Study objective

Chronic kidney disease patients have an increased risk of adverse kidney and cardiovascular outcomes. The Effect of Dapagliflozin in CKD patients with or without type 2 diabetes is not known. The trial assessed the role of Dapagliflozin in CKD patients.

Methods

Four thousand three hundred fourpatients with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m² of the bodysurface area and 200-5000 urinary albumin-to-creatinine ratio were randomly assigned to receive dapagliflozin-10 mg once a day or placebo.

The primary outcome was a combination of a persistent reduction in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular reasons.

Results

The study trial was recommended to be stopped by an independent trial committee owing to its efficacy. Over a median of 2.4 years, the primary outcome event occurred in 197 of 2152 partakers (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.). Dapagliflozins effects were similar in participants with type 2 diabetes and those without type 2 diabetes. This confirmed the known safety profile of Dapagliflozin.

Conclusions

Dapagliflozin was shown to lead to a significant fall in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular reasons compared with placebo in chronic kidney disease patients, regardless of the presence or absence of diabetes.

Reference

Heerspink HJL, Stefansson BV, Correa-Rotter R, Greene T, Hou F-F, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020; 383: 1436-1446. DOI: 10.1056/NEJMoa2024816