with placebo." wrote the research team.
Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes.
Dapagliflozin and other SGLT2 inhibitors were initially developed as medications for type 2 diabetes, but their beneficial effects on renal and cardiovascular outcomes—even in patients without diabetes—have become clear.
To investigate this further, Researchers randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m2 of the body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo.
The primary outcome was 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.
On analysis, the following results were noted.
- The independent data monitoring committee recommended stopping the trial because of efficacy.
- Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P<0.001; number needed to treat to prevent one primary outcome event, 19 [95% CI, 15 to 27]).
- The hazard ratio for the composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and the hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P=0.009).
- Death occurred in 101 participants (4.7%) in the dapagliflozin group and 146 participants (6.8%) in the placebo group (hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P=0.004).
- The effects of dapagliflozin were similar in participants with type 2 diabetes and those without type 2 diabetes.
- The known safety profile of dapagliflozin was confirmed.
For the full article click on the link:DOI: 10.1056/NEJMoa2024816
Primary source: The New England Journal Of Medicine